Assignmet-C

Vision 2030 of Kingdom of Saudi Arabia

will discussed some of value based health competetion and some other issue.

let’s delve into major aspects of the healthcare transformation as part of Vision2030. Based on our reading, please respond to the below questions:

1-In your words, what is the value-based healthcare? In your response, differentiate it from other similar models of healthcare, such as pay-for service model and etc. (4 paragraphs).

2-Summarize the benefits of value-based healthcare? (3-4 paragraphs).

3-How can the New Model of Care contribute into having a value-based healthcare? (3-4 paragraphs).

4-In page 94 in the Health Sector Transformation Program Delivery Plan one of the initiatives is to group healthcare organizations (Accountable Care Organization). Discuss how can the grouping of healthcare organizations in clusters (e.g. E1 cluster, C1 cluster) can improve quality and efficiency of healthcare services. (4-5 paragraphs).

Discuss how DRG is linked to ACOs? (2 paragraphs).

Academic Medicine, Vol. 95, No. 5 / May 2020682

Invited Commentary

Value in health care is the measured
improvement in a patient’s health
outcomes for the cost of achieving that
improvement.1 The goal of value-based
care transformation is to enable the
health care system to create more value
for patients. Because value is created only
when a person’s health outcomes improve,
descriptions of value-based health care that
focus on cost reduction are incomplete.
Reducing costs is important but not
sufficient: If the real goal of value-based
health care were cost reduction, pain killers
and compassion would be sufficient.

Value-based health care is often
conflated with quality, a vague concept

that implies myriad virtues and in
health care often focuses on inputs
and process compliance. Quality
improvement efforts may not improve
patients’ health outcomes, however;
even given similar processes, different
teams’ results vary. In addition,
requirements to track and report
process compliance may distract
caregivers from the more significant
goal of improving health outcomes.
Diabetes care in Italy provides one
example of process compliance not
ensuring better outcomes: Analysis
of regional variations in process
compliance and in outcome indicators
showed better process compliance in the
north but better outcomes for patients
in the south.2

Certainly clinicians should practice with
the consistency demanded by scientific
methods and follow evidence-based care
guidelines. But results matter. The goal
of value-based health care is better health
outcomes.

Value and patient satisfaction are also
commonly confused. While the patient
satisfaction movement has brought a
much-needed emphasis on treating
people with dignity and respect, the
essential purpose of health care is
improving health. Value is about helping
patients. Satisfaction surveys ask
patients, “How were we?” Value-based
care providers ask, “How are you?”

Why Improving Value Matters

Improving a patient’s health outcomes
relative to the cost of care is an aspiration
embraced by stakeholders across the
health care system, including patients,
providers, health plans, employers, and
government organizations. Value-based
health care aligns these diverse parties’
goals so well that, shortly after the
concept was introduced in 2006, health
economist Uwe Reinhardt described it
as “a utopian vision.”3 While Reinhardt
expressed concern about the challenges
of moving to a value-based system,
he lauded the larger objectives of the
transformation.

By focusing on the outcomes that matter
most to patients, value aligns care with
how patients experience their health.
In this context, health outcomes can be
described in terms of capability, comfort,
and calm.4 Capability is the ability of
patients to do the things that define
them as individuals and enable them to
be themselves. It is often tracked with
functional measures. Comfort is relief
from physical and emotional suffering.
In addition to reducing pain, improving
patients’ comfort requires addressing
the distress and anxiety that frequently
accompany or exacerbate illness. Calm is
the ability to live normally while getting
care. It encompasses freedom from the
chaos that patients often experience in
the health care delivery system, and it

Abstract

Value in health care is the measured
improvement in a person’s health
outcomes for the cost of achieving
that improvement. While some
descriptions conflate value-based
health care and cost reduction, quality
improvement, or patient satisfaction,
those efforts—while important—are
not the same as value, which focuses
primarily on improving patient health
outcomes. A decade of research into
organizations that have achieved better
outcomes while often lowering costs
suggests a strategic framework for

value-based health care implementation
that starts with identifying and
understanding a segment of patients
whose health and related circumstances
create a consistent set of needs. An
interdisciplinary team of caregivers
then comes together to design and
deliver comprehensive solutions
to address those needs. The team
measures the health outcomes and
costs of its care for each patient and
uses that information to drive ongoing
improvements. Care provided in this
way aligns delivery with how patients

experience their health and reconnects
clinicians to their purpose as healers. It
also asks physicians to think differently
about their role within the larger care
team and about the services that team
provides. The authors suggest medical
schools should incorporate education
on the principles and implementation
of value-based health care throughout
the undergraduate medical curriculum
to prepare their graduates to lead
the transformation to value-based
health care as they enter the physician
workforce.

Defining and Implementing Value-Based
Health Care: A Strategic Framework
Elizabeth Teisberg, PhD, Scott Wallace, JD, MBA, and Sarah O’Hara, MPH

Acad Med. 2020;95:682–685.
First published online December 10, 2019
doi: 10.1097/ACM.0000000000003122

Please see the end of this article for information
about the authors.

Correspondence should be addressed to Scott
Wallace, Value Institute for Health and Care, Dell
Medical School, 1601 Trinity St., Bldg. B, Stop Z1600,
Austin, TX 78712; telephone: (512) 495-5202;
email: Scott.Wallace@Austin.UTexas.edu; Twitter:
@DellMedValue.

Copyright © 2019 The Author(s). Published by
Wolters Kluwer Health, Inc. on behalf of the
Association of American Medical Colleges. This is an
open-access article distributed under the terms of
the Creative Commons Attribution-Non Commercial-
No Derivatives License 4.0 (CCBY-NC-ND), where
it is permissible to download and share the work
provided it is properly cited. The work cannot be
changed in any way or used commercially without
permission from the journal.

mailto:Scott.Wallace@Austin.UTexas.edu

http://creativecommons.org/licenses/by-nc-nd/4.0/

Invited Commentary

Academic Medicine, Vol. 95, No. 5 / May 2020 683

is especially important for people with
chronic and long-term conditions. Care
that improves outcomes in all 3 of these
dimensions creates a better experience for
patients. Moreover, capability, comfort,
and calm describe outcomes that result
from the efficacy and empathy of health
care, rather than its hospitality.

Value-based health care connects
clinicians to their purpose as healers,
supports their professionalism, and
can be a powerful mechanism to
counter clinician burnout. Critics who
characterize value-based health care as
underpinning a model of “industrial
health care”5 distort the meaning of the
term value, misinterpreting it as focused
on cost. Instead, value-based health
care’s focus on better health outcomes
aligns clinicians with their patients. That
alignment is the essence of empathy.
Measured health outcomes demonstrate
clinicians’ ability to achieve results
with patients and families and drive
improvement in the results that matter
most to both patients and clinicians. This
intrinsic motivation is often missing in
the health care system, where clinicians
are directed to spend countless hours on
tasks that do not impact their patients’
health.

Better outcomes also reduce spending
and decrease the need for ongoing care.
By improving patients’ health outcomes,
value-based health care reduces the
compounding complexity and disease
progression that drive the need for more
care. A patient whose diabetes does not
progress to kidney failure, blindness, and
neuropathy is, over time, dramatically less
expensive to care for than a patient whose
condition continually worsens.6

Value-based health care is a path to
achieving the aspirational goals of the
Institute for Healthcare Improvement’s
“triple aim”—improving the patient
experience of care, improving the health
of populations, and reducing the per
capita cost of health care—as well as
improving clinician experience, a fourth
aim that others have proposed.7,8 Patient
and clinician experience improvements
are described above. Population health
only improves when the health outcomes
of many individuals improve, which is the
focus of value-based health care. Costs
also cumulate from the care provided
for individuals. By organizing teams to
care for individuals with similar needs, a

value-based approach enables expertise
and efficiency, rather than rationing, to
drive costs down. This puts decisions
about how to deliver care in the hands
of the clinical team, rather than those of
an insurance administrator, supporting
the professionalism of clinicians and the
power of clinician–patient relationships
to deliver effective and appropriate care.

A Framework for Implementing
Value-Based Health Care

Improving value in health care is
not an unreachable utopian ideal.
Around the globe, health care delivery
organizations—in varied payment
settings, with an array of regulatory
structures and many different care
traditions—have demonstrated
dramatically better health outcomes
for patients, usually at lower overall
costs.1,4,9,10 More than a decade’s research
into these organizations by 2 of the
authors (E.T. and S.W.) elucidates a
clear framework for value-based care
transformation.11

That framework, shown in Figure 1
and described below, can guide
organizations in building value-based
health care systems. This transformation
starts when the organization identifies
and understands a segment of
patients whose health and related
circumstances create a consistent set
of needs. A dedicated, co-located,
multidisciplinary team of caregivers
designs and delivers a comprehensive
solution to those needs. This integrated
team measures meaningful health
outcomes of its care for each patient
and the costs of its services and then
learns from that information to drive
ongoing improvements in care and
efficiency. Finally, as health outcomes

improve, evidence of better care creates
opportunities for the team to serve more
patients through expanded partnerships.

Understand shared health needs of
patients

Throughout the economy, service
providers organize their offerings around
a defined set of customers whose needs
are similar. Think, for example, of
transportation providers. Transportation
is an incredibly broad economic sector.
Services range from jets that deliver tons
of time-sensitive cargo to drones that
deliver individual bags of blood, and
from buses to rented electric scooters. In
each case, the transportation company
matches its services to the needs of its
customer segment.

Health care is the outlier. In the
health care system, most services are
organized around the service providers.
Endocrinologists practice in groups
with other endocrinologists, as do
cardiologists, ophthalmologists, and
podiatrists. A patient with diabetes, who
likely needs the coordinated—or, even
better, integrated—services of these
various clinicians, has to be the organizer.
Health care’s general failure to structure
around patient needs accounts for its
inconvenience and lack of integrated
services. Failing to structure for what is
common and routine also increases the
burden on caregivers, who too often must
improvise to solve routine problems. This
structural mismatch is a root cause of
why health care is so expensive and does
not deliver better results for patients.1

To be effective and efficient, health care
should be organized around segments
of patients with a shared set of health
needs, such as “people with knee pain”
or “elderly people with multiple chronic

Figure 1 Strategic framework for value-based health care implementation to achieve better
patient outcomes.

Invited Commentary

Academic Medicine, Vol. 95, No. 5 / May 2020684

conditions.” Organizing care in this
way allows clinical teams to anticipate
consistent patient needs and provide
frequently needed services efficiently,
doing common things well. The efficiency
afforded by structuring care around
patient segments frees clinicians from
scrambling to coordinate services that are
needed routinely. The added bandwidth
allows them to personalize services
for individual patients who may have
somewhat different needs.

Design a comprehensive solution to
improve health outcomes

Starting by identifying the common
needs of a patient segment enables teams
to design and deliver care that provides
a comprehensive solution for patients
or families. When the goal of care shifts
from treating to solving patients’ needs,
care teams can both address the clinical
needs of patients and begin to address
the nonclinical needs that, when left
unmet, undermine patients’ health.
For example, a clinic for patients with
migraine headaches might provide not
only drug therapy but also psychological
counseling, physical therapy, and
relaxation training. Similarly, a clinic
for patients with cancer might include
transportation assistance as a service for
those who have difficulty getting to their
regular chemotherapy appointments.
Broadening and integrating the services
provided to patients achieves better
outcomes by identifying and addressing
gaps or obstacles that undermine
patients’ health results.4

Integrate learning teams

Implementing multifaceted solutions
requires a dedicated team drawn from
an array of disciplines, many of which
are not typically viewed as medical.
An effective team integrates services,
reducing or even eliminating the need for
coordinators. Team members are often
co-located, enabling frequent informal
communication that supplements the
formal channels of communication to
ensure effective and efficient care. What
is critical is thinking together to improve
and personalize care and learning
together so health outcomes improve
with experience. The team structure can
also expand across locations, extending
state-of-the-art knowledge to remote
clinicians and enabling world-class
care to be delivered locally rather than
requiring patients to travel.

Measure health outcomes and costs

It is a truism of business that
management requires measurement.
Recognizing that the essential purpose
of health care is improving the health of
patients, it is axiomatic that health care
teams must measure the health results
as well as the costs of delivering care
for each patient. Leaders cannot align
health care organizations with their
purpose without measurement of health
outcomes. In addition, the current dearth
of accurate health outcomes and cost data
impedes innovation.

Measurement of results allows teams to
know they are succeeding. Measuring
health outcomes also provides the data
needed to improve care and efficiency.
Although caregivers are burdened with
reporting reams of information, they
rarely consistently track the health
outcomes that matter most to patients
and thus to themselves as clinicians. Cost
and health outcomes data also enable
condition-based bundled payment
models, empowering teams of caregivers
to reclaim professional autonomy and
practice clinical judgment—two integral
elements of professional satisfaction and
powerful antidotes to the affliction of
burnout.1,12–14

Measuring health outcomes is not as
complex as it is often perceived to be.
Routine clinical practice does not dictate,
nor can it support, the voluminous health
outcome measure sets used in clinical
research. Instead, clinicians need to focus
on measuring the outcomes that define
health for their patients. Those outcomes
cluster by patient segment—the
outcomes that matter most to patients
with congestive heart failure are strikingly
consistent while also markedly different
from the outcomes that matter most to
women who are pregnant. Within any
given patient segment, though, patients
define health in terms of capability,
comfort, and calm, as described above,
and these dimensions can be usually
captured in 3 to 5 measures. For
example, men undergoing prostate
cancer surgery are most concerned about
the common impairments from that
procedure—incontinence, impotence,
and depression—as well as time away
from work for recovery.

In addition to health outcomes, teams
must measure the costs of their services

for every patient. Cost-grouping
methodologies like the one developed at
the University of Utah15 or applications
of time-driven activity-based costing16
can provide the data teams need both
to demonstrate the value of their care
and to identify areas for improving their
efficiency.

Expand partnerships

Organizing around patients with shared
needs and demonstrating better value
in care create opportunities to expand
partnerships and improve health
outcomes for more people. For example,
with evidence of care that has fewer
complications and allows employees to
return to work more quickly, employers
are increasingly willing to contract
directly with providers and even to
pay more per episode of care than
they had previously, because faster and
fuller recovery reduces other employer
costs such as those associated with
absenteeism.17 Partnerships among
clinical organizations may also expand
as teams gain expertise and the ability
to work across more stages of the care
cycle or more locations. Integrated teams
may work with partners for an array of
reasons, such as using new technology
to share information with patients,
supporting rural clinicians as they
provide patients with care close to home,
or offering services to support lifestyle
changes in a community. These are
natural partnerships because the shared
goals of creating high value and achieving
better health outcomes for patients align
the interests of patients, family members,
employers, health plans, and clinicians,
as well as medical technology suppliers
whose services may facilitate these
relationships.

Value-Based Health Care in
Medical Education

Moving to a system of value-based
health care requires that physicians and
physicians-in-training learn to think
differently about their role within the
larger care team, about what constitutes
an effective care solution, and about
the importance of measuring the health
outcomes that matter most to patients.
That learning should begin during
medical school.

The University of Texas at Austin’s Dell
Medical School (DMS) offers an example

Invited Commentary

Academic Medicine, Vol. 95, No. 5 / May 2020 685

of how education about value-based
health care can be incorporated into
undergraduate medical education.
Throughout the 4 years of medical
school, DMS students study the
principles of value-based care delivery
described above. During their clinical
rotations, they also see these principles in
practice in UT Health Austin’s affiliated
clinics, which are organized around
segments of patients with shared needs
and designed to provide comprehensive
solutions delivered by interdisciplinary,
outcomes-focused teams.

In the joint pain clinic, for instance,
DMS students observe interdisciplinary
care teams providing comprehensive
care to alleviate pain and improve
functioning. Treatment may entail joint
replacement surgery, but surgery is used
less frequently than in other orthopedic
care settings. Those who are not seen
as good candidates for surgery might
instead receive physical therapy, care
for depression or other mental health
conditions, and/or weight loss support.
The clinic tracks health outcomes for all
patients and has found that while the
rate of patients receiving lower extremity
surgery is 30% lower than that of patients
in conventional care settings, more
than 60% of patients report significant
reductions in pain and improvements
in function 6 months after the initial
appointment.18

DMS’ curriculum also allows third-
year medical students (and other
interested health professionals) to
complete a master’s degree in health care
transformation, focused on the principles
and implementation of value-based
health care. We encourage other medical
schools to incorporate similar training

throughout their curricula to prepare
their graduates to lead the transformation
to value-based health care as they enter
the physician workforce.

Funding/Support: None reported.

Other disclosures: None reported.

Ethical approval: Reported as not applicable.

E. Teisberg is executive director, Value Institute for
Health and Care, Cullen Trust for Higher Education
Distinguished University Chair in Value-Based Care,
Dell Medical School, and professor, McCombs School
of Business, University of Texas at Austin, Austin, Texas.

S. Wallace is managing director, Value Institute
for Health and Care, and associate professor,
Department of Education, Dell Medical School,
University of Texas at Austin, Austin, Texas.

S. O’Hara is a course and content specialist, Value
Institute for Health and Care, Dell Medical School,
University of Texas at Austin, Austin, Texas.

References
1 Porter ME, Teisberg EO. Redefining Health

Care: Creating Value-Based Competition
on Results. Boston, MA: Harvard Business
School Press; 2006.

2 Cimino A, Giorda C, Meloncelli I, et al.
Indicators of Quality of Diabetes Care in
Italy: The AMD Annals. Rome, Italy: AMD
Associazione Medici Diabetologi; 2006.

3 Reinhardt UE. Health Reform: Porter and
Teisberg’s utopian vision. Health Affairs.
https://www.healthaffairs.org/do/10.1377/
hblog20061010.000063/full. Published October
10, 2006. Accessed November 12, 2019.

4 Wallace S, Teisberg EO. Measuring
what matters: Connecting excellence,
professionalism, and empathy. Brain Inj Prof.
2016;12:12–15.

5 Montori VM. Turning away from industrial
health care toward careful and kind care.
Acad Med. 2019;94:768–770.

6 Deerberg-Wittram J, Ludtke L. Diabeter:
Value-Based Healthcare Delivery in Diabetes.
Boston, MA: Boston Consulting Group; 2016.

7 Berwick DM, Nolan TW, Whittington J. The
triple aim: Care, health, and cost. Health Aff
(Millwood). 2008;27:759–769.

8 Bodenheimer T, Sinsky C. From triple
to quadruple aim: Care of the patient
requires care of the provider. Ann Fam Med.
2014;12:573–576.

9 Morales DL, Carberry KE, Heinle JS,
McKenzie ED, Fraser CD Jr, Diaz LK.
Extubation in the operating room after
Fontan’s procedure: Effect on practice and
outcomes. Ann Thorac Surg. 2008;86:576–581.

10 Stowell C, Akerman C. Better value in health
care requires focusing on outcomes. Harvard
Business Review. https://hbr.org/2015/09/
better-value-in-health-care-requires-
focusing-on-outcomes. Published September
17, 2015. Accessed November 21, 2019.

11 Teisberg EO, Wallace S. Creating a high-value
delivery system for health care. Semin Thorac
Cardiovasc Surg. 2009;21:35–42.

12 Andrawis JP, McClellan M, Bozic KJ. Bundled
payments are moving upstream. NEJM
Catalyst. https://catalyst.nejm.org/bundled-
payments-upstream-musculoskeletal-
institute. Published February 26, 2019.
Accessed November 20, 2019.

13 Kaplan RS, Porter ME. The big idea: How to
solve the cost crisis in health care. Harvard
Business Review. https://hbr.org/2011/09/
how-to-solve-the-cost-crisis-in-health-
care. Published September 2011. Accessed
November 21, 2019.

14 Porter ME, Barron JF, Chacko JM, Tang
R. The UCLA Medical Center: Kidney
Transplantation. Boston, MA: Harvard
Business School Publishing; 2012.

15 Kawamoto K, Martin CJ, Williams K, et
al. Value Driven Outcomes (VDO): A
pragmatic, modular, and extensible software
framework for understanding and improving
health care costs and outcomes. J Am Med
Inform Assoc. 2015;22:223–235.

16 Kaplan RS, Anderson SR. Time-driven
activity-based costing. Harvard Business
Review. https://hbr.org/2004/11/time-driven-
activity-based-costing. Published November
2004. Accessed November 20, 2019.

17 Woods L, Slotkin JR, Coleman MR. How
employers are fixing health care. Harvard
Business Review. https://hbr.org/cover-
story/2019/03/how-employers-are-fixing-
health-care. Published March 2019. Accessed
November 12, 2019.

18 Koenig K, medical director, Musculoskeletal
Institute, UT Health Austin. Personal
communication with S. Wallace and S.
O’Hara, June 20, 2019.

https://www.healthaffairs.org/do/10.1377/hblog20061010.000063/full

https://hbr.org/2015/09/better-value-in-health-care-requires-focusing-on-outcomes

https://catalyst.nejm.org/bundled-payments-upstream-musculoskeletal-institute

https://hbr.org/2011/09/how-to-solve-the-cost-crisis-in-health-care

https://hbr.org/2004/11/time-driven-activity-based-costing

https://hbr.org/cover-story/2019/03/how-employers-are-fixing-health-care

Center for Improving Value in Health
Saudi Arabia

Global Innovation Hub for
Improving Value in Health

TRANSFORMATION TOWARDS
SUSTAINABLE HEALTH
SYSTEMS THROUGH VALUE
BASED HEALTH CARE

www.g20.org

|Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

This report collects key messages and insights f rom the G20 side event on Value
Based Health Care (VBHC) held in Riyadh between the 13th and 14th of January,
2020. The event, Accelerating Transformation Towards Sustainable Health Systems
Through Value Based Health Care (‘the event’) was attended by G20 member
and guest nations, representatives of relevant International Organizations (IOs),
international experts, and 200 delegates f rom more than 25 countries.

The Report is intended as a resource for policymakers and leaders of healthcare
institutions and provides practical learnings on the introduction of VBHC in health
systems.

The event was hosted by the Center for Improving Value in Health (‘the Center’)
and had contributions f rom 25 speakers f rom 21 countries for keynotes and panels.
It provided a platform for presentations and panel discussions for international
experts and more than 50 policymakers and senior professionals f rom the Saudi
Health System and civil society.

The event offered an opportunity to share experience and learning f rom both
public and private sectors and was embraced by the participants with high levels of
engagement, a sense of openness and a willingness to collaborate to improve the
lives of citizens.

Figure 1: The G20 Side Event on VBHC
was attended by international and local
stakeholders

“This event focuses
on sharing practical
knowledge on VBHC”

Dr. Reem Al Bunyan,
CEO, Center for Improving
Value in Health,
Saudi Arabia

3www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Editors:

Prof. Rifat Atun, Harvard University

Dr. Reem Al Bunyan, The Center for
Improving Value in Health, Saudi Arabia

Dr. Sara Al Munif, The Center for
Improving Value in Health, Saudi Arabia

Ms. Israa Bargo, The Center for
Improving Value in Health, Saudi Arabia

Mr. Craig Barratt, The Center for
Improving Value in Health, Saudi Arabia

Dr. John McGhee, The Center for
Improving Value in Health, Saudi Arabia

Contributors:
In alphabetical order

Ms. Herta Adam, European Commission
Mr. Lav Agarwal, India
Dr. Ahmed AlJedai, Saudi Arabia
Mr. Lars Dahl Allerup, Denmark
Dr. Riyadh AlShamsan, Saudi Arabia
Dr. Omar AlShanqeety, Saudi Arabia
Dr. Pilar Aparicio, Spain
Mr. Sinan Atlig, Pfizer
Mr. Ramon Maspons Bosch, Spain
Mrs. Francesca Colombo, OECD
Mrs. Joanne Fitzgerald, Australia
Prof. Lyalya Gabbasova, Russia
Mr. Said Haddad, Johnson & Johnson
Dr. Derrick Heng, Singapore
Dr. David Herr, Germany
Mr. Christian Howell, Medtronic
Dr. Chintan Maru, Leapf rog to Value
Dr. Giuseppe Ruocco, Italy
Mr. Mohammed Saleh, Microsoft

Mr. Lucas Scherdel, WEF

Dr. Peter Schmeissner, United States
Dr. Agnès Soucat, WHO
Mr. Erik Jan Wilhelm, Zilveren Kruis
Ms. Rose Willis, United Kingdom

4www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

SUMMARY OF KEY FINDINGS

I. Value Based Health Care (VBHC) can be realized in diverse settings

A. VBHC approaches introduce innovative solutions to transform health
systems to achieve greater value and sustainability
B. VBHC involves development of new data tools and analytic capabilities
C. Non-financial incentives and factors impact on the success of VBHC
D. A key enabler for the successful delivery of VBHC is the ability to identify and
measure outcomes that matter most to patients and individuals

II. Collaborations and knowledge transfer between organizations and countries is
critical for scale-up of VBHC solutions

E. VBHC can be applied and have a positive impact at different scales
F. Reciprocity among stakeholders is key to successful collaborations
G. Large scale VBHC projects only succeed when roadblocks are removed to
implementation
H. Practical learning is transferable within and across countries
I. One can leverage learning f rom other sectors in introducing and scaling up
and new solutions

5www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

INTRODUCTION

Current trends in global health care systems

Globally, health systems face immense challenges due to growing demand for
healthcare services, rising costs and increasingly higher complexity of illnesses
and the solutions to address them. Despite higher expenditures in health systems,
health outcomes have not improved proportionately. From 2014 to 2040, the world’s
spend on health care will increase almost three-fold to reach approximately USD 25
trillion per year. This increase in spending is primarily driven by population ageing,
increase in chronic diseases, inefficiency and ineffectiveness of the current health
system models and rising costs f rom f new technologies. In most Organisation for
Economic Co-operation and Development (OECD) countries, health care spending
is increasing faster than economic growth and driven by ageing and excess cost
growth due to chronic illness and health system inefficiency.

The combined challenges of rising demand and growing healthcare expenditures
that exceed the rate of economic growth pose a real and substantial risk to
sustainability of health systems and their ability to provide better access to safe,
high quality health care to all citizens of the G20 member countries and beyond.
The conference participants recognized the critical importance of VBHC as an
instrumental part of achieving sustainable Universal Health Coverage (UHC) – a
target for the United Nations Sustainable Development Goal (SDG) 3 ‘Ensure healthy
lives and promote well-being for all at all ages’.

Accelerating the introduction and scale-up of VBHC to address pressing threats to
health systems

“Health systems are
organized to manage
acute events with single/
short interventions and
need moving towards
medium long term
health caring”

Dr. Giuseppe Ruocco,
Ministry of Health, Italy

Health systems need to transition to
VBHC models that achieve a better
balance of outcomes and resources used,
if the current threats are to be effectively
managed.

Traditional health care models use
payment models, such as ‘fee for service’
and ‘activity-based payment’, primarily
focus on paying for inputs and the volume
of services provided. These payment
models reward ever-increasing volumes
of activities and services, but without the
commensurate improvement in health
outcomes and outcomes that matter
to patients. By contrast, VBHC offers a
model that puts increasing value for

6www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

patients first. This includes increased accessibility and affordability of health care for
patients. From the pharmaceutical industry perspective, Mr. Sinan Atlig f rom Pfizer,
the Regional President Biopharma MEA, agreed that health care costs and overall
spending on medicines need to be kept in check to create a more sustainable health
system.

Furthermore, many panelists emphasized the importance of defining health care
broadly to include maintenance or improvement of health through promotion of
good health, and through prevention, diagnosis and treatment of illness, injury,
disease, and other physical or mental impairments.

The CEO of the Center for Improving Value in Health, Dr. Reem AlBunyan highlighted
in her opening remarks, that value in health care means better health and better
care at lower cost, with a focus on the person. Ms. Herta Adams, the Deputy Head
of Health Determinants and International Relations at the European Commission
proposed a similarly broad definition of value in the context of VBHC, based on four
pillars:

Personal value, accomplishing the personal goals of patients
Technical value, achieving highest outcome quality with limited resources
Population value, equitably delivering care and allocating resources to
patient populations
Societal value, fostering societal participation by delivering health care

The report consists of two sections that explore: (1) how VBHC can be realized through
common key enablers in diverse settings and (2) how collaborations and knowledge
transfer between organizations and countries help spread and establish successful
VBHC models.

“VBHC means placing
patients – both their
experience and
outcomes – at the heart
of decision-making”

Ms. Herta Adam,
European Commission

7www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

SUMMARY OF KEY FINDINGS

1. VBHC can be realized through common enablers in diverse settings

The first section of this report explores learnings f rom various sessions revolving
around the necessary building blocks and levers to set up VBHC models. Case
studies illustrate key learnings and best practices on VBHC approaches.

A. VBHC approaches introduce innovative solutions to transform health
systems to achieve greater value and sustainability

According to Prof. Rifat Atun, Professor of Global Health Systems at Harvard University,
current health systems are under pressure because of a coalescence of several
fundamental contextual drivers that pose threats, including rapid population ageing,
rising burden of chronic illnesses, higher patient expectations, fiscal constraints on
governments due to economic downturns. This is against a backdrop of an ever-
increasing innovation in new health technologies, diagnostics and medicines which
are not optimally harnessed to improve system performance.

Worldwide, health systems are struggling to achieve desired levels of effectiveness,
efficiency, equity and responsiveness that meet user expectations. This is because
health systems are failing to innovate because of:

(i) Innovation misalignment: There is robust ‘delivery of innovations’, such as
new diagnostics, health technologies and medicines, but there is
a failure in the ‘innovation in delivery’, with few fundamental
improvements in healthcare service delivery models which remain archaic.
(ii) Policy misalignment: Innovation is encouraged for by industrial policies but
their adoption and scale-up is constrained by health policies

8www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

In his presentation, Prof. Atun explained
how health systems have historically
transitioned f rom one model to another
over time: f rom a model with structural
focus, where payments followed
inf rastructures (e.g. hospitals), to a more
functional focus, in which payments
follow activities. However, we are currently
observing a new fundamental shift
towards value, and the many practical
examples shared during the event are
the best examples of this trend. In this
model, payments follow value, with
better health outcomes for individuals
or populations, as exemplified by VBHC
approaches.

“There is no shortage
of innovation, but they
are in pockets. We need
to scale innovation to
create impact”

Ms. Herta Adam,
European Commission

“Everything is new, and
we do not have off-the-
shelf solutions. There
is no such thing as
failure, it is a learning
experience”

Prof. Rifat Atun,
Harvard University

According to Prof. Atun, VBHC is underpinned by four major principles: transparency,
optimization of cost and outcomes, shared accountability, and shared risk and reward.
In practice VBHC models include several core critical components. The first of these
is ‘digital data systems’ and analytic capability that enable pooling and application
of data to measure costs, processes and outcomes. The second is ‘stratification’ or
‘categorization’ of population groups according to their characteristics to ensure
better understanding of needs and the development of targeted solutions. The third
is ‘risk-adjusted bundled care’, which brings together a targeted set of interventions
across the care continuum for populations with different levels of risk of illness.

The fourth component is the ‘integrated care’ across the care continuum, enabled by
‘integrated care pathways’ and integrated provider networks that ensure seamless
care. An integrated care pathway ideally contains the entire patient journey for a
specific disease, f rom prevention, detection, treatment, monitoring to rehabilitation
(Figure 2). The fifth component is
‘outcome based payment models’
that incentivize achievement of better
outcomes and lowering of costs. The sixth
and often overlooked crucial component
is ‘behavior change’ in policymakers,
payers, healthcare providers and health
service users that creates a conducive
environment to challenge the status quo
and encourage the development and
scale-up of VBHC solutions to address the
current weaknesses in health systems.

9www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Figure 2: Integrated Care Pathways

Legacy Focus

VBHC Focus

Digital systems are a critical ingredient that connects these components to enable
the development of person centered integrated care delivery models aimed at
achieving better patient reported outcomes and creation of greater value, as
illustrated by case study [1]: DigiPROM at Charite Berlin.

Case study [1]: DigiPROM at Charite Berlin

Situation: The Federal Ministry of Health, Germany wanted to study the feasibility
of patient-reported outcome measures (PROMs) in German hospitals.
Ambition: Testing digitalized PROMs for back pain-related interventions and
exploring DigiPROM as a concept for standardization across Germany. Additionally,
this pilot tests the technical feasibility to combine clinical data with PROMs.
Outcome: Patients benefited f rom improved treatment due to quality transparency
and improvement.

Case study [2]: Ayushman Bharat

Situation: The Indian government strives towards UHC for its population to address
urging issues such as the increasing burden of non-communicable diseases and
rising healthcare costs.

Ambition: In 2017, the Ayushman Bharat program was launched. This program
rests on two main pillars, AB-HWCs and PMJAY. AB-HWCs, Ayushman Bharat
Health and Wellness Centers, provide primary care to all citizens for an initially
limited selection of health services. PMJAY, Pradhan Mantri Jan Arogya Yojana,
aims to prevent excessive health expenditures for the 40% poorest for secondary
and tertiary health care services.

Outcome: To date, 27,923 AB-HWCs have been transformed across the country and
provided treatment to 11.3m. people for hypertension, 5.7m. for diabetes and 9.2m.
women screened for breast cancer. To date, approx. 20,000 hospitals participate in
PMJAY and 7.5m. patients were treated under this cover worth USD 1.8 bn.

10www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

With a focus on outcomes, VBHC considers the whole
patient journey, including disease prevention and
monitoring of health. This contrasts with legacy systems
that mainly focus on diagnosis and treatments, driven
by their focus on reimbursement by activity (e.g. fee-for-
service, and activity-based payment models)

Focusing the care pathways only on the direct delivery of clinical care would be too
narrow an approach in achieving value. Around 80% of the factors that determine
health outcomes lie not within healthcare services but include social-determinants
of health, as Mr. Lav Agarwal, the Joint Secretary, Indian Ministry of Health & Family
Welfare, points out. These factors include nutrition, sanitation and water access, air
pollution, physical activity, and among others consumption of alcohol and tobacco.
That is why the Indian government has acted and initiated programs aimed at
educating its population and promoting healthier lifestyles. Such programs include
“Fit India Movement” and “Eat Right India.” Those programs are part of a larger
national initiative, Ayushman Bharat: “Bless India with long healthy life” in Hindi,
which aims to provide UHC in primary care, based on VBHC principles (case study
[2]: Ayushman Bharat).

The delegation f rom Australia shared a case study f rom their recent reforms on
activity-based funding (ABF) that aimed to achieve the following:

Improving access to services for patients
Increasing the efficiency of public hospitals
Improving the transparency and sustainability of public hospital funding
The development and implementation of funding and pricing approaches
for safety and quality.

As part of these reforms, the Independent Hospital Pricing Authority (IHPA) was
established to determine the National Efficient Price, and set up the underlying
inf rastructure to support ABF, such as classifications, data specifications, costing
and pricing. (Case study [3]: Pricing Framework for Australian Public Hospitals)
IHPA’s decisions on these matters were detailed in the Pricing Framework for
Australian Public Hospital Services 2017-18:

1. No funding for a public hospital episode including a sentinel event, applying
to all relevant episodes of care in all hospitals
2. Reduced funding level for all Hospital Acquired Complications, to reflect the
additional cost of a hospital admission with a hospital acquired complication
3. Undertake further public consultation to inform a future pricing and funding
approach in relation to avoidable hospital readmissions, based on a set of
definitions to be developed by the Australian Commission on Safety and
Quality in Health Care.

11www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Case study [3]: Pricing Framework for Australian Public Hospitals

Ambition: to improve Australians’ health outcomes and decrease avoidable
demand for public hospital services.
Outcome: Whilst this reform is still in the early stages of implementation, there
is evidence that clinicians and hospital managers are using the pricing signal to
undertake significant work to improve the rate of occurrence of HACs across the
system.

B. An enabler for the successful delivery of VBHC is the ability to identify and
measure outcomes that matter most to individuals

During the event Ms. Francesca Colombo, Head of the OECD’s Health Division,
highlighted two noteworthy numbers: first, the average spending of 36 OECD
member states for health care amounts to around 8.8% of GDP, with the United
States leading the pack with 16.9%; second, some OECD countries (e.g. Switzerland
and Germany), undertake six times more knee replacement operations per 100,000
inhabitants than others (e.g. Poland). This raises the questions of whether this
spending and variance in elective surgery rates are due to over/undertreatment, or
differing health needs in different contexts and if a country is getting value f rom the
spending and health interventions.

Such questions can only be answered by measuring patients’ wellbeing before
and after the treatment. To measure the value of treatments in a comprehensive
and standardized way, the OECD launched the Patient-Reported Indicators
Surveys (PaRIS) initiative. This initiative aims to record and report the outcomes
and experiences of patients undergoing various health treatments. Initial data sets
collected by PaRIS include data regarding hip surgery and cancer, with data points
that include; the extent of pain and when they are mobile after surgery, what health-

“It is not about what is
being done in health
systems, it is about what
health systems deliver to
people and populations
at large”

Ms. Francesca Colombo, OECD

related quality of life do patients have
undergoing cancer therapy and to what
extent do they experience anxiety and
depression.

Ms. Colombo highlighted that when
people are at the center of health care,
we can really measure what matters to
them and therefore bring benefits to
them as well as healthcare providers and
policymakers. For example, healthcare
providers profit f rom a new source of
feedback to improve the quality they

12www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

provide. On the other hand, policymakers profit f rom focusing their attention on
areas that need legislative improvements to create a favorable environment for the
development of person-centered healthcare delivery models.

The OECD is not alone in investing in programs that record and report the outcomes
and experiences of patients undergoing various health treatments. Many countries
such as Germany and Spain are designing systems for recording and measuring
patient-reported outcomes in pilot projects. For example, Germany has had over
15 years of experience with patient-reported outcomes (Case study [1]: DigiPROM
at Charite Berlin; Case study [4]: Martini Hospital in Hamburg). The collection of
data on patient-reported outcomes has had important implications for the quality
of treatment, as Dr. David Herr f rom the German Ministry of Health explained. The
follow up of clinical outcomes provided valuable feedback to individual surgeons
that actively started to learn f rom each other by sharing best practices. The use of
patient-reported outcomes have enabled similar success in the case of prostate
cancer in Spain (case study [5]: Patient-centric care in Cruces Hospital)

Lastly, to facilitate measurement of outcomes and patient experience, new data tools
and analytic capability are currently being developed, which are discussed later in
this paper.

Case study [4]: Martini Hospital in Hamburg

Situation: The Martini hospital, specialized in high volume radical prostatectomy
introduced patient-reported outcomes collection.
Ambition: Recording systematically the clinical outcome of patients after one
week, six months, and then yearly.
Outcome: Patient-reported outcomes provided valuable feedback to individual
surgeons and allowed best practice sharing, raising the quality of clinical
intervention.

13www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Case study [5]: Patient-centric care in Cruces Hospital

Situation: The Cruces Hospital in Spain deploys the guidelines of the International
Consortium for Health Outcomes Measurement (ICHOM) for a selection of
candidate diseases. One of them is prostate cancer.
Ambition: Creating a more patient-centric approach by following the guidelines
f rom ICHOM. These guidelines include the collection of standardized data sets
concerning clinical parameters as well as information reported by patients.
Outcome: In the case of prostate cancer, symptoms such as urinary incontinence
were significantly reduced after treatment, along with decreasing costs. The
initiative is interesting due to the long history of structured recording of the clinical
data and PROMs in the Basque health system.

C. Non-financial incentives and factors impacting the success of VBHC

The panel discussions revealed that money is only one lever in an inventory of
incentives to drive the transformation of health systems towards VBHC. Recalling that
change is driven by people, Dr. Omar Alshanqeety, CEO of the Program for Health
Assurance and Purchasing in Saudi Arabia, illustrated that purpose, fulfillment and
enjoyment are also incentives that people long for in their work. Addressing the
intrinsic motivation of people is key, summarized Dr. Derrick Heng, Group Director
of Public Health f rom the Singaporean Ministry of Health.

Recognition for achievements can also be a powerful incentive: the representative
f rom the Russian Ministry of Health, Prof. Lyalya Gabbasova, Assistant to the Minister
of Health, highlighted that best practice primary care facilities in Russia are awarded
special recognition and status, and to date more than 3,000 facilities have received
this status.

“Finance is necessary,
but not suff icient to
change behavior ”

Dr. Omar Alshanqeety, Program
for Health Assurance and
Purchasing, Saudi Arabia

People need to feel empowered and
enabled by providing them the right
tools. Additionally, health professionals
and patients should be empowered to
take ownership of their decision making.
This links back to motivating people by
allowing them to change the system, as
it was emphasized by Mr. Agarwal f rom
the Indian Ministry of Health & Family
Welfare. He also raised the important
point of educating consumers, not
only current patients, and taking them
along on the journey of health system
transformation.

14www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

D. VBHC involves development of new data tools and analytic capabilities

Data are available in vast quantities, and this holds true in the context of health care.
However, these data should not only be collected but also connected, as agreed
by virtually all the speakers who were present at the conference. Only by linkage of
available data, can one readily leverage advanced analytics to derive genuine and
novel insights for improving health care. Microsoft’s MEA Regional Industry Lead for
Health and Life Sciences, Mr. Mohammed Saleh identified five major categories of
health data:

Clinical (e.g. electronic medical records [EMRs], images, scans)
Pharma and life sciences (e.g. clinical trials, -omics)
Patient and citizen (e.g. purchasing data)
Claims and cost (e.g. claim requests, prices)
Geo/social/environmental (e.g. social service data)

Most of the data exist for every patient today but the data sources cannot talk to each
other. Today, we have a system of record, e.g. Electronic Medical Records (EMRs),
with little analytics and connections to other data sets. Pushing the connectivity and
exchange of data and adding analytical capabilities, systems of Artificial Intelligence
(AI) can be created. Such systems can cross-analyze large amounts of data in real-time
and perform prescriptive analytics (Case study [6]: Ochsner Health System).

To enable such technologies, it is important to share comprehensive high-quality
data sets among institutes, entities and across borders. In interviews with the
organizers of the event, both the representatives f rom the OECD and the World
Economic Forum (WEF) called for better global convergence and interoperability of
digital systems and outcome measurements.

“It’s not about
integrating data, it’s
about connecting data”

“From a technology
perspective the tools are
there. The open question
is governance, and this is
the big issue nowadays.
Who owns the data?”

Mr. Mohammed Saleh,
Microsoft

“It is not just good
enough to collect data,
there are oceans of data.
We need analytics that
generate intelligence ”

Prof. Rifat Atun,
Harvard University

15www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Case study [6]: Ochsner Health System

Situation: Physicians supervise many patients and need to split their time among
those patients. Cardiac arrests in patients can occur and are life-threatening
without warning signs perceivable by treating physicians.
Ambition: Predict cardiac arrest before it happens by reading out vitals every
minute and having them analyzed and processed by machine learning algorithms.
If the software detects suspicious signals it will alert a physician preemptively.
Outcome: During a 90-day pilot, the number of patients suffering a cardiac or
respiratory arrest was reduced by 44%, mortality by cardiac arrest was eliminated
on the floor during the trial.

Mr. Agarwal f rom the Indian Ministry of Health & Family Welfare showcased that
creating a unique medical ID on a robust IT platform is pivotal to ensure interoperability
as:

–

“What we need to do is
to create a standard for
interoperability that is
applicable in different
realities. It needs to be
focused on outcomes.”

Mr. Lucas Scherdel, WEF

“ There is a strong
impetus to extract more
value f rom our health
care system to ensure
sustainability”

Dr. Derrick Heng,
Ministry of Health, Singapore

It will allow information and
feedback flow across primary,
secondary and tertiary healthcare
by mapping of facilities and
resources at every level of care
It enhances trust and accountabili
ty due to simplicity and ease of use
It allows robust f raud detection
by developing an integrated fraud
and abuse detection system

Dr. Heng f rom the Singaporean
Ministry of Health mentioned that by
collecting and analyzing clinical quality
and cost data, one cannot only identify
opportunities for improvements but also
determine best practices for enhancing
value.
A survey of the event participants revealed
that one third of the respondents thought
co-production of solutions by different
stakeholders the most important
enabler, but 44% thought consulting
widely, challenging existing practice, co-
production of solutions and the creation
of an ecosystem for innovation were all
equally important (Figure 3).

16www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Figure 3: Event Audience Poll. Which is
the most important VBHC enabler?

II. Collaborations and knowledge transfer between organizations and countries

This section explores key learnings f rom insightful presentations and panel
discussions on the critical success factors and those hindering the establishment of
VBHC models.

E. VBHC can be applied and have positive impact at different scales

There is no ‘boilerplate’ solution that countries can simply pick up and apply
unchallenged locally. During the meeting a variety of pilots, initiatives and international

“In the past we talked a
lot about VBHC, but we
had no actions. We had
those actions in the last
years”

“When [VBHC] was
def ined it was more a
doctrine, now it is much
more practical because
we are working with
it. We understand now
what we can do with it
and what not”

Mr.Erik Jan Wilhelm, Zilveren
Kruis

collaborations were presented. All the
examples were guided by trust between
the involved parties, transparency and
alignment on collected data, focus
on solutions rather than procedures,
novel reimbursement models, a shift in
mindset of all involved stakeholders, and
patient centricity.

The presence of multiple examples across
different geographical scales provides a
proof-of-concept that VBHC approaches
can be adapted, applied and scaled-up
globally in different realities and scopes.
Panelists at the conference were positive
that the philosophy of VBHC is now
supported by concrete examples f rom
different geographies and sizes.

The acceleration of the introduction and

17www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

adoption of different VBHC approaches has happened thanks to public and private
initiatives and partnerships at varied scales, such as the partnerships between Roche
and The Capital Region in Denmark or Medtronic with the Lehigh Valley Health
Network. Or partnerships that require government commitment at the region or
country level, such as in Italy and Saudi Arabia, and investments in programs by

“You cannot scale
solutions ‘as is’, each
solution is different”

Mr.Said Haddad, Johnson &
Johnson

large international organizations at the
international scale.
As an example of a countrywide program,
involving many stakeholders, are UK
initiatives with the aim to measure
variability in the delivery of care. As
described by Ms. Rose Willis, Deputy
Head of Provider Efficiency at the UK
Department of Health and Social Care, a
large volume of inefficient spending in the
system can be prevented by measuring
and communicating variability in care
and clinical practice, e.g. in hospitals. The
measures of variability were developed
in collaboration with clinicians to whom
they will apply. £2.9bn has been saved so far by this initiative.

On the interface between the country and international levels, panelists presented
first international collaborations across country borders, for example the collaboration
between a Dutch payer and a clinic in Germany for prostate cancer surgeries (Zilveren
Kruis in the Netherlands and the Martini Clinic in Hamburg), or the innovative shared
value-driven procurement by Catalonia in Spain and in the UK for pacemakers.

18www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Figure 4: Some of the initiatives, pilots, and case studies discussed during the G20
side event on VBHC, categorized by geography and type

F. Reciprocity is key to successful collaborations

Successful VBHC pilots which are subsequently extended for broader implementation
require strong ties and goal alignments with collaborators. Collaboration between
patients, physicians, and organizations need to be mutually beneficial to create
strong enough incentives for all concerned to follow through and generate a
necessary level of trust.

To create this trust and special relationship, it is important to ascertain what VBHC
means to each party. VBHC means different things to different people, for example
better outcomes, better efficiencies, or better financials. The knowledge of context
is instrumental to align on what the partners want to achieve by the use of VBHC
approaches.

“Partnership is not a
noun, it is a verb. You
have to work on it”

Prof. Rifat Atun,
Harvard University

Mr. Said Haddad, the VP of Ethicon
EMEA for Johnson & Johnson, called for
a value based model of procurement.
Traditionally, stakeholders oppose each
other when negotiating prices. The
purchaser wants to obtain the lowest
possible price whereas the vendor wants
the opposite. To overcome the fixation
on price as the key decision criteria,
requires a shift in the mindset – moving
away f rom price and towards value.
Interestingly, 70% of procurement in

19www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Europe is done through tenders with a major focus on price. In the Middle East, Mr.
Haddad explained, it’s even higher at 80-85%.

Mr. Ramon Maspons, the Chief Innovation Officer f rom the Catalonian Ministry of
Health, shared a similar view. He described the need to transition to value based
procurement as more and more innovations and solutions that incorporate
innovative technologies, devices and medicines developed and more funds are
needed to procure these innovations.

There are 22 value based projects currently operational in Catalonia. In one of
the pilots, the Catalonian Ministry of Health procured an automated implantable
cardioverter defibrillator for Sant Pau hospital (Case study [7]: The Sant Pau case). This
defibrillator allowed remote monitoring and included cardiac re-synchronization,
adding another layer of care for patients. Patient outcome and wellbeing improved,
hospital productivity rose and their overall spending was reduced while the vendor
made money. This was achieved because procurement was not of the product

“We are not buying
products anymore, we
are buying solutions.
Using procurement as a
trigger for change”

Prof. Rifat Atun,
Harvard University

“Never before was there
so much innovation in
the funnel, never before
so little money for
adopting innovation”

Ramon Maspons, Catalonian
Ministry of Health

alone, but an entire solution; the remote
monitoring and maintenance of each
device was done by the manufacturer,
reducing hospital visits by the patients,
and both sides had the common aim of
lowering mortality as an incentive.

20www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Case study [7]: The Sant Pau case

Situation: The Catalan Ministry of Health, together with the Hospital de la Santa
Creu I Sant Pau piloted a new approach to treat patients with arrhythmias
(abnormal heartbeats)
Ambition: Comprehensive treatment of patients with automated implantable
cardioverter defibrillator (AICD) including cardiac re-synchronization. This
approach was designed to reduce follow up visits, introduce remote monitoring
of patients, and reduce costs by including health outcomes.
Outcome: Quality of life for patients improved drastically. There was a reduction
in in-office visits by ca. 10% and reduction of inappropriate shocks per patient by
ca. 66%.

Mr. Lars Dahl Allerup, New Business Development Manager f rom The Capital Region
of Denmark, concurred that price should not be the most important criterion in
procurement. Moreover, he raised the question if providers of care really knew what
patients want. What really matters to the specific patient? The answer for Mr. Allerup
is obvious: ask the patient and then center health care around patients and their
needs and wellbeing (Case study [8]: Public-private partnership (PPP) for a new way
to treat renal cancer).

Case study [8]: Public-private partnership (PPP) for a new way to treat renal
cancer

Situation: The Capital Region of Denmark and Roche Pharma started a public-
private partnership for patients with non-clear celled renal cancer.
Ambition: Tailoring the treatment to the patient’s need and thereby increasing
patient value overall. This will be achieved by collecting data on patient-reported
outcomes and real-world treatment data.
Outcome: First patient treatment will start in February 2020.

21www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Another example of adapting the mentality of achieving greater value for money in
health systems was provided by Singapore. The Singaporean Ministry of Health has
initiated a comprehensive health care transformation process that rests on three
pillars:

Value driven care
Bundled payments
Health technology assessment & value based pricing

The first pillar, value driven care, is implemented through a major initiative in
Singapore currently focusing on 17 conditions treated in an inpatient setting, with
the aim to improve outcomes and lowering costs. More details of the value driven
care initiative are provided in case study [9].

The second pillar, bundled payments (i.e. single price for all services required during
a patient’s entire episode of care), present an effective way to cap the costs of
treatment: payments are based on the diagnosed condition and not the volume of
procedures or the hours spent by a physician managing a case. Singapore plans to
introduce this bundled payment system by 2021.

For the third pillar, the Agency for Care Effectiveness (ACE) was established in
2015. The ACE conducts health technology assessments (HTA) to evaluate health
technologies in terms of clinical and cost effectiveness. HTA assessment agencies are
widespread in Europe, North America and Japan, and Singapore learned f rom those
countries. Moreover, ACE also engages in price negotiations with manufacturers to
ascertain value based pricing. As a striking example, Dr. Heng mentioned a 50%
price discount on a new medicine for treating Hepatitis C.

Case study [9]: Value driven care approach in Singapore

Situation: In 2018, the Singaporean Ministry of Health started a program for value
driven care. This program covers inpatient treatments in all public health care
institutions for a collection of 17 conditions. These conditions include Caesarean
section, total hip replacement and ischemic stroke.
Ambition: Maximizing the value of treatment by improving the outcomes while
lowering the costs. This can be achieved by generating learnings f rom patient
outcomes and cost data.
Outcome: So far, there are indications for improving value at the national level. One
of the next steps is to include patient-reported outcome measurements (PROMs).

22www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Singapore’s bundled payment approach is increasingly used elsewhere. Dr. Agnès
Soucat, Director for Health System Governance and Financing f rom the World Health
Organization, explained that bundling and blending different payment methods is
a prudent way forward in pursuit of improving quality. Estonia, a pioneer of bundling
payments in primary health care, has had such a system since the 2000s. In 2011, their
mix consisted of a basic allowance, capitation (predefined payments per person and
a certain period), fee for service and performance based payments. A prudent mix
of payments leverages the advantages of each kind while minimizing their caveats.

Panelists agreed that only when stakeholders join forces and organizations f rom
the public, private, and third sector realign their capabilities can a larger scale VBHC
implementation be feasible.

G. Large scale VBHC projects only succeed when roadblocks are removed

Italy is currently rolling out a successful VBHC project to encompass the whole country.
The Italian government already provides UHC to its entire population, irrespective
of any individual and social condition, and it is financed by a solidarity system. To
further improve patient experience and reduce costs, they have successfully tested
VBHC in pilots (Case study [10]: Lombardy). Now, Italy is striving to implement the
concept of VBHC universally. For this to become a reality, Dr. Giuseppe Ruocco,
Secretary General and Chief Medical Officer at the Italian Ministry of Health stressed
that VBHC needs to be fully embedded into the Italian health system and society.
For Italy, this strategy rests on an array of initiatives, among them:

The creation of a monitoring system to assess the burden of disease in two
dimensions: health implications and required investments
The measurement of value created by organizational processes and resource
consumption

Concrete measures that were taken by the government are the creation of

An e-Health National Plan, which provides health to patients outside of the
hospital setting
The new Health Pact, coordinating the reorganization of territorial health
care by newly developed collaborative organization network and
establishing pharmacies as first point of contact in the territories
The National Prevention Plan, promoting better and healthier lifestyles and
improving food safety. The National Prevention Plan also promotes health
literacy across the population and better training for health professionals.

23www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Case study [10]: Lombardy

Situation: In 2011, Lombardy was one of the first in regions in Europe to pilot the
concept of the VBHC for treating patients with chronic diseases.
Ambition: Replacing the hospital-centric and f ragmented system with a system
that leverages collaboration between the various health actors and establishing a
single take-over fee. Furthermore, the care of chronic patients should be shifted
more to a home-based setting with the support of telemedicine.
Outcome: Successful projects tested in the initial phase were added to an initiative
called Nuove Reti Sanitarie (NRS), which aims to make those innovative approaches
a common practice in care delivery.

As described earlier in this report, India launched a similarly comprehensive and
disruptive health care project to benefit its population (Case study [2]: Ayushman
Bharat). A cornerstone of their initiative is that payment incentives are aligned with
the outcomes of treatments, e.g. pay for performance.

These nation-wide improvements in health care would have not been possible
without the willingness of legislators to allow disruption in health care. Legislators
need to introduce reforms to support VBHC models and cut down on regulatory,
institutional and legal VBHC barriers, as pinpointed by Mr. Christian Howell, the
vice president of Medtronic VBHC partnerships within the Americas region. Equally
important are ways to cultivate innovations in an ecosystem of aligned stakeholders
(Case study [11]: Partnership Lehigh Valley Health Network and Medtronic). Such
an ecosystem, Mr. Howell explained, is an environment that is mutually beneficial
because all stakeholders agree on critical components. This requires stakeholders
to agree on a strategic f ramework, governance model and operating model. In
practice this means that the provider’s and manufacturer’s teams need to speak
the same language, be aligned on what is measured, and aligned on how conflicts
are resolved. Furthermore, the legal f ramework needs to be discussed, and data
and information system inf rastructure built. Once the cornerstones of agreement
and the model have been set, the clinical intervention process can be initiated. This
intervention process can be split into three stages:

Benchmarking and design the intervention: Def ining the opportunity of
intervention, the measurement of the current state, the development
of value models and the design and building of the clinical intervention
approach
Creation of compliance mechanisms and business model
Kick-off and improvements: Taking the new clinical intervention live and
establishing continuous measurements and monitoring of the impact of the

24www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

interventions allow for data-driven amendments of the intervention
For Mr. Howell, such an ecosystem between provider, payer and producer needs to
be in place before any clinical intervention starts in a specific location, e.g. a hospital
or provider network.

What was clear f rom the examples presented at the event was that VBHC models
require an open mind for new approaches to traditional problems and the
establishment of deeper relationships within healthcare stakeholders such as the
development of innovative solutions rather than sale of products by manufacturers,
which requires better alignment with the needs of providers and payers. Mr. Haddad
f rom Johnson & Johnson summarized this effectively; “To create viable VBHC systems,
we need:

Mindset change of all stakeholders including payers, patients, providers and
governments
Trust in the system between stakeholders, they should take risk and
experiment together
Flexibility in the system; where hospitals at the community level should be
given some autonomy to enter new kind of agreements, without having to
wait for the respective health care system as a whole to change”

Mr. Allerup f rom The Capital Region of Denmark emphasized that education and
training of stakeholders are instrumental and should not be neglected. In this
context, not only the education of citizens and patients but especially that of the
workforce needs to be improved. Dr. Omar Alshanqeety f rom the Program for

Case study [11]: Partnership Lehigh Valley Health Network and Medtronic

Situation: Lehigh Valley health network and Medtronic agreed on a 5-year strategic
partnership. This partnership serves to create a mutually beneficial environment
to deliver VBHC. Indications of interest include, among others, stroke, type I
diabetes, and heart failure.
Ambition: Improving health, care and satisfaction of patients while reducing
costs. This should be achieved by the co-creation of new applications, health
care platforms, beta-testing of new ideas and the sharing of data and an aligned
governance.
Outcome: It was a win-win for both parties. The health care system benefited f rom
a reduction in care variation while complying with the care pathway, better health
outcomes and lower cost of care. Medtronic profited f rom increased revenue, new
business opportunities and new expert knowledge in health care.

25www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Health Assurance and Purchasing in Saudi Arabia agreed and pointed out that the
new way of delivering care is different f rom the old way care has been delivered. This
necessitates a different understanding, a new mindset and new skills.

According to Ms. Colombo f rom the
OECD we need to rethink fundamentally
the training of health workers. Ms.
Colombo raised the question of how to
teach skills that allow professionals to
accelerate in a rapidly changing health
environment. They will need to learn how
to coordinate in such environments and
demonstrate an understanding of how
patients make decisions.

“We need different
medical skills for the 21st
century.”

Ms. Francesca Colombo, OECD

H. Practical learning is transferable within and across countries

Throughout the event there was a strong agreement that this was the first global
event where practical learning on global applications of VBHC models was shared.
Previously, similar conferences focused mainly on the theoretical aspects of value
driven health care models, lacked the richness of examples and were not global in
scope.

The richness and diversity of the shared examples were apparent to all participants,
and there was a shared consensus that the dialogue between stakeholders across
geographies and organizations would need to continue to drive forward in health
systems the transformation towards VBHC.

Everybody agreed that practical examples
f rom countries cannot be transferred
‘as-is’ without an understanding of the
different contexts. The stakeholders
need an understanding of which
learnings are transferrable to different
contexts, and which are context agnostic.
Such understanding is necessary
to accelerate the implementation
of VBHC both in similar and diverse
situations. One example is the VBHC
model implemented by Medtronic in
collaboration with several providers. The
first implementation took 18 months as
it required in-depth experimentation
and learning across the Medtronic

“ This is a journey that
several countries are
undertaking, and there
is a huge opportunity in
co learning.”

Dr. Omar Alshanqeety,
Program for Health Assurance
and Purchasing, Saudi Arabia

26www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

organization. Thanks to this experience, the latest project was implemented in as
little as one month.

The need for international experimentation and knowledge sharing was reinforced
by Dr. Soucat, f rom the WHO, whom suggested to establish international
experimentation, in which new implementations of VBHC would introduce
controlled changes in the models chosen in order to comparatively test hypotheses.
Such experiments already exist; however, it is hard to currently draw conclusions due
to limited comparability.

Another example of an international organization promoting international learning
on VBHC is the WEF. To foster international learning, the WEF set up the Global
Coalition for Value in Healthcare to encourage Public-Private Partnerships on
VBHC. This platform partners with various stakeholders in health to co-design and
test innovative concepts promoting patient-centered health care. Partners include
universities, research institutes, management consultancies and many more.
According to Mr. Lucas Scherdel f rom WEF, such programs have shown signs of
success. In his view, what is needed now, is a global organization that will bundle all
the efforts and takes an active lead on global learning on and implementation of
VBHC, especially around the IT and data topic.

Dr. Chintan Maru, Founder of Leapf rog to Value at The Global Development
Incubator, emphasized that low-income and middle-income Countries (LMICs)
provide important VBHC lessons for all countries. This may come as a surprise, but
can be pinpointed on three aspects that promote innovation in LMICs:

Experimentations in those geographies are not restricted by legacy health
systems. They have little inf rastructure and do not suffer f rom structural
rigidness seen in developed countries. This rigidity is driven by regulatory
constraints and a medical education focused on knowledge acquisition
and not agility
LMICs, in contrast to high-income countries, have the political will and
necessity to increase health care spending to increase access
Innovation in LMICs is often driven by the ingenuity of the countries’
poor populations. As a powerful example f rom the tech sector, he
mentioned the rapid penetration of mobile payments in Af rica, driven
by the usage of prevalent mobile phones as a convenient payment vehicle.

To move forward with VBHC, LMICs need to further cultivate their own robust
ecosystem for experimentation. There is no fixed blueprint for transferring concepts
f rom high-income countries to LMIC. To further promote such experimentations,
those realities will need the necessary risk capital, and Dr. Maru suggests that some
bilateral development funds could be allocated for such purpose.

In line with Dr. Maru’s findings, the WHO offers support for country decision makers

27www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

in a new online repository, the WHO compendium of innovative health technologies
for low-resource settings launching in 2020. This repository will provide information
on recommended interventions for therapeutic areas, type of services, age groups
and so forth. Additionally, it will have guidelines for necessary investments and give
orientation on a country specific level about costs and cost-effectiveness.

Furthermore, Ms. Herta Adam f rom the European Commission highlighted the
Commission’s support for countries in building strong, good quality and resilient
health care systems. In 2019, they expanded its efforts by entering in a partnership
program with the WHO to further improve health systems and promote UHC in over
100 countries.

I. Leveraging other sector learnings to improve the health care sector

The Event gathered valuable knowledge on the current state of the field. It translated
theoretical f rameworks into real-world examples f rom across the globe. Further
knowledge sharing events can help foster the urgently required alignment across
nations and other stakeholders.

Attendees at the Event and panelists suggested that future events may dedicate
some time to welcome experts f rom other fields, industries and sectors that have
successfully tackled similar issues facing health care today.

One f requently used comparison was re-iterated by Ms. Colombo f rom the OECD on
the aspect of safety: in the aviation industry errors and incidents are transparently
shared across the entire industry to prevent similar errors f rom happening again.
According to Ms. Colombo, health care needs a different safety culture, where we do
not panic on error, but value transparency.

Parallels to the tech industry were drawn by Mr. Howell f rom Medtronic. In the
company’s view, a platform in VBHC should work in a similar way like Uber connects
service providers with the end-users. Both stakeholders are aligned on the same
values, e.g. safe driving. This economy of trust needs to be governed:

How we share data, e.g. Uber App, no sharing of cell phone numbers
How to resolve disputes, e.g. exclusion of drivers with low ratings, reimbursement
of fees to end-user in case of dissatisfaction
How to measure outcomes, e.g. 5 star rating for drivers and passengers

Similarly, Mr. Bosch f rom the Catalan Ministry of Health, offered to the audience the
parallelism between VBHC models and Spotify. Spotify disrupted the music industry.
Traditionally, consumers used to pay by volume, paying a fee for service or buying
a CD or single song f rom iTunes. This business model pivoted to a flat rate model
in which users pay for value/outcome: value based reimbursement or flat rate for
unlimited consumption of music.

28www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

The participants of the event agreed
that it was a huge success and had the
potential to lead to real change. Prof.
Atun stated that this has been the
first time that he has seen such rich
experiences on VBHC shared, indicating
that the field is really in the transition
f rom theoretical f rameworks toward
real-world applications.

“We have an opportunity
now to capture these
experiences and share
them globally”

Prof. Rifat Atun,
Harvard University

29www.g20.org |Accelerating Transformation Towards Sustainable Health Systems Through Value Based Health Care

Figure 5: Event Audience Poll. How
important is it to have a shared definition
of what value means?

Participants and panelists re-iterated the need to openly discuss and share
their experiences and learnings. Furthermore, they urged for convergence and
interoperability, especially on the IT and data & analytics dimensions. This discussion,
they stressed, should involve all stakeholders in the health and care ecosystem.

The Event participants felt that further convergence and agreement was needed on
the nomenclature and use of terms (Figure 5):

How do we define value?
How do we define platforms?
How we define outcomes?

Prof. Atun closed his final remarks with the call for greater solidarity and sustainability
in health systems to drive economic growth. VBHC provides an opportunity to build
health systems that are better prepared for the future.

CONCLUSION and LOOKING AHEAD

www.g20.org

PBL-038
October 2019

Design and development of the Diagnosis
Related Group (DRG)

Prospective payment rates based on Diagnosis Related Groups (DRGs) have been established as
the basis of Medicare’s hospital reimbursement system. The DRGs are a patient classification
scheme which provides a means of relating the type of patients a hospital treats (i.e., its case
mix) to the costs incurred by the hospital. The design and development of the DRGs began in the
late sixties at Yale University. The initial motivation for developing the DRGs was to create an
effective framework for monitoring the quality of care and the utilization of services in a hospital
setting. The first large-scale application of the DRGs was in the late seventies in the State of New
Jersey. The New Jersey State Department of Health used DRGs as the basis of a prospective
payment system in which hospitals were reimbursed a fixed DRG specific amount for each
patient treated. In 1982, the Tax Equity and Fiscal Responsibility Act modified the Section 223
Medicare hospital reimbursement limits to include a case mix adjustment based on DRGs. In
1983 Congress amended the Social Security Act to include a national DRG-based hospital
prospective payment system for all Medicare patients.

The evolution of the DRGs and their use as the basic unit of payment in Medicare’s hospital
reimbursement system represents a recognition of the fundamental role which a hospital’s case
mix plays in determining its costs. In the past, hospital characteristics such as teaching status and
bed size have been used to attempt to explain the substantial cost differences which exist across
hospitals. However, such characteristics failed to account adequately for the cost impact of a
hospital’s case mix. Individual hospitals have often attempted to justify higher cost by
contending that they treated a more “complex” mix of patients; the usual contention being that
the patients treated were “sicker.” Although there has been a consensus in the hospital industry
that a more complex case mix results in higher costs, the concept of case mix complexity had
historically lacked a precise definition. The development of the DRGs provided the first
operational means of defining and measuring a hospital’s case mix complexity.

The concept of case mix complexity
The concept of case mix complexity initially appears very straightforward. However, clinicians,
administrators and regulators have often attached different meanings to the concept of case mix
complexity depending on their backgrounds and purposes. The term case mix complexity has
been used to refer to an interrelated but distinct set of patient attributes which include severity
of illness, prognosis, treatment difficulty, need for intervention and resource intensity. Each of
these concepts has very precise meaning which describes a particular aspect of a hospital’s case
mix.

• Severity of illness. Refers to the relative levels of loss of function and mortality that may be
experienced by patients with a particular disease.

Design and development of the Diagnosis Related Group (DRG)

• Prognosis. Refers to the probable outcome of an illness including the likelihood of
improvement or deterioration in the severity of the illness, the likelihood for recurrence and
the probable life span.

• Treatment difficulty. Refers to the patient management problems which a particular illness
presents to the health care provider. Such management problems are associated with
illnesses without a clear pattern of symptoms, illnesses requiring sophisticated and
technically difficult procedures and illnesses requiring close monitoring and supervision.

• Need for intervention. Relates to the consequences in terms of severity of illness that lack of
immediate or continuing care would produce.

• Resource intensity. Refers to the relative volume and types of diagnostic, therapeutic and
bed services used in the management of a particular illness.

When clinicians use the notion of case mix complexity, they mean that the patients treated have
a greater severity of illness, present greater treatment difficulty, have poorer prognoses and
have a greater need for intervention. Thus, from a clinical perspective case mix complexity refers
to the condition of the patients treated and the treatment difficulty associated with providing
care. On the other hand, administrators and regulators usually use the concept of case mix
complexity to indicate that the patients treated require more resources which results in a higher
cost of providing care. Thus, from an administrative or regulatory perspective case mix
complexity refers to the resource intensity demands that patients place on an institution. While
the two interpretations of case mix complexity are often closely related, they can be very
different for certain kinds of patients. For example, while terminal cancer patients are very
severely ill and have a poor prognosis, they require few hospital resources beyond basic nursing
care.

In the past, there has sometimes been confusion regarding the use and interpretation of the
DRGs because the aspect of case mix complexity measured by the DRGs has not been clearly
understood. The purpose of the DRGs is to relate a hospital’s case mix to the resource demands
and associated costs experienced by the hospital. Therefore, a hospital having a more complex
case mix from a DRG perspective means that the hospital treats patients who require more
hospital resources but not necessarily that the hospital treats patients having a greater severity
of illness, a greater treatment difficulty, a poorer prognosis or a greater need for intervention.

Patient classification
Given that the purpose of the DRGs is to relate a hospital’s case mix to its resource intensity, it
was necessary to develop an operational means of determining the types of patients treated and
relating each patient type to the resources they consumed. While all patients are unique, groups
of patients have demographic, diagnostic and therapeutic attributes in common that determine
their level of resource intensity. By developing clinically similar groups of patients with similar
resource intensity, patients can be aggregated into meaningful patient classes. Moreover, if
these patient classes covered the entire range of patients seen in an inpatient setting, then
collectively they would constitute a patient classification scheme that would provide a means of

Design and development of the Diagnosis Related Group (DRG)

establishing and measuring hospital case mix complexity. The DRGs were therefore developed as
a patient classification scheme consisting of classes of patients who were similar clinically and in
terms of their consumption of hospital resources.

During the process of developing the DRG patient classification scheme, several alternative
approaches to constructing the patient classes were investigated. Initially, a normative approach
was used which involved having clinicians define the DRGs using the patient characteristics
which they felt were important for determining resource intensity. There was a tendency for
their definitions to include an extensive set of specifications, requiring information which might
not always be collected through a hospital’s medical information system. If the entire range of
patients were classified in this manner, it would ultimately lead to thousands of DRGs, most of
which described patients seen infrequently in a typical hospital. It, therefore, became evident
that the process of DRG definition would be facilitated if data from acute care hospitals could be
examined to determine the general characteristics and relative frequency of different patient
types. In addition, statistical algorithms applied to this data would be useful to suggest ways of
forming DRGs that were similar in terms of resource intensity. However, it was also discovered
that statistical algorithms applied to historical data in the absence of clinical input would not
yield a satisfactory set of DRGs. The DRGs resulting from such a statistical approach, while similar
in terms of resource intensity, would often contain patients with a diverse set of characteristics
which could not be interpreted from a clinical perspective. Thus, it became apparent that the
development of the DRG patient classification scheme required that physician judgment,
statistical analysis and verification with historical data be merged into a single process. It was
necessary to be able to examine large amounts of historical data with statistical algorithms
available for suggesting alternative ways of forming DRGs but to do so in such a way that
physicians could review the results at each step to insure that the DRGs formed were clinically
coherent.

Basic characteristics of the DRG patient classification
scheme

Given the limitations of previous patient classification schemes and the experience of
attempting to develop DRGs with physician panels and statistical analysis, it was concluded that
in order for the DRG patient classification scheme to be practical and meaningful it should have
the following characteristics:

1. The patient characteristics used in the definition of the DRGs should be limited to
information routinely collected on hospital abstract systems.

2. There should be a manageable number of DRGs which encompass all patients seen on an
in-patient basis.

3. Each DRG should contain patients with a similar pattern of resource intensity.

4. Each DRG should contain patients who are similar from a clinical perspective (i.e., each class
should be clinically coherent).

Design and development of the Diagnosis Related Group (DRG)

Restricting the patient characteristics used in the definition of the DRGs to those readily
available insured that the DRGs could be extensively applied. Currently, the patient information
routinely collected includes age, principal diagnosis, secondary diagnoses and the surgical
procedures performed. Creating DRGs based on information that is only collected in a few
settings or on information which is difficult to collect or measure would have resulted in a
patient classification scheme which could not be applied uniformly across hospitals. That is not
to say that information beyond that currently collected might not be useful for defining the
DRGs. As additional information becomes routinely available it must be evaluated to determine
if it might result in improvements in the ability to classify patients.

Limiting the number of DRGs to manageable numbers (i.e., hundreds of patient classes, not
thousands) insures that for most of the DRGs, a typical hospital will have enough experience to
allow meaningful comparative analysis to be performed. If there were only a few patients in
each DRG, it would be difficult to detect patterns in case mix complexity and cost performance
and to communicate the results to the physician staff.

The resource intensity of the patients in each DRG must be similar in order to establish a
relationship between the case mix of a hospital and the resources it consumes. Similar resource
intensity means that the resources used are relatively consistent across the patients in each
DRG. However, some variation in resource intensity will remain among the patients in each DRG.
In other words, the definition of the DRG will not be so specific that every patient is identical,
but the level of variation is known and predictable. Thus, while the precise resource intensity of
a particular patient cannot be predicted by knowing to which DRG he belongs, the average
pattern of resource intensity of a group of patients in a DRG can be accurately predicted.

Since one of the major applications of the DRGs is as a means of communicating with the
physician community, the patients in each DRG must be similar from a clinical perspective. In
other words, the definition of each DRG must be clinically coherent. The concept of clinical
coherence requires that the patient characteristics included in the definition of each DRG relate
to a common organ system or etiology and that a specific medical specialty should typically
provide care to the patients in the DRG. For example, patients who are admitted for a D&C or a
Tonsillectomy are similar in terms of most measures of resource intensity such as length of stay,
preoperative stay, operating room time and use of ancillary services. However, different organ
systems and different medical specialties are involved. Thus, the requirement that the DRGs be
clinically coherent precludes the possibility of these types of patients being in the same DRG.

A common organ system or etiology and a common clinical specialty is a necessary but not
sufficient requirement for a DRG to be clinically coherent. In addition, all available patient
characteristics which medically would be expected to consistently affect resource intensity
should be included in the definition of the DRG. Furthermore, a DRG should not be based on
patient characteristics which medically would not be expected to consistently affect resource
intensity. For example, patients with appendicitis may or may not have peritonitis. Although
these patients are the same from an organ system, etiology and medical specialist perspective,
the DRG definitions must form separate patient classes, since the presence of peritonitis would
be expected to consistently increase the resource intensity of the appendicitis patients. On the
other hand, sets of unrelated surgical procedures cannot be used to define a DRG since there

Design and development of the Diagnosis Related Group (DRG)

would not be a medical rationale to substantiate that the resource intensity would be expected
to be similar.

The definition of clinical coherence is, of course, dependent on the purpose for the formation of
the DRG classification. For the DRGs, the definition of clinical coherence relates to the medical
rationale for differences in resource intensity. If, on the other hand, the purpose of the DRGs
related to mortality, the patient characteristics which were clinically coherent and, therefore,
included in the DRG definitions might be different. Finally, it should be noted that the
requirement that the DRGs be clinically coherent caused more patient classes to be formed than
would be necessary for explaining resource intensity alone.

Formation of the DRGs
The process of forming the DRGs was begun by dividing all possible principal diagnoses into 23
mutually exclusive principal diagnosis areas referred to as Major Diagnostic Categories (MDC).
Two new MDCs were created in the eighth version of the DRGs. The 25 MDCs are listed in table
1.

The MDCs were formed by physician panels as the first step toward insuring that the DRGs
would be clinically coherent. The diagnoses in each MDC correspond to a single organ system or
etiology and in general are associated with a particular medical specialty. Thus, in order to
maintain the requirement of clinical coherence, no final DRG could contain patients in different
MDCs. In general, each MDC was constructed to correspond to a major organ system (e.g.,
Respiratory System, Circulatory System, Digestive System) rather than etiology (e.g.,
malignancies, infectious diseases). This approach was used since clinical care is generally
organized in accordance with the organ system affected, and not the etiology. Thus, diseases
involving both a particular organ system and a particular etiology (e.g., malignant neoplasm of
the kidney) were assigned to the MDC corresponding to the organ system involved. However,
not all diseases or disorders could be assigned to an organ system-based MDC and a number of
residual MDCs were created (e.g., Systemic Infectious Diseases, Myeloproliferative Diseases and
Poorly Differentiated Neoplasms). For example, the infectious diseases food poisoning and
Shigella dysenteriae are assigned to the Digestive System MDC while pulmonary tuberculosis is
assigned to the Respiratory System MDC. On the other hand, infectious diseases such as miliary
tuberculosis and septicemia which usually involve the entire body are assigned to the Systemic
Infectious Disease MDC.

Once the MDCs were defined each MDC was evaluated to identify those additional patient
characteristics which would have a consistent effect on the consumption of hospital resources.
Since the presence of a surgical procedure which required the use of the operating room would
have a significant effect on the type of hospital resources (e.g., operating room, recovery room,
anesthesia) used by a patient, most MDCs were initially divided into medical and surgical groups.
The medical-surgical distinction is also useful in further defining the clinical specialty involved.

Patients were considered surgical if they had a procedure performed which would require the
use of the operating room. Since the patient data generally available does not precisely indicate
whether a patient was taken to the operating room, surgical patients were identified based on

Design and development of the Diagnosis Related Group (DRG)

the procedures which were performed. Physician panels classified every possible procedure
code based on whether the procedure would in most hospitals be performed in the operating
room.

Table 1. Major Diagnostic Categories

MDC Description
1 Diseases and Disorders of the Nervous System

2 Diseases and Disorders of the Eye

3 Diseases and Disorders of the Ear, Nose, Mouth and Throat

4 Diseases and Disorders of the Respiratory System

5 Diseases and Disorders of the Circulatory System

6 Diseases and Disorders of the Digestive System

7 Diseases and Disorders of the Hepatobiliary System and Pancreas

8 Diseases and Disorders of the Musculoskeletal System and
Connective Tissue

9 Diseases and Disorders of the Skin, Subcutaneous Tissue and Breast

10 Endocrine, Nutritional and Metabolic Diseases and Disorders

11 Diseases and Disorders of the Kidney and Urinary Tract

12 Diseases and Disorders of the Male Reproductive System

13 Diseases and Disorders of the Female Reproductive System

14 Pregnancy, Childbirth and the Puerperium

15 Newborns and Other Neonates with Conditions Originating in the
Perinatal Period

16 Diseases and Disorders of the Blood and Blood Forming Organs and
Immunological Disorders

17 Myeloproliferative Diseases and Disorders, and Poorly Differentiated
Neoplasm

18 Infectious and Parasitic Diseases (Systemic or Unspecified Sites)

19 Mental Diseases and Disorders

20 Alcohol/Drug Use and Alcohol/Drug Induced Organic Mental
Disorders

21 Injuries, Poisonings and Toxic Effects of Drugs

22 Burns

Design and development of the Diagnosis Related Group (DRG)

MDC Description
23 Factors Influencing Health Status and Other Contacts with Health

Services

24 Multiple Significant Trauma

25 Human Immunodeficiency Virus Infections
1.

Thus, closed heart valvotomies, cerebral meninges biopsies and total cholecystectomies would
be expected to require the operating room while thoracentesis, bronchoscopy and skin sutures
would not. If a patient had any procedure performed which was expected to require the
operating room that patient would be classified as a surgical patient. A complete list of all the
procedures expected to require the operating room is contained in Appendix E.

Once each MDC was divided into medical and surgical categories, then, in general, the surgical
patients were further defined based on the precise surgical procedure performed while the
medical patients were further defined based on the precise principal diagnosis for which they
were admitted to the hospital. The general structure of a typical MDC is shown by the tree
diagram found at the end of this chapter (figure 1). In general, specific groups of surgical
procedures were defined to distinguish surgical patients according to the extent of the surgical
procedure performed. For example, the procedure classes defined for the Endocrine, Nutritional
and Metabolic MDC are amputations, procedures for obesity, skin grafts and wound
debridements, adrenal and pituitary procedures, parathyroid procedures, thyroid procedures,
thyroglossal procedures and other procedures relating to Endocrine, Nutritional or Metabolic
diseases.

Since a patient can have multiple procedures related to their principal diagnosis during a
particular hospital stay, and a patient can be assigned to only one surgical class, the surgical
classes in each MDC were defined in a hierarchical order. Patients with multiple procedures
would be assigned to the surgical class highest in the hierarchy.

Thus, if a patient received both an extraction of endometrium (D&C in ICD-9-CM) and a resection
of uterus (hysterectomy in ICD-9-CM), the patient would be assigned to the hysterectomy
surgical class. It should be noted that as a result of the surgical hierarchy the ordering of the
surgical procedures on the patient abstract has no influence on the assignment of the surgical
class and DRG. Appendix D lists the surgical hierarchy for each MDC.

In general, specific groups of principal diagnoses were defined for medical patients. Usually the
medical classes in each MDC would include a class for neoplasms, symptoms and specific
conditions relating to the organ system involved. For example, the medical classes for the
Respiratory System MDC are ventilator support, pulmonary embolism, infections and
inflammations, neoplasms, chest trauma, pleural effusion, pulmonary edema and respiratory
failure, chronic obstructive pulmonary disease, simple pneumonia and pleurisy, interstitial lung
disease, pneumothorax, bronchitis and asthma, respiratory signs and symptoms and other
respiratory diagnoses.

Design and development of the Diagnosis Related Group (DRG)

In each MDC there is usually a medical and a surgical class referred to as “other medical
diseases” and “other surgical procedures,” respectively. The “other” medical and surgical classes
are not as precisely defined from a clinical perspective. The other classes would include
diagnoses or procedures which were infrequently encountered or not well defined clinically. For
example, the “other” medical class for the Respiratory System MDC would contain the diagnoses
“other somatoform disorders” and “congenital malformation of the respiratory system,” while
the “other” surgical class for the female reproductive MDC would contain the surgical
procedures “excision of liver” (liver biopsy in ICD-9-CM) and “inspection of peritoneal cavity”
(exploratory laparotomy in ICD-9-CM).

The “other” surgical category contains surgical procedures which, while infrequent, could still
reasonably be expected to be performed for a patient in the particular MDC. There are,
however, also patients who receive surgical procedures which are completely unrelated to the
MDC to which the patient was assigned. An example of such a patient would be a patient with a
principal diagnosis of pneumonia whose only surgical procedure is a destruction of prostate
(transurethral prostatectomy in ICD-9-CM). Such patients are assigned to a surgical class referred
to as “unrelated operating room procedures.” These patients are ultimately never assigned to a
well-defined DRG.

The process of defining the surgical and medical classes in an MDC required that each surgical or
medical class be based on some organizing principle. Examples of organizing principles would be
anatomy, surgical approach, diagnostic approach, pathology, etiology or treatment process. In
order for a diagnosis or surgical procedure to be assigned to a particular class, it would be
required to correspond to the particular organizing principle for that class. For example, in the
Urinary System MDC a surgical group was formed for all patients with a procedure on the
urethra (i.e., organizing principle based on anatomy). This surgical group was then further
divided based on whether the procedure performed was transurethral (i.e., organizing principle
based on surgical approach).

Figure 1 displays the basic structure of the DRG. Until the eighth version, the first step in the
determination of the DRG had been the assignment of the appropriate MDC based on the
principal diagnosis. The eighth version of the DRGs contained the first departure from the use of
principal diagnosis as the initial variable in DRG assignment, when the initial step in DRG
assignment was based on procedure (PRE MDC). If a patient has a heart transplant or implant of
heart assist system, ECMO or tracheostomy, liver transplant and/or intestinal transplant, bone
marrow transplant, lung transplant simultaneous pancreas/kidney transplant, or pancreas
transplant, then the patient is assigned to these DRGs independent of the MDC of the principal
diagnosis. Heart, intestinal, liver, bone marrow, lung, pancreas/kidney and pancreas transplants
are very resource intensive and can be performed for diagnoses in many different MDCs.
Tracheostomies are performed primarily for patients on long term ventilator support and
therefore such patients are very resource intensive. The eighth version also created two new
MDCs for patients with multiple trauma (MDC 24) and patients with an HIV infection (MDC 25).
Assignment to MDC 24 and 25 is based on both principal and secondary diagnoses. An
assignment to MDC 24 is based on the presence of two or more significant traumas in different
body systems (e.g. a fractured skull and a fractured femur). Assignment to MDC 25 is based on a
principal diagnosis of an HIV infection or a principal diagnosis of an HIV related complication

Design and development of the Diagnosis Related Group (DRG)

combined with a secondary diagnosis of an HIV infection (e.g. principal diagnosis of
pneumocystosis and a secondary diagnosis of an HIV infection).

Once the medical and surgical classes for an MDC were formed, each class of patients was
evaluated to determine if complications, comorbidities, the patient’s age or discharge status
consistently affected the consumption of hospital resources. Physician panels classified each
diagnosis code based on whether the diagnosis, when present as a secondary condition, would
be considered a substantial complication or comorbidity. A substantial complication or
comorbidity was defined as a condition, that because of its presence with a specific principal
diagnosis would cause an increase in length of stay by at least one day in at least 75 percent of
the patients. For example, sarcoidosis of lung, chronic obstructive pulmonary disease and
pneumococcal pneumonia are considered substantial complications or comorbidities for certain
diseases, while nontoxic diffuse goiter and essential hypertension are not. Each medical and
surgical class within an MDC was tested to determine if the presence of any substantial
comorbidities or complications would consistently affect the consumption of hospital resources.
For example, the presence of complications or comorbidities was not significant for patients
receiving a median nerve release (carpal tunnel release in ICD-9-CM) but was very significant for
patients with arrhythmia and conduction disorders. The same basic list of complications and
comorbidities are used across most DRGs. However, depending on the principal diagnosis of the
patient, some diagnoses in the basic list of complications and comorbidities may be excluded if
they are closely related to the principal diagnosis. For example, urinary retention is a
complication or comorbidity for a patient admitted for congestive heart failure but not for a
patient admitted for enlarged prostate. In addition, in some cases such as newborns or acute
myocardial infarction patients, special complications and comorbidity definitions were used in
defining the DRGs.

The final variable used in the definition of the DRGs was the patient discharge status. Separate
DRGs were formed for newborns if the patients were transferred to another acute care facility.
In addition, separate DRGs were formed for patients with alcoholism or drug abuse who left
against medical advice and for acute myocardial infarction patients and newborns who died.

For versions 2-24 of the DRGs, the further subdivisions of some medical and surgical DRGs was
primarily based on the presence or absence of a CC or pediatric age (0-17). For example, in DRG
version 24 there were 115 pairs of DRGs subdivided based on the presence or absence of a CC
and 43 pediatric DRGs (age 0-17). Beginning with version 25 the use of CCs and patient age was
completely revised. The revisions were so extensive that the version 25 DRGs were renamed to
be the Medicare Severity DRGs (MS-DRGs).

Except for new diagnosis codes that were added to ICD-9-CM after FY1984 (e.g., HIV), the CC list
of diagnoses used in the DRGs remained virtually identical to the original CC list used in FY1984.
As a result of the changes that occurred in hospitals during the first 22 years of PPS, the CC list
had lost much of its power to discriminate hospital resource use. Better coding of secondary
diagnoses, stricter criteria for extended hospital stays, increased availability of post acute care
services and the shift to outpatient care resulted in most patients (nearly 80 percent) admitted
to hospitals having a CC. Therefore, in version 25 (MS-DRGs) the diagnoses comprising the CC list
were completely redefined. The revised CC list is primarily comprised of significant acute
disease, acute exacerbations of significant chronic diseases, advanced or end stage chronic

Design and development of the Diagnosis Related Group (DRG)

diseases and chronic diseases associated with extensive debility. In general, most chronic
diseases were not included on the revised CC list. For a patient with a chronic disease, a
significant acute manifestation of the chronic disease was required to be present and coded for
the patient to be assigned a CC. The revision of the CC list reduced the number of Medicare
patients with a CC from approximately 80 percent to 40 percent.

In addition, to the revision of the CC list, each CC was also categorized as a major CC or a CC (i.e.,
non major CC) based on relative resource use. Approximately, 12 percent of all diagnoses codes
were classified as a major CC, 24 percent as a CC and 64 percent as a non CC. Diagnoses closely
associated with mortality (ventricular fibrillation, cardiac arrest, shock and respiratory arrest)
were assigned as a major CC if the patient lived but as a non CC if the patient died.

The major CC, CC and non CC categorization was used to subdivide the surgical and medical
DRGs into up to three levels with a patient being assigned to the most extreme level (e.g., a
patient with an MCC and a CC is assigned to the MCC level). Before subdividing the medical and
surgical DRGs into CC levels all the pediatric age distinctions were removed from the DRGs. To
create the MS-DRGs, individual DRGs were subdivided into three, two or one level depending on
the CC impact on resources used for that patient. The two way subdivision either created a
separate level for just the major CC patients or a separate level for the non CC patients. The CC
levels relate to the relative severity of illness of the patient. In the MS-DRG version 25, 152 DRGs
had 3 CC levels, 107 DRGs had two CC levels and 76 DRGs had no CC levels resulting in 745
MS-DRGs which is a net increase of 207 DRGs over the 538 in version 24. The following table
provides the MS-DRG version 37.0 subdivisions:

Table 2. MS-DRG v37.0 subdivisions

Base MS-DRGs Split Type Total MS-DRGs
159 3-way 477

42 2-way MCC/CC and no CC 84

66 2-way MCC and CC/no CC 132

68 No split 68

335 Total Base [blank] 761 Total MS-DRGs
2.

In MS-DRG version 37.0 there are 72,184 diagnoses and 77,559 procedures.

The Deficit Reduction Act of 2005 (P.L.109-171) requires CMS to eliminate any increase in
payment due to the occurrence of selected post admission complications, known as Hospital
Acquired Conditions (HACs). HACs are harmful events (e.g. accidental laceration during a
procedure) or negative outcomes (e.g. decubitus ulcer) that result from the processes of care
and treatment rather than from a natural progression of underlying illness. Under the Medicare
inpatient prospective payment system, the occurrence of an HAC can result in a higher payment
because the presence of the HAC diagnosis may cause the patient to be assigned to a
higher-paying MS-DRG, in effect financially rewarding poor quality care.

Design and development of the Diagnosis Related Group (DRG)

When IPPS was implemented the standard claim form did not contain a specification of whether
a secondary diagnosis was present on admission (POA). The Deficit Reduction Act requires
hospitals to report a POA indicator for all diagnoses beginning in fiscal year 2008. The reporting
of the POA indicator allows complications that occur post admission to be identified. The Deficit
Reduction Act requires that the post admission complications selected as HACs be (1) high cost,
high volume, or both; (2) be a CC or Major CC in MS-DRGs and (3) be reasonably preventable
through the application of evidence-based guidelines. For Fiscal Year 2009, CMS designated 12
conditions as HACs:

1. Foreign object retained after surgery

2. Air embolism

3. Blood incompatibility

4. Stage III and IV pressure ulcers

5. Falls and trauma

6. Catheter-associated urinary tract infection (UTI)

7. Vascular catheter-associated infection

8. Surgical site infection – Mediastinitis following Coronary Artery Bypass Surgery (CABG)

9. Manifestations of poor glycemic control

10. Deep vein thrombosis (DVT) /pulmonary embolism (PE) following total knee replacement
or hip replacement

11. Surgical site infection following bariatric surgery

12. Surgical site infection following certain orthopedic procedures of spine, shoulder or
elbow

For Fiscal Year 2013, two additional HACs were added:

13. Surgical site infection following cardiac device procedures

14. Iatrogenic pneumothorax with venous catheterization.

If an HAC diagnosis is present at admission, it will continue to be classified as a CC or major CC
and allowed to affect the MS-DRG assignment. However, if the HAC diagnosis is not present at
admission, it will no longer be classified as a CC or major CC and will not affect MS-DRG
assignment. The exclusion of an HAC diagnosis from MS-DRG assignment does not necessarily
mean the MS-DRG will change. Some MS-DRGs are not differentiated by the presence of a CC or
Major CC. For such MS-DRGs the exclusion of an HAC diagnosis will have no impact on MS-DRG
assignment. Further, if in addition to an HAC diagnosis there are non-HAC diagnoses present that
are a CC or major CC, the exclusion of the HAC diagnosis may not change the MS-DRG. Beginning
in Fiscal Year 2009, HAC diagnoses are excluded from MS-DRG assignment.

The actual process of forming the DRGs was highly iterative, involving a combination of
statistical results from test data with clinical judgment. At any point during the definition of the
DRGs there would often be several patient characteristics which appeared important for
understanding the impact on hospital resources. The selection of the patient characteristics to

Design and development of the Diagnosis Related Group (DRG)

be used and the order in which they would be used was a complex task with many factors
examined and weighed simultaneously. A complete list of the MS-DRGs is contained in Appendix
A in the MS-DRG definitions manual.

There are several MS-DRGs which contain patients whose medical record abstracts contain
clinically inconsistent or invalid information. For example, there are MS-DRGs for patients for
whom all their operating room procedures performed are unrelated to the major diagnostic
category of the patient’s principal diagnosis. Typically, these are patients admitted for a
particular diagnosis requiring no surgery, who develop a complication unrelated to the principal
diagnosis and have an operating room procedure performed for the complication or have a
diagnostic procedure performed for another concurrent diagnosis. The unrelated operating
room procedures have been divided into two groups based on hospital resource use: extensive
and non-extensive. For example, a patient with a principal diagnosis of congestive heart failure
who develops acute cholecystitis and whose only procedure is a resection of gallbladder
(cholecystectomy in ICD-9-CM) will be assigned to the extensive unrelated procedure MS-DRG
since a cholecystectomy is considered an extensive procedure. However, if a patient has a
principal diagnosis of arrhythmia and has a diagnostic excision of breast (breast biopsy in
ICD-9-CM) discovered while in the hospital, the patient will be assigned to the non- extensive
unrelated MS-DRG since the biopsy is considered a non-extensive procedure. The complete
definition of unrelated operating room procedures is contained in Appendix F.

When a principal diagnosis is coded which, although it is a valid ICD-10-CM code, is not precise
enough to allow the patient to be assigned to a clinically coherent MS-DRG the patient is
assigned to a diagnosis invalid as principal diagnosis MS-DRG. For example, ICD-10-CM code
O0930 is an unspecified complication of pregnancy with the episode of care unspecified. Thus,
this diagnosis code does not indicate the type of complication nor whether the episode of care
was antepartum, postpartum or for delivery. Since the MS-DRG definitions assign patients to
different sets of MS-DRGs depending on whether the episode of care was antepartum,
postpartum or for delivery, a patient with a principal diagnosis of O0930 must be assigned to the
diagnosis invalid as principal diagnosis MS-DRG.

It should be noted that patients with a principal diagnosis not typically considered a reason for
hospitalization such as Z413 (ear piercing) are not assigned to the diagnosis invalid as principal
diagnosis MS-DRG but are assigned a MS-DRG in the MDC most related to the diagnosis.

Patients are assigned to an ungroupable MS-DRG if certain types of medical records errors which
may affect MS-DRG assignment are present. Patients with an invalid or non-existent ICD-10-CM
code as principal diagnosis will be assigned to the ungroupable MS-DRG. Patients will also be
assigned to the ungroupable MS-DRG if their sex, or discharge status is both invalid and
necessary for MS-DRG assignment. For example, if a patient has a non-numeric discharge status
and has a principal diagnosis of an acute myocardial infarction, the patient will be assigned to
the ungroupable MS-DRG since patients with acute myocardial infarction will be assigned to
different MS-DRGs depending on whether their discharge status is alive or died. On the other
hand, if the same patient had a principal diagnosis of hypertension, the assignment would not be
to the ungroupable MS-DRG since discharge status is not used in the determination of the
MS-DRG for hypertensive patients.

Design and development of the Diagnosis Related Group (DRG)

The DRGs were originally developed at the Yale University School of Organization and
Management during the 1970’s under contract to the Centers for Medicare and Medicaid
Services (formerly Health Care Financing Administration). The second version and all subsequent
versions of the DRG definitions have been updated by 3M Health Information Systems under
contract with CMS. All versions of the DRGs, since the inception of the Medicare Prospective
Payment System, are summarized in the following table.

Table 3. Grouper versions

Grouper version Effective time period
MS-DRG 37.0 10/01/2019 – 09/30/2020

MS-DRG 36.0 10/01/2018 – 09/30/2019

MS-DRG 35.0 10/01/2017 – 09/30/2018

MS-DRG 34.0 10/01/2016 – 09/30/2017

MS-DRG 33.0 10/01/2015 – 09/30/2016

MS-DRG 32.0 10/01/2014 – 09/30/2015

MS-DRG 31.0 10/01/2013 – 09/30/2014

MS-DRG 30.0 10/01/2012 – 09/30/2013

MS-DRG 29.0 10/01/2011 – 09/30/2012

MS-DRG 28.0 10/01/2010 – 09/30/2011

MS-DRG 27.0 10/01/2009 – 09/30/2010

MS-DRG 26.0 10/01/2008 – 09/30/2009

MS-DRG 25.0 10/01/2007 – 09/30/2008

CMS 24.0 10/01/2006 – 09/30/2007

CMS 23.0 10/01/2005 – 09/30/2006

CMS 22.0 10/01/2004 – 09/30/2005

CMS 21.0 10/01/2003 – 09/30/2004

CMS 20.0 10/01/2002 – 09/30/2003

CMS 19.0 10/01/2001 – 09/30/2002

CMS 18.0 10/01/2000 – 09/30/2001

CMS 17.0 10/01/1999 – 09/30/2000

CMS 16.0 10/01/1998 – 09/30/1999

CMS 15.0 10/01/1997 – 09/30/1998

Design and development of the Diagnosis Related Group (DRG)

Grouper version Effective time period
CMS 14.0 10/01/1996 – 09/30/1997

CMS 13.0 10/01/1995 – 09/30/1996

CMS 12.0 10/01/1994 – 09/30/1995

CMS 11.0 10/01/1993 – 09/30/1994

CMS 10.0 10/01/1992 – 09/30/1993

CMS 9.0 10/01/1991 – 09/30/1992

CMS 8.0 10/01/1990 – 09/30/1991

CMS 7.0 10/01/1989 – 09/30/1990

CMS 6.0 10/01/1988 – 09/30/1989

CMS 5.0 10/01/1987 – 09/30/1988

CMS 4.0 10/01/1986 – 09/30/1987

CMS 3.0 05/01/1986 – 09/30/1986

CMS 2.0 10/01/1983 – 04/30/1986

Summary
The DRGs, as they are now defined, form a manageable, clinically coherent set of patient classes
that relate a hospital’s case mix to the resource demands and associated costs experienced by
the hospital. DRGs are defined based on the principal diagnosis, secondary diagnoses, surgical
procedures, age, sex and discharge status of the patients treated. Through DRGs, hospitals can
gain an understanding of the patients being treated, the costs incurred and within reasonable
limits, the services expected to be required. The classification of patients into DRGs is a
constantly evolving process. As coding schemes change, as more comprehensive data is
collected or as medical technology or practice changes, the DRG definitions will be reviewed and
revised.

DRG versions 2.0–32.0 were defined using the ICD-9-CM codeset. MS-DRG v37.0 was
implemented using the ICD-10-CM/PCS codeset effective October 1, 2019.

Design and development of the Diagnosis Related Group (DRG)

Type of Surgery

O.R.
Procedure

Principal Diagnosis

Major Surgery

Major
Diagnostic
Category

Minor Surgery

Other Surgery

Surgery
Unrelated to

Principal
Diagnosis

Specific
Conditions

Relating to the
Organ System

Symptoms

Other

Neoplasm
No

Yes

Figure 1: Typical DRG structure for a Major Diagnostic Category

2/2/22, 5:34 PM What Is Value-Based Healthcare?

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B R I E F A R T I C L E

What Is Value-Based Healthcare?
Explore the definition, benefits, and examples of value-based healthcare. How does value-based healthcare
translate to new delivery models?

NEJM Catalyst

January �, ��

This article appeared in NEJM Catalyst prior to the launch of the NEJM Catalyst Innovations in Care Delivery journal. Learn
more.

Value-based healthcare is a healthcare delivery model in which providers, including hospitals and physicians, are paid
based on patient health outcomes. Under value-based care agreements, providers are rewarded for helping patients
improve their health, reduce the effects and incidence of chronic disease, and live healthier lives in an evidence-based
way.

Value-based care differs from a fee-for-service or capitated approach, in which providers are paid based on the amount
of healthcare services they deliver. The “value” in value-based healthcare is derived from measuring health outcomes
against the cost of delivering the outcomes.

What Are the Benefits of Value-Based Healthcare Delivery?

The benefits of a value-based healthcare system extend to patients, providers, payers, suppliers, and society as a whole.

Value-Based Healthcare Benefits: Lower Healthcare Costs, Higher Patient Satisfaction, Reduced Risks

Figure � . 

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1. Patients spend less money to achieve better health. Managing a chronic disease or condition like cancer,
diabetes, high blood pressure, COPD, or obesity can be costly and time-consuming for patients. Value-based care
models focus on helping patients recover from illnesses and injuries more quickly and avoid chronic disease in the
first place. As a result, patients face fewer doctor’s visits, medical tests, and procedures, and they spend less money
on prescription medication as both near-term and long-term health improve.

2. Providers achieve efficiencies and greater patient satisfaction. While providers may need to spend more
time on new, prevention-based patient services, they will spend less time on chronic disease management. Quality
and patient engagement measures increase when the focus is on value instead of volume. In addition, providers are
not placed at the financial risk that comes with capitated payment systems. Even for-profit providers, who can
generate higher value per episode of care, stand to be rewarded under a value-based care model.

3. Payers control costs and reduce risk. Risk is reduced by spreading it across a larger patient population. A
healthier population with fewer claims translates into less drain on payers’ premium pools and investments. Value-
based payment also allows payers to increase efficiency by bundling payments that cover the patient’s full care
cycle, or for chronic conditions, covering periods of a year or more.

4. Suppliers align prices with patient outcomes. Suppliers benefit from being able to align their products and
services with positive patient outcomes and reduced cost, an important selling proposition as national health
expenditures on prescription drugs continue to rise. Many healthcare industry stakeholders are calling for
manufacturers to tie the prices of drugs to their actual value to patients, a process that is likely to become easier with
the growth of individualized therapies.

5. Society becomes healthier while reducing overall healthcare spending. Less money is spent helping
people manage chronic diseases and costly hospitalizations and medical emergencies. In a country where
healthcare expenditures account for nearly 18% of Gross Domestic Product �GDP�, value-based care has the
promise to significantly reduce overall costs spent on healthcare.

How Does Value-Based Healthcare Translate to New Delivery Models?

The proliferation of value-based healthcare is changing the way physicians and hospitals provide care. New healthcare
delivery models stress a team-oriented approach to patient care and sharing of patient data so that care is coordinated
and outcomes can be measured easily. Two examples are reviewed here.

Value-Based Care Models: Medical Homes

In value-based healthcare models, medical care does not exist in silos. Instead, primary, specialty, and acute care are
integrated, often in a delivery model called a patient-centered medical home �PCMH�. A medical home isn’t a physical
location. Instead, it’s a coordinated approach to patient care, led by a patient’s primary physician who directs a patient’s
total clinical care team.

PCMHs rely on the sharing of electronic medical records �EMRs� among all providers on the coordinated care team.
The goal of EMRs is to put crucial patient information at each provider’s fingertips, allowing individual providers to see
results of tests and procedures performed by other clinicians on the team. This data sharing has the potential to reduce
redundant care and associated costs.

Value-Based Care Models: Accountable Care Organizations

Accountable care organizations �ACOs� were originally designed by the Centers for Medicare & Medicaid Services
�CMS� to provide high-quality medical care to Medicare patients. In an ACO, doctors, hospitals, and other healthcare
providers work as a networked team to deliver the best possible coordinated care at the lowest possible cost. Each
member of the team shares both risk and reward, with incentives to improve access to care, quality of care, and patient
health outcomes while reducing costs. This approach differs from fee-for-service healthcare, in which individual
providers are incentivized to order more tests and procedures and manage more patients in order to get paid more,
regardless of patient outcomes.

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F E B R U A RY �, ��

Like PCMHs, ACOs are patient-centered organizations in which the patient and providers are true partners in care
decisions. Also like PCMHs, ACOs stress coordination and data sharing among team members to help achieve these
goals among their entire patient population. Clinical and claims data are also shared with payers to demonstrate
improvements in outcomes such as hospital readmissions, adverse events, patient engagement, and population health.

Hospital Value-Based Purchasing

Under CMS’s Hospital Value-Based Purchasing Program �VBP�, acute care hospitals receive adjusted payments based
on the quality of care they deliver. According to the CMS website, the program encourages hospitals to improve the
quality and safety of acute inpatient care for all patients by:

Eliminating or reducing adverse events �healthcare errors resulting in patient harm�
Adopting evidence-based care standards and protocols that make the best outcomes for the most patients
Changing hospital processes to create better patient care experiences
Increasing care transparency for consumers
Recognizing hospitals that give high-quality care at a lower cost to Medicare

CMS is expected to continue to refine its VBP measurements, making it important for hospitals to continuously
improve their clinical outcomes so they can simultaneously improve reimbursement and their reputation among
healthcare consumers.

What Is the Future of Value-Based Healthcare?

Moving from a fee-for-service to a fee-for-value system will take time, and the transition has proved more difficult than
expected. As the healthcare landscape continues to evolve and providers increase their adoption of value-based care
models, they may see short-term financial hits before longer-term costs decline. However, the transition from fee-for-
service to fee-for-value has been embraced as the best method for lowering healthcare costs while increasing quality
care and helping people lead healthier lives.

NEJM Catalyst

Topics

Value-Based Care

Accountable Care Organizations (ACO)

P H YS I C I A N J O B S

Silver Spring, MarylandChiefs / Directors / Dept. Heads

Director, Center for Tobacco Products

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Northwell Health – Senior Director, Division of Hematopathology

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Sleepy Hollow, New YorkChiefs / Directors / Dept. Heads

Associate Medical Director, Emergency Medicine – Phelps Hospital – Sleepy Hollow, New York

Salt Lake City, UtahChiefs / Directors / Dept. Heads

Medical Director, Neonatology Level II NICU/Special Care Nursery

Sayre, PennsylvaniaChiefs / Directors / Dept. Heads

Chair, Department of Medicine

New YorkChiefs / Directors / Dept. Heads

Director of Heart Failure – Westchester, Northern Westchester Hospital and Phelps Hospital

JAN ��

NOV ��

A R T I C L E VOL. � NO. �

ACO and Social Service Organization Partnerships: Payment, Challenges, and Perspectives
D. Velasquez and J.F. Figueroa

The intersection between health care and social services is increasingly relevant to care delivery, but the contractual
mechanisms in place have yet to produce evidence of the clinical or operational improvements that are needed to
support and expand the model.

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Health Technology, Quality, Law,
and Ethics

Chapter 15

The New Public Health. http://dx.doi.org/10.1016/B978-0-12-415766-8.00015-X
Copyright © 2014 Elsevier Inc. All rights reserved.

Learning Objectives

Upon completion of this chapter, the student should be
able to:
1. Describe responsibility for and methods of assessing and

regulating technological developments in health care;
2. Describe methods of health facility accreditation and

peer review;
3. Describe the concept of total quality management;
4. Identify and discuss ethical and legal issues in national

health systems;
5. Apply ethical considerations to health issues in his or

her home setting.

INTRODUCTION

Management of a production or a service system requires
attention to the quality of personnel as much as to the system
in which they work. Their motivation and sense of participa-
tion, the scientific and technological level of the program,
and the legal and ethical standards of individual providers
and of the system as a whole, are all important to the quality
of care provided and equity of health status achieved.

Quality is the result of input and process, and is measured
by outcome or performance indicators as well as perception
of the service by the patients, the staff, and the community
as a whole. Input refers to the institutional and financial
resources for education, human resources, supplies, medica-
tions, vaccines, diagnostic capacity, and services available.
Process refers to the use of those resources, including peer
group expectations of professionalism. Outcomes generally
include measures of morbidity, mortality, and functional sta-
tus of the patient and the population. Defining and measuring
achievements of national health objectives and targets, the
methods of financing services, and the efficiency of organi-
zation help to determine quality. Training, supply, and dis-
tribution of health personnel are all determinants of access
to and quality of care. Continuous and adequate availability
of essential preventive, diagnostic, and treatment services,
as well as accountability and internal methods of promoting
standards, are all elements of the quality of a health service

771

for the individual, the population as a whole, and groups
within the population with special needs.

The content and standards of service are assessed
through organized review by professional peers within
an institution, and from outside. Peer review within an
institution and external evaluation by accreditation or
governmental inspection, based on cumulative evidence
and the recognized current “state of the art”, contribute
to accountability and improved quality of care. Continu-
ous quality improvement (CQI) among health care teams
and organizations includes regular practice assessments,
evidence gathering, remediation, and re-evaluation, which
will be discussed later in this chapter. The perception of
the services by the community, along with the knowledge,
attitudes, beliefs, and practices of health, are all vital to
improvement of health status.

Health-related technology is also in a continuing state
of change. Systematic review and absorption of new scien-
tific knowledge, technology, and innovations are essential
to promote and renew health care methods. Public health
serves in a regulatory role to assure high-quality care to the
individual and the community. New technology, whether in
the form of diagnostic procedures, new drugs, devices, or
vaccines, or new types of health personnel, requires evalu-
ation for effectiveness and appropriateness to the system.

Technology assessment also involves epidemiological and
economic aspects of effectiveness. Failure to continuously
monitor developments and to assimilate those that are demon-
strably successful is an ethical and management failure which
tragically costs many millions of lives from preventable dis-
eases yearly, such as in delayed adoption of well-proven vac-
cines or tobacco restriction legislation. This is due to political
failure even more than professional weakness, and constitutes
one of the saddest ethical dilemmas of public health: failure
to convince policy makers of the prime importance of health
promotion and disease prevention in the health sector.

Ethics and law in public health reflect the values of a
society. They inevitably evolve as they face dramatic social,
economic, demographic, and political changes; new health
challenges; and new technological and scientific possibili-
ties for improving health. Ethics are the foundation of the
value systems of a society and thus of its health concepts.

772

Biblical sources articulated values of the Ten Command-
ments, Sanctity of Human Life, Improve the World, along
with the Hippocratic Oath of physicians to “do good and do
no harm”. Modern definitions of public health and bioethics
emerged from lessons learned from the horrors of eugenics
and genocide in the twentieth century with humanistic pre-
cepts of “Universal Human Rights” and “Health for All” in
the recent era (see Chapters 1 and 2).

The law is both permissive and restrictive. It sets the basic
responsibilities, powers, and limitations of public health prac-
tice, with legislation and court decisions. Innovations in the
technology of medical care and public health are powerful
forces contributing to increased longevity, quality of life, and
economic growth, but they also bring challenges to imple-
mentation impeded by additional costs of the health system
and slow adaptation in countries with the greatest need.
These are challenges to national and international political,

The New Public Health

organizational, and economic systems to address health with
the full potential for saving lives. Determining standards of
“good practice” is a continuing process with the rapid devel-
opment of new knowledge, technology, and experience.

The law is a dynamic process involving old and new
legislation, court decisions, and new issues not previously
faced, often following rather than anticipating public health
issues. Public health has had both positive and negative ethi-
cal experiences and continues to face new issues with chang-
ing population needs, technology, science, and economics.

INNOVATION, REGULATION, AND
QUALITY CONTROL

Health care technology has advanced with an increasing
stream of innovation since the seventeenth-century epidemi-
ological discoveries of Lind on scurvy (1747) and smallpox

TABLE 15.1 Health Care Innovations from the Seventeenth to the Twenty-First Centuries

Period Selected Highlights of Scientific, Technological, and Organizational Innovations in Health

17th century Biological basis of disease (Descartes), circulation of blood (Harvey), microscope (Leeuwenhoek)

18th century Thermometer, lime juice supplements (Lind, 1756), vaccination (Jenner, 1796), surgical anatomy (Hunter), clinical
sciences (Sydenham)

19th century Miasma theory vs germ theory; inventions of stethoscope (1816), blood transfusion (1818), anesthesia (1842),
hypodermic syringe (1852), ophthalmoscope (1851), laryngoscope (1855), pasteurization of wine, beer, milk
(1860s), cholera vaccine (1879), X-ray (1895), blood pressure cuff (1896); sanitation, municipal health depart-
ments, chlorination and filtration of community water supplies, antisepsis, Braille printing, hygiene in obstetrics,
nursing, microscopic pathology, pathological chemistry, microbiology, vaccines, X-ray, national health insurance,
syringes, well-child care, aspirin (1899), Bismarkian social insurance (1881)

1900–1930 Electrocardiogram (1901), Flexner report on medical education, salvarsan, insulin (1922), blood groups, vitamins,
conquest of yellow fever, vitamin B, vaccine for diphtheria (1923), tetanus vaccine (1924), electroencephalogram
(1924), iron lung respirator (1927), Social Security Act (1935), cost–benefit analysis, food fortification (iodized salt,
flour with vitamin B complex), improved work safety

1931–1945 Mandatory fortification of milk, salt, and flour in USA (1941), Pap test (1942), penicillin (1928), streptomycin,
randomized clinical trials, antimalarial drugs, vector controls, dialysis machine (1945)

1946–1960 Contact lens (1948), DNA double helix (1953), heart–lung bypass machine (1953), ultrasound (1955), cardiac
pacemaker (1958), Salk polio vaccine (1955), kidney transplant (1959), advances in vaccines, antihypertensives,
psychotropic drugs, cancer chemotherapy, prepaid group practice, UK National Health Service (1948), Medicare
in Canada (1946–1971)

1961–1980 Oral polio vaccine (Sabin), hip replacement (1962), oral rehydration therapy, measles vaccine (1964), coronary
bypass (1964), Medicare, Medicaid (1965), mammography (1965), portable defibrillator (1965), measles–mumps–
rubella vaccine, cost-effectiveness analysis, open heart surgery, pacemakers, organ transplantation, computed
tomography (CT), eradication of smallpox (1972), health maintenance organizations (HMOs), diagnosis-related
groups (DRGs), district health systems

1981–2000 Health promotion (1987), magnetic resonance imaging (MRI), positron emission tomography (PET), endoscopic
surgery, Helicobacter pylori and chronic peptic ulcer disease (1982), managed care, Haemophilus influenzae b
(Hib) vaccine, statins (1987), poliomyelitis eradication campaign (1982), local eradication of beta-thalassemia,
pandemic of HIV (1981 onward), AZT antiretroviral approved (1987), robotic surgery (2000)

2001–2013 Millennium Development Goals (MDGS 2000) with substantial progress achieved, managing emergencies of mass
terrorism and natural disasters, new vaccines (HPV), managing epidemics of measles and influenza, new diag-
nostic technologies, flour fortification to prevent birth defects, HIV still deadly but effective treatment and control
measures, new treatments for hepatitis C, robotic surgery, nanotechnology, scientific advances with great potential
benefit, Affordable Care Act (2010), Accountable Care Organizations

Source: Adapted from Health United States 2009. Special Feature: Medical technology. Introduction and timeline. 2009. Available at: http://www.ncbi.nlm.
nih.gov/books/NBK44737/#specialfeature.sec1 [Accessed 15 December 2012]. See Historical Markers in Chapter 1.

http://www.ncbi.nlm.nih.gov/books/NBK44737/#specialfeature.sec1

Chapter 15 Health Technology, Quality, Law, and Ethics

vaccination by Jenner (1796), to the dramatic innovations of
the end of the twentieth century (Table 15.1). The pace of
innovation is rapid, creating the need for regulation, quality
control, and technology assessment.

National governments are responsible for assuring that
pharmaceuticals, biological products, food, and the environ-
ment are regulated to protect the public. In some countries,
these responsibilities are divided among ministries of trade,
industry, commerce, health, and environment. In a federal
system of government, there may be a division of responsi-
bility among federal, state, and local government, but with
the national government often providing national standards
and leadership in this area.

Government regulation and control are meant to protect
the public health. The US Food and Drug Administration
(FDA) is responsible for enforcing the Food, Drug and Cos-
metic Act, the Fair Packaging and Labeling Act, sections of
the Public Health Services Act relating to biological prod-
ucts for control of communicable diseases, and the Radiation
Control for Health and Safety Act. The FDA is a Division
of the Department of Health and Human Services (DHHS).
State governments have the authority to supervise pharma-
cies and their products, which may be marketed across dif-
ferent states. All national governments have departments
responsible for conducting supervision of food, drugs, and
medical devices, often relying on international standards.

Drugs and devices include all drugs, diagnostic prod-
ucts, blood and its derivatives, biologicals, veterinary
medicines, and medicated premixed animal products. All
manufacturers and distributors are required by law to reg-
ister these products with the national authority in order to
be allowed to market or import them. All countries need to
govern the food, drugs, vaccines, and cosmetics regulated
for production, importation, marketing, and use within
their jurisdiction. Organizations within each government
must be responsible for assuring the consumer that foods
are pure (unadulterated) and wholesome, safe to eat, and
produced under sanitary conditions; that drugs and medical
devices are safe and effective for their intended uses; that
cosmetics are safe and made from appropriate ingredients;
and that labeling is truthful, informative, and not deceptive.

National authorities such as the FDA, under legisla-
tion and regulations, govern both domestic and imported
products. They establish and enforce standards, or adopt
external agency standards as a “gold standard”, meaning
that products meet high standards of safety and efficacy.
The FDA also monitors and inspects contents manufactur-
ing standards under good manufacturing practices (GMPs),
which includes regular accreditation of a manufacturer’s
facilities, staffing, planning, and monitoring capacity. Test-
ing of products is carried out to assess safety, potency, and
toxicity using accepted reference laboratory procedures as
published in the compendium Official Methods of Analysis
of the Association of Official Analytical Chemists.

773

When federal, state, or local investigators, sometimes
known as consumer safety officers, detect through labora-
tory monitoring or observe conditions that may result in a
public health hazard, and violation of food and drug laws
and regulations, they issue a written report to the manufac-
turers with recommendations for correcting the conditions.
In more blatant cases, the authorities may issue urgent recall
or seizure orders for products in violation of standards con-
stituting a danger to public health, such as contaminated
products, lead-painted children’s toys, or contaminated
foods causing foodborne disease outbreaks, which occur
not infrequently in imported and domestically produced
foods in the USA. The Los Angeles County Department of
Health inspects restaurants regularly and places a promi-
nent placard in the window giving a grade A, B, or C to
the restaurant for sanitation and safety. Those given D rat-
ings may be closed until specified faults are eliminated, or
a restaurant may be closed permanently. State governments
require restaurants to list calorie and salt content of foods
on their menus as part of the public health efforts to reduce
obesity.

Supervision of food standards may also fail, as occurred
in Israel in 2004 when total absence of vitamin B1 in a soy-
based baby formula imported from Germany resulted in
three deaths and permanent brain damage to other infants
due to severe beriberi. This episode led to criminal charges
in 2008 of negligence resulting in death against the own-
ers of the company that imported or produced the foods and
staff members of the Ministry of Health. Animal foods in
2007 and infant milk products imported from China in 2008
were found to be contaminated with melamine, which was
meant to mimic protein content but was toxic in combination
with other chemicals used. The infant formula caused seri-
ous illness in some 300,000 Chinese babies and six deaths.

The FDA and its counterparts in each country are
responsible for regulation of:

l food – foodborne illness, nutritional content, labeling,
dietary supplements

l drugs – prescription drugs and generics, over-the-counter
products

l medical devices – pacemakers, stents, contact lenses,
hearing aids

l biologics – vaccines, blood products
l animal feed and drugs – for livestock, pets
l cosmetics – safety, labeling
l radiation-emitting products – cell phones, lasers, micro-

waves
l combination products.

New drugs and biological products for human use are
required to pass rigorous review before approval for mar-
keting is granted. Applications are submitted by the manu-
facturer or sponsor with acceptable scientific data including
test results to evaluate the safety and effectiveness of the

774

product for the conditions under which it is being offered.
All manufacturers of drugs are required to be registered
with the FDA and to meet its requirements for each drug
produced and marketed, including the reporting of adverse
reactions and labeling criteria. Manufacturers are required
to operate in conformity with current GMPs, which include
stringent control over manufacturing processes, personnel
training, computerized operations, and testing of finished
products. The FDA publishes guidelines to help manufac-
turers to familiarize themselves with current standards. The
United States Pharmacopoeia, National Formulary, and
WHO Model Formulary 2008 are the official listings of
approved products.

Medical devices are also regulated by the FDA. Thou-
sands of products for health care purposes require premarket
approval, ranging from basic articles such as thermometers,
tongue depressors, and intrauterine devices (IUDs), to more
complex devices such as cardiac monitors, pacemakers,
breast implants, and kidney dialysis machines. These prod-
ucts are subject to controls of GMPs, labeling, registration
of the manufacturer, and performance standards.

Monitoring for efficacy and potential hazards has
been strengthened since the 1970s as a result of find-
ings of long-term carcinogenic and mutagenic effects of
estrogens, and toxic effects of chloramphenicol on bone
marrow. The drug thalidomide, widely used as an antin-
auseant and sleeping pill for pregnant women in Europe,
Canada, and Australia in the 1960s, was not approved by
the US FDA. This drug was found to cause large numbers
of serious birth deformities leading to its being banned in
most countries. Controls of blood and blood products have
been strengthened since the transmission of human immu-
nodeficiency virus (HIV), hepatitis B, and hepatitis C by
contaminated blood products in the 1980s. The responsi-
bility of this regulatory function is well illustrated by the
1995 criminal conviction of several senior health officials
in France for failing to stop the use of blood products con-
taminated with HIV in the mid-1980s. Concern regarding
possible carcinogenic effects of silicone breast implants
led to legal action and greater controls of all implantable
products. A balance between safety and well-regulated
approval of new products requires a highly professional
and motivated regulatory agency, well-developed proce-
dures, and well-trained staff.

The concepts of standardization of GMPs for pharma-
ceutical products and written protocols for good medi-
cal practice or good public health practice are accepted
norms based on best available evidence of current scientific
knowledge and experience. Recommended immunization
schedules, water quality, ambient air standards, food fortifi-
cation, and screening programs for early stages of diabetes
are examples of accepted practice that have become rec-
ommended standards of public health practice, paralleling
qualitative measures developed in clinical care.

The New Public Health

APPROPRIATE HEALTH TECHNOLOGY

The concept of intermediate technology pioneered by Dr
Ernst Schumacher in the 1960s proposed the development
of simple and inexpensive technology for developing coun-
tries such as India to promote local economic development.
Environmentally sustainable development and sources of
energy, energy conservation, and reductions in toxic and
harmful emissions are encouraged. In recent years ideas
have included small loan systems for rural entrepreneurs in
developing countries, and the use of simple cell phones for
communication, farm produce marketing, cash transfers in
remote areas without banking services, and many others.
Now called appropriate technology, this topic has gained
adherence in the health field in the search for low-cost and
simple techniques for preventing and managing common
illnesses.

Appropriate technology is defined by the World Health
Organization (WHO) as the level of medical technology
needed to improve health conditions in keeping with the
epidemiological, demographic, and financial situation of
each country. All countries have limited resources and
so must select strategies of health care and appropriate
technology to use those resources effectively to achieve
health benefits. Improved water pumps, solar energy, rain-
water collection and water reservoirs, sanitary latrines,
fly traps, insecticide-impregnated bed nets, biogas from
animal waste, improved home cooking stoves, and many
other simple devices can make enormous differences in
local sustainable agriculture, economic growth, and living
conditions. Cell phones are now used to monitor health
conditions such as hypertension, diabetes control, weight
and body mass index, and other non-communicable con-
ditions, and to transmit imaging from remote areas to
specialists in medical centers who can provide test read-
ings online. Simple, affordable, portable information tech-
nology can effectively support public health programs,
even in resource-poor environments.

The topics discussed in the growing literature and meet-
ings of the International Society of Technology Assessment
in Health Care represent the dynamic field of technology
assessment. The issues range from economic evaluation
of pharmaceuticals to modeling approaches, measures of
quality of life, technology dissemination and impact, and
outcomes measurement. The range of issues also includes
finance and health insurance, health care in developing
countries, informatics, telemedicine, technologies for the
disabled, screening, and cost-effectiveness. Evaluations
in the scrutiny of both high- and low-technology services
based on a combination of clinical, epidemiological, and
economic factors are necessary. As health costs rise, dis-
abling conditions increase and populations age, medical
innovation proceeds at a rapid rate, and both client and
community expectations in health care continually rise.

Chapter 15 Health Technology, Quality, Law, and Ethics

In developing countries, the training and supervision of
traditional birth attendants (TBAs) for prenatal preparation
and normal deliveries are important ways to reduce maternal
mortality in rural areas, as discussed elsewhere, and an impor-
tant Millennium Development Goal (MDG) which will not
be met by 2015. Community health workers (CHWs) in well
supervised and supported programs are essential to provide
preventive care to underserved rural poor populations with a
defined package of services that can be tailored to meet spe-
cific local needs, such as immunization, child growth moni-
toring, nutrition counseling, and malaria and TB control.

A major example of appropriate technology has
been the WHO initiatives to promote national drug for-
mularies (NDFs) as a consensus list of essential drugs
that are sufficient for the major health needs of a coun-
try, eliminating unnecessary duplication and combined
products on the commercial market. The WHO calls on
all member states to ensure the availability and rational
use of drugs and vaccines, and supports states wishing
to select an essential list of drugs for economic procure-
ment. Assistance with drug regulatory agencies, legisla-
tion, quality control, information, supply, and training is
offered to help the member countries. Standard reference
laboratories, the International Pharmacopoeia, and the
WHO Drug Bulletin promote international standards and
provide guidance to member states. The WHO Model List
of Essential Drugs is a valuable tool to improve quality
and cost management in national health systems.

Cochlear implants are now routinely used for chil-
dren with congenital or other loss of hearing, as well as in
elderly people. In August 2013, a new cell phone applica-
tion was announced which photographs the eye and can be
used to diagnose cataracts, macular degeneration (AMD),
and other eye pathology, for interpretation by experts far
away and to enable arrangements to be made for appropri-
ate intervention to prevent blindness, which is common in
developing countries. Other applications allow for moni-
toring of blood sugar of diabetics, hypertension, exercise,
dietary management, and other aspects of health. In the
same month, a camera, computer, and auditory device
allowing blind people to “see and read” was demonstrated.
The costs of such devices are initially high but will fall with
advances in computing and other technical developments.

In both developing and industrialized countries major
causes of death include cardiovascular diseases (coronary
heart disease and stroke), along with respiratory diseases,
cancer and injuries, all amenable to preventive and cura-
tive medical care. The key preventive measures for these
are: healthful diet, reduced obesity, smoking cessation,
exercise and physical fitness, hypertension management,
aspirin, immunizations and other low-cost and highly effec-
tive medications such as statins. These are all low-cost self-
care measures that can be promoted by local, state, and
national governments, private advocacy organizations, and

775

individuals in their families and communities. The princi-
ples of low technology, cost-effectiveness, and sound health
policy converge in addressing these fundamental issues.

Priority Interventions in Low- and Medium-
Income Countries

Disease control priorities for low- and medium-income coun-
tries are an important challenge for public health. Selection has
often been based on individual initiatives due to strong advo-
cacy in international organizations by donor countries, orga-
nizations, or individuals. In 1993, two landmark documents
attempted to apply a logical system to such considerations:
one was the World Bank’s now classic World Development
Report: Investing in Health and the other was Disease Control
Priorities in Developing Countries. The World Development
Report defined cost-effective clinical and public health cluster
programs essential to improving health outcomes for low- and
middle-income developing countries. The programs focus on
those diseases that contribute heavily to the burden of disease
and are amenable to relatively inexpensive interventions. The
report defined interventions most able to reduce the burden
of disease in low- and middle-income countries using clinical
and public health interventions, as summarized in Table 15.2.

The 1993 World Development Report provided policy
makers and public health practitioners with a concept
and tools for assessing cost-effectiveness of available
interventions for the major health problems in the devel-
oping world. It also provided useful measuring tools in
the form of disability-adjusted life years (DALYs) to
calculate the burden of disease and the cost-effective-
ness of interventions to address them. This World Bank
report addressed clinical interventions that would reduce
DALYs lost by 24 percent in low-income countries and
8 percent in middle-income countries, including treat-
ment of TB, with directly observed therapy, short course
(DOTS); integrated management of the sick child; pre-
natal and delivery care; family planning; treatment of
STIs; and limited care for pain, infections, and trauma
as resources permit. It also addressed public health inter-
ventions, which would reduce DALYs lost by 8.2 percent
in low-income countries and 4 percent in middle-income
countries, expanded immunization with vitamin A sup-
plements; tobacco and alcohol control; AIDS prevention;
and school health including deworming. Together, the
total reductions would be 32 percent for low-income and
12 percent for middle-income countries (Table 15.2).

These estimates have been refined by numerous stud-
ies conducted over the subsequent two decades. The sec-
ond edition of the Disease Control Priorities in Developing
Countries (2006) incorporates important changes in the
technologies available. The concept of viewing priorities
with an economic epidemiology model is still applicable,
and has increased in importance (Box 15.1).

776

As the MDGs are reaching their endpoint in 2015,
follow-up global health targets will need to recognize the
vital importance of non-communicable diseases (NCDs)
in developing countries. The global consensus on MDGs,
set out by the United Nations (UN) in 2001, indicates
progress in the epidemiological understanding of realities

TABLE 15.2 World Bank Model for Priority Cost-
Effective Health Interventions in Low- and Middle-
Income Developing Countries

Burden of Disease Averted
(%)

Service Type Low-Income
Countries

Middle-Income
Countries

Public health interventions

EPI-plus immunization (DPT,
polio, measles, BCG, hepatitis
B, yellow fever, vitamin A)

6.0 1.0

Other public health programs
(family planning, health, and
nutrition education)

NA NA

Tobacco and alcohol control
programs

0.1 0.3

AIDS prevention program 2.0 2.3

School health program
(including deworming)

0.1 0.4

Subtotal (public health) 8.2 4.0

Clinical interventions

Treatment of tuberculosis
(short course)

1.0 1.0

Integrated management of the
sick child

14.0 4.0

Prenatal and delivery care 4.0 –

Family planning 3.0 1.0

Treatment of STIs 1.0 1.0

Limited care: pain, trauma,
infection plus as resources
permit

1.0 1.0

Subtotal (clinical care) 24.0 8.0

Total 32.2 12.0

Note: Low-income = < US$350 gross national product (GNP) per capita; middle income = > US$2500 GNP per capita. Cost per immunized
child = US$14.60 (US$0.50 per capita) and US$27.20 (US$0.80 per
capita) in low- and middle-income countries, respectively.
DPT = diphtheria–pertussis–tetanus; BCG = bacille Calmette–Guérin;
AIDS = acquired immunodeficiency syndrome; STI = sexually transmitted
infection.
Note: The World Development Report was an innovative basis for follow-
up work, as reported in Jamison DT, Breman JG, Measham AR, Alleyne
G, Claeson M, Evans DB, et al., editors. Disease control priorities in
developing countries. 2nd ed. Disease Control Priorities Project. Wash-
ington, DC: World Bank; 2006.
Source: Adapted from World Bank. World development report. Investing
in health. New York: Oxford University Press; 1993.

The New Public Health

in low-income countries and the need for consensus over
common targets. Since then, attention has been directed
towards the epidemiological shift to NCDs, which are the
most common causes of death in low- and medium-income
countries. Thus there is a double burden of infectious, nutri-
tion, maternal, and child priorities, alongside the NCDs.
The increasing adoption of vaccines such as Haemophilus
influenzae type b (Hib) and rotavirus alongside the standard

BOX 15.1 Disease Control Priorities in Developing
Countries

l Average life expectancy in low- and middle-income
countries increased dramatically since the 1960s, while
cross-country health inequalities decreased.

l Improved health has contributed significantly to eco-
nomic welfare since the 1960s.

l Five critical challenges face developing countries (and
the world) at the beginning of the twenty-first century:
– Rapid demographic growth
– HIV pandemic improved but still rampant
– Persistent malaria, TB, diarrhea, pneumonia
– Micronutrient malnutrition for mothers and infants
– NCDs
– Possible pandemics.

l Cost-effective interventions include:
– Interventions to reduce neonatal mortality (50 per-

cent of total child deaths)
– Treatment of HIV-positive mothers, treatment of sex-

ually transmitted infections
– Controlling tobacco use, particularly through

taxation
– Lifelong medical management of risk factors in indi-

viduals at high risk for heart attacks or strokes, using
aspirin and other drugs, would benefit tens of millions
of individuals.

l Reform of health services and systems is needed,
including:
– Provider incentives
– Provider focus on selected intervention to gain

experience
– Strengthening surgical capacity at district hospitals
– Targeting limited resources to diseases affecting the

poor, e.g., TB in low-income countries
– In middle-income countries, public finance (or pub-

licly mandated finance) of a substantial package of
clinical care for all.

l Generation and diffusion of new knowledge and prod-
ucts underpinned the enormous improvements in health
in the twentieth century and need to be applied for the
control of NCDs, HIV, TB, and neglected populations.

Note: HIV = human immunodeficiency virus; TB = tuberculosis;
NCD = non-communicable disease.
Source: Adapted from Jamison DT, Breman JG, Measham AR, Alleyne
G, Claeson M, Evans DB, et al., editors. Disease control priorities in
developing countries. Chapter 1, Investing in health, Table 1.1. 2nd ed.
Washington, DC: World Bank; 2006.

Chapter 15 Health Technology, Quality, Law, and Ethics

diphtheria–pertussis–tetanus (DPT), poliomyelitis (polio),
and measles–mumps–rubella (MMR) vaccines provides
new possibilities to control the major infectious disease
killers of children. New technologies such as the advent of
antiretroviral treatment for HIV have led to startlingly suc-
cessful improvements in the quality of life and longevity of
HIV/AIDS patients, and the prevention of onward transmis-
sion of HIV from mothers to babies and sexual partners.
The WHO and many other global health stakeholders con-
tinue this work and produce analyses to contribute to policy
making based on economic epidemiological evidence. This
work affects policy, slowly but importantly.

In 2003, the Bellagio Study Group on Child Survival
estimated that the lives of 6 million children could be saved
each year if 23 proven interventions were universally avail-
able in the 42 countries in which 90 percent of child deaths
occurred in 2000. The MDGs set out in 2001 provided tar-
gets for economic, educational, and environmental improve-
ments, with three specifically focused on health: reducing
child mortality; reducing maternal mortality; and control of
HIV, TB, and other diseases. While important progress is
being made, some of these targets will not be achieved by
2015. The global public health infrastructure will need to be
expanded in content and strengthened in order to implement
lessons learned in childhood routine immunization, safe
maternity care, and nutritional security (see Chapter 16).

In medium- and low-income countries the difficulties are
much more severe because of limited resources for health and
the weak infrastructure of facilities and human resources in
many countries. The key issues relate to NCDs, as in developed
countries, so the interventions most needed address cardiovas-
cular diseases, cancer, and injury, as well as diarrheal diseases,
malnutrition, vaccine-preventable diseases, HIV, TB, malaria,
and neglected tropical diseases. Efforts should be focused on
low-cost interventions such as smoking reduction, vitamin and
mineral fortification of foods, HIV, TB, and malaria control,
along with maternal and child health protection.

Priority Selection in High-Income Countries

As discussed in Chapters 5 and 13, high- and middle-income
countries also face complex health challenges, including
aging populations, health costs, rapid development of new
drugs and technologies, high rates of NCDs, and the rising
prevalence of obesity and diabetes. Selection of priorities
for health care expenditure from public and private sources
has become a major focus of managing health systems.

In the industrialized countries, technological advances in
the medical and public health fields have been major contribu-
tors to increasing longevity but also rising health costs. This
situation has led to pressures for greater selectivity in adopting
costly innovations without adequate assessment of benefits
and costs. Many countries have adopted more cautious poli-
cies with regard to financing high levels of expansion of new

777

technology in the field of medical equipment, clinical proce-
dures, or medications. Organized assessment of technology is
now an essential feature of health management at the interna-
tional, national, and local levels of service delivery. The major
responsibility for technology assessment is at the national
level, even with decentralization of service management.

With available resources being limited, health systems
must choose interventions to be selected and how health
systems are to be organized for efficiency and effectiveness
while meeting public expectations. The US Patient Protec-
tion and Affordable Care Act (PPACA, more generally called
ACA or “Obamacare”) is undertaking reform measures to
promote efficiency and prevention to reduce per capita health
costs and to include more people in prepaid health care (see
Chapters 10 and 13). These include preventive measures as
recommended by Healthy People 2020 and implementation
committees for selection of cost-effective measures to reduce
morbidity and mortality to reduce health costs. The range
of services to be promoted includes smoking cessation,
increased physical activity, weight loss, healthy dietary prac-
tices, cancer screening, and many others that have not been
previously accessible to those living in poverty and with no
or limited health insurance. There is an emphasis on vaccina-
tion for children and adults.

The WHO promotes the widespread use of basic radio-
logical units (BRUs) to increase access to low-cost, effective,
diagnostic X-rays, especially in rural areas in developing
countries. BRUs are hardy, relatively inexpensive pieces of
radiological examination equipment that can be used in harsh
field conditions for simple diagnosis of fractures and respi-
ratory infections. The WHO estimates that 80 percent of all
diagnostic radiology can be performed adequately using sim-
ple, safe, and low-cost equipment, supported by training of
local people to operate and maintain the equipment. This is a
consensus view of leading radiologists and clinicians helping
the WHO to develop model equipment and training material.

The WHO World Health Report of 2009 focused on
health technology assessment, stating:

“Technology continues to transform the medical care system and
to improve length and quality of life – but at substantial cost. It
is almost inconceivable to think about providing health care in
today’s world without medical devices, machinery, tests, computers,
prosthetics, or drugs. Medical technology can be defined as the
application of science to develop solutions to health problems or
issues such as the prevention or delay of onset of diseases or the
promotion and monitoring of good health.”

Appropriate technology in the health field is becoming
increasingly complex, laden with economic, legal, and ethi-
cal issues. Professional and public opinion demands make
this a highly sensitive area of health policy, but responsible
management of resources requires decision making that
includes consideration of the effectiveness, costs, and alter-
natives of any new technology (Box 15.2). Failure to adopt

778

new innovations can result in obsolescence, while excessive
expenditures for hospitals and medical technology prevent
a health system from developing more cost-effective pre-
ventive approaches, such as improved ambulatory care, or
supportive care for the chronically ill.

HEALTH TECHNOLOGY ASSESSMENT

Technology adoption can be a highly emotional and con-
troversial issue, in advocacy of new cancer treatments or in
criticism of managed care or national regulatory agencies,
but spending limited national resources on some devices
or medications of unproven value or inappropriately long
hospital stays denies resources needed for other aspects of
health care. A society must be able and willing to pay for
medical innovation or improving quality of life by medical
and public health interventions. Underfunding of a health
system can deny these benefits just as misallocation of
resources does, and this is a political issue even more than
a professional one.

Medical and health technology assessment is the pro-
cess of determining the contribution of any form of care
to the health of the individual and community. It is a sys-
tematic analysis of the anticipated impact of a particular

BOX 15.2 Health Technology Assessment

Questions that form the basis of technology assessment for a
medical innovation include the following:
l Is it safe and cost-effective for the stated purpose?
l Is it a new service, or does it replace a less efficient inter-

vention which can be phased out of service?
l What is the need it addresses?
l Where is it in the order of priorities of development of

the facility?
l Does it duplicate a service already available in the

community?
l Does it make medical sense (i.e., does it help in diagnosis

and treatment for the patient’s benefit)?
l What are the alternatives?
l What are the resources needed in terms of supplies, staffing,

and upkeep?
l Can the facility afford it?
l What could otherwise be done with the resources it

requires?

Sources: Adapted from Kass N. Public health ethics: from foundations
and frameworks to justice and global public health. J Law Med Ethics
2004;32:232–42.
Sullivan SD, Watkins J, Sweet B, Ramsey SD. Health technology assess-
ment in health-care decisions in the United States. Value Health
2009;12:S39–44. Available at: http://www.ispor.org/htaspecialissue/
Sullivan [Accessed 14 December 2012].
Velasco-Garrido M, Busse R. Policy brief: Health technology assessment:
an introduction to objectives, role of evidence, and structure in Europe.
Geneva: WHO on behalf of the European Observatory on Health Systems
and Policies; 2005. Available at: http://www.euro.who.int/__data/assets/
pdf_file/0018/90432/E87866 [Accessed 22 October 2012].

The New Public Health

technology in regard to its safety and efficacy as well as its
social, political, economic, legal, and ethical consequences.
The technology may be a machine, a vaccine, an opera-
tion, or a form of organization and management of services.
Analysis should include cost–benefit and cost-effectiveness
studies (see Chapter 11) as well as clinical outcomes and
other performance indicators.

Pressures from medical professionals, manufacturers of
new medical equipment, and the public for adoption of new
methods can be intense and continuous. Care must be taken
that the specialists involved in committees for assessment
are not those who may directly or indirectly benefit from
the exploitation of technology, and who therefore may have
conflicts of interest. Assessment must be multidisciplinary,
involving policy analysts, physicians, public health special-
ists, economists, epidemiologists, sociologists, lawyers,
and ethicists. The available information needs to include
evidence from clinical trials, critical analysis of the litera-
ture, and the economic effect of adopting the technology on
allocation of resources.

Medical technology varies in complexity and cost, not
only to produce but in its utilization. Medical technology
that is inexpensive to supply and administer is known as
low technology or low-tech, while high technology or high-
tech refers to costly and complex diagnostic and treatment
devices or procedures.

At the low-tech end of the technology scale, oral rehy-
dration therapy (ORT) was developed in the 1960s for oral
replacement of fluids and electrolytes lost in diarrheal dis-
ease, particularly in children. It has been described as one
of the greatest medical breakthroughs of the twentieth cen-
tury. The introduction and wide-scale use of ORT for pre-
vention of dehydration from diarrheal diseases throughout
the world has saved hundreds of thousands of lives. Use
of insecticide impregnated bed nets and reintroduction of
DDT in household spraying along with vector control and
improving diagnostic tools are low-tech but effective and
key tools in malaria control.

Advances in endoscopic surgical techniques since the
1990s, and in robotic surgery since 2000, have greatly
improved patient care by reducing trauma, discomfort, and
length of hospital stay and endoscopy has become the surgi-
cal approach of choice for many procedures. Since reports
of the first 100 operations performed in France in 1990,
endoscopy has spread rapidly to all parts of the world. It is
now recognized by surgeons worldwide as a safer, less trau-
matic and more effective alternative to traditional invasive
surgery. Although the operating time is longer, patients are
discharged from the hospital within several days and return
to work shortly thereafter, compared to the long hospital
stays after more invasive surgical procedures in the past.
Following traditional abdominal surgery, a patient may
acquire infections and require intensive care initially and a
recovery period of many weeks.

http://www.ispor.org/htaspecialissue/Sullivan

http://www.euro.who.int/__data/assets/pdf_file/0018/90432/E87866

Chapter 15 Health Technology, Quality, Law, and Ethics

Endoscopic surgery for cholecystectomy and esopha-
geal, colorectal, hernia repair, renal, orthopedic, and other
forms of surgery which previously were carried out with the
patient remaining in hospital for many days are now done
on a not-for-admission basis. Not-for-admission surgery has
become standard practice in hospitals, extending the range
of outpatient surgery and the comfort of patients who can
return to their own homes to recuperate and return to regu-
lar activities much sooner. Fewer complications arise and
patient comfort and economic implications are important.
As a result, fewer hospital beds are needed for postoperative
care than previously thought necessary, while surgical and
ambulatory care facilities may need expansion to accommo-
date the growing elderly populations needing surgical inter-
ventions but requiring shorter recovery. This innovation is
now accepted as the standard of much of modern surgical
care and shows that simple organizational changes can save
money and improve patient safety and comfort.

The bacterium Helicobacter pylori was first identified
as the cause of peptic ulcers of the stomach and duodenum
in 1982 (Robin Warren and Barry Marshall, Nobel Prize
2005). This discovery led to effective diagnosis and rapid,
inexpensive treatment of chronic peptic ulcer disease. This
has resulted in elimination of a major component of surgi-
cal procedures for chronic peptic ulcer diseases as well as a
reduction in gastric cancer (see Chapter 4). Surgery for gas-
trectomies, vagotomies, and other outdated forms of treat-
ment are now virtually gone, contributing to a decreased
need for hospital beds even for an aging population. This
and many other innovations in medical care have led to a
growth in the use of ambulatory care for many forms of
surgical, medical, and mental health care, along with much
shorter length of hospital stay than in previous times. All of
these factors have led to greater emphasis on ambulatory,
outpatient, and home care services.

The dissonance between high-tech and low-tech proce-
dures may lead to serious consequences in any health system.
Choices require well-informed analysis of benefits, costs,
alternatives, ethical considerations, and political consequences
before limited health care resources are allocated between
hospital-based high-tech medicine and low-tech primary care.

High-tech procedures are usually applied in hospital
settings in the context of other highly specialized care for
seriously ill, often terminal, patients. Computed tomogra-
phy (CT), invented in the 1960s, quickly proved to be an
extremely valuable diagnostic tool. Advances in CT, mag-
netic resonance imaging (MRI), and subsequent imaging
techniques have proven to be cost-effective and lifesaving,
replacing less efficient and more dangerous invasive proce-
dures. The CT and MRI scans allow the clinician to reach a
rapid diagnosis of many lesions before they can be detected
by other invasive and dangerous diagnostic techniques, at
stages where the lesions are subject to earlier and more
effective interventions. Imaging technology is advancing

779

rapidly and promising inexpensive new systems for long-
distance transmission of imaging to medical centers may
provide enormous benefits to people living in rural or
developing countries. Recent advances in low-intensity CT
screening of long-term heavy smokers for lung cancer have
recently been added to recommended and potentially effec-
tive and cost-saving practice and may change the outlook
for this disease in the coming decade (US Preventive Ser-
vices Task Force, 2012 Flahault and Martin Moreno, 2013).

Technology assessment also examines methods of pre-
venting and managing medical conditions. Treatment proto-
cols or clinical guidelines are based on decision analysis of
accumulated weight of evidence. Published clinical studies
are assessed in meta-analyses, using statistical methods to
combine the results of independent studies, where the stud-
ies selected meet predetermined criteria of quality. This pro-
vides an overview from pooling of data, but also implies an
evaluation of the studies and data used. Clinical guidelines
are part of raising standards of care, but also contribute to
cost containment. Many countries form professional study
groups to carry out meta-analyses on important health pol-
icy issues and new technologies.

Technology Assessment in Hospitals

There is considerable variance among countries, hospitals
consume between 40 and 70 percent of total national health
expenditures, with pressures for increased staffing and
novel medical technology being a continual inflationary
factor. Industrialized countries have all reduced their acute
care hospital bed supplies and length of stay so that their
expenditures for hospital care have fallen to between 30-40
percent of total health expenditures. Shorter stays and older
patients have resulted in a drift towards intensive care, espe-
cially for internal medicine patients. Medical innovation is
a continuing process with new diagnostic and treatment
modalities reaching the market.

Hospitals no longer live in splendid isolation in the
medical economy. A national or state government needs
regulatory procedures to rationalize distribution of medical
technology. The “certificate of need” is a form of technology
assessment that has been used in the USA since the 1960s
to assess and regulate the development of hospital services
to prevent oversupply and costly duplication of services. It
attempts to establish and implement the use of rational crite-
ria for diffusion of expensive new technology. Whether this
has had a lasting impact on restraining the excesses of high-
tech medicine is arguable. This regulatory approach was
limited to the hospital setting and failed to stop the develop-
ment of high-tech medical services such as ambulatory for-
profit CT, imaging, and in vitro fertilization centers.

Many countries have adopted national technology
assessment systems to review topics as far-ranging as
guidelines for acute cardiac interventions; liver, heart, and

lung transplantation; minimal access surgery; and beam and
isotope radiotherapy. Other technology assessment guide-
lines include diagnostic ultrasound, sleep apnea, molecu-
lar biology, prostate cancer, MRI, and new medications for
inclusion in a national health system’s approved basket of
services.

Despite the limitations of this approach, where govern-
ments do not directly operate health care services, gov-
ernmental regulation is necessary to prevent inequities in
services by excessive development in some geographic
areas at the expense of others, or by overexpansion of the
institutional sector of health care at the expense of primary
care. Regulatory mechanisms are essential in health care
planning to restrain excessive and inappropriate use of
high-tech services, but need augmentation by fiscal incen-
tives to promote other essential services.

Hospitals everywhere face serious problems of hospital-
acquired infections, which occur in about 5 percent of all
hospitalizations. Healthcare-associated infections (HAIs),
including multidrug-resistant bacterial infections, cause
long lengths of stay, high costs, and most importantly, unex-
pected deaths and serious disabilities. Prevention of hospital-
acquired infection requires ongoing training, staffing, and
organization. The Centers for Disease Control and Prevention
(CDC) defines HAIs as “infections caused by a wide variety
of common and unusual bacteria, fungi, and viruses during
the course of receiving medical care”. Some of the preventive
measures are simply promoting frequent hand washing by
caregivers and visitors, and immunization of staff members
against influenza and pneumonia, which can be problematic
if there is staff resistance to influenza vaccination.

Training and routine supervision of cleaning staff are
also vital, as are strict infection control measures for isola-
tion rooms, strict protocols for catheter care, surgical suite
sterility, surgical site infections, central line associated
bloodstream infections, ventilator-associated pneumonias,
catheter-associated urinary tract infections, and Clostridium
difficile-associated disease. Guidelines for their control in
surgical dialysis, pediatric, outpatient, and other vulnerable
departments are available from CDC. The benefits of pre-
ventive procedures for this problem include cost estimates
ranging from US$5.7–6.8 billion (20 percent of infections
preventable) to US$25.0–31.5 billion, yet 70 percent of HAIs
are preventable by well-known methods such as frequent and
careful hand washing by medical and nursing staff, catheter
and infusion care, and other similar measures (CDC, 2012).

Technology Assessment in Prevention and
Health Promotion

Technology assessment of preventive care programs
includes evaluation of the methodology itself, along with
the costs and measurable benefits, as in reduced burden

The New Public Health

of disease. DOTS is the standard management of sputum-
positive and sputum-negative TB, at low cost for DALYs
saved. The coexistence of HIV and other complications
has created multidrug-resistant tuberculosis (MDR-
TB), which is difficult and costly to treat and cases
constitute a source of continuing spread of the disease.
A 2012 meta-analysis of cost-effectiveness of MDR-TB
treatment in Estonia, Peru, the Philippines, and Russia
shows it to be cost-effective and best carried out on an
ambulatory basis (Fitzpatrick and Floyd, 2012).

Wide use of available and effective vaccines such as
Hemophilus influenza b (Hib), pneumococcal pneumo-
nia, influenza and rotavirus reduce hospitalizations and
mortality from respiratory and diarrhoeal diseases among
children, the elderly and other age groups. Vaccine prices
generally fall after their initial period of use as manu-
facturing costs are lessened by improved methods or by
bulk purchase contracts, as occurs in the public sector. For
example, in 2012 MMR vaccine cost US$19.33 per dose if
purchased through the CDC, but US$52.73 per dose if pur-
chased in the private sector in 10 packs of single-dose units
of the vaccine. A combined diphtheria, tetanus, acellular
pertussis (DTaP) vaccine cost US$15.00 when purchased
through CDC, while the same vaccine purchased with hep-
atitis B and inactivated polio vaccine (IPV) cost US$52.10 per
dose. But the combination saves repeated visits and loss
of compliance for that reason. The new human papilloma-
virus (HPV) cervical cancer vaccine cost US$130.27 per
dose for the series of three doses per person, while the vac-
cine against diarrhea-causing rotavirus, approved in 2006,
cost US$106.57 per dose for the recommended three doses
(CDC, 2012).

The WHO recommends the inclusion of rotavirus vac-
cination in a country’s immunization program, but the costs
of the current generations of rotavirus vaccines are high in
comparison to the budgets for vaccines for prevention of
childhood illnesses in many developing countries. Many
cost-effectiveness studies have shown this vaccine to be
highly beneficial and it could help to reduce the very high
global burden of disease of over 500,000 child deaths and 2
million hospitalizations occurring annually (Tu et al., 2011).

Vaccine programs must take into account transportation
and administrative costs and expenses of ordering, storing,
inventory control, cold chain, insurance, wastage, and spoil-
age. Multiple vaccines in one dose are less costly and less
inconvenient for all. Examples include DTaP plus polio and
Hib, or MMR (see Chapters 4 and 6). There is a need for
implementation of legal protection of manufacturers from
excessive litigation judgments while protecting the interests
of the public and individuals who may have reactions to
vaccines.

In 2012, the reappearance of pertussis and diphthe-
ria raised concerns about immunization coverage and

Chapter 15 Health Technology, Quality, Law, and Ethics

efficacy. Public opinions on vaccination may not be as
supportive as in previous years. Mothers who oppose per-
tussis immunization for their children, such as occurred in
the UK during the 1980’s, leave their children vulnerable
to a serious and often deadly disease, which has recurred
since 2010.

The WHO estimates the cost of all immunization activi-
ties in all 117 low- and middle-income countries for the
period 2006–2015 to be US$75 billion, while low-income
countries would need US$35 billion. The rate of adoption
of currently available and new vaccines will be determined
by governmental decisions in each country, although exter-
nal aid – such as that of the Global Alliance for Vaccines
and Immunization (GAVI), an international public–private
consortium to promote vaccination – is a valuable resource.
The United Nations Children’s Fund (UNICEF) is con-
cerned about supply problems as well as costs, but the key
issue relates to political decisions, funding, and capacities
of national immunization systems.

Despite an excellent vaccine having been available since
the 1960s, measles epidemics continue to occur in the indus-
trialized countries. In the 1900s global deaths from measles
were in the order of 1 million people per annum. Two major
epidemics of measles occurred in Canada in the early 1990s,
despite high rates of immunization coverage. Following this, a
1993 Delphi conference of experts from 31 countries reached
a consensus recommending a two-dose measles immuniza-
tion policy. Measles eradication has been set as a goal by the
WHO and 90 percent reduction in cases and fatalities has
been achieved since the 1990s. However, measles elimination
requires coverage of 95 percent of children and two doses of a
measles-containing vaccine (preferably MMR).

Measles reappeared as a widespread disease in Europe in
2010–2013 with tens of thousands of cases, many hospital-
izations, and some deaths. It spread to the Americas, brought
by travelers, and resulted in modest sized outbreaks, includ-
ing the UK in 2012–2013. Eradicating measles by 2020 is
projected to cost an additional discounted US$7.8 billion and
avert a discounted 346 million DALYs between 2010 and
2050. As new vaccines enter the field, it is important to evalu-
ate their effectiveness, costs, and the benefits to be derived.

The cost of the hepatitis B vaccine initially was over
US$100 for an immunization schedule of three doses but
has come down dramatically to less than US$1 per dose
in developing countries for bulk purchases. However, in
the USA, the price of vaccination per dose is estimated at
US$41 if given by a general practitioner, US$15 if adminis-
tered through an existing childhood immunization program,
and US$17 if given through the school medical system.
This is a standard vaccine covered by public and private
health insurance systems. The vaccine is a cost-effective
method to prevent liver cancer and the long-term effects of
chronic hepatitis.

781

Screening and education for thalassemia in high-prev-
alence areas have nearly eradicated the clinical disease but
not its carrier status in Cyprus, southern Greece, and other
countries. Newborn screening and case management for
phenylketonuria, congenital hypothyroidism, Tay–Sachs
disease, and many other genetic diseases have been shown
to be far less expensive than post-facto treatment of severely
developmentally delayed and dependent children born with
these diseases (see Chapter 6).

The success of Papanicolaou (Pap) smear screening in
reducing cancer of the cervix mortality since the 1960s has
been dramatic. The discovery of causation of cancer of the
cervix by HPV strains led to development of an effective
vaccine, which has been in use since 2006. Recent evidence
shows that male circumcision can reduce transmission of
HPV as well as HIV and other sexually transmitted dis-
eases, and it is being adopted as an effective intervention
in countries with high rates of both HIV and cancer of the
cervix, such as in sub-Saharan Africa.

The drastic reduction in cancer of the cervix provides
a powerful demonstration of the effectiveness of public
health screening and other measures to control this major
malignant cause of death in women. Screening for cervi-
cal cancer by Pap smears is recommended annually for
high-risk groups, and every 2 or 3 years for other adult
women (Box 15.3). Screening will remain vital for many
years to come as the HPV vaccine comes into general
use, and as its cost is reduced, but its protective effect for
individual and herd immunity will not replace the need
for ongoing screening for this very common cancer. HPV
vaccine is also being recommended for all boys to pre-
vent oral and anogenital cancers and HPV transmission
to girls.

Routine mammography screening for breast cancer
every 1–2 years is recommended by the US National Can-
cer Institute for women over the age of 40 and for younger
women with high-risk factors (e.g., previous cancer, fam-
ily history, genetic markers). Cost-effectiveness analysis is
now an essential part of decision making in health policy
and priorities. While there is controversy over the frequency
of routine testing, mammography remains a mainstay in
women’s health and contributes to early case finding and
falling mortality rates from breast cancer. Figure 15.1 dem-
onstrates differences in utilization of mammography among
US women in the age group 50–64 years within the previ-
ous 2 years, by insurance status. US women with private
insurance (mostly through place of employment) had over
70 percent compliance, those with public insurance (pri-
marily Medicaid) averaged about 60 percent compliance,
while those with health insurance had average compliance
rates of about 45 percent during the period 1993–2010.
The UK National Health Service (NHS) invites women
between the ages of 50 and 70 for screening every 3 years;

Cancer of the cervix is the second most common cancer among
women worldwide, with about 500,000 new cases and 250,000
deaths worldwide annually. Approximately 80 percent of cases
occur in low-income countries, where cervical cancer is the
second commonest cancer in women (WHO, 2012).

In the USA, and other industrialized countries, the incidence
and mortality of cancer of the cervix have been going down
steadily since the introduction of Papanicolaou (Pap) smear
testing. Cervical cancer incidence declined during the period
1999–2008 by 2.3 percent per year and mortality declined by
1.9 percent per year an estimated 12,170 cases of invasive cer-
vical cancer diagnosed in the USA with 4220 deaths in 2012.

Prevention of cancer of the cervix has until recently mainly
focused on Pap smears to detect the disease while still in a pre-
cancerous (cancer in situ) phase, and this procedure reduced
rates dramatically over the latter part of the twentieth century. The
newly developed and highly effective vaccines against key strains
of human papillomavirus (HPV) is now being used in routine
immunization of young girls and more recently boys as well. The
high cost of the vaccine precludes its rapid diffusion to most parts
of the world but its use is spreading and being included in immu-
nization programs funded by donor agencies in sub Saharan
Africa. The vaccine should, in principle, also be used by adult
women, in addition to continuation of routine Pap smear testing.

In the past decade, evidence of HPV as the cause of cancer
of the cervix and the presence of HPV in uncircumcised men has
brought circumcision back to professional and public debate.
Reports from Africa of reduced risk of acquiring HIV among
circumcised men have brought new attention to adult male cir-
cumcision, which is now actively promoted many sub-Saharan
African countries.

The technological breakthroughs of the Pap smear in the
1950s, HPV testing in the 1990s, and the HPV vaccine in the
2000s should also include prevention by male circumcision.
Visual inspection of the cervix and cryotherapy can treat pre-
cancerous cervical lesions in areas of developing countries
as part of community health worker programs.

Colorectal cancer, the 7th leading cause of death in high
income countries, is amenable to prevention by early screening
using colonoscopy and fecal occult blood (FOB) testing. Screening
is recommended for all persons over age 50 at 5 year intervals
along with annual FOB testing. Where there is a family history of
colorectal cancer or polyps, routine screening should begin ear-
lier. Increasing use of screening and improved medical care are
resulting in improving survival and declining mortality rates.

Stomach cancer is 10th leading cause of death in upper
middle income countries. Prevention relies on early treatment
of chronic peptic ulcer disease caused by Helicobacter pylori
infection. This is readily diagnosed by a simple breath test and
completely cured by low cost antibiotics. Increased awarenss
and access to these services would enhance long term trends of
reducing mortality from stomach cancer.

Liver cancer is 8th leading cause of death in upper middle
income countries due to the global prevalence of hepatitis B
and helaptitis C. Hepatitis B is now falling due to widespread
vaccination in childhood. Hepatitis C is now the major cause
of liver cancer affecting hundreds of millions of persons world-
wide. There is still no vaccine currently available, but screen-
ing and treatment is now used in the industrialized countries
and will become more widely used as simpler, less costly treat-
ments with less side effects are becoming available.

Early detection of lung cancer with spiral low dose
tomodensitometry for smokers is recently being recommended
by many professional bodies.

More basic cancer preventive measures such as smoking
cessation, healthy diets, regular exercise, and moderate alco-
hol use are discussed in chapter 5.

Sources: World Health Organization. Sexual and reproductive health.
Cancer of cervix. Available at: http://www.who.int/reproductivehealth/top-
ics/cancers/en/ World Health Organization. The top 10 leading causes of
death (2011). Available at: http://who.int/mediacentre/factsheets/fs310/en/
index1.html
Centers for Disease Control and Prevention. Cervical cancer trends 2012.
Available at: http://www.cdc.gov/cancer/cervical/statistics/trends.htm
[Accessed (13.12.2012)].

BOX 15.3 Technology for Prevention of Cervical, Colorectal, Liver, Stomach and Lung Cancers

1993
0

P
er

ce
nt

ag
e 60

100

1995 1997 1999 2001
Year

2003 2005 2007 2009

Private insurance
Public insurance only
No insurance

FIGURE 15.1 Self-reported percentage of women aged 50–64 years
receiving a mammogram in the past 2 years, by health insurance sta-
tus, USA, 1993–2010. Source: Centers for Disease Control and Prevention.
QuickStats from the National Center for Health Statistics: Percentage of women
aged 50–64 years who reported receiving a mammogram in the past 2 Years,
by health insurance status — National Health Interview Survey, United States,
1993–2010. MMWR Morbid. Mortal. Wkly. Rep. 2013;62:651. Available at:
http://www.cdc.gov/mmwr/pdf/wk/mm6232 (accessed 12.1.14).

with an average of 75 percent respond to the invitation, of
whom 4 percent are referred for further testing (UK Can-
cer Research, 2012) and as in most industrailized countries
breast cancer mortality rates are falling impressively (see
Chapter 5).

Health promotion in reducing exposure to HIV and
cigarette smoking has been shown to be very cost-effec-
tive despite its low-tech or non-technological meth-
odology, involving primarily group or mass education.
Hypertension screening and case management is low-
tech but highly effective in preventing strokes and blind-
ness.

Low-tech innovations have had an important impact
in reducing death and injury. These include mandatory
use of car seat belts (introduced since the 1970s and
1980s in many countries), children’s car seats, air bags,
and bicycle and motorcycle helmets. Iodization of salt,
vitamin A supplementation, and food fortification pre-
vent large numbers of clinical cases of severe retarda-
tion, death, and blindness at low cost per child protected.

http://www.who.int/reproductivehealth/topics/cancers/en/

http://who.int/mediacentre/factsheets/fs310/en/index1.html

http://www.cdc.gov/cancer/cervical/statistics/trends.htm

http://www.cdc.gov/mmwr/pdf/wk/mm6232

783Chapter 15 Health Technology, Quality, Law, and Ethics

TABLE 15.3 Examples of High-Tech and Low-Tech Health Problem Solving

Problem High Tech Low Tech

Birth defects Surgical repairs, rehabilitation Folic acid fortification of flour, vitamin supplementation
before and during pregnancy

Infectious diseases Treatment – antibiotics Vaccination, sanitation, handwashing, infection control in
hospitals, health facilities, and nursing homes

Breast cancer Screening – mammography Nutrition, self-examination, routine medical examination

Colon cancer screening Colonoscopy Nutrition, vitamin D supplements; fecal occult blood testing

Acute myocardial infarction,
primary, secondary prevention

Coronary angioplasty, stent, bypass
surgery, heat transplantation

Antiplatelet thrombosis treatment (e.g., aspirin, intravenous
streptokinase, beta-blocker); rehabilitation; diet, exercise,
smoking cessation

Gallstones Lithotripter, abdominal
cholecystectomy

Endoscopic surgical removal

Head injuries Intensive care Helmets for bicycle riders and motorcyclists, seat belts in
front and rear of motor vehicles

Thalassemia Transfusions, chelating agents;
prenatal diagnosis, amniocentesis,
chorionic villus biopsy

Screening, education, counseling

Dehydration Infusions Oral rehydration

Neural tube defects Surgery, pregnancy termination Folic acid fortification of flour and grain products, supple-
ments for women of fertile age

Liver cirrhosis, liver failure,
cancer

Liver transplant Hepatitis B vaccine, risk reduction activities among intrave-
nous drug users, screening blood donors

Cancer of stomach Surgery, chemotherapy Dietary change, cure of Helicobacter pylori-generated
gastric ulcers

Cancer of cervix Pap smear screening; visual inspection and cryotherapy;
human papillomavirus vaccine

Education for reducing risk factors for the cardiovascu-
lar disorders is far less costly than the premature deaths
and high medical costs of patients suffering stroke and
congestive heart failure. Health education, condom and
needle supply, and screening of blood donations are the
most important effective community health measures
against the spread of HIV. Table 15.3 shows a compari-
son of high-tech and low-tech approaches, which often
complement each other, to selected health problems.

Technology assessments represent the current con-
sensus derived from reviews of published studies and
exchange of views of highly qualified clinicians, epide-
miologists, and economists within a context of technol-
ogy assessment. They may change over time as new data
or innovations are reported, and this possibility should
be kept in mind in such discussions. Technology assess-
ment mobilizes information and critically analyzes many
aspects of medical technology to build a wide community
consensus to influence policy decisions. Public opinion,
political leadership, and administrative practice, as well
as the scientific merit of a case are all factors in develop-
ing a consensus.

Technology Assessment in National Health
Systems

Technology assessment requires an organization within
the framework of national regulatory agencies. The FDA
serves this purpose as a statutory body within the US Pub-
lic Health Service. Sweden, Canada, Australia, the UK, the
Netherlands, Spain, and other countries also have technol-
ogy assessment advisory or regulatory agencies established
by national governments to monitor and examine new tech-
nologies as they appear. Sweden has a widely representa-
tive national Swedish Council for Technology Assessment
in Health Care which has an advisory role to the national
health authorities.

The processes used in traditional systems to regulate
food and drugs for efficacy, safety, and cost are more
recently being applied to new medical devices and proce-
dures. The unrestricted proliferation of new procedures
presents serious dilemmas for national agencies con-
cerned with financing health care and controlling cost
increases. Non-governmental health insurance shares
this concern, as does industry, which bears much of the

784

cost of health insurance through negotiated, collective
bargaining, “voluntary” health insurance in the USA.
Most industrialized countries have national health ser-
vices or national health insurance and are thus vitally
interested in health costs and technology assessment.
Many industrialized countries maintain technology
assessment and cost-control activities. In the USA, the
Agency for Healthcare Research and Quality (AHRQ)
maintains oversight and studies related to clinical infor-
mation, including evidence-based practice, outcomes and
effectiveness, comparative clinical effectiveness, risks
and benefits, and preventive services.

In Canada, the Health Protection Branch of the Federal
Department of Health reviews medical devices and drugs
and, with consent of the provincial governments, approves
new medical procedures. Concern by governments over the
cost implications of new procedures led to this practice.
Since 1988, a network of government and professional
bodies has formed a non-profit agency for technology
assessment (Canadian Agency for Drugs and Technologies
in Health, CADTH). This supports the provincial adminis-
tration of health insurance in resisting professional, com-
mercial, or political pressures to add untested technology
or procedures to the health system as covered benefits. A
comparison of rates of procedure performance between
provinces shows very high discrepancies, as high as two-
fold, in procedures such as coronary artery bypass graft or
prostatectomy. Control of acquisition of high-tech equip-
ment by national or state authorities is essential to prevent
expenditures on high-cost equipment without adequate
assessment.

The New Public Health

DISSEMINATION OF TECHNOLOGY

The rapid spread of high-tech medical equipment has played
a substantial role in escalating health costs. A comparison of
the number of MRI scanners per million population in mem-
ber countries of the Organisation for Economic Co-operation
and Development (OECD) (Table 15.4) showed Japan and the
USA with the highest number at 43.1 in 2010 (23.2 in 2000–
01) and 31.6 (15.4 in 2000) per million, respectively, while
the median was 10.5. Canada ranked fourteenth among the 20
OECD countries with 8.2 MRI scanners per million. Compar-
ing CT scanners showed that Japan had the highest number
at 97.3 while the median was 15.6. Canada was in eighteenth
place among the 28 OECD countries reporting in 2010 with
14.2 CTs per million population. However, it should be noted
that countries with the most machines have lower productiv-
ity per machine. The USA has far fewer examinations per
machine than other countries (OECD, 2012).

The use of endoscopic surgery has spread worldwide
since the 1990s. Health professionals become almost
instantly aware of new developments from the news media
as well as professional diffusion of information at confer-
ences, in exchange visits, in published articles, and most
dramatically via the Internet. National policy to foster the
introduction of appropriate new technology requires a
careful program of regulatory and financial incentives and
disincentives to encourage or discourage diffusion of new
methods of prevention as well as of treatment and com-
munity health care. Kidney transplantation has become a
cost-effective and patient-friendly alternative to long-term
dialysis both in hospital and at home. The key limitation is

TABLE 15.4 High-Tech Medical Equipment Units, Selected Organisation for Economic Co-operation and
Development Countries and Years, 1986–2010 (Rate per Million Population)

CTs MRIs

Country 1986 2000 2005 2010 1986 2000 2005 2010

Japan 27.5 84.4a 92.6 97.3c 0.1 23.2a 40.1 43.1c

USA 12.8 25.1a 32.3 40.7d 0.5 15.4a 26.7 31.6

Israel – 5.7 6.6 9.2 – 1.4 1.7 2.0

Germany 6.9 12.2 15.4 17.7 0.7 4.9 7.1 10.3

UK 2.7 5.4 7.5 8.2 0.3 5.6 5.4 5.9

Canada – 9.8b 11.6 14.2 – 2.5 5.7 8.2

France 4.7 7.0 10.0 11.8 0.5 1.7 4.8 7.0

CTs = computed tomography scanners per million population; MRIs = magnetic resonance imaging units per million population.
Notes:
a1999
b2001
c2008
d2011.
Source: Organisation for Economic Co-operation and Development. Health policies and data: OECD health data – 2012 data; frequently requested data.
Available at: http://www.oecd.org/health/healthpoliciesanddata/oecdhealthdata2012-frequentlyrequesteddata.htm [Accessed 13 October 2012].

http://www.oecd.org/health/healthpoliciesanddata/oecdhealthdata2012-frequentlyrequesteddata.htm

Chapter 15 Health Technology, Quality, Law, and Ethics

the shortage of donors. The same can be said for liver trans-
plantation, which has also been shown to be cost-effective
in terms of DALYs saved from chronic liver diseases such
as cirrhosis and hepatitis B and C. Heart transplantation has
spread among major centers in western countries.

The black market in organs for transplantation has
become an international scandal of exploitation of poor
people in low-income countries, and is the subject of police
investigation in many countries, but it is difficult to control.

Bone marrow transplantation is now used widely and
is effective in saving the lives of many people with malig-
nant and non-malignant hematological disorders. Stem cell
therapy, by introducing new adult and embryonic stem cells
into damaged tissue to treat disease or injury, is becoming
feasible for a wide variety of conditions including cancer,
type 1 diabetes mellitus, Parkinson’s disease, Huntington’s
disease, celiac disease, cardiac failure, muscle damage, and
neurological disorders.

Limitation of new techniques or procedures to selected
medical centers allows the passage of time to fully assess
the merits and deficiencies of new technology before gen-
eral diffusion into the health care system. Such limitation,
however, is fraught with the danger of depriving the popu-
lation of benefits of new medical technology, and the pos-
sibility of restraint of trade to the economic advantage of
selected providers. Current advances in robotic-assisted sur-
gery will expand during the coming decade for brain, bone,
joint, prostate, and other surgery, and need to be assessed
with regard to patient care benefits, costs, and the econom-
ics of capitalization of such innovations. Stem cell therapy
is already widespread for some malignant conditions, and
with advances in genomics and molecular biological tech-
nology it is very likely to become a major therapeutic inter-
vention for many more conditions in the coming years. The
effects of new technology on insurance and managed care
systems are necessarily involved in decision making as to
inclusion of new procedures in their service plans.

Publication in the professional literature is an accepted
method of establishing the scientific merit of a treatment or
an intervention. Too rapid diffusion of a medical practice
can lead to disillusionment and confusion as to the mer-
its of a particular medical procedure, as happened during
the 1960s and 1970s with anticoagulant therapy for acute
myocardial infarction and gastric freezing for peptic ulcers.
Reviews of the literature should be critical and should
assess the scientific merits of published data, as well as the
sources of funding. Well-controlled large-scale clinical tri-
als are vital to establish the relative values of alternative
therapeutic approaches, as are meta-analyses of multiple
studies.

Dissemination of information about new medical inno-
vations in the popular media is almost immediate. Many
major newspapers and television networks have well-
informed medical reporters and commentators who have

785

access to electronic medical journals as quickly as do medi-
cal specialists in each field. News magazines may carry spe-
cial articles on new innovations, creating instant demand for
them as benefits in a health program. This ready access to
information has both benefits and dangers.

In the USA, health insurers have led the way in develop-
ing technology assessment and information synthesis, and
in evaluating the costs and benefits of new procedures. The
process is affected by public opinion, as well as by court
decisions. A landmark decision against a health mainte-
nance organization (HMO) in 1993 awarded US$29 million
in damages to the family of a terminal breast cancer patient
who died following refusal of the HMO to authorize a bone
marrow transplant, which was at the time an experimental
procedure. Denial of new technology may lead to increases
in malpractice suits. In countries with limited financial
resources, selection of technological innovations in health
care that can benefit patient care or the public health
requires a careful balance in order to use limited resources
well, and to gain from the application of appropriate new
health care technology.

Payment systems by national or private insurance
systems are crucial to introduce and control diffusion of
technology. Block budgets for hospitals have been more
effective in Canada than in the USA in restraining the pro-
liferation of high-tech equipment. This has led to criticism
of the limited access of Canadians to medical technology,
such as CT, MRI, and advanced cancer therapies. In the
USA, universal application of the diagnosis-related group
(DRG) payment system for Medicare, Medicaid, and most
private insurance had the effect of increasing ambulatory
surgery very dramatically, from 16 percent of all surgery
in 1980 to 80 percent in 2008 of all surgical procedures in
community hospitals (i.e., non-federal short-stay hospitals
or 85 percent of all hospitals in the country). Inpatient sur-
gical procedure rates declined from 85 percent in 1980 to
35 percent in 2008. Although the rate of visits to hospital-
based surgery centers remained largely unchanged in the
USA from 1996 to 2006, the rate of visits to private ambula-
tory surgery centers increased by about 300 percent.

HMOs and managed care organizations are paid on a
per capita basis and have a strong incentive for cost contain-
ment. They have developed procedures and medical guide-
lines for investigation and intervention that seek to reduce
unnecessary procedures. At the same time, HMOs are very
active in promoting preventive care and non-hospital care
insofar as this is compatible with good patient care.

Coronary bypass procedures decreased in frequency in
the USA between 2001–02 and 2007–08. In the USA, such
procedures are less frequently carried out in women and
African Americans, because of lesser access to health insur-
ance for African Americans and possibly because of biases
in terms of case assessment criteria in women. Cardiac
invasive procedures increased dramatically since the 1980s

786

in most industrialized countries, but with wide variation in
their use. The benefits of aggressive invasive management
of cardiovascular diseases remain controversial, but many
such procedures have proven beneficial in reducing mortal-
ity rates and improving quality of life.

Critical analysis of the need for surgery has resulted in
lower tonsillectomy and radical mastectomy rates along
with the increased use of outpatient procedures. Tonsillec-
tomy, a routine procedure until the 1960s, is now performed
infrequently since it was found to be of little medical value.
Cataract surgery is now largely done on an ambulatory
basis. The technology of home care has come to play an
important role in early discharge of patients from the hospi-
tal, as has the wide use of cancer chemotherapy and radia-
tion therapy on an outpatient basis.

DIFFUSION OF TECHNOLOGY

Innovations in health care through scientific and technologi-
cal advances are continuing, with exciting breakthroughs
being made in effective new treatments and public health
interventions, and this requires health authorities, practitio-
ners, and the public to maintain constant awareness of the
current state of the art. Diffusion of new technology or adap-
tations from basic science advances may begin slowly, and
then reach a “tipping point”, at which time a dramatic change
of trend occurs and it becomes the new standard or fashion.

Those with economic interests in the product try to
advertise and promote sales, while practitioners are ready
to try new methods to help their patients, but those who
must pay for services may ask for evidence of effectiveness,
safety, added value over present and known methods, and
benefit to the length or quality of life of the individual. This
can become a highly charged debate when those responsible
for adopting new measures in national health plans must
weigh one proposed addition against another, each with its
ardent professional, community, or business promoters. The
new HPV vaccine approved by the FDA in 2006 for preven-
tion of cancer of the cervix is an example.

The HPV vaccine is recommended for preteen girls at the
age of 11–12 years and also for females aged 13–26 to off-
set future sexual exposure to HPV-infected males and since
2012 recommended routinely for teenage boys as well. The
two competing main manufacturers of HPV vaccine are nat-
urally interested in increasing their market and market share,
and willing to reduce prices. The cost has been lowered
substantially for use in developing countries if purchased in
bulk, but costs are still prohibitive unless funded by interna-
tional donors. Competing low-cost manufacture in India has
encouraged the two main manufacturers to lower prices to
seek broader markets. In 2011, one manufacturer lowered its
price dramatically to US$5 per dose, a 67 percent reduction
in the current lowest public price. This has allowed GAVI to
adopt an HPV strategy for developing countries, where 88

The New Public Health

percent of cervical cancer deaths occur, with 275,000 deaths
of relatively young women each year (GAVI, 2011, 2012).

Pioneering projects promoting visual examination of the
cervix and local cauterization of abrasions by trained nurses
and community health workers are meant to increase access
to care in traditional villages remote from medical centers.
The duration of immunity and whether booster doses will
be required are still not known. Policy makers need to con-
sider whether the same money would have greater benefit
if used to provide pneumococcal pneumonia and rotavirus
vaccine for children in developing countries, which would
quickly save hundreds of thousands of lives. It is likely that
the wonderful new public health technology that is the HPV
vaccine will be absorbed quickly into public health prac-
tice at least in the industrialized countries, and is now being
introduced by international donor agencies in sub-Saharan
Africa.

QUALITY ASSURANCE

Quality assurance is an integral part of public health func-
tion and involves ensuring the quality of both health prac-
titioners and facilities. It is an approach that measures and
evaluates the proficiency or quality of services rendered.
Hospital accreditation is a long-standing method of qual-
ity assurance, providing many generations of health provid-
ers in North America with first hand experience of quality
assurance in community hospitals and long-term care facili-
ties, as well as ambulatory and mental health services.
Hospital accreditation has contributed to improvement in
standards of facilities and patient care throughout Canada
and the USA and has provided a working model for replica-
tion or adaptation internationally.

Adverse Events and Negligence

Iatrogenic diseases are adverse events that occur as a result
of medical management and result in measurable disability.
Negligent adverse events are those events caused by a failure
to meet standards of care reasonably expected of the aver-
age physician or other provider of care. Hospital-acquired
infections, anesthesia mishaps, falls, and drug errors are the
most common iatrogenic events.

Iatrogenic disease is a major cause of morbidity, pro-
longation of hospitalization, and even death. Hospital-
acquired (nosocomial) infections are estimated to occur
in 7–10 percent of hospital cases in Britain and the USA.
Primarily these are caused by urinary, respiratory tract, and
wound infections. It is becoming more common that infec-
tions involving organisms previously responsive to antibi-
otics are now resistant to many antibiotics and difficult to
treat. Infection control in hospitals is therefore an essential
part of hospital organization. Because hospitals are increas-
ingly being paid by DRGs, any secondary event prolonging

Chapter 15 Health Technology, Quality, Law, and Ethics

hospital stays may have adverse financial effects on the hos-
pital. In the USA, recent decreases in Medicare reimburse-
ments for nosocomial infections reflect this trend to provide
financial incentives to improve hospital infection control.
There is, therefore, a strong financial as well as professional
interest in reducing hospital-acquired infections.

A classic study of 32,000 hospitalizations in New York
State carried out by a Harvard University team showed
that 3.7 percent of hospitalized patients suffered adverse
events or injuries caused by medical mismanagement which
resulted in measurable disability. Of these, 28 percent were
due to negligence, so that 1.03 percent of all hospitalizations
involved medical negligence leading to measurable injury.
Of the total of some 100,000 adverse events in the study
group, 57 percent recovered within a month and 7 percent
had severe injury. Some 14 percent or 14,000 people with
adverse events died as a result; 51 percent of these deaths
were due to negligence. A 1999 report of the US National
Institute of Medicine estimated that between 44,000 and
98,000 people die annually in the USA from medical errors
occurring in hospitals, but these data are considered to be
overestimated in some studies. Adverse drug events (ADEs)
result in 700,000 emergency department visits and 120,000
hospitalizations annually, with US$3.5 billion spent on
extra medical costs. CDC estimates that at least 40 percent
of the costs of ambulatory (non-hospital setting) ADEs are
preventable.

A 2008 report by the Office of Inspector General of the
US DHHS reported that 13.5 percent of Medicare benefi-
ciaries experienced adverse events and that for 1.5 percent
of beneficiaries, these adverse events contributed to their
deaths. An additional 13.5 percent of beneficiaries in the
sample experienced temporary harm as a result of their
medical care, bringing the total percentage of beneficiaries
experiencing instances of care-related harm to 27 percent.
Nearly half (44 percent) of these adverse or temporary harm
events were preventable.

Hospital-acquired infections cause 99,000 patients
deaths in the USA every year (AHRQ, 2009). Higher rates
are seen among the elderly and the poor. Rates are lower in
teaching hospitals than in community hospitals. About 20
percent of the events were related to drug reactions or dos-
age errors. Less than 3 percent of those injured brought civil
litigation for the negligence. The search for “bad apples” –
that is, unethical, criminal, or incompetent health providers –
is necessary, but not sufficient to stem the problems created
by the health system itself. Prevention requires organized
activity. Investigation of adverse events helps to identify
methods of prevention and to protect the patient’s rights.
A program of measures to reduce hospital infection must be
based on epidemiological analysis of recorded events in the
search for common causes and preventable factors.

Organized surveillance and control requires a ratio of
one infection control practitioner per 250 acute care beds,

787

a trained hospital epidemiologist, and routine reporting of
wound infections to practicing surgeons (CDC, Hospital
Infection Program). Computer-aided medication dispens-
ing, as well as automated and other safety systems are
critical elements in minimizing morbidity and mortality
resulting from preventable human errors. In response to
the high frequency and cost of medical litigation, many
states in the USA have enacted legislation to restrict court
awards for medical negligence. Proposals for alternatives
to the tort system of medical malpractice compensation
include arbitration and mediation, an administrative sys-
tem similar to that used for workers’ compensation, and
a no-fault system of compensation, such as exists in New
Zealand, Sweden, and Finland. In a no-fault system the
complainant need not prove negligence on the part of the
provider, but only that he or she suffered an adverse event
which is compensable at standard rates depending on the
degree of disability. In the USA, federal legislation pro-
vides compensation for vaccine injuries, and three states
have enacted restricted no-fault systems for birth-related
neurological injuries.

In addition, there is greater emphasis on the adoption of
failsafe mechanisms, such as introducing warning systems
in anesthesia machines to alert the anesthetist if oxygen
flow in the patient’s tubing falls below a safe point. This
system was tested in Boston hospitals and found to reduce
adverse anesthetic events to zero cases over a 3-year period.
Vitamin K injection was made mandatory for all newborns
in New York State, as was already the case in some other
states, when a study showed deaths from hemorrhagic
disease of the newborn in cases where vitamin K was not
administered.

Inappropriate medical practice patterns are an equal, or
even larger problem for health systems. Comparisons of
surgical rates within the USA for coronary bypass proce-
dures, hysterectomies, and caesarean sections show wide
variation between different areas of the country. The costs
of excess surgery not only are economically wasteful but
also involve risks for the patient from the surgery itself
or anesthesia mishaps, infection, pain, and discomfort,
with legal and ethical questions of unwarranted interven-
tions not for the benefit of the patient. Health systems are
increasingly required to evaluate and control excess surgi-
cal, investigative, or other medical procedures, not only for
financial reasons but also for protection against litigation
and infringement of patients’ rights.

Licensure and Certification

The requirements that society establishes for allowing an
individual to practice medicine, and any health profession,
are vital to maintaining and improving the quality of care
(see Chapter 14). These standards require defining the train-
ing and experience needed by the individual, examination

788

procedures, and recognition for continued education and
maintenance of competence. This requires a statutory base
and national bodies operating under a national authority, sep-
arate from the agency operating the health system services.
Separation of licensing from operation of the health service
is essential in maintaining high professional standards.

The licensing authority is accountable to the state and
the public. In some cases, this function is delegated to self-
regulating professional bodies. In Canada, the licensing of
the medical profession and specialty recognition are carried
out by the medical profession with self-regulation. In the
UK, medical licensing is by a state-appointed board and in
the USA by state boards.

Medical schools, postgraduate training programs,
and fellowships are all subject to periodic comprehensive
assessments. Institutions that fail to meet the standard may
have funding or licensure suspended until they have per-
formed adequate remediation.

Health Facility Accreditation

Hospital accreditation in North America is by a voluntary
grouping of professional associations, including the Cana-
dian and American Colleges of Physicians and Surgeons,
the hospital associations, and the Colleges of Nurses. The
Joint Commission, originally operating in both Canada and
the USA, carries out regular inspections of hospitals. In Can-
ada, other organizations including the federal Department of
Health, provincial ministries of health, the Canadian Diabetes
Association, the Public Health Association, and the Standards
Council of Canada participate in the Joint Commission as
observers. Initially focusing on acute care hospitals, accredi-
tation has been gradually extended to cover special hospi-
tals, long-term facilities, home care programs, public health
departments, and ambulatory care services.

Health facility accreditation is a systematic, multidisci-
plinary inspection of the physical and organizational struc-
ture of the facility or program and the functioning of its
component parts. Factors measured include staff qualifica-
tions, facilities, organization, record keeping, and continu-
ing education of staff.

The process of accreditation requires a request for
accreditation from the board of governors of the hospital
or health facility, implying acceptance of the standards
of the commission. The accreditation process includes a
self-assessment, an on-site survey, and follow-up action
for correction of deficits and improvements. The com-
mission is invited to conduct a survey, and resurvey as it
sees fit. The hospital pays a fee and commits itself to pro-
vide all data requested and to cooperate with the site visit.
The commission issues a confidential report, giving the
accreditation rating and interim statement of deficiencies,
and requests progress reports in correcting deficiencies. It
is also empowered to carry out follow-up inspections and

The New Public Health

resurveys. Box 15.4 lists the areas of a large community
or teaching hospital, regional health authorities, hospitals,
and community-based programs and services, from both
private and public sectors, not only in Canada but around
the world.

The assessment survey examines the goals and objec-
tives of the organization and its administration, the direc-
tion and staffing of the facility, policies, and procedures.
Review includes medical staff organization, credentials and
review procedures, clinical privileges, selection of depart-
ment chairpersons and their responsibilities, standing com-
mittees, schedule of meetings, bylaws, and the role of the
governing board of the hospital. The presence and nature of
quality assurance organization, records review procedures,
and continuing educations are assessed. The quality of
clinical records is assessed by examination of charts for the
completeness of histories and documentation of the course
of the hospital stay including laboratory reports.

Each section of the program being accredited is assessed
in the following categories:

l statement of purposes, goals, and objectives
l organization and administration
l human and physical resources
l orientation, staff development, and continuing education
l patient care
l quality assurance.

These categories are also used in the programs covered
by the contracts between Accreditation Canada, formerly
the Canadian Council on Health Services Accreditation
(CCHSA), and other health and social service agencies.

Hospital accreditation was established in the UK and
Australia in the 1980s and is attracting interest in other
countries seeking ways to maintain and promote standards.
The procedure for accreditation of hospitals is still volun-
tary in Canada, but in effect has become universal for hos-
pitals of medium and large size (over 75 beds) and common
for smaller hospitals. It is seen as advantageous for the gov-
erning board and the community and also for the medical
staff in terms of medicolegal protection. In the USA, hospi-
tal accreditation has become virtually universal since pay-
ment for federally funded health insurance (Medicare and
Medicaid) beneficiaries is not allowed for non-accredited
hospitals, and many private insurers make this requirement
as well. In some states, accreditation is mandatory for all
hospitals.

Since the 1990s, CCHSA’s accreditation program has
expanded to cover a diversity of health care and service
areas, through contract arrangements with independent non-
hospital facilities such as highly specialized programs as well
as community health and social service organizations. In 2006,
CCHSA introduced standards for child welfare, hospice, pal-
liative and end-of-life care facilities, prison facilities, biomedi-
cal laboratories, and supplementary criteria for telehealth. In

789Chapter 15 Health Technology, Quality, Law, and Ethics

l System wide:
– Governance
– Infection prevention and control
– Leadership
– Leadership for aboriginal health services
– Leadership for assisted reproductive technology
– Leadership for primary care
– Managing medications

l Population based:
– Cancer populations
– Child and youth populations
– Maternal/child populations
– Mental health populations
– Populations with chronic conditions
– Public health services

l Service excellence:
– Acquired brain injury services
– Ambulatory care services
– Ambulatory systemic cancer therapy services
– Assisted reproductive technology
– Case management services
– Child welfare services
– Community health services
– Community-based mental health services and support

standards
– Critical care services
– Developmental disabilities services
– Diagnostic imaging services
– Emergency department services
– Health care staffing services
– Home care and support services
– Hospice palliative and end-of-life services

– Independent medical/surgical facilities
– Laboratory and blood services
– Long-term care services
– Medical imaging centers
– Medicine services
– Mental health services
– Obstetrics services
– Operating rooms
– Organ and tissue donation standards for deceased

donors
– Organ and tissue transplant
– Organ donation standards for living donors
– Point-of-care testing
– Primary care services
– Rehabilitation services
– Reprocessing and sterilization of reusable medical

devices
– Spinal cord injury acute services
– Spinal cord injury rehabilitation services
– Substance abuse and problem gambling services
– Surgical care services
– Telehealth services

l Service distinction:
– Acute stroke services
– Audit tool for reprocessing and sterilization of reusable

medical devices
– Inpatient stroke rehabilitation services
– Providing an integrated system of services to people

with stroke

Source: Accreditation Canada. Available at: http://www.accreditation.ca/
en/content.aspx?pageid=54 [Accessed 14 December 2012].

BOX 15.4 Accreditation Canada Standards

2008 CCHSA officially became Accreditation Canada, pro-
viding services to other countries. The ever-changing health
and social environment now accommodates specialized needs
in a diversity of service areas as an adjunct to the hospital
accreditation process. Examples are shown in Box 15.5.

Licensing and regulation of health facilities are a gov-
ernment responsibility, but an independent accreditation
authority has advantages. The national authority may fail to
monitor its own facilities with the diligence or objectivity
needed, and there may be a conflict of interest. Where there
is a national system of organization, distinct departmen-
talization of the operating and certification functions may
provide a greater measure of objectivity. Assistance from
countries experienced in voluntary accreditation can help to
establish accreditation mechanisms and provide technical
and professional support to countries wishing to establish
such programs.

In the current period of transition from central to decen-
tralized management of health services in many countries,
health facilities are being transferred from government

operation to independent operation as not-for-profit or
even for-profit facilities. Present methods of regulation by
national or state levels of government will require review
as decentralization and privatization take place. Regulation
by governmental authorities and non-governmental pro-
fessional bodies is mutually complementary in promoting
accountability, standards, and quality of services.

Peer Review

A large part of the work of clinical and departmental man-
agers in hospitals or other care settings relates to qual-
ity assurance. A major method of improving quality in a
health program is through peer review by which the staff
organizes systematic review of cases and records, using
statistics on performance indicators. In hospitals, this
includes review of deaths, maternal mortality and infant
mortality cases, surgical rates, complications following
surgery, and infection rates. Medical records and com-
puter information systems permit users to review records

http://www.accreditation.ca/en/content.aspx?pageid=54

790

BOX 15.5 Accreditation Canada International
Accreditation Program

The Canadian health services accreditation program began
in 1917 in conjunction with the American College of
Surgeons (ACS) with a hospital standardization program. The
first Minimum Standard for Hospitals developed require-
ments of just one page. In 1918, on-site inspections of hos-
pitals began, with 89 of 692 hospitals surveyed meeting the
requirements of the Minimum Standard. In 1926, the first
Standards Manual was issued.

In 1951, the American College of Physicians, the
American Hospital Association, the American Medical
Association, and the Canadian Medical Association joined
with the ACS to create the Joint Commission on Accreditation
of Hospitals (JCAH). It is an independent, not-for-profit orga-
nization whose purpose is to provide voluntary accredita-
tion. In 1953, the Canadian Hospital Association (now the
Canadian Healthcare Association), the Canadian Medical
Association, the Royal College of Physicians and Surgeons,
and l’Association des Médecins de Langue Française du
Canada established the Canadian Commission on Hospital
Accreditation. The Commission’s purpose was to create a
Canadian program for hospital accreditation, and in 1958
the Canadian Council on Hospital Accreditation (CCHSA)
was incorporated.

In 2008 CCHSA became Accreditation Canada
International. The accreditation program is used by all
types of health facilities, from large and complex hos-
pitals, to health systems, community health organiza-
tions, and residences providing long-term care. Its scope
includes a wide range of programs, including standards
on child welfare, hospice palliative and end-of-life care,
biomedical laboratory services, blood banks, and supple-
mentary criteria for Telehealth. The accreditation program
covers a diversity of health care and service areas, service
programs for brain injury, ambulatory care, assisted repro-
ductive technology – clinical and laboratory services,
Canadian Forces health services, cancer agencies, child
welfare organizations, First Nations and Inuit addictions
and community health services, the Federal Department
of Veterans’ Affairs, substance abuse and problem gam-
bling treatment services.

The accreditation service is on a contract basis with
specialized health programs, other federal government
departments, for-profit health facilities, and community
organizations across the provinces.

Accreditation Canada International works with other
countries to develop national accreditation programs for
their countries, and launched its first international program
for acute care, primary care, ambulatory care, and clinical
laboratories in 2010.

Source: Accreditation Canada International. Available at: http://www.
internationalaccreditation.ca/Accreditation/AccreditationProgram.aspx
[Accessed 12 September 2012].

The New Public Health

by diagnosis. These records can be utilized to assess other
events in hospitals, such as time from admission to sur-
gery, lengths of stay by diagnosis, response to abnormal
laboratory findings, and many other indicators of the pro-
cess of care. Obstetric departments can review the fre-
quency of and criteria for caesarean section deliveries.
Surgical departments review their appendectomy rates to
separate pathological findings from normal appendices.
Organized peer review has also been called medical audit
and essentially describes methods of self-policing and
education to learn from mistakes and experience and to
improve the quality of care.

In 1972, an amendment to the US Social Security Act
required hospitals and long-term care facilities to moni-
tor the quality of care given to Medicare and Medicaid
patients through professional standards review organiza-
tions (PSROs). These were medical audit committees with
specified tasks to conduct utilization review, medical care
evaluation, and profile analysis of physician or institutional
performance compared to accepted standards of the medical
community. In 1982, peer review organizations (PROs) were
created by federal statutes to replace PSROs. The PROs are
non-profit corporations, staffed by physicians and nurses,
to review medical necessity, quality, and appropriate level
of care under the Medicare and Medicaid programs. The
Centers for Medicaid and Medicare Services have an Office
of Clinical Standards to conduct surveys, provide certifica-
tion, and develop best practices guidelines, in a health care
quality improvement program (HCQIP).

Hospitals have departmental clinical meetings, adverse
incident or outcome committees, mortality rounds, and
clinical pathology conferences to help staff to evaluate and
learn from difficult cases. The presence of functioning peer
review mechanisms indicates that quality is of concern to
the professional and administrative network, raising the
consumer’s confidence in the system.

Maternal mortality committees have been widely used
to assess preventable factors in deaths related to maternity
and to point out areas of needed improvement in services.
Identification of high-risk pregnancies emerged from this
process and has become an important part of prenatal care.
Infant mortality reviews by professional groups can simi-
larly demonstrate areas of needed improvement in services.
Death rounds are held to review cases of death following
surgery or soon after admission, or “incidents”, such as
inappropriate medication given in error.

The successive waves of peer review initiatives in
the USA represent attempts by the federal government
to establish mandatory quality of care review by profes-
sional peers for facilities providing care to Medicare and
Medicaid patients. The concept of requiring standards of
care review has probably contributed to a greater aware-
ness of the accountability of hospital-based practice. Fre-
quent litigation may have contributed more to the sense that

http://www.internationalaccreditation.ca/Accreditation/AccreditationProgram.aspx

Chapter 15 Health Technology, Quality, Law, and Ethics

the physician is accountable for services and outcomes of
care. PROs are a form of quality regulation that represent a
commitment by funding agencies to accountability in care
systems and to identification of organizational and admin-
istrative weaknesses in health care generally and not only
in hospitals. The generation of US physicians and health
systems managers trained since the 1970s accepts peer
review as an integral part of health services. Other coun-
tries use this kind of mechanism to maintain and promote
quality of care.

Tracer Conditions

Tracer conditions are common medical conditions (or pro-
cedures) for which diagnostic criteria are well established
and clear, there are effective preventions or treatments, and
a lack of treatment can cause significant harm to the patient.
Examples of tracer conditions include otitis media, appen-
dectomy, caesarean section, and hysterectomy. These con-
ditions, if evaluated in terms of incidence and actual chart
review, can provide useful insights into departmental medi-
cal standards. Incident reports by nursing staff and nosoco-
mial infections are examples of the functioning of the tracer
condition concept.

Incident reports in hospitals are designed to determine
the causes of errors, so that remedial action can be taken
and similar events prevented. Tracer condition studies have
become such an accepted part of modern health manage-
ment that the absence of an organized review system could
be considered a serious structural flaw in a health service,
requiring remedial action.

Setting Standards

Standards recommended by independent professional
organizations or by advisory committees appointed by
ministries of health can play important roles in defining
standards of care for specified conditions. In addition,
organized professional bodies can issue practice guidelines
or help governments or health care agencies to develop
standards or algorithms for management of specific topics
and conditions.

Specifying standards for preventive care, such as for
infants and adults, assists local health authorities in plan-
ning and evaluating services. The American Academy of
Pediatrics (AAP) has an extensive professional committee
structure that publishes periodic guidelines for pediatricians
on a wide variety of infant and child topics including nutri-
tion, immunization, prevention of anemia and lead toxicity,
child safety, and school health. Mandatory preventive care
for newborns includes eye care and vitamin K injection in
the USA (see Chapter 6). Mandatory immunization require-
ments for school entry and for health care personnel are dis-
cussed in Chapter 4.

791

The American Public Health Association (APHA) pub-
lishes the Control of Communicable Diseases Manual, now
in its nineteenth edition (2008). It is the authoritative US
manual on this topic. The AAP’s Red Book on infectious dis-
eases is used across North America by pediatricians in clini-
cal practice. These organizations and their counterparts in
obstetrics and many other clinical fields directly relevant to
public health continually update practitioners and policy per-
sonnel in the “state of the art” or “gold standard”, discussed
previously. This constitutes a professional self-guidance sys-
tem in standards. Managed care and other health provider
systems also issue guidelines for member practitioners that
serve to maintain standards of service.

The wide use of treatment protocols and scoring systems
in hospital medicine helps to define standards of care in a
measurable way. The Apgar score for rating newborn sta-
tus has been a standard in hospitals worldwide for decades,
helping to standardize infant assessment and care. The
APACHE (Acute Physiology And Chronic Health Evalua-
tion) scoring system is used widely to assess the chances
of survival of patients admitted to intensive care units and
to compare outcomes, for example, between teaching hos-
pitals and community hospitals. It is also used in assessing
patient outcomes with different modes of treatment. Scor-
ing systems are also used in community health care, as in
risk scoring for pregnancy care (see Chapter 6).

Algorithms and Clinical Guidelines

Algorithms are decision trees or a systematic series of deci-
sions based on the outcomes of previous decisions, tests, or
findings. Derived from operations research, this approach
applied to medicine identifies all available choices (e.g.,
exposed versus non-exposed) and follow-up decisions
based on findings from each previous option substantiated
by observation. It is often presented graphically like the
branches of a tree, showing the alternatives and subsequent
decisions to be made.

A clinical algorithm is a systematic process defining
a sequence of alternative, logical steps depending on out-
comes of previous ones, incorporating clinical, laboratory,
and epidemiological information, applied to maximize ben-
efits and minimize risks for the patient. It gives the provider
a review of the relevant literature and recommended stan-
dards of practice on a particular topic for preventive care
or case management. These guidelines are usually arrived
at by consensus of multidisciplinary working groups taking
into account published studies on the topic. The guidelines
may suggest that some procedures should not be carried out
routinely.

Clinical guidelines are meant to establish accepted stan-
dards of care and may have important economic implica-
tions. Medical Letter, published by the Consumers’ Union,
is a long-standing and useful publication that reviews

The New Public Health792

TABLE 15.5 Adult Health Maintenance Checklist by Age Group

Age (years)

Procedure 20–39 40–64 65+

Checkup visit Every 3 years Every 2 years Annually

Cholesterol With checkups With checkups With checkups

Fecal occult blood Age 40–49 if high risk Annually Annually

Clinical breast examination Every 1–3 years Annuallya Annuallya

Mammography Baseline age 35 Age 40–49, every 1–2 years Over 70, every 2 years

Pelvic examination Every 1–3 years Every 1–3 years Every 1–3 years

Pap smear From age 21-29 every 3 years;
from 30-65 every 5 years with
HPV DNA test

From age 30–65 every 5 years
with HPV DNA test

If previously negative,
may stop 3 years

Colonoscopy No From age 40 for those with family
history of colon cancer or polyps.

After age 50, every 3–5 years

Prostate and PSA Immunizations No Annuallya Annuallya

Tetanus–diphtheria Every 10 years Every 10 years Every 10 years

Pneumococcal pneumonia For high risk For high risk Every 6 years

Influenza For high risk For high risk Annually

Skin cancer Annuallya Annuallya Annuallya

Bladder cancer Annual routine urinalysis Annual routine urinalysis Annual routine urinalysis

Lung cancer Routine examinationb Routine examinationb Routine examinationb

Testicular cancer Routine examinationb Routine examinationb Routine examinationb

Oral cancer Routine examinationb Routine examinationb Routine examinationb

Ovarian cancer Routine examinationb Routine examinationb Routine examinationb

Pancreatic cancer Routine examinationb Routine examinationb Routine examinationb

Routine vitamin supplements Routineb Routineb Routineb

Note:
PSA = prostate-specific antigen.
Agency for Healthcare Research and Quality. Rockville, MD: AHRQ. http://www.ahrq.gov [Accessed 13 September 2012].
aInconclusive
bnegative recommendation. The topics are under continuing review, and recommendations are in some cases left to the opinion of the provider as the current
cumulative evidence is not affirmative, e.g., clinical breast examination annually or breast self-examination.
Sources: US Preventive Services Task Force Ratings: Strength of recommendations and quality of evidence. guide to clinical preventive services. 3rd ed.
Periodic updates, 2000–2003. Available at: http://www.uspreventiveservicestaskforce.org/3rduspstf/ratings.htm [Accessed 13 September 2012].

therapeutic issues of everyday medical practice and the rele-
vant studies. It represents a balanced, updated view of medi-
cal practice and summaries of current literature, reviewed
by respected, experienced, and competent medical authori-
ties. Clinical practice guidelines are produced by hundreds
of professional, medical, and governmental agencies in
order to standardize and improve medical care.

Clinical and preventive care guidelines are helpful
in clinical practice and in preventive medicine. They are
increasingly used in managed care environments to assure
standards, quality of care, and cost-effectiveness as well as
legal protection. Guidelines for preventive medicine and
public health practice are also part of the process of pro-
moting the quality of individual and community health,
as discussed in Chapter 11. Annual revision of the infant

immunization program, discussed in Chapter 4, is a prime
example, as is the set of guidelines for preventive care for
adult health maintenance in Table 15.5.

The issue of application of current scientific knowledge
for population health is a continuing struggle for recognition
of the prime importance of health promotion and preventive
care for health of a population. The selection of priorities in
use of resources is vital especially in the many developing
countries that are in various stages of economic development,
or which have abundant income from natural resources such
as oil and minerals. Implementation of programs designed to
achieve the MDGs can help to serve this purpose.

Public health standards and clinical practice guidelines
are an increasing part of quality improvement. It is impor-
tant, however, that they are developed as best practices and

http://www.ahrq.gov

http://www.uspreventiveservicestaskforce.org/3rduspstf/ratings.htm

Chapter 15 Health Technology, Quality, Law, and Ethics

influenced as little as possible by commercial interests of
drug or vaccine manufacturers. The proliferation of such
guidelines by health authorities or professional associations
of the USA, the UK, Canada, Australia, and other countries
indicates a wide consensus on the importance of such writ-
ten standards, guidelines, or “best practice” statements. The
recommended childhood immunization program put for-
ward annually by the CDC in conjunction with the AAP and
other professional organizations is an example of such best
practices and is accepted by health insurers and providers as
the gold standard in this field. The concept of promotion of
quality in health care and the adoption of current scientific
standards are global issues and an integral part of the New
Public Health (Box 15.6).

BOX 15.6 EISC: The Excellence in Science Committee
of the Centers for Disease Control and Prevention

The Excellence in Science Committee (EISC) promotes the
Centers for Disease Control and Prevention’s (CDC’s) sci-
entific infrastructure and facilitates communication and
collaboration that enhance scientific areas and activities
needed for state-of-the-art conduct of science. EISC serves as
a consulting body for science-related issues and makes rec-
ommendations to the CDC to foster, support, and protect an
environment for the promotion of scientific integrity, quality
assurance, and the rapid dissemination of scientific innova-
tions, technology, and information, with the ultimate goal of
improving public health.

EISC’s specific functions include:
l promoting and protecting the scientific infrastructure
l providing a forum for information exchange among

administration, directors for science, and liaison work-
ing members/groups

l communicating science-related issues to the CDC and
related scientists

l promoting professional development and training
l recognizing and rewarding quality science
l acting as an advocate for scientific resources
l identifying and disseminating new information, e.g.,

new statistical/epidemiological techniques or new scien-
tific technologies

l developing, revising, and promoting the implementation
of cross-cutting scientific policies and procedures

l serving as a consulting body for science-related issues
and making recommendations to the CDC

l fostering the development of methods for assessing and
monitoring:
– the environment for quality science and qualitative

and quantitative scientific output within CDC and
related organizations

– the impact of CDC science on public health.

Source: Adapted from Centers for Disease Control and Prevention.
Science coordination and innovation [updated 3 November 2011].
Available at: http://www.cdc.gov/od/science/excellence/ [Accessed 13
September 2012].

793

The Canadian Province of Saskatchewan Health Ser-
vices Utilization and Research Commission publishes peri-
odic reports presenting consensus positions of panels of
medical faculty, clinical specialists in pathology and physi-
cal medicine, and public health specialists in nutrition, com-
munity health, and epidemiology. Its reports are circulated
widely and serve to update medical practitioners, reduce
unnecessary testing, promote appropriate use of laboratory
and other diagnostic procedures, and provide standards of
care for individual patients and community services, such
as long-term care facilities and home health agencies.

The Canadian Medical Association issued its Handbook
on Clinical Practice Guidelines in 2007, based on a system-
atic review of the literature, interviews of key professionals,
consensus conferences, and continuing evaluation of both
process and content of such guidelines. The Guideline Inter-
national Network (GIN) Fourth International Conference,
held in Toronto in 2007, involved experts in national and
international practice guidelines from 31 countries to share
experience and concepts in this ongoing field. The GIN
library contains more than 6600 (by October 2012) guide-
lines, evidence reports and related documents, developed or
endorsed by GIN member organizations (GIN, 2012).

An Institute for Clinical Evaluation (ICES) organization
at the University of Toronto, established in 1992 with core
funding provided by Ontario’s Ministry of Health and Long
Term Care, is mandated to conduct research that contributes
to the effectiveness, quality, equity, and efficiency of health
care and health services in Ontario. ICES uses an interdis-
ciplinary research approach to health care, health services,
and health policy.

The American College of Cardiology (ACC) provides a
framework of evidence-based clinical statements and guide-
lines developed by leaders in the field of cardiovascular med-
icine with continuing adoption of new scientific information
and experience in many aspects of this field (ACC, 2012).
Many professional organizations such as the AAP, American
Congress of Obstetricians and Gynecologists (ACOG), UK
Faculty of Public Health, and European Society of Cardiol-
ogy produce clinical guidelines which are updated regularly
to provide physicians and health systems managers with
current consensus on state-of-the-art standards, such as the
European Society of Hypertension Guidelines released in
2013 (i.e., less than 140 mm. systolic for all).

The US Health Care Financing Administration (HCFA),
Center for Medicare & Medicaid Services (CMS), and
National Institutes of Health (NIH) have consensus pro-
grams to develop guidelines that are widely disseminated
and set standards of practice. In 1977, the NIH issued its
first consensus paper on breast screening for cancer, and
this has been followed by many other topics each year
since. The AHRQ also produces research related to efficacy
of current and new practices and training material to pro-
mote their diffusion across the US health system. Cochrane

http://www.cdc.gov/od/science/excellence/

794

reviews and the Cochrane Library provide high standards of
literature reviews and meta-analysis on many topics which
serve to guide practitioners and policy makers in current
standards. The US Healthy People 2020 project provides
gold standards for preventive care which serve clinicians,
public health practitioners, and health planner standards
for their work. Evidence-based consensus guidelines were
issued on the following topics: breast cancer screening
for women aged 40–49, interventions to prevent HIV risk
behavior, management of hepatitis C, genetic testing for
cystic fibrosis, acupuncture, and effective medical treat-
ment for heroin addiction.

Clinical guidelines are increasingly being promoted
by professional, governmental, and managed care orga-
nizations with the purpose of promoting rational use of
health care resources and at the same time promoting
standards of care to incorporate good standards of clinical
practice. Clinical practice guidelines are now common in
the practice of primary care, mental health, and clinical
specialties. The University of Southern California’s list
of clinical guidelines website (http://medicine.ucsf.edu/)
provides access to hundreds of websites for such practice
guidelines.

Clinical guidelines provide practicing doctors, peer
review committees, health care managers, managed care
companies, governmental bodies, and professional organi-
zations with channels to set standards of practice and expec-
tations of care standards. Legal aspects of health care also
increasingly recognize the importance of clinical guidelines
where committees of appropriate medical professionals
convene and set out average or minimum standards of care
for defined clinical entities. Thus, peer-reviewed guide-
lines set an appropriate standard (a silver if not a gold stan-
dard) for judging malpractice or adequate practice. Clinical
guidelines should be under periodic review and subject to
critical discussion and updating using the Cochrane review
methods of literature review and analysis. Promotion by
advocacy or special interest groups can be constructive,
but the influence of drug companies can be insidious and
reduce the professional objectivity of such reviews and their
recommendations, a concern that must be carefully moni-
tored and continuously kept in mind as a potential compro-
mising bias.

The AAP produces policy statements, practice param-
eters, and model bills which have a wide distribution and
influence; they are published in the academy’s journal, Pedi-
atrics. The AAP clinical practice guidelines issued include
diagnosis and treatment of urinary tract infection in febrile
infants and young children, long-term treatment of the child
with simple febrile seizures, management of acute gastroen-
teritis in young children, management of otitis media with
effusion in young children, and others. The policy state-
ments of the AAP cover a wide range of topics including
use of bicycle helmets, 55 mile per hour maximum speed

The New Public Health

limits, folic acid for the prevention of neural tube defects,
and ethics in the care of critically ill infants and children.
AAP guidelines are valid for 5 years only and are reissued
or reconfirmed in order to keep up to date and to incorporate
new or revised knowledge into practice standards.

Empirically derived, peer-reviewed, regularly updated
guidelines have become an appropriate standard for prac-
tice and for judging malpractice, as well as balancing qual-
ity and cost-effectiveness. Clinical guidelines may become
restrictive, but they help to reduce practice by whim and
unsubstantiated belief to improve the quality of care over-
all. In large health care organizations they provide a basis
for continuing education for staff and advancement of stan-
dards of the organization.

The Community Guide produced by the CDC provides
an excellent source of evidence-based advice for community
programs. It serves the needs of public health professionals,
health care providers, legislators and policy makers, research-
ers, community-based organizations, employer–employee
groups, and other purchasers of health services. The guide
covers a wide range of health issues including alcohol, can-
cer, diabetes, mental health, motor vehicle safety, nutrition
and obesity, oral health, physical activity, pregnancy, sexual
behavior, social environment, substance abuse, tobacco, vac-
cines, violence, and workplace health issues.

In 1999, the UK National Health Service (NHS) estab-
lished the National Institute for Clinical Excellence (NICE)
as an independent organization to provide guidelines for
public health, health technologies, and clinical practice
guidelines for specific conditions. The Health Development
Agency of the NHS was included in the NICE organization
in 2005. Now called the National Institute for Health and
Care Excellence, NICE publishes guidelines that provide a
helpful basis for clinical practice and public health as well
as other areas in the NHS to update the services provided.
Topics for public health include smoking and tobacco con-
trol, diet and obesity, exercise and physical activity, sexual
and mental health, and alcohol.

ORGANIZATION OF CARE

Administrative and financing systems are essential ele-
ments of quality assurance. They can be designed to pro-
mote standards of care and to reduce fiscal incentives that
foster excess supply and overservicing. The organization
of financing health care has important implications for
quality, technology, and ethical issues in the New Public
Health.

Diagnosis-Related Groups

DRGs, discussed extensively in Chapter 11, were developed
in the 1960s as an alternative way of paying for hospital care
in order to encourage shortened lengths of stay. Experience

http://medicine.ucsf.edu/

Chapter 15 Health Technology, Quality, Law, and Ethics

with payment by days of care (per diem) showed that it pro-
moted unnecessary, lengthy, and potentially dangerous use
of hospital care, an important factor in the rapid escalation
of costs in the health system. DRGs were adopted for pay-
ment for Medicare beneficiaries in the USA in 1983 and
later became the standard method of payment for all insur-
ance systems.

In the DRG system the insurer pays the provider hos-
pital for a procedure or diagnosis rather than the number
of days of stay in hospital. This has led to a large reduc-
tion in hospital days of care and a remarkable growth in the
number of surgical procedures done on an outpatient basis.
Since the introduction of DRGs, outpatient surgical proce-
dures have grown from less than one-fifth to more than half
of inpatient surgical cases. Outpatient surgery is safer for
the patient and less costly to the insurer. DRGs have gradu-
ally been adopted as a case payment system for reimbursing
hospitals in most developed countries.

The DRG system is widely considered to promote qual-
ity of care as an active process focusing on quickly address-
ing the diagnosis and management of the patient with rapid
mobilization of treatment and return home. Critics of this
system allege that DRGs encourage inappropriate early
discharge of patients before optimal patient education and
follow-up care have been provided, but long length of hos-
pital stay has not been shown to improve patient outcomes.
Critics also suggest that this may promote altering diagno-
ses to higher cost units of service. Others think that DRGs,
by reducing length of stay, have turned hospitals into inten-
sive care units with ultra-sick patients. Despite these issues,
the trend towards short hospital stays and newer approaches
to active treatment seems to be compatible with better care
and improved outcomes, according to some measures. The
rapid decline in mortality rates from coronary heart disease
is thought to be due in large part to the activist treatment
approach, with lengths of stay of 1 week or less for acute
myocardial infarction compared to 6 weeks on average up
to the 1970s.

Managed Care

Managed care systems developed in the USA in response
to rapid cost escalation for health care and the successful
experience of HMOs. Managed care is based on the con-
cepts of resource management, and quality assurance with
rationalized use of technology. The system developed over
time with checks and balances to provide comprehensive
care at lower cost than traditional fee-for-service systems
by discouraging excessive utilization without compromis-
ing quality of service. Managed care systems include tradi-
tional HMOs and various other organizations which employ
physicians or are made up of independent physicians work-
ing together who own or contract for hospital services (see
Chapter 10).

795

HMOs, both for-profit and not-for-profit, and man-
aged care itself, have been widely criticized as excessively
limiting patient access to appropriate care in the interest
of cost containment. The 2010 PPACA (Obamacare) is
promoting development of newer innovations including
patient-centered medical homes (PCMH), accountable
care organizations (ACOs), and population health man-
agement systems (PHMSs), and early evidence shows that
these models are quality management approaches for inte-
grated primary and hospital patient care (see Chapter 11).
Obamacare is a highly politicized and much debated topic
in the USA; it seems likely to make a very big difference
in coverage and fair practices of insurance with lower
costs of private insurance.

District health systems in the UK, the Scandinavian
countries, and the post-Soviet model of health care incor-
porate organizational and financial linkage between care
systems and funding from tax sources. HMOs, sick benefit
funds, and district health systems provide both prepayment
and health services. Even in traditional private health insur-
ance systems, the insurer is increasingly taking on the role
of regulating reimbursement for medical services in order to
contain costs and curb abuses by providers. In this context,
emphasis is placed on maintaining health, preventive care,
and financial incentives to efficiency in overall care. Clini-
cal indications, utilization review, and organizational and
professional standards are now becoming accepted parts of
the health insurance milieu.

The competition between hospitals for referrals from
managed care plans in the USA has created a market
situation in which a high proportion of hospital beds are
empty, and in which mergers or closures of hospitals
are common. Closures or reductions in hospital bed sup-
ply are also occurring in the UK and in most industrial-
ized countries of Europe.

PERFORMANCE INDICATORS

Performance indicators are measures such as morbidity,
mortality, functional status, or immunization rates in a com-
munity, used to monitor the functioning of a health service.
Routinely collected statistics are analyzed to compare per-
formance against objectives, help monitor efficiency and
effectiveness, point out problem areas within the service,
and plan new health programs. This method is based on the
use of the concept of management-by-objectives in health
administration to promote achievement of national health
targets.

The UK has a strong tradition of mapping diseases as a
basis of epidemiological analysis and has applied this strat-
egy to mapping of performance indicators to assess health
care performance. The UK financing system is based on
capitation adjusted by standardized mortality rates on the
premise that mortality rates standardized and compared to

796

the national average serve as indicators of need. In this way,
the approach helps to promote equitable funding among
wealthy and poorer regions of the country, and thereby
improve services in areas of greater need.

Performance indicators were introduced into the NHS
during reforms of the late 1980s, providing a series of
outcome or performance measures that are used to adjust
payments allocated on a per capita basis to district health
authorities. These authorities can be penalized for low rates
of immunization, whereas general practitioners receive
incentive payments for full immunization coverage. The
result was a rapid improvement in immunization coverage
of infants and children compared to rates in the previous
decade. Incentive payments in many countries encourage
women to go to hospitals for delivery or to attend prenatal
care by making social maternity grants conditional on seek-
ing care.

Use of performance indicators requires the development
of health information systems with district health profiles
to provide ongoing monitoring of health indicators in a dis-
trict, compared to regional and national rates and targets.
Health profiles help to establish and monitor the prevalence
of chronic disease and measure the impact of health ser-
vices. This enables the study of the performance of preven-
tive and curative services, such as managing hypertension
to reduce the incidence of strokes and related conditions.
There are criticisms of performance indicators alleging a
potential for manipulation and abuse of health intervention
measures when the financial incentives are used for a spe-
cific activity. However, financial incentives are part of the
DRG system and have been successfully used in the UK to
improve vaccination coverage and implementation of other
preventive health practices by family physicians. In Israel in
2007, payments to hospitals provided a bonus for surgical
interventions for hip fracture within 48 hours of the event,
resulting in a marked rise in early intervention and a reduc-
tion in mortality from hip fractures.

CONSUMERISM AND QUALITY

With decentralization and the growth of managed care,
health systems must increase their attention to the attitudes
of the consumer. Quality is, in part, how the client per-
ceives the system, and how the system meets client needs
in an acceptable manner, where privacy, dignity, the right to
know, and the right to a defined set of services are protected.
However, the rights of the client are not unlimited. A public
or private health plan has the duty to manage the basket of
services responsibly, which includes limitations such as in
access to specialist services.

Patients’ rights and consumer protection in health care
often (but not always) include the right to select and change
a health care provider, as well as the right to receive high-
quality care for a designated range of services. The UK NHS

The New Public Health

issued a patient’s Charter of Rights during the 1990s, which
is perhaps idealistic and may not be actualized in practice,
but still outlines an ideal of value both for practical applica-
tion and for legal rights. The consumer’s formal protection
includes the right to complain and to seek redress of grievance
and compensation for injury suffered from neglect or incom-
petent care (Box 15.7). In North America and Europe, there
are at least four models of defining the rights of patients: the
paternalistic model, the informative model, the interpretive
model, and the deliberative model (WHO, 2012). Many new
charters have been established such as data protection, end-
of-life care, mental health, access to health services, quality
of care and care giving environment, nationally approved
treatments, drugs and programs, respect, consent and confi-
dentiality specific to the UK and in Canada, New Zealand
and other countries. The new US federal Affordable Care Act
of 2010 (PPACA) includes a large element of patient’s rights
protection, as discussed in Chapter 10.

The patient or consumer of health care needs to be
informed and conscious of health care costs if efforts to
restrain cost increases are to be effective. Public attitudes
are vital in terms of self-care, demands on the health service,
and limitations to the potential of health care and resources
for health care. The media and consumer organizations can
play important roles in advocacy for health, in raising pub-
lic consciousness of self-care, and as watchdogs on abuses.

Consumer acceptance is manifested through choice of
health plan and practitioner, or by seeking alternative care

BOX 15.7 Patients’ Rights, European Union, 2009

A review of patients’ rights in countries of the European
Union in 2009 focused on the following:
l Right to informed consent based on access to informa-

tion for care or participation in research
l Right to information concerning own health, diagnosis
l Right to medical records
l Right to confidentiality of personal and health informa-

tion and physical privacy during care
l Right to complain and compensation
l Right of free choice of provider and of treatment
l Respect of patient’s time
l Right to observance of quality standards access to high-

quality health services
l Right to safety and freedom from harm caused by the

poor functioning of health services, medical malpractice
and errors, and the right of access to health services and
treatments that meet high safety standards

l Right of access to innovative procedures, including diag-
nostic procedures, according to international standards and
independently of economic or financial considerations.

Source: European Patients’ Forum. Patients’ rights in the European Union.
Available at: http://www.eu-patient.eu/Documents/Projects/Valueplus/
Patients_Rights [Accessed 25 October 2012].

http://www.eu-patient.eu/Documents/Projects/Valueplus/Patients_Rights

Chapter 15 Health Technology, Quality, Law, and Ethics

privately when service is unacceptable because of quality or
style. Erosion of confidence in a public system of care can
lead to a two-tier system with the public system serving the
poor and a private parallel system serving the middle and
wealthy classes. Such a division can seriously undermine a
public system unless it is addressed by improving the qual-
ity and manner of the service and by establishing supervi-
sion and limitations on public and private practice.

The growing inequality caused by the rise of private
practice outside a national health care system is a chronic
problem in the UK’s NHS, in Israel’s health system, and in
many countries developing their health systems through par-
allel public and private care. The issue is also surfacing in
the USA in the transition to managed care with its inherent
limitations of choice for people insured through their place of
work or covered under the Medicare and Medicaid programs.

The PPACA requires insurance companies to accept any-
one requesting cover without restrictions due to prior con-
ditions or high expenses for serious conditions, and without
other forms of discrimination common in the past. It also
includes provisions for coverage of preventive care services
and incentives for quality improvement. Extra billing, banned
in Canada’s national health insurance plan, is a recurring
issue with the medical profession in some provinces.

Consumer knowledge, attitudes, beliefs, and practices
are part of the health system, from health promotion to
tertiary care. Informed and health-conscious consumers
are stronger partners in the health system in achieving
improved health than an ill-informed and apathetic public,
so that health education and health promotion are funda-
mental to modern public health. The role of the consumer
in health care is unique in that there is a significant infor-
mation asymmetry between the consumer and provider.
Health education programs and wide use of the Internet
increase access to health and medical information, but this
gap can never completely be eliminated. Patients may use
their power as consumers to demand inappropriate care,
such as unnecessary surgery or antibiotics when clearly
not indicated, because of their preference for interven-
tion and action over watchful waiting. However, there is
an equal or perhaps greater danger of provider-induced
demand for repeated and possibly unnecessary interven-
tions that may be related to methods of paying the doctor
or the hospital. The traditional doctor–patient relationship
is still an important factor for the interests of patients and
their health. A still effective method of having an individ-
ual quit smoking is a brief but stern lecture by the family
physician.

THE PUBLIC INTEREST

Population-based interventions are often more effective
and less costly ways to reduce morbidity and mortal-
ity than individual prevention or treatment services. A

797

population-based preventive program may require behav-
ior change by the individual, such as in mandatory seat
belt and motorcycle helmet enforcement or banning smok-
ing in public places. Fortification of flour, milk, and salt
with essential micronutrients is a well-established public
health measure. There is an element of compulsion in this,
with the social gain usually considered to be sufficiently
important to outweigh individual rights. Immunization
is for the protection of individuals but also for the popu-
lation, so that refusals to immunize children and adults
can cause injury to others. Herd immunity is protective
of people who are at high risk. Mandatory immunization
for school entry in the USA has been effective in increas-
ing coverage to levels akin to the most advanced health
systems, over 95 percent coverage. Refusals and failure to
harmonize immunization policies in Europe have resulted
in mass epidemics of measles, rubella, and mumps in
recent years.

There is often a delicate balance between community
rights and individual rights which can lie at the heart of
many controversies in modern public health and health
care, ranging from chlorination or fluoridation of com-
munity water supplies to managed care systems for
health services. Women’s rights, gay rights and abortion
are highly controversial and politicized in the USA, and
in many other countries. The differences can become
extreme and the source of international strife, such as in
the movement to promote fundamentalist Sharia law in
many countries that are severely restrictive of women’s
and minority rights.

In public health, issues should be examined on their
merits, especially in terms of what is accepted as good pub-
lic health practice, based on evidence from clinical trials,
documented experience, and best practices in other coun-
tries. The evidence of successful public health measures in
improving individual and collective health status is power-
ful, yet must always be balanced within the context of indi-
vidual rights and the public interest. The ethical issues of
individual and community rights of public health are dis-
cussed later in this chapter.

TOTAL QUALITY MANAGEMENT

Total quality management (TQM), as discussed in Chap-
ter 12, was adapted from business management theory and
practice to health care in the 1990s and provides a basis for
promoting continuous improvement in health care systems.
TQM involves everyone in the system, from all levels of
management to production or service personnel and sup-
port staff, and thus helps to raise staff morale because of the
shared involvement. Health is provided through multidisci-
plinary groups which need to approach problems with open
and shared scientific inquiry and hypothesis formation, test-
ing, and revision to find operational solutions to problems.

798

Electronic health records and information technology pro-
vide many new opportunities to improve patient care and
data systems for monitoring the health status of population
groups for process and outcome measures, or health targets,
such as immunization coverage, or screening compliance
for colon, cervical, or breast cancer, as measures of perfor-
mance in primary care. Information technology adds a great
deal of capacity for quality monitoring and improvement
measures.

TQM incorporates statistical methods, comparing varia-
tions in patterns of service or use of resources. It employs
epidemiological methods to draw conclusions for policy
needs. It looks for continuous improvement, encouraging
cooperation, and motivation to achieve common goals of
service and client satisfaction. Psychological theory helps to
foster higher levels of motivation, with early identification
and resolution of conflict. Leadership is shared, and there is
a basic need for cooperation. Cost and quality are interre-
lated, as poor quality leads to waste, inefficiency, and dis-
satisfaction of both clients and staff. High-quality, humane,
and effective services are especially important in a competi-
tive environment where clients have the right to choose and
where costs and efficiency are factors in the well-being and
indeed the survival of institutions.

Medical care is increasingly practiced in larger health
care organizations. To provide technically competent
medicine is not by itself sufficient. The patient’s rights
and sense of personal worth are also of great importance.
Financial incentives can be effective in redirecting health
care priorities, such as in reducing hospital length of
stay and admissions, but may result in the patient or the
family feeling that they are not receiving the best care.
DRGs, HMOs, and other organizational and funding sys-
tems meant to increase efficiency of care may have the
effect of alienating patients from a health care system.
Staff attitudes towards patients are important for client
satisfaction. The service must include ready access to
a continuum of supportive services, such as home care
and counseling, so that the patient and family do not feel
abandoned by the system.

A byproduct of TQM is continuous quality improve-
ment (CQI), by which institutions wishing to improve qual-
ity train and empower the staff to work in teams to assess
their own performance and seek solutions to problems in
their operational unit. People of different ranks and profes-
sions work in a network organization as well as in a tradi-
tional hierarchical organization in which rank and seniority
provide authority. This community of practice is important
for staff morale and a shared sense of responsibility for the
patient and the institution.

CQI involves multidisciplinary approaches, not only
to review problems but also to seek better ways of func-
tioning and improving consumer satisfaction. The process
includes all those involved in providing care, support ser-
vices, and administration of a department, hospital, clinic,

The New Public Health

or community health program. This is not only professional
self-policing but a method to find better ways of meeting
needs and using resources. The involvement of all provid-
ers improves motivation and promotes a sense of common
purpose in the organization.

Applying these principles in a health care setting can
take many forms. Selection of topics by TQM/CQI com-
mittees in a hospital or another health facility may be
based on surveys or interviews with staff, patients, or
management. Satisfaction surveys among women follow-
ing delivery in an obstetrics unit could point out remedi-
able problems. An obstetrics department may be faced
with issues related to high or low volume of deliveries,
staff training, equipment and supplies, communica-
tion among staff, and among staff and patients and their
families, cleanliness, sterile technique, staff satisfaction,
client satisfaction, and many others. The team looking
at such a problem should be multidisciplinary, and the
emphasis should be on client attitudes and satisfaction.

Examination of the function of an emergency depart-
ment in a hospital would similarly look at many functional
and attitudinal aspects of the service including staff atti-
tudes, training needs, waiting times, consultation ser-
vices, and others. Addressing waiting times, for example,
can lead to ways to reduce these substantially, improving
both client satisfaction and the efficient management of
the emergency department. Any service is there to serve
patients and the community. A service is not primarily for
the benefit of the staff, but staff satisfaction and morale are
essential for successful service to clientele. CQI can also
be applied to assessing and improving compliance with
clinical guidelines or evidence. An example is assessing
the proportion of diabetics whose hemoglobin A1c (HbA1c)
is measured at least twice annually, who have eye and
feet examinations regularly, or whose blood pressure is
managed with an angiotensin-converting enzyme (ACE)
inhibitor.

The European Region of the WHO and the national
medical associations in Europe agreed in 1995 that medi-
cal associations should take leading roles in programs of
CQI to achieve better outcomes of health care in terms of
functional ability, patient well-being, consumer satisfac-
tion, and cost-effectiveness. This is in keeping with the
European Region’s Health for All targets: there should
be structures and processes in all member states to
ensure continuous improvement in the quality of care and
appropriate development and use of health technolo gies.

The introduction in the 1990s of general practitioner
fundholding for hospital care for patients on the general
practitioners’ roster in the UK encouraged the hospital to
maximize patient satisfaction with the care system. This
promotes application of CQI to improving the quality and
acceptability of care. Similarly, performance indicators
provide regional and district health authorities in the UK
with tools for CQI approaches. The UK NHS established

799Chapter 15 Health Technology, Quality, Law, and Ethics

The National Institute for Clinical Excellence (NICE), estab-
lished in 1999, has a mandate to review health service treat-
ments and effective therapies that should be commissioned
and made available within the National Health Service (NHS)
throughout England and Wales. The mission statement for
NICE is that it “contributes to better health around the world
through the more effective and equitable use of resources”.
In 2005 NICE was revised to include reviews of public health
interventions, and its mandate was expanded to include quality
standards for the English social care sector (English Health and
Social Care Act of 2011). Now renamed the National Institute
for Health and Care Excellence, NICE operates as a statutory
independent special health authority in England and Wales.
Commissioning bodies of the NHS are required to observe its
recommendations. Guidance can be used by the NHS, local
authorities, employers, voluntary groups, and anyone else
involved in delivering care or promoting well-being.

NICE recommendations are respected elsewhere in the
UK, but are not mandatory; in Scotland NICE recommen-
dations are published after further review by NHS Quality
Improvement Scotland (for health services issues) and by NHS
Health Scotland (for public health recommendations). NICE
recommendations are respected worldwide, including by the
European Commission and by national governments; NICE
International is a section of NICE established to meet non-UK
needs (e.g., evaluating rural health programs in China).

An independent committee including lay representation
advises on priorities for NICE consideration but final deci-
sions on topics referred to NICE are made by the Department
of Health. When making recommendations to the NHS on
which services (e.g., treatments) should be provided routinely,
it calculates the cost-effectiveness of treatment for each quality-
adjusted life year (QALY) of health gain purchased.

NICE publications include guidance on 374 interventional
procedures, 270 technology appraisals, 162 clinical guide-
lines, and 43 public health topics. From this latter group, some
examples include:
l Prevention of cardiovascular diseases (2010) – provides

evidence of effectiveness of population-based prevention
programs as more effective than programs aimed at high-
risk groups.

l Alcohol dependence and harmful alcohol use (2011) –
summarizes all NICE guidance; designed to inform mem-
bers of the public as well as health professionals.

l Preventing type 2 diabetes through population and com-
munity interventions (2011) – provides guidance to gov-
ernment departments, the commercial sector, health
service organizations, and non-governmental organiza-
tions on integration of public policy to prevent obesity, and
reduce diabetes prevalence and complications.

l Preventing uptake of smoking by children and young peo-
ple (2008) – document to advise local health service com-
missioners; identifies target populations, reviews campaign
messages, and provides recommendations for the mass
media and retailers.

l Promoting mental well-being at work (2009) – guidance
aimed at employers; reviews evidence in the field and rec-
ommends strategic approaches by firms, opportunities to
promote well-being and assess risk, and systems of flexible
working.

l Preventing unintentional injuries among under-15s in the
home (2010) – reviews evidence and makes recommenda-
tions to local authorities and related agencies on training
an appropriate workforce, advises government to fund cur-
ricula development, and indicates to the NHS appropriate
surveillance and treatment services.
NICE is often criticized (especially by the pharmaceuti-

cal industry) for the time taken to carry out investigations of
new treatments. It is also criticized by relatives of patients with
“glamorous” conditions (e.g., cancer) for not approving drugs
that might extend life by only 4–6 weeks, and perhaps approv-
ing instead new psychiatric therapies. The current government
has recently sought to overrule some of these NICE recommen-
dations in England. However, NICE methods and recommen-
dations are held in high repute, within the UK and beyond.

Sources: Christopher Birt FRCP FFPH, University of Liverpool, UK. Personal
communication.
National Institute for Health and Care Excellence. 2012. Available at: http://
guidance.nice.org.uk [Accessed 24 December 2012].
O’Flaherty M, Flores-Mateo G, Nnoaham K, Lloyd-Williams F, Rayner M,
Capewell S. Estimating potential cardiovascular mortality reductions with
different food policy options in the UK. Bull World Health Organ 2012;90:
522–31.
National Institute for Health and Clinical Excellence. Promoting mental
wellbeing through productive and healthy working conditions: guidance
for employers. NICE; 2009. Available at: http://www.nice.org.uk or http://
www.apho.org.uk/resource/item.aspx?RID=83868 [Accessed 18 August
2013].
Campbell B. Regulation and safe adoption of new medical devices and
procedures. Br Med Bull 2013;1–14 [Epub ahead of print]. http://dx.doi.
org/10.1093/bmb/ldt022.

BOX 15.8 The UK’s National Institute for Health and Care Excellence (NICE)

NICE as an independent body to promote “national
guidance on promoting good health and preventing and
treating ill-health”. NICE produces guidance in three
areas:

l public health – guidance for those working in the NHS,
local authorities and the wider public and voluntary sector
on promotion of good health and the prevention of disease

l health technologies – guidance on use of new and
existing medicines, treatments and procedures within
the NHS

l clinical practice – guidance on appropriate treatment
and care within the NHS of people with specific dis-
eases and conditions.

NICE guidelines are recommended practices with the
objective of reducing ineffective practices. During 2007,
guidelines were issued on topics including asthma, derma-
titis, caesarean section, chronic obstructive lung disease,
depression (in children and adults), eating disorders, fertil-
ity, contraception, multiple sclerosis, post-traumatic stress
disorder, and diabetic foot care (Box 15.8).

http://guidance.nice.org.uk

http://www.nice.org.uk

http://www.apho.org.uk/resource/item.aspx?RID=83868

http://dx.doi.org/10.1093/bmb/ldt022

800

BOX 15.9 Organizations to Promote Quality in Health,
USA

l National Committee for Quality Assurance (NCQA) –
This non-profit organization, founded in 1979 by the
managed care industry, conducts surveys among man-
aged care plans to evaluate clinical standards, mem-
bers’ rights, and health service performance. It accredits
over 550 managed care plans in the USA, and in 2007
published rankings of the “best” health plans. Website:

Health Care Accreditation, Health Plan Accreditation Organization – NCQA

l Agency for Healthcare Research and Quality (AHRQ) –
This is part of the US Public Health Service. Founded in
1995, it was mandated to develop an evidence-based
practice program in 12 centers in the USA. It conducts
systematic reviews of the literature and publishes analy-
ses and findings of these reviews. Website: http://www.
ahrq.gov/

l Centers for Medicare & Medicaid Services (CMS) 2001 –
The CMS, previously the Health Care Financing
Administration (HCFA, 1977), is the federal agency of
the Department of Health and Human Services, respon-
sible for administering the Medicare and Medicaid and
the State Children’s Health Insurance Program (CHIP)
health plans. Its roles include quality assurance, the
requirements for managed care organizations, and qual-
ity improvement. Website: http://www.cms.gov/

l Institute for Healthcare Improvement (IHI) – Non profit
organization founded in 1991 as a global resource for
health care improvement knowledge to improve health
care by fostering collaboration among health care orga-
nizations. IHI examines office practices of physicians,
educational reform, and promotes interdisciplinary team
work in quality improvement. Website: http://www.ihi.
org/ihi/

l National Patient Safety Foundation (NPSF) – Sponsored
by the American Medical Association as a response to
findings of high rates of injury and death from iatrogenic
disease in the USA, the NPSF promotes research into
human error among health care providers, seeking ways
to reduce the frequency and effects of medical error,
such as misdiagnosis, medication errors, and mistakes
during procedures. Website: http://www.npsf.org/au/

l Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) – Originating in 1917 by the
American College of Surgeons, it began accrediting
hospitals in 1918. It developed in 1953 as the JCAHO,
becoming a national voluntary accreditation organiza-
tion focusing mainly on hospitals. Its mandate was broad-
ened in 1987 and, as of 2007, had accredited more than
15,000 health care organizations. Accreditation is man-
datory for Medicare and Medicaid payment. The JCAHO
is changing its approach from standards-based assess-
ment every 3 years to one of reviewing performance data
quarterly as a continuous surveillance activity for risk
reduction. Website: http://www.jointcommission.org/

Source: Websites accessed 12 September 2012.

The New Public Health

The USA has a number of government and independent
organizations dedicated to improving quality in health care
systems. The CDC and the Institute of Medicine of the US
National Academies of Science play active roles in promot-
ing research quality and methods of CQI in the US health
care system. Canada is also very active in this regard, hav-
ing national and provincial institutes for the evaluation of
clinical effectiveness and clinical guidelines, and so too are
European countries (Box 15.9).

PUBLIC HEALTH LAW

Public health workers need knowledge of government
structure and public health legislation as basic to their pro-
fessional work to understand their responsibilities, powers
and liabilities. Law consists of a system of rules, regula-
tions, and orders that govern the behavior of individuals
and of society. Law represents the consensus of a society, as
enacted by an elected legislature, put into effect by the exec-
utive branch of government, and interpreted by the courts
as need be from time to time. The legislative and execu-
tive branches are separate under the US Constitution, but
the two are united in the parliamentary system (Box 15.10).
The authority, responsibility, and power to provide for and
protect the public health are basic functions of a sovereign
government, which may be delegated to another level of
government (higher or lower) or even a non-governmental
agency. The constitution of a sovereign government states
explicitly or implicitly that responsibility, but accepted
practice and court decisions (i.e., the common law) define
the powers of the national, state, or local government to
monitor and protect the health of its citizens.

In the USA, national legislation is enacted under the
powers of the federal government, namely to regulate inter-
state commerce and the power to tax and spend for the
general welfare. State legislation is enacted under the basic
power of the state to protect the health, welfare, and safety
of its citizens. Under these federal and state powers, a wide
range of health legislation and regulations is enacted affect-
ing public health, labor, and occupational health and safety,
environmental controls, public welfare, and the financing
of health services, agriculture, food, drugs, cosmetics, and
medical devices. Public health law relies on a wide range of
constitutional, statutory, administrative, and judicial deci-
sions in both civil and criminal actions. Appropriation of
funds is a legal act of legislative bodies to achieve objec-
tives directly or indirectly by financial incentives.

Categorical programs may be directed to specific issues
such as combating TB and promoting immunization or for
work to combat NCDs such as diabetes, or in improving
standards of facilities, and in providing health care services.
The regulatory, enforcement, policing, and punitive func-
tions of public health laws have evolved over many decades
and in many countries lack clear definition. In the USA,

Health Care Accreditation, Health Plan Accreditation Organization – NCQA

http://www.ahrq.gov/

http://www.cms.gov/

http://www.ihi.org/ihi/

http://www.npsf.org/au/

http://www.jointcommission.org/

801Chapter 15 Health Technology, Quality, Law, and Ethics

In federal nations, political authority is divided between two
autonomous sets of governments, one national and the other
subnational. Both operate directly with the people in their juris-
diction based on a constitutional division of power between
the national government, which exercises authority over the
whole national territory, and state or provincial governments
with independent authority within their own territories. The
constitution is the supreme law of a country. It sets out the
divisions of governmental powers including statutory authority,
administrative, natural resources, and taxation between federal
and state levels of government.

A federal legislature or congress makes the law of the land,
but is subject to rulings of a Supreme Court as are state and
local governments. State or provincial governments in a fed-
eral system have functions set out in the Constitution. They
also have elected legislatures, and executive branches with
taxing, regulatory, and punitive powers. Local governments
for county, municipal, or city governments also have dele-
gated taxing and regulatory powers including those of public
health.

Canada, the USA, Brazil, Australia, India, and Argentina
are organized on a federal basis. Federal countries also include
Austria, Germany, Malaysia, Mexico, Nigeria, Switzerland, and
Venezuela. Russia is called a federation. Usually there is some
overlapping or shared powers between national and state con-
stitutions, legislatures, and court systems, and public agencies,
taxing powers and regulatory functions, such as in interstate
commerce and emergency response to natural or other disasters.

In a unitary government system, most or all of the governing
power resides in a centralized government. This contrasts with
a federal system. In unitary systems the central government

commonly delegates authority to subnational units and chan-
nels policy decisions down to them for implementation.
A majority of nation-states are unitary systems. They vary greatly.
The UK includes England, Scotland, Wales, and Northern
Ireland, each with legislatures, but the Westminster Parliament
in London maintains national powers. In health, each of the four
member entities of the UK conducts a National Health Service
with autonomy but common features. The national government
may delegate certain powers to self-governing regions/local
authorities, and there is a growing tendency to devolve various
governmental functions such as health to regional authorities.
More than 150 countries are unitary states, including France,
Italy, Spain, China, and Japan.

In both forms of government, local authorities are estab-
lished under state law with governance by councils elected
by the people, with taxing and regulatory powers within the
state or provincial laws, with a high degree of autonomy but
within state regulation, standards, and financial support. Local
authorities have major responsibilities in public health such as
in sanitation, licensing, and regulation of businesses and zon-
ing, as well as many other areas, including social welfare.

Note: See also Chapter 10.
Source: Differences between federal and unitary forms of government.
Available at: http://www.preservearticles.com/201107139054/difference-
between-unitary-and-federal-forms-of-government.html [Accessed 15
December 2012].
Encyclopedia Britannica. Unitary government. Available at: http://www.
britannica.com/EBchecked/topic/615371/unitary-system [Accessed 15
December 2012].
Encyclopedia Britannica. Political systems. Available at: http://www.britan-
nica.com/EBchecked/topic/467746/political-system/36704/Federal-systems
[Accessed 15 December 2102].

BOX 15.10 Legal Structure of Federal and Unitary Countries

efforts are being made to update and reform laws in the pub-
lic health sector. In 1988, the Institute of Medicine (IOM) in
the USA (the Future of Public Health) called for codifica-
tion of public health law as essential for the public good,
while questioning the soundness of certain US public health
laws. More recently, the Model State Emergency Health
Powers Act in the USA, the Quarantine Act in Canada, and
the revised International Health Regulations (2007) have
sought to update century-old legislation. The revised inter-
national regulations provide for a global approach to con-
trol the spread of epidemics and public health emergencies
while minimizing disruption to international activities such
as travel, trade, and economics.

A combination of the regulatory, persuasive, and fund-
ing approaches is widely used in public health in control of
communicable and non-communicable diseases, in improv-
ing standards of facilities, and in providing health services.
The regulatory, enforcement, policing, and punitive func-
tions of public health are important in health promotion and
assurance of health care. The taxing power of government is
essential for public health to ensure that adequate facilities

and access to care are available to all members of the com-
munity, especially those in financial need and thus at greater
risk for disease.

Medical officers of health and their staff have legal
authority to issue formal orders for health protection of
the public. Situations which require court proceedings are
referred to the justice system. Situations that may require
enforcement by court proceedings are referred to the justice
system. Laws may be enacted to fund public health activi-
ties, whether provided by public health authorities or by
acting through official or non-official agencies or providers.
Public health authorities, namely medical officers of health,
have the legislative power to issue orders to individuals or
businesses where there is a threat to the health of the public
such as food establishments. Administrative resources are
needed to enforce laws, such as through the FDA and the
Environmental Protection Agency, which come under the
aegis of the Department of Health and Human Services.
Other departments such as Agriculture, Education, or inter-
departmental agencies (e.g., Homeland Security), also are
key to public health activities, such as in disaster situations.

http://www.preservearticles.com/201107139054/difference-between-unitary-and-federal-forms-of-government.html

http://www.britannica.com/EBchecked/topic/615371/unitary-system

http://www.britannica.com/EBchecked/topic/467746/political-system/36704/Federal-systems

802

Other intergovernmental activities may require special leg-
islation to empower, finance, and promote their cooperation,
such as in the case of establishing an authority to manage
long-term efforts to clean up a contaminated river or basin,
which involves the cooperation and coordination of many
local authorities.

Health protection of individuals and communities may
require legal action to detain a person in order to prevent
the spread of a reportable communicable disease, to protect
a mentally ill patient, or to restrain a violent person. Such
powers should be used as a last resort if voluntary compli-
ance and education fail, and where the danger to the commu-
nity or the individual is sufficient to convince a court of the
public need to override the personal liberty of an individual.
An example is a 2007 case of a person with MDR-TB who
was taken into custody on arrival for compulsory treatment
after traveling across the Atlantic Ocean on a commercial
airline, against the specific instructions of his physician, thus
endangering fellow passengers. Outbreaks of measles in the
UK (2006–2007) and in Israel via imported cases among
ultraorthodox Jews or conservative protestant groups in the
Netherlands, with transmission among religious people who
tend not to immunize their children, led to pressure by health
authorities to immunize those placed at risk by such contacts
at weddings or other large public events.

However, these measures are currently used less than
voluntary isolation or quarantine and placarding homes for
reportable infectious diseases such as measles. Powers are
essential in extreme cases where refusal to comply with
public health measures endangers others. Such powers
should have been used more vigorously in the early years
of the AIDS epidemic at a time when individual rights took
precedence over protection of the population, including
vulnerable high-risk groups. The severe acute respiratory
syndrome (SARS) epidemic of 2003 led to sequestering
hospital staff in Toronto, Canada, for lengthy periods to
prevent spread of the disease, and subsequent influenza
pandemic threats have raised questions as to whether hos-
pital personnel should be required to be immunized to pro-
tect patients and their families from onward transmission
of dangerous infections.

Recent cases in the USA, the UK, and Norway dem-
onstrate the responsibility of governments to protect the
public from incidents of violence by dangerous, mentally
disturbed individuals who carry out mass killings. In Nor-
way, 69 people, mostly teenagers, were killed by a radical
ideologue while many others sustained serious injuries; and
in the USA, Islamic terrorists at the Boston Marathon killed
three and seriously injured more than 200 others; a 20-year
old fatally shot his mother then killed 20 children and six
adult staff members at Sandy Hook elementary school in
Newtown, Connecticut, before killing himself; and an army
psychiatrist who had become an increasingly devout and

The New Public Health

radicalized Muslim psychiatrist shot and killed 13 people
and injured more than 30 others in a Texan army base.
Background checks and other restrictions on gun sales are
an important public health and political issue, especially in
the USA. The wide availability of guns, including military-
style assault weapons, presents a serious danger for impul-
sive or planned mass killings.

Public health has generally evolved with greater reli-
ance on health promotion through voluntary cooperation of
a patient or community than on compulsion. Enabling leg-
islation may permit a local authority to fluoridate its water
supply, but the enactment of local legislation and funding to
implement it may also require a public referendum. In some
states in the USA and in Israel, fluoridation of community
water supplies is mandatory, which is also part of the health
promotion approach to public health.

Appropriation of public funds to promote public health is
through approval by the legislature for a specified program.
Provision of public funds may take the form of categorical
grants for specified services, such as immunization, prenatal
care, school health, or specific disease management such as
TB control, cancer control, or AIDS education. Programs may
be designed to promote certain types and quality of services,
such as the Hill–Burton Act, which provided federal grants
for hospital construction in the 1950s to 1970s, conditioning
these grants on certain requirements concerning hospital licen-
sure and hospital planning. Such legislation has a “carrot and
stick” effect of attracting lower levels of government to seek
such funding but also requiring them to accept the conditions
and regulations that accompany the grants. The Canadian fed-
eral government’s cost sharing of provincial health (hospital
and medical) insurance programs is based on federal criteria
requiring public administration, portability between provinces,
accessibility without payment, comprehensiveness, and ban-
ning extra billing by physicians (see Chapter 13).

Public funds are also appropriated in the context of
legislated programs in which people are entitled to the ser-
vices defined in the appropriation legislation, such as in the
amendments to the Social Security Act providing Medicare
and Medicaid programs, or national health insurance legis-
lation in many countries. These and their regulations spell
out categories and specified entitlement benefits.

Legislation and court decisions to protect the rights of
the individual are part of public health. Public health law
is meant to protect individuals and communities from
potential abuse, of both individual and community human
rights, as in the US Bill of Rights. Enforcement of public
health law may infringe on individual rights by enforcing
sanitation, food and drug safety, and supervision of res-
taurants and catering firms. Laws may allow restriction of
civil rights, such as rarely used mandatory treatment of a
person with a dangerous contagious disease or mental ill-
ness. Freedom of religion may come into conflict with other

Chapter 15 Health Technology, Quality, Law, and Ethics

laws in public health where restrictive practices may deny
the use of publicly supported health facilities, as when a
religiously affiliated hospital may refuse an abortion proce-
dure in a case of rape. Religious practices or other personal
beliefs may endanger others in the community, such as in
the refusal to immunize children so that an imported infec-
tious disease may spread among non-immunized people
and even affect those who are immunized, as occurs with
imported measles cases even when domestic transmission
of the disease has previously been eradicated. General legis-
lative provisions applied to public health forbid misleading
or unethical advertising. Legislative provisions may also
ban advertising for products, such as tobacco, which are
legal but may be harmful to health. These laws affect public
health but are provisions in other statutes such as the regu-
lation of business enterprises. Legislation may also make
smoking in public places illegal, with fines for offenders
and operators of places such as public bars.

Since the 1973 US Supreme Court decision of Roe v.
Wade, the law has allowed women to seek safe and legal
abortion. This remains a highly controversial political issue
in the USA and several other countries. The potential con-
flict between community and individual interests and rights
is part of the dynamics of public health law and public health
practice. The issues involved are complex and highly politi-
cized, and often involve ethical distinctions where “the great-
est good for the greatest number” may limit the legitimate
rights of individuals and vice versa. The PPACA in 2010 is a
fundamental legislative initiative, upheld by the US Supreme
Court to become the law of the land. It will bring millions of
Americans into regulated health insurance with many protec-
tive elements to prevent abuse by private insurance company
through arbitrary exclusions or limitations.

The legal aspects of public health are vital to its opera-
tion and are increasingly complicated by ethical issues, and
by public and political debate. Health protective legislation
and regulation for sanitation of food, water, and air are fun-
damental to public health, as is the control of drugs, cosmet-
ics, vaccines, and biologicals, the manufacture of devices,
and the licensing of health personnel and facilities. Limi-
tations of legal suits (torts) against manufacturers of vac-
cines proved to be a successful measure in the USA with
the introduction of the National Vaccine Injury Compensa-
tion Program (NVICP) in 1988. This is funded by a modest
surcharge tax collected from vaccine manufacturers. It pro-
tects both public and private interests while providing a fair
compensation system to ensure patients’ rights but without
jeopardizing immunization to prevent widespread disease,
and also protects manufacturers from litigation with high
legal costs and excessive compensation awards by the jury
system. Promoting healthy behavior through the prudent
use of the legal system of regulation and taxation is increas-
ingly utilized to protect the health of the population. This is

803

widely applied in promoting road safety, in tobacco control
measures regarding banning of advertising, high taxes on
alcohol, and banning smoking in public places including
restaurants and bars.

Environmental Health

There is growing concern by the public and by governments
over climate change, global warming, air and water pollu-
tion, and other noxious and harmful industrial and com-
mercial processes. Environmental laws affecting the public
health include legislation on clean air, clean water, toxic
substances, solid waste control, and other noxious sub-
stances. Non-compliance with the legislative provisions can
result in prosecution in the civil or criminal courts or both.

Infringement of public health laws and regulations may
lead to criminal action as an increasingly common method
of sanction. While such violations may not be seen as “truly”
criminal and may be treated in the courts as misdemeanors,
they can lead to fines or even jail. Such cases are increas-
ingly being addressed seriously in the judicial system.

The CDC, in 1999, defined 10 great achievements
of public health of the twentieth century. These achieve-
ments are identified as control of infectious disease, motor
vehicle safety, fluoridation of drinking water, recognition
of tobacco use as a health hazard, immunization, decline
in deaths from coronary heart disease and stroke, safer
and healthier foods, healthier mothers and babies, family
planning, and safer workplaces (Goodman et al., 2006).
Of the 10 great achievements in the twenty-first century
(2001–2010) identified by CDC, seven of the 15 leading
causes of death (largely NCDs) resulted in a decline in the
age-adjusted death rate in the USA from 881.9 per 100,000
population in 1999 to 741.0 in 2009. This decline was a
result of a combination of supportive laws and legal tools
at the local, state, and federal levels. In other industrial-
ized countries similar legislation has led to equal or greater
achievements in public health over the past century.

Public Health Law Reform

Public health law is scattered through many legislative stat-
utes and administrative documents which developed his-
torically. Efforts to codify public health law may contribute
to greater understanding and enforceability of the many
separate pieces of legislation (Box 15.10). Such reform
will enhance understanding in the legislative, judicial, and
administrative branches of government as well as in busi-
ness, non-governmental organizations, and the community.
Box 15.11 suggests topics for model public health consoli-
dation or compendia for states. The principles of this formu-
lation may also apply to other countries at the national and
state or provincial levels.

804

ETHICAL ISSUES IN PUBLIC HEALTH

The field of public health includes a wide range of activities
and professional disciplines, ranging from health promo-
tion to disease protection, epidemiology to environmental
health, and financing to supervision or provision of clinical
care. Each of these disciplines works within systems that
face ethical dilemmas, and public health workers’ under-
standing and motivation within the ethical guidelines of
their professions and roles are important in their training
and practice conduct. Ethical frameworks have evolved in
part as the result of bitter experience with ethical failures
which were later recognized and affect public health stan-
dards of practice for future generations (Box 15.12).

Ethics in health are based on the fundamental religious
and humanistic values and concepts of a society. If the prin-
ciple of saving a life is valued above all other considerations
(i.e., Sanctity of Life or Pikuah Nefesh) (see Chapter 1),
then all measures available are to be used, irrespective of
the condition of the patient or the cost. If sickness and death
are seen as acts of God, possibly as punishment for sin, then
prevention and treatment may be considered to be interfer-
ing with the divine will, and the ethical obligation may be
limited to relief of suffering. Humanism balances these two
ethical imperatives: saving of life and relief of suffering.
Materialistic political philosophies may view health care as
primarily a function to preserve health for economic pros-
perity and social well-being. Secular humanism adopted
many of the religious precepts of the worth and rights of the
individual and these have become part of the standards of
law and ethics in modern secular societies.

The role of society in protecting the health of the popula-
tion grew during the nineteenth century with the sanitation

BOX 15.11 Public Health Law Program of the Centers
for Disease Control and Prevention

The Public Health Law Program (PHLP) is administered by
CDC’s Office for State, Tribal, Local and Territorial Support
(OSTLTS). PHLP develops law-related tools and provides
legal technical assistance to public health practitioners and
policy makers in state, tribal, local, and territorial (STLT)
jurisdictions.

The PHLP works with state/territorial health departments
and other partners to:
l identify public health law priorities
l research laws that impact the public’s health
l analyze public health legal preparedness
l conduct comparative analyses across jurisdictions;

prepare guidance, articles, reports, and toolkits; and
develop and disseminate public health law curricula.

Source: Centers for Disease Control and Prevention. Public health law.
Available at: http://www.cdc.gov/phlp/about.htm [Accessed 27 October
2012].

The New Public Health

movement, while medical care became an effective part of
public health during the twentieth century. The astonishing
successes of public health during the past century increased
life expectancy in the high-income countries by some 30
years, mostly through improved living conditions and
health protection, as well as societal and medical advances
to make care available to all. In the 1970s the Lalonde con-
cept that individual behavior was one of the key determi-
nants of health (see Chapter 2) placed much of the onus
of illness and its prevention on the individual, but fostered
health promotion as an essential component of public health
theory and practice. All these points of view are involved
in the ethical issues of the New Public Health (Box 15.13).

Resources for health care are limited even in indus-
trialized countries, so that priority setting and judicious
allocation of scarce resources are always issues. Money
spent on new technology with only marginal medical
advantages is often at the expense of well-tried and proven
lower cost techniques to prevent or treat disease. The
potential benefits gained by the patient from more and
more interventions are sometimes very limited in terms
of length or quality of life. These are difficult issues when
the physician’s commitment to do all to preserve the life
of the patient conflicts with the patient’s concept of qual-
ity of life and his or her right to decline or terminate heroic
measures of intervention. Many health systems use clini-
cal guidelines that are mandatory for a health facility or a
doctor in the clinic. Preparation for surgery requires a sig-
nature from the patient to consent to the procedure being
carried out, careful preoperative procedures to ensure that
the correct organ is addressed, antiseptic preparation of
the site, and checking that all instruments are accounted

BOX 15.12 Topics for a Model State Public Health Act

l Mission and functions
l Public health infrastructure
l Collaboration and relationships
l Public health authorities and powers
l Public health emergencies
l Public health information privacy
l Criminal/civil
l Enforcement
l Legislative response to the need to reform core public

health powers such as surveillance, reporting, epide-
miological investigations, partner notification, testing,
screening, quarantine, isolation, vaccination, and nui-
sance abatement

l Medicaid
l Affordable Care Act insurance agency

Source: Centers for Law and the Public’s Health. A Collaborative at Johns
Hopkins and Georgetown Universities (CDC Collaborating Center).
Available at: http://www.publichealthlaw.net/ [Accessed 23 September
2012], and Chapter 10 references.

Centers for Law and the Public’s Health

http://www.cdc.gov/phlp/about.htm

Chapter 15 Health Technology, Quality, Law, and Ethics

for. The checklist approach is well established for care
in many settings and protects the patient from neglect or
faulty follow-up, such as in the management of hyperten-
sion and diabetes.

The suffering that a terminally ill patient may endure
during radical treatment, which may prolong life by only
hours or days, clashes with the physician’s ethical obli-
gation to do no harm to the patient. The ethical value
of sustaining the life of a terminally ill patient suffering
extensively is an increasing medical dilemma. The issue is
even more complex when economic values are included in
the equation. There are potential conflicts among the eco-
nomic issues, the role of the physician in preserving life,
the physician’s obligation to do no harm, the felt needs
of the patient and his or her family, and the needs of the
community as a whole. The complex issues involved in
the “right to die” and end-of-life care raise many ethical
and legal questions for the patient, the family, society, and
caregivers.

The state represents organized society and has, among
its responsibilities, a duty to promote healthful conditions
and to provide access to health care and public health

BOX 15.13 Study and Practice of Public Health Ethics

Ethics is a branch of philosophy that deals with distinctions
between right and wrong, with the moral consequences of
human actions. The ethical principles that arise in epidemio-
logical practice and research include:
l informed consent
l confidentiality
l respect for human rights
l scientific integrity.

“As a field of study, public health ethics seeks to understand
and clarify principles and values which guide public health
actions. Principles and values provide a framework for decision
making and a means of justifying decisions. Because public
health actions are often undertaken by governments and are
directed at the population level, the principles and values
which guide public health can differ from those which guide
actions in biology and clinical medicine (bioethics and medical
ethics) which are more patient or individual-centered.

As a field of practice, public health ethics is the application
of relevant principles and values to public health decision mak-
ing. Public health ethics inquiry carries out three core functions:

(1) identifying and clarifying the ethical dilemma posed,
(2) analyzing it in terms of alternative courses of action and their

consequences, and
(3) resolving the dilemma by deciding which course of action

best incorporates and balances the guiding principles and
values.” (CDC, 2001)

Sources: Last JM, editor. A dictionary of epidemiology. 4th ed. New York:
Oxford University Press; 2001.
Centers for Disease Control and Prevention. Science coordination and
innovation. Public health ethics; 2001. Available at: http://www.cdc.gov/
od/science/phec/ [Accessed 23 September 2012].

805

services. The conflict between individual rights and com-
munity needs is a continuous issue in public health. Appli-
cation of accepted public health measures for the benefit of
some people in society may require applying an interven-
tion to everyone in a community or a nation. The major-
ity thus are subject to a public health activity to protect a
minority, without designating which individual’s life may
be saved. Furthermore, a society may in special cases need
to restrict individual liberties to achieve the goal of reducing
disease or injury in the population. Raising taxes on alco-
hol and tobacco products, mandatory speed limits, driving
regulations, and seat belt usage laws are examples of pub-
lic health interventions that interfere with individual liberty
but protect individuals, and thereby the community at large,
from potential harm.

Many public health measures originally criticized as
interventions in private rights are generally accepted as
essential for health protection and promotion to reduce
the risk of disease in the population. Chlorination of com-
munity water supplies is a well-established, effective, and
safe intervention to protect the public health. Fluoridation
of drinking water to prevent tooth decay in children means
that other people are also drinking the same fluoridated
water, which is of less direct benefit to them. Fortification
of foods with vitamins and minerals is also a cost-effective
community health measure with advocates and opponents.
The addition of folic acid to food as the most effective way
to prevent neural tube defects in newborns is an intervention
mandated by the US FDA since 1998.

Confidentiality to assure the right of the individual to
privacy involves ethical issues in the use of health infor-
mation systems. Birth, death, reportable conditions (not
all reportable diseases are infectious), and hospitalization
data are basic tools of epidemiology and health manage-
ment. The use of detailed individual data is needed for
case-finding and follow-up activities which are vital to
good epidemiological management of diseases, includ-
ing STIs. However, caution is needed in data use to avoid
individual identification that could be used punitively,
for example, in denial of access to health insurance for
smokers, alcoholics, or AIDS patients because health
damage may be attributable to a self-inflicted risk factor.
Increasingly, however, reporting is also mandatory for
physical or sexual abuse and criminally linked injuries
as essential for the protection of individuals at risk or the
general public from serious harm.

Individual and Community Rights

The protection of the individual’s rights to privacy, and free-
dom from arbitrary and harmful medical treatments, proce-
dures, or experiments, may come up against the rights of the
community to protect itself against harmful health issues.
This conflict comes into much of what is done in public

http://www.cdc.gov/od/science/phec/

806

health practice, which has both an enforcement basis in law
and practice and a humanitarian and protective aspect based
on education, persuasion, and incentives. Society permits
its governments to act for the common good, but sets limits
that are protected by the courts and administrative appeal
mechanisms.

Society has the right to legislate the side of the road
on which one is permitted to drive, the speed permitted,
the wearing of seat belts, and the non-use of alcohol or
drugs before driving or cell phones while driving. Offend-
ers may be punished by significant fines or jail and are
subject to strong educational efforts to persuade them to
comply. Similarly, the community must ensure sanitary
conditions and prevent hazards or nuisances from bother-
ing neighbors or the public. Society must act to protect the
environment against unlawful contamination or poisoning
of food, drugs, the atmosphere, the water supply, or the
ground.

Enforcement is thus a legitimate and necessary activ-
ity of the public health network to protect the community
from harm and danger to health. Table 15.6 shows topics
where individual rights and responsibilities predominate,
and a second set of rights that are the prerogative of the
community to protect its citizens against public health haz-
ards. Sometimes the issues overlap and sometimes come to
political, advocacy, or legal action, so that court decisions
are needed to adjudicate precedents for the future.

The AIDS epidemic in the 1980s and 1990s raised a
host of public health, ethical, and issues. Management of
the AIDS epidemic is in some respects in conflict with the
long-established role of society in contacting and quarantin-
ing people suffering from transmissible diseases. It is not
acceptable or feasible in modern society to isolate HIV car-
riers. But failure or delay of public health authorities even
in the late 1980s to close public bathhouses in New York
and other cities in the USA, where exposure to multiple
same-sex partners promoted transmission of the infection,
could be interpreted as negligence. During the 1980s, the
gay community in the USA centered its concern that HIV
testing would be used in a discriminatory manner. AIDS was
initially addressed as a civil liberties issue and not as a pub-
lic health problem. Screening, reporting, and case contact
follow-up were seen as an invasion of privacy and proved
counterproductive by increasing resistance to and avoidance
of testing. Protection of privacy and an educational approach
were adopted as most feasible and acceptable. International
opinion and national court decisions have emphasized the
right to privacy with decriminalization of non disclosure of
HIV status to sex partners (UNAIDS 2013).

The AIDS epidemic and public anxiety about contract-
ing AIDS through casual contact reinforced the need for
public education on safe sex. This has been raised as an
ethical issue because such education may be construed as
condoning teenage and extramarital relations. The issue of

The New Public Health

HIV screening of pregnant women in general or in high-risk
groups took on a new significance with the findings that
treatment of the pregnant woman reduces the risk of HIV
infection of the newborn, and that breastfeeding may be
contraindicated. This issue is arising anew in the context of
using the HPV vaccine for preteen girls to prevent the sexu-
ally transmitted infection, which is also controversial, and in
the USA this vaccination will be mandatory for school entry.

A pre-eminent ethical issue in public health is that of
assuring universal access to services, and/or the provision
of services according to need. An important ethical, politi-
cal, and social issue in the USA in the twenty-first century
is how to achieve universal access to health care. The soli-
darity principle of socially shared responsibility for fund-
ing universal access to health care is based on equitable
prepayment for health care for all by nationally regulated
mechanisms through place of work or general revenues of
government. A society may see universal access to health
care as a positive value, and at the same time utilize incen-
tives to promote the use of services of benefit to the indi-
vidual, such as hospital care, immunization, and screening
programs. Some services may be arbitrarily excluded from
health insurance, such as dental care, although this is to the
detriment of children and a financial hardship for many.
Strategies for program inclusion are often based on his-
torical precedent rather than cost-effectiveness or evidence.
While efforts are being made to include more children in the
program, the Medicaid system in the USA defines eligibil-
ity at income levels of 185 percent of the poverty line, thus
excluding a high percentage of the working poor. Health
is also a political issue in countries with universal health
systems where funding may be inadequate or patient dis-
satisfaction common.

Choices in health policy are often between one “good”
and another. Limitations in resources may make this issue
even more difficult in the future, with aging populations,
increasing population prevalence of physical disabilities,
and rapid increases in technology and its associated costs.
For example, the UK’s NHS at one point refused to provide
dialysis to people over the age of 65. When computed tomog-
raphy was first introduced, Medicare in the USA refused to
insure this service as an untested medical technique. Owing
to a lack of facility resources such as incubators and poor
prospects for the survivors, the Soviet health system con-
sidered newborns as living only if they weighed over 1000 g
and survived for more than 7 days. Those under 1000 g, who
would be considered living by other international definitions,
would be placed in a freezer to die. At the opposite extreme,
many western medical centers use extreme and costly mea-
sures to prolong life in terminally ill patients, preserving life
temporarily but often with much suffering for the person and
at great expense to the public system of financing health care.

In many countries, such as those in the former Soviet
system of health care, spending for hospital services, in

807Chapter 15 Health Technology, Quality, Law, and Ethics

TABLE 15.6 Individual and Community Rights and Responsibility in Health: Ethical/Legal Issues

Ethical/Legal Issues Individual Rights and Responsibilities Community Rights and Responsibilities

Sanctity of human life Right to health care; responsibility for
self-care and risk reduction

Responsible for providing feasible basket
of services, equitable access for all

Individual vs community
rights

Immunization for individual protection Immunization for herd immunity and community
protection; education; community may mandate
immunization

Right to health care All are entitled to needed emergency,
preventive, and curative care

Community right to care regardless of location,
age, gender, ethnicity, medical condition, and
economic status

Personal responsibility Individual responsible for health behavior,
diet, exercise, and non-smoking

Community education to health-promoting
lifestyles; avoid “blame the victim”

Corporate responsibility Management accountability to criminal
and civil action

Producer, purveyor of health hazard accountable
for individual and community damage

Provider responsibility Professional, ethical care and communication
with patient

Access to well-organized health care,
accredited to accepted standards

Personal safety Protection from individual, family, and
community violence

Public safety, law enforcement, protection of
women, children, and elderly; safety from
terrorism

Freedom of choice Choice of health provider; limitations of
gatekeeper functions; control costs while
function; right to second opinion; right of appeal

Confidentiality; informed consent; birth control
ensuring individual rights; limitations of
self-referrals to specialist

Euthanasia Individual’s right to die; limitations by
societal, ethical, and legal standards

Assure individual and community interests;
prevention of abuse by family or others with
conflict of interests

Confidentiality Individual’s right to privacy, limitation of
information

Mandatory reporting of specified diseases;
data for epidemiological analysis

Informed consent Right to know, risks vs benefits; agree or
disagree to treatment or participation i
n experiment

Helsinki Committee approval of research;
regulate fair practice in right to know; Patient’s
Bill of Rights

Birth control Right to information and access to birth
control and fertility treatment; woman’s
rights over her body

Political, religious promotion of fertility;
alternatives to abortion; protection of women’s
rights to choose

Access to health care Universal access, prepayment; individual
contribution through workplace or taxes

Solidarity principle and adequate funding; right
to cost containment, limitations on service
benefits

Regulation and incentives
to promote preventive care

Social security for hospital delivery,
attendance for prenatal care; primary care,
ambulatory care; home care

Incentive grants to assist communities for
programs of national interest; limit institutional
facilities

Global health Human rights and aspirations; economic
development, health, education, and jobs

Transfer of health risks; occupational hazards
and environmental damage

Rights of minorities Equality in universal access Special support for high-needs groups

Prisoners’ health Human rights Security and human rights; reduce inequalities in
sentencing convicts, harsh dangerous conditions
in prisons; prohibition of torture and execution

Allocation of resources Lobbying, advocacy for equity and innovation Equitable distribution of resources; targeting
high-risk groups; cost containment

some cases grossly in excess of need, is accompanied by
a lack of adequate funds for primary care or adding new
vaccines to the immunization program for children. The
majority of Americans have health insurance which increas-
ingly includes preventive care services, but a substantial

percentage lack such coverage which limits their access to
routine preventive care. The Affordable Care Act brings an
improvement in coverage and inclusion of preventive care
with incentives (see Chapters 10 and 13). In many coun-
tries, including in Europe, delay in updating immunization

808

programs may be due to a lack of funding or to delays
in professional or governmental acceptance of “new”
vaccines.

The closure or amalgamation of hospitals involves dif-
ficult decisions and is a source of friction between central
health authorities, the medical professions, and local com-
munities. Health reforms in many industrialized countries,
such as reducing hospital bed supplies and managed care
systems promoting cost containment and reallocation of
resources, raise ethical and political issues often based on
vested interests such as private insurance systems, hospi-
tals, and private medical practitioners.

Where there is a high level of cumulative evidence from
the professional literature and from public health practice
in “leading countries” with a strong scientific base and case
for action on a public health issue, when does it become bad
practice or even unethical public health practice to ignore and
fail to implement such an intervention? Such ethical failures
occur frequently and widely. For example, is it “unethical”
not to fortify grain products with folic acid, and salt with
iodine? Should there be a recommended European immu-
nization program; should milk be fortified with vitamin D;
should vitamin and mineral supplements be given to women
and children; should all newborns be given intramuscular
vitamin K routinely? Other examples include the issues of
fluoridation of water supplies and opposition to genetically
modified crops or generic drugs in African countries. These
issues are continuously debated and the responsibility of
the trained public health professional is to review the inter-
national literature on a topic and formulate a position based
on the cumulative weight of evidence. It is not possible to
wait for indisputable evidence because in epidemiology and
public health this rarely occurs. This is another reason for
guidelines established by respected agencies and profes-
sional bodies, which are free from financial obligations to
vested interest groups, being essential for review of the evi-
dence which continues to accumulate on many issues thought
to have been resolved or which reappear repeatedly despite
strong evidence of effectiveness and public health benefit.

Tragic Deviations in Public Health Ethics

In the nineteenth century the germ and miasma theories both
produced enormous gains in public health. The biomedical
paradigm addressed alleviation of disease risk or manifest
disease; the health paradigm addressed the improvement of
social and environmental conditions for reducing disease.
During the early part of the twentieth century, a segment of
the social hygiene movement promoted ideas of Social Dar-
winism or racial improvement by sterilization of mentally
ill, retarded, and other “undesirable” people.

The dominant biomedical model of public health and
medical professionals adopted policies of eugenics in
Sweden, the USA, and Canada, leading to policies and

The New Public Health

programs to force the sterilization of mentally handi-
capped or mentally ill patients. This distorted a socially
oriented concept of public health. This euthenasia policy
was adapted to a racially oriented policy with horrendous
policies of mass murder in the name of racial purity as a
public health policy in Nazi Germany with the near-total
support and participation of a highly Nazified medical
profession, and used in murder, by gassing or planned
starvation, of half a million “undesirables” under the
eugenics “T-4” program administered from Hitler’s head-
quarters. Although this program was stopped after parental
and Church protests in Germany, the methods used were
adopted in newly occupied countries and for concentra-
tion camps organized for the mass extermination of Jews,
Gypsies, and others in the Holocaust.

The eminent historian Sir Richard Evans (Regius Pro-
fessor of History at Cambridge University), in his classic
The Third Reich at War, wrote:

“At the heart of German history in the war years lies the mass
murder of millions of Jews in what the Nazis called ‘the final
solution to the Jewish question in Europe’. This book provides a full
narrative of the development and implementation of this policy of
genocide, while also setting it in the broader context of Nazi racial
policies toward the Slavs, and toward Gypsies, homosexuals, petty
criminals and ‘asocials’. … For many years, and not merely since
1933, the medical profession, particularly in the field of psychiatry,
had been convinced that it was legitimate to identify a minority of
handicapped as ‘a life unworthy of life’, and that it was necessary
to remove them from the chain of heredity if all the many measures
to improve the German race under the Third Reich were not to be
frustrated. Virtually the entire medical profession has been actively
involved in the sterilization programme, and from here it was but a
short step in the minds of man to involuntary euthanasia.”

The twentieth century was replete with mass murders,
executions, and genocide, with nationalistic, ideological,
and racist motives perpetrated by fascist, Stalinist, and
radical xenophobic political or religious movements when
gaining governmental power by election or by revolution,
in some cases applying common public health terminol-
ogy and concepts to uses of genocide and ethnic cleansing
(Box 15.14).

An outline of genocides of the past 100 years is seen
in Box 15.15. These include the Turkish genocide of the
Armenians in 1917 followed by horrific genocides in which
many millions of people were killed, carried out under the
communist regime of the Soviet USSR in the 1920s and
subsequently, in the People’s Republic of China under
Chairman Mao in the 1950s, and by the Khmer Rouge in
Cambodia in the 1980s, and in the wars resulting from the
breakup of the Yugoslav Republic in the 1990s.

The human and national cost of genocide lasts for gen-
erations. The hatred and fear may wane but the trauma goes
deep. It lasts with the victims and their descendants, but

Chapter 15 Health Technology, Quality, Law, and Ethics

also with the perpetrating country and its culture. The Nazi
Holocaust has had downstream effects in public health in
the German-speaking countries which last to the present
time, seven decades since the events took place. The long-
term damage done to public health in Germany and Austria
is described in Box 15.16.

The Nuremberg Doctors’ Trial in 1946–47 convicted
many leading Nazi physicians of crimes against humanity
and resulted in severe punishments including hanging or
long prison terms. This trial was a seminal event in estab-
lishing the ethical standards required for medical research
and human rights. However, many in the medical profession
aligned with these horrors remained leading figures in the

BOX 15.14 Values and Ethical Principles of Public
Health

l Sanctity of human life.
l Individual human rights – liberty, privacy, protection

from harm.
l Solidarity – sharing the burden of promoting and main-

taining health.
l Beneficence – reduce harm and burdens of disease and

suffering.
l Non-malfeasance – do no harm.
l Proportionality – restriction on civil liberties must be

legal, legitimate, necessary, and use the least restrictive
means available.

l Reciprocity principle – public responsibility to those who
face disproportionate health and social burden.

l Transparency principle – honest and truthfulness in the
manner and context in which decisions are made must
be clear and accountable.

l Precautionary principle – decision makers have a general
duty to take preventive action to avoid harm even before
scientific certainty has been established.

l Failure to act – public health officials and policy mak-
ers have a duty to act and implement preventive health
measures demonstrated to be effective, safe, and benefi-
cial to population health. Failure to enforce public health
regulations with resulting disease or deaths may consti-
tute negligence on the part of responsible officials with
civil or criminal penalties.

l Equity – reduce inequities.
l Cost and benefits
l Stewardship – responsibility of governance in a trustwor-

thy and ethical manner.
l Trust between the many stakeholders in health.
l Reasonableness – decisions should be evidence based

and revised based on new evidence.
l Responsive to needs and challenges as they may be

anticipated and appear with close monitoring of health
status.

Source: Modified from Lee LM. Guest editorial: Public health ethics
theory: review and path to convergence. Public Health Rev 2012;34(1).
Available at www.publichealthreviews.eu [Accessed 17 December 2012].

809

German medical community, one even being elected to head
the World Medical Association, then discussing the Helsinki
Declaration of Ethics in Biomedical Research, before being
forced to resign. The Nuremberg Trials and the subsequent
Helsinki Declaration laid the fundamentals of biomedical
ethics for the following generations, regulated by require-
ments of ethical procedures and institutional research board
approvals for funding, conducting, and publishing research
involving human subjects (Table 15.7).

The United Nations Convention on Prevention and Pun-
ishment of the Crime of Genocide (UNGC) of 1948 defines
acts committed with intent to destroy, in whole or in part,
members of a national, ethnical, racial, or religious group
as crimes against humanity. This convention specifies that
incitement to genocide is itself a crime against humanity.
Legal action should focus on state-sanctioned incitement
as a recognized early warning sign. The UNGC defines
genocidal acts to include the following as punishable under
international law:

l genocide
l conspiracy to commit genocide
l direct and public incitement to commit genocide
l attempt to commit genocide
l complicity in genocide.

The reappearance of genocide in the late twentieth cen-
tury in the Balkans and Rwanda, and in the twenty-first cen-
tury by Sudanese in Darfur, highlights genocide as a public
health concern and its prevention as a public health and
international political responsibility. Incitement to genocide
is a crime against humanity and was the basis for the trials
and convictions of leaders of the Rwandan Tutsi tribe, as
well as inciters to ethnic violence and the political leaders
and perpetrators of mass murders in the former Yugoslav
Republic. The threat and practice of genocide are still pres-
ent, whether in the murderous raids of Sudanese Janjaweed
militias in Darfur and South Sudan, the threats of genocide
by Iran and associated terrorist organizations against Israel
and Jews in general, or the killing of Christians in northern
Nigeria and Egypt, of Muslims in Burma/Myanmar, and
others. Incitement to genocide is now common as part of
international discourse.

Genocide represents the most extreme assault on the right
to life and respect for life. In the twentieth century, an esti-
mated 200 million people perished through genocide. Totali-
tarian dictatorships, past wars, and ideologies of exclusiveness,
ethnic purity, and religious fundamentalism increase the risks
for genocide. Perpetrators use dehumanizing, demonizing,
and delegitimizing hate language to desensitize or intimidate
bystanders and to mobilize, order, and instruct followers.

Genocide prevention requires international surveillance
networks for monitoring and reporting incitement and hate
language in the media, textbooks, places of worship, and the
Internet, which should monitor and identify their sources

Mattress Review – Which is the best mattress of 2018?

The New Public Health810

Eugenics was a movement within the “social hygiene” con-
cept of the early part of the twentieth century. It was widely
promoted to reduce births among mentally ill and handi-
capped people in some states in the USA and was upheld
in decisions of the Supreme Court. It was also practiced
in Canada and Sweden. This idea was promoted by Hitler
in Mein Kampf and adopted by the Nazi Party, which was
legally elected to office in 1933 and began to implement it.
Organized massacres of mentally ill and handicapped chil-
dren and adults led to practices of organizing various modes
of killing, including gas chambers, which were applied in
concentration camps and in the Holocaust murder of 6 mil-
lion Jews and millions of others.

Genocide represents the most extreme assault right to life
and respect for life. In the twentieth century, an estimated 200
million have perished from genocide. Totalitarian dictator-
ships, past war and defeat, ideologies of exclusiveness, ethnic
purity, and religious fundamentalism increase risks for geno-
cide. Perpetrators use dehumanizing, demonizing, and delegit-
imizing hate language to desensitize or intimidate bystanders
and to mobilize, order, and instruct followers.

1915–1917 Armenian genocide by Ottoman Turkish
Empire – 1.2 million killed
1920s–1940s Eugenics movement in USA and Sweden
1920s Mass executions, deportations, and starvation as
policy in Soviet Union Stalinist regimes
1930s–1940s Mass sterilization of “defectives” in the USA
and Sweden
1930–1940s Mass murder of “defectives” in Nazi Germany
– 750,000 killed
1940s Quarantining as pretext for ghettos by Nazis
1940s Concentration camps, human experimentation

1940s Holocaust of 6 million Jews and genocide in Nazi
occupation of Poland and in Soviet Union
1947 Nuremberg Trials – convictions and capital punishment
for war crimes and genocide by Nazi leaders and doctors
1950s Mass starvation in Maoist China – estimated deaths
of 21 million people
1948 Convention on the Prevention and Punishment of the
Crime of Genocide
1975–1979 Cambodian genocide – 1.7 million killed
1988 Iraqi genocide of Kurds in town of Halabja by
poison gas
1988 Brazil genocide conviction of Tikuna people
1995 Serbian massacres in Srebrenica in Bosnia and
Herzegovina
2004 Rwandan genocides
2003–2012 Sudanese genocide in Darfur – over 400,000
killed
2011 Sudanese genocide of Nuba people
2012 Iran incitement to genocide of Israel
2012 Syria: civil war and genocide
2012 Democratic Republic of Congo massacres of Kivu
reported

Sources: Richter ED, Genocide Prevention Center, Braun School Public
Health, Hebrew University –Hadassah, Jerusalem, Israel. Personal commu-
nication.
United Nations. Convention on the prevention and punishment of the crime
of genocide. Available at: http://www.hrweb.org/legal/genocide.html and
www.un.org/millennium/law/iv-1.htm [Accessed 16 December 2012].
Richter ED. Commentary. Genocide: can we predict, prevent, and protect? J
Public Health Policy 2008;29:265–74.
Stanton G. The eight stages of genocide; 1998. Available at: www.genocide-
watch.org/aboutgenocide/8stagesofgenocide.html
Genocide Watch. http://www.genocidewatch.org/ [Accessed 25 December
2012].

BOX 15.15 Eugenics and Genocide: The Slippery Slope

and map their distribution and spread. Dehumanization,
demonization, delegitimization, disinformation, and denial
are the danger signs of potential genocidal actions. Geno-
cide results from human choice and bystander indifference.
One lesson of the Holocaust is that silence in response to
incitement to genocide makes one a complicit bystander.
Public health professionals and institutions have a responsi-
bility to speak out publicly on such dangerous early warn-
ing signs (Richter E, personal communication, 2012).

Human Experimentation

Human experimentation has been a subject of great concern
since the Nazi and Imperial Japanese armed forces’ experi-
ments on prisoners and concentration camp victims during
World War II. The Nuremberg Trials set forth standards of
professional responsibility to comply with internationally
accepted medical behavior (Table 15.7).

The Helsinki Declaration was first adopted by the
World Medical Assembly in 1964, and amended in 1975,
1983, 1989, and 1996. It delineates standards of medical
experimentation and requires informed consent from sub-
jects of medical research. These standards have become an
international norm for experiments, with national, state,
and hospital Helsinki committees regulating research pro-
posals within their jurisdiction. Funding agencies require
standard approval by the appropriate Helsinki committee
before considering any proposal, with informed consent on
any research project.

The Tuskegee experiment (Box 15.17) was a grave and
tragic violation of medical ethics, but in the context of the
1930s was consistent with widespread and institutionalized
racism. It provides an important case study which has reper-
cussions until the present time in suspicion of public health
endeavors, particularly among the African American com-
munity in the USA.

http://www.hrweb.org/legal/genocide.html

http://www.un.org/millennium/law/iv-1.htm

http://www.genocidewatch.org/aboutgenocide/8stagesofgenocide.html

http://www.genocidewatch.org/

811Chapter 15 Health Technology, Quality, Law, and Ethics

In the German context the social–ecological health paradigm
can be traced back to the late eighteenth and early nineteenth
centuries when the country was a loose alliance of kingdoms
or princedoms lagging behind the economic, cultural, and
political developments in England and France. Ensuring popu-
lation health was seen as the obligation of the state, while the
family was responsible for caring for the health and well-being
of its members. Organized health care and health maintenance
was seen in the framework of Medizinische Polizey, as a model
of the health systems. Leading scholars in law and medicine
shared a normative perspective of promoting a healthy life-
style (known as dietetics), and provision of shelter, food, and
spiritual aid in asylums for the sick and disabled, or in private
homes the for wealthy.

In the second half of the nineteenth century evidence from
medical statistics and overwhelming practical experience indi-
cated that widespread poverty was the critical factor explain-
ing high rates of typhus or cholera epidemics in lower social
classes among children and industrial workers. A social health
movement fought for healthier living and working conditions,
education, and democracy. The movement’s prominent lead-
ers were Salomon Neumann, a physician pioneer in medical
statistics, and Rudolf Virchow, the renowned pathologist and
outspoken political activist.

Between 1890 and 1930 the conceptual framework of pub-
lic health was defined as “social hygiene” or “health science”,
an interdisciplinary field to conduct scientific research, aca-
demic teaching, and community-based activities aiming at the
promotion of individual and collective health and the preven-
tion of disease. In the 1920s the field was highly developed and
pioneering the modern academic public health.

Social hygiene was a general framework open to different
definitions. A group of academic teachers and publishing scien-
tists sharing the social–ecological paradigm, among them a high
proportion of German Jews, wanted to continue the social reform
strategy and to strengthen local communities to take an active role
in the formulation and implementation of health policies.

Public health activists sharing the biotechnological disease
paradigm favored a more focused approach aiming at the con-
trol of disease through medical care. Although there was no

supportive evidence, in the late nineteenth century a racial
eugenic movement emerged widely in Europe and the USA.
A conceptual model derived from the disease paradigm postu-
lated racial factors to explain disease. A healthy population was
assumed to be “free” of “racially contaminated” individuals and
inferior groups. Health-related public policy was supposed to
eliminate racially “unclean” members, e.g., by forced steriliza-
tion or murder. This was a central theme in Hitler’s Mein Kampf
and was enacted as basic policy by the Nazi Party in Germany
as a fundamental ideological basis of racial theory and public
health.

When the Nazis were legally elected in Germany in 1933,
and later seized power in Austria, this policy provided fertile
ground to open the door to euthanasia, leading to mass mur-
der. This was implemented in the well-organized, medically
directed execution of mentally and physically handicapped
Germans and others in psychiatric facilities. This provided a
working model for the industrialized murder of 6 million Jews
in the Holocaust and millions of gypsies, homosexuals, com-
munists, and others.

It took only 10 years to eradicate a 200-year tradition of
German socially oriented public health grounded largely in the
political philosophy of human rights and social justice. Most
of those advocates were exiled or murdered. Many of the aca-
demic medical leaders after World War II remained in key posi-
tions in the German public sector for decades.

In contrast to many other countries, the two wealthy
German-speaking countries, with over 90 million people,
have few academic public health resources. In there is only
one German School of Public Health, and a small number of
institutes, far fewer in Austria than in Germany. More than half
a century has passed since the Nazi period and the populations
of these two countries are slow to build a new socially oriented
public health system.

Sources: Horst Noack MD, PhD, Professor Emeritus, Medical University of
Graz, Austria. Personal communication; 24 December 2012.
Flügel A. Public Health und Geschichte. Weinheim: Beltz Juventa; 2012.
Heinzelmann W. Sozialhygiene als Gesundheitswissenschaft. Bielefeld:
Transcript Verlag; 2009.
Noack H. Governance and capacity building in German and Austrian public
health since the 1950s. Public Health Rev 2011;33:264–76.

BOX 15.16 The Rise, Fall, and Slow Recovery of German Public Health

Ethics in Public Health Research

The border between practice and research is not always
easy to define in public health, which has as one of its
major tasks the surveillance of population health. This
surveillance is mostly anonymous but relies on individu-
ally identifiable data needed for reportable and infec-
tious disease control as well as for causes of death, birth
defects, mass screening programs, and other special dis-
ease registries. It may also be necessary to monitor the
effects of chronic disease, for example, to ascertain repeat
hospitalizations of patients with congestive heart failure
to assess the long-term effects of treatment, and the effects

of strengthening ambulatory and outreach services to sus-
tain chronic patients at a safe and functional level in their
own homes.

Hospitalizations, immunizations, and preventive care
practices (e.g., Pap smears, mammography, and colonosco-
pies) are all part of the New Public Health. Impact assessment
of preventive programs may require special surveys and are
important to assess smoking and nutritional status and other
measures of health status and risk factors. Every effort must be
made to preserve the anonymity and privacy of the individual
but in some cases, where the disease is contagious, case contact
is crucial. This can entail identifying people who attended an

The New Public Health812

TABLE 15.7 Ethical Issues of Medical Research Derived from the Nuremberg Trials, the Universal Declaration of
Human Rights, and the Declaration of Helsinki

Nuremberg Doctors Trial,
1946–47

The voluntary consent of a human subject is absolutely essential, with the exercise of free power of
choice without force, fraud, deceit, duress, or coercion

Experiments should be such as to bear fruitful results, based on prior experimentation and the natural
history of the problem under study. They should avoid unnecessary physical and mental suffering

The degree of risk should not exceed the humanitarian importance of the experiment

Persons conducting experiments are responsible for adequate preparations and resources for even the
remote possibility of death or injury resulting from the experiment

The human subject should be able to end his participation at any time

The scientist in charge is responsible to terminate the experiment if continuation is likely to result in
injury, disability, or death

Universal Declaration
of Human Rights, 1948

Everyone has the right to a standard of living adequate for the health and well-being of himself and of his
family, including food, clothing, housing, and medical care and necessary social services

United Nations covenants for
protection of human rights

Covenant on Civil and Political Rights

Optional Protocol to the Covenant on Civil and Political Rights

Covenant on Economic, Social, and Cultural Rights

Convention Against Torture

Convention Against Genocide

The Geneva Conventions

Convention on the Rights of the Child

Convention on Elimination of Discrimination Against Women

Charter of the United Nations

Declaration of Helsinki, 1964 Research must be in keeping with accepted scientific principles, and should be approved by specially
appointed independent committees

Biomedical research should be carried out by scientifically qualified persons, only on topics where
potential benefits outweigh the risks, with careful assessment of risks, where the privacy and integrity
of the individual is protected, and where the hazards are predictable. Publication must preserve the
accuracy of research findings

Each human subject in an experiment should be adequately informed of the aims, methods,
anticipated benefits, and hazards of the study. Informed consent should be obtained, and a
statement of compliance with this code

Clinical research should allow the doctor to use new diagnostic or therapeutic measures if they
offer benefit as compared to current methods

In any study, the patient and the control group should be assured of the best available methods.
Refusal to participate should never interfere with the doctor–patient relationship. The well-being
of the subject takes precedence over the interests of science or society

Source: Summarized from the Nuremberg Trials (1948) and World Medical Association, Declaration of Helsinki.
Website sources include: World Medical Association. Available at: http://www.wma.net/
Australian Government Department of Health and Ageing. Available at: http://www.nhmrc.gov.au/health-ethics/human-research-ethics-committees-hrecs/
human-research-ethics-committees-hrecs/national
United Nations. A Summary of United Nations Agreements on Human Rights. Available at: http://www.hrweb.org/legal/undocs.html (accessed 10.1.14).
United Nations. Available at: http://www.un.org/en/events/humanrightsday/2007/hrphotos/declaration%20_eng (accessed 10.1.14).
US Food and Drug Administration. World Medical Association Declaration of Helsinki. Available at: http://www.fda.gov/ohrms/dockets/
dockets/06d0331/06D-0331-EC20-Attach-1 (accessed 10.1.14).

event or traveled on an airplane where an infected person may
have been, so as to take appropriate preventive measures.

The general distinction between research and practice
has to do with the intent of the activity. Clinical research uses
experimental methods to establish the efficacy and safety of
new interventions or unproved interventions; many drugs
and procedures in common use have never been subjected

to randomized controlled trials. In practice, many methods
are devised that are held to be effective and safe by expert
opinion and documented as such. Researchers comparing
HIV or hepatitis B transmission rates among intravenous
drug users not using needle-exchange programs would be
conducting unethical research, according to accepted cur-
rent standards, by giving needles to the experimental group

Home

http://www.nhmrc.gov.au/health-ethics/human-research-ethics-committees-hrecs/human-research-ethics-committees-hrecs/national

http://www.un.org/en/events/humanrightsday/2007/hrphotos/declaration%2520_eng

http://www.fda.gov/ohrms/dockets/dockets/06d0331/06D-0331-EC20-Attach-1

Chapter 15 Health Technology, Quality, Law, and Ethics

and withholding them from the control group. The scientific
justification of an experiment must be made explicit and
justifiable. Clinical equivalence is a necessary condition
of all clinical and public health research and provision of
standard of care treatment to control groups is a minimal
requirement for most research ethics boards. Determination
of the standard, and whether it should be place, time, and
community specific, is an area of ongoing controversy.

In 1996 a US Public Health Service study, supported by
the NIH and WHO, compared a short course of zidovudine
(AZT) to a placebo given late in pregnancy to HIV-positive
women in Thailand, measuring the rate of HIV infection
among the newborns. The experiment was terminated when
a protest editorial appeared in a prominent medical journal.
This study confirmed previous findings that AZT given dur-
ing late pregnancy and labor reduced maternal–fetal HIV
transmission by half. When a study shows clearly positive
results, it should be discontinued and reported so that the
findings can be applied generally. The findings indicated
that AZT should be used in developing countries, and the

BOX 15.17 The Tuskegee Experiment

The Tuskegee experiment was carried out by the US Public
Health Service between 1932 and 1972. It was meant to fol-
low the natural course of syphilis in 399 already infected
African American men in Alabama and 201 uninfected men.
The men were not told that they were being used as research
subjects. The experiment had been intended to show the
need for additional services for those infected with syphilis.
However, when penicillin became available, the research-
ers did not inform or offer the men treatment, even those
who were eligible when drafted into the army in 1942. The
experiment was stopped in 1972 as “ethically unjustified”
when the media exposed it to public scrutiny.

The case is considered unethical research practice
because, even at the time it was conducted, it did not pro-
vide the patients with available care and their well-being
was put aside in the interest of the descriptive study. A similar
experiment was conducted by the US Public Health Service
in cooperation with the Guatamala Ministry of Health dur-
ing the 1960s, in which syphilis was actually given to sol-
diers, prisoners, and others by sexual contact with prostitutes
known to have the disease, but the study was terminated
when it was discovered by a public health historian and
reached public attention in the USA.

In 1997, President Bill Clinton apologized to the survi-
vors and families of the men involved in the experiment on
behalf of the US government. The Tuskegee experiment is
the source of lingering widespread suspicion in the African
American community to the present time.

Sources: Lombardo PA, Dorr GM. Eugenics, medical education and pub-
lic health: another perspective on the Tuskegee syphilis experiment. Bull
Hist Med 2006;80:291–316.
Centers for Disease Control and Prevention. US Public Health Service
Syphilis Study at Tuskegee. Available at: http://www.cdc.gov/tuskegee/
timeline.htm [Accessed 13 December 2012].

813

manufacturers agreed to make it available at reduced costs.
The result has been a major success in helping with more
recent medications to reduce maternal–fetal transmission in
many places in Africa with help from GAVI, and a slowing
of the spread of HIV/AIDS-related deaths.

Public health may face the challenge of pandemic influ-
enza, such as avian flu, with decisions regarding the allocation
of vaccines, treatment of massive numbers of patients arriv-
ing at hospitals in acute respiratory distress with very limited
resources available, coping with sick or absent staff, and many
other issues requiring not only individual life and death situ-
ations, but mortality en masse. The ethical questions will be
replaced by struggles to cope with such situations. Preparation
for such potential catastrophic events will be a challenge to
public health organizations and the health system in general.

An outstanding case of a breach of ethics in public health
research occurred with the “Wakefield effect”, as described
in Chapter 4 and Box 15.18.

Ethics in Patient Care

Ethical issues between the individual patient and health
care provider are important in the New Public Health. A
doctor is expected to use diligence, care, knowledge, skill,
discretion, and caution in keeping with practice standards
accepted at the time by responsible medical opinion and
to maintain the basic medical imperative to do no harm
to the patient. Patients have the right to know their condi-
tion, available alternatives for treatment, and the risks and
benefits involved. They also have a right to seek alterna-
tive medical opinions, but this right is not unlimited, as any
insurance plan or health service may place restrictions on
payment for further opinions and consultation without the
agreement of a primary care provider.

Health care has a responsibility beyond that of the pay-
ment of health service bills and individual care by a physi-
cian, in institutions, or through services in the community
or the home. The contract for service is becoming less
between an individual physician and his or her patient, and
more among a health system, its staff, and the client. This
places a new onus on the physician to ensure that patients
receive the care they require. Conversely, the US provider
often faces the dilemma of knowing that a patient may not
access needed services because of a lack of adequate health
insurance.

Sanctity of Life Versus Euthanasia

The imperative to save a life is an important ethical and prac-
tical issue in health care. Advocates of physician-assisted
suicide (euthanasia) argue for the right of the patient to die
with dignity when the illness is terminal and the individual
is suffering excessively. This is not a medical decision alone,
and is an agonizing issue for society to address. The Nazi
euthanasia program and its human experiments provided

http://www.cdc.gov/tuskegee/timeline.htm

The New Public Health814

In 1998, The Lancet, published an article by a number of well-
known researchers headed by Dr Andrew Wakefield. The article
reported on 12 cases of autistic children and alleged to show a
connection to immunization with the MMR (measles–mumps–
rubella) vaccine.

The immediate effect of this “revelation” was widespread
alarm over the MMR vaccine and a fall off in immuniza-
tion coverage by measles-containing vaccines in the UK
and elsewhere with many mothers refusing to have their
child vaccinated due to a “risk of autism”. As a result,
measles epidemics occurred in the UK and in many other
countries, with measles again becoming endemic in many
parts of Europe, especially England and France.

After a long series of investigative journalism in the British
press, the article came under scientific scrutiny and withdrawal
of many of the coauthors but a consistent insistence by the lead
author of its authenticity.

Investigation by British medical authorities later found
Dr Wakefield guilty of medical negligence and the UK
General Medical Council withdrew his license to practice
medicine. The coauthors were found to have been credulous
and insufficiently vigilant in agreeing to coauthorship of the
paper. In 2000, 12 years after the original publication, The
Lancet formally withdrew the article.

The effect of this fraudulent scientific publication was a
serious loss of credibility of immunization in general and
especially regarding the MMR vaccine, one of the greatest life
savers in public health technology.

The return of measles in Europe to large scale epidemics
with frequent international transmission furthered the loss of

confidence of mothers in immunizations and public health.
Measles-containing vaccines were particularly strongly
affected owing to the publicity given to the Wakefield case.
The journal editors could be seen as irresponsible for failing
to ensure the scientific integrity of lead authors and coauthors,
and the journal for failing to retract a fraudulent article sooner
than 12 years after the first publication.

In other public health issues, single publications of findings
of small sample and poorly assessed studies published in haste
without adequate inquisitive review occur with great frequency.
The electronic media often include unscientific opinion blogs
which appear larger than life which provoke great anxiety over
accepted and successful public health interventions such as flu-
oridation or folic acid fortification of flour, with unsubstantiated
claims that they cause cancer, asthma, and other ill-effects.

The interface between ethics, law, and science in pub-
lic health requires continuous sensitivity to the downstream
effects of “shouting fire in the theater”.

Sources: Wakefield AJ, Murch SH, Anthony A, Linnell, Casson DM,
Malik M, et al. Ileal lymphoid nodular hyperplasia, non-specific colitis,
and pervasive developmental disorder in children [retracted]. Lancet
1998;351:637–41.
Office of Research Integrity. Definition of research misconduct. Available at:
http://ori.hhs.gov/misconduct/definition_misconduct.shtml
General Medical Council. Andrew Wakefield: determination of serious
professional misconduct 24 May 2010. Available at: www.gmc-uk.org/
Wakefield_SPM_and_SANCTION _32595267
Murch SH, Anthony A, Casson DH, Malik M, Berelowitz M, Dhillon AP, et al.
Retraction of an interpretation. Lancet 2004;363:750.
Godlee F, Jane Smith J, Harvey Marcovitch H. Editorial. Wakefield’s
article linking MMR vaccine and autism was fraudulent. BMJ
2011;342:c7452.

BOX 15.18 The Wakefield Effect

the direst of warnings to societies of what may follow when
the principle of the sanctity of the individual human life is
breached. The issue, however, returned to the public agenda
in the 1980s and 1990s as advances in medical science have
allowed the prolongation of human life beyond all hope of
recovery. Legislation in the Netherlands, the USA (“assisted
suicide” in the states of Washington, Oregon, and Montana),
and northern Australia has legally sanctioned euthanasia
with various safeguards in a variety of circumstances, such
as long-term comas or terminal illnesses.

Doctors, patients, relatives, and health care organiza-
tions need clear guidelines, orientation, procedures, legal
protection, and limitations where failure to take utmost
steps to “save” the patient by intubation, resuscitation, or
transplantation may cause legal jeopardy. Even though a
distinction can be drawn theoretically between permitting
and facilitating death, in practice, doctors in intensive care
units face such decisions regularly where the line is often
blurred. Hospital doctors routinely go to extreme mea-
sures to prolong the life of hopeless cases. Such decisions
should not be considered for economic reasons alone, but in

practice the costs of care of the terminally ill will be a driv-
ing force in debate of the issue. Living wills allow a patient
to refuse heroic measures such as resuscitation, with “do
not resuscitate” standing orders and assignment of power of
attorney to family members to make such decisions. Fam-
ily attitudes are important, but the social issue of redefining
the right of a patient to opt for legal termination of life by
medical means will be an increasingly important issue in
the twenty-first century.

The Imperative to Act or Not Act in Public
Health

As in other spheres of medicine and health, in public health
the decision whether to intervene on an issue is based on
identification and interpretation of the problem, the poten-
tial of the intervention to improve the situation, to do no
harm, and to convince the public and political levels of the
need for such intervention along with the resources to carry
it out. This process requires patience and a longer time-
frame than many other fields in health.

http://ori.hhs.gov/misconduct/definition_misconduct.shtml

http://www.gmc-uk.org/Wakefield_SPM_and_SANCTION _32595267

Chapter 15 Health Technology, Quality, Law, and Ethics

Some interpretations of ethics in health consider that the
only purpose for which power can be rightfully exercised
over any member of a democratic community, against his
will, is to prevent harm to others. But this is not a dictum
that is applied to public health, which is obliged to act to
protect the public health in so many spheres such as food
and drug safety and environmental health, on a spectrum
that extends to banning smoking in public places, mandat-
ing food fortification, and many other areas of civil society.

Failure to act is an action, and when there is convincing
evidence of a problem that can be alleviated or prevented
entirely by an accepted and demonstrably successful inter-
vention, then the onus is on the public health worker to
advocate such action and to implement it as best as possible
under the existing conditions. Failure to do so is a breach of
“good standards of practice” and could be unethical. Iner-
tia of the public health system in the face of evidence of a
demonstrably effective modality such as adoption of state-
of-the-art vaccines or fortification of flour with folic acid
to prevent birth defects would come under this categoriza-
tion and may even constitute neglect and unethical practice.
This is not an easy categorization, because there is often
disagreement and even opposition to public health interven-
tions, as was the case with opposition to vaccination long
after Jenner’s crucial discovery of this procedure in the late
eighteenth century. It is also true today with opposition to
many proven measures such as fluoridation or fortification
of basic foods. Box 15.19 shows the ethical standards of the
APHA in 2006.

The use of ethical and high standards of practice in pub-
lic health (Box 15.20) requires an ideological commitment
to the advancement of health standards and use of best prac-
tices of international standards to the maximum extent pos-
sible under the local conditions in which the professional is
working. This is not an easy commitment as there is often
dispute and outright hostility to public health activities, in
part because of ethical distortions of great magnitude in the
past. But this is an optimistic field of activity because of the
great achievements it has brought to humankind. Prepara-
tion for disasters and unanticipated health emergencies in
addition to addressing current issues is a vital part of the
New Public Health and our ethical and professional com-
mitments.

SUMMARY

In order to maintain and improve standards of care, health
systems need quality assurance and technological assess-
ment as part of their ongoing operation. Poor-quality care
is costly in terms of iatrogenic diseases and prolonged or
repeated hospitalization. If innovations such as endoscopic
surgery are not introduced, then longer hospital stays are
needed for the same operation, wasting the patient’s time
and productivity, while utilizing expensive health care

815

resources, and incurring the risks associated with more
invasive surgery.

Health care is provided by people, as well as by insti-
tutions with a range of devices and equipment. The people
providing care, more than the technological facilities, set the
quality of care. Nevertheless, progress on the technological
side of medical care is vital to the continuing development
of the field. Modern medications, monitoring equipment,
laboratory services, and imaging devices have made enor-
mous contributions to advances in medical care. Appropriate

BOX 15.19 Principles of Ethical Public Health Practice:
American Public Health Association, 2006

l Public health should address principally the fundamen-
tal causes of disease and requirements for health, aiming
to prevent adverse health outcomes.

l Public health should achieve community health in a way
that respects the rights of individuals in the community.

l Public health policies, programs, and priorities should be
developed and evaluated through processes that ensure
an opportunity for input from community members.

l Public health should advocate and work for the empow-
erment of disenfranchised community members, aiming
to ensure that the basic resources and conditions neces-
sary for health are accessible to all.

l Public health should seek the information needed to
implement effective policies and programs that protect
and promote health.

l Public health institutions should provide communities
with the information they have that is needed for deci-
sions on policies or programs and should obtain the
community’s consent for their implementation.

l Public health institutions should act in a timely manner
on the information they have within the resources and
the mandate given to them by the public.

l Public health programs and policies should incorpo-
rate a variety of approaches that anticipate and respect
diverse values, beliefs, and cultures in the community.

l Public health programs and policies should be imple-
mented in a manner that most enhances the physical and
social environment.

l Public health institutions should protect the confidential-
ity of information that can bring harm to an individual or
community if made public. Exceptions must be justified
on the basis of the likelihood of significant harm to the
individual or others.

l Public health institutions should ensure the professional
competence of their employees.

l Public health institutions and their employees should
engage in collaborations and affiliations in ways that
build the public’s trust and the institution’s effectiveness.

Source: American Public Health Association. Public Health Leadership
Society. Principles of the ethical practice of public health. APHA; 2002.
Available at: http://www.apha.org/NR/rdonlyres/1CED3CEA-287E-4185-
9CBD-BD405FC60856/0/ethicsbrochure [Accessed 13 December
2012].

http://www.apha.org/NR/rdonlyres/1CED3CEA-287E-4185-9CBD-BD405FC60856/0/ethicsbrochure

The New Public Health816

Publication in peer-reviewed journals is a key part of the
advancement in science and a vital part of the development
of the scientific basis for public health practice. The process of
publication should promote rigorous standards of high quality
ethical research and the wide dissemination of their findings.
Codes of practice for editors and publishers of peer-reviewed
journals have been developed by both the Committee on
Publication Ethics (COPE) (Rees, 2011) and the World
Association of World Editors (WAME).

Editors are subject to competitive pressures, and the over-
arching metric of success is seen to be the impact factor, a
measure of the frequency with which the “average article”
in a journal has been cited in a particular year or period.
Relevant, rigorous research of better quality will tend to be
cited more frequently, and thus editorial strategies that look
for quality and relevance in the given field will increase the
impact factor. However, there can also be potential distort-
ing factors. Publishing a highly controversial paper can result
in high citation levels. Publishing studies which demonstrate
negative findings may be less likely to attract large numbers
of citations.

Key issues relate to conflicts of interest, and the potential for
advertising and sponsorship to distort editorial decision mak-
ing (Gray, 2012). A particular concern has been the pernicious
influence of the tobacco industry in sponsoring, frequently
covertly, research which has aimed to confuse or obfuscate key
findings linking second hand exposure to tobacco to adverse
impacts on health. Similar tactics are used in other areas where
health and commercial interests collide. Clear statements of
potential conflicts of interest are essential. Journal owners must
not interfere in the evaluation, selection, or editing of individ-
ual articles, either directly or by creating an environment in
which editorial decisions are strongly influenced.

Other challenging areas are plagiarism and research mis-
conduct. The latter is extremely difficult both to detect and to
deal with, and requires close working between institutions and
editors who may suspect professional misconduct. In cases of
fraud, the publishing journal should withdraw the article in a
timely fashion (see Box 15.18: The Wakefield Effect).

There has been a rapid rise in open access publishing, in
part underpinned by an ethical belief that research is a public
good, and an increasing number of influential research funders
now require that there should be unrestricted access to the
published output of research. In addition, several publishers
make their journals free to those in selected low-income coun-
tries, promoting dissemination to those who might not other-
wise afford them.

In summary, publication in peer-reviewed journals remains
a key method for establishing and progressing the evidence
base for public health practice. The consequences of poor
or frankly fraudulent science can have a substantial adverse
impact both on health and on the use of resources. Editors must
adhere to high ethical and professional standards and remain
vigilant to avoid allowing external drivers to distort their deci-
sion-making processes. They must strive to maintain integrity
and high scientific standards to advance the field of public
health practice (Smith, 2007).

Sources: Selena Gray, BSc, MBCHB, MD, FFPH, FRCP, Professor, University
of West of England, Bristol, and Deputy Postgraduate Dean, Severn Deanery,
Bristol, UK. Personal communication.
Rees M. Code of conduct and best practice guidelines for journal editors.
Committee on Publication Ethics; 2011. Available at: http://publicationeth-
ics.org/ [Accessed 21 August 2012].
Gray S. The ethics of publication in public health. Public Health Rev 2012;34.
Epub ahead of print. Available at: www.publichealthreviews.eu [Accessed 20
December 2012].
Smith R. The trouble with medical journals. London: Royal Society of
Medicine Press; 2007.

BOX 15.20 The Ethics of Publication in Public Health

technology is a critical issue for international health, since
the most advanced technology may be completely inappro-
priate in a setting that cannot afford to maintain it or lacks
the trained personnel to operate it, or where it comes in
place of more vital basic primary care services. Technology
assessment needs to be seen in the context of the country and
its resources for health care.

Ethical issues in public health are no less demanding
than those related to individual clinical care. The rights of
the individual and those of the community are sometimes in
conflict. Technology, quality, the law, and ethics are closely
interrelated in public health. Well-informed and sensitive
analysis of all aspects of their development is a part of the
New Public Health. The balance between individual and
community rights is very sensitive and must be kept under
continuous surveillance.

The New Public Health is replete with technological
and ethical questions, especially in a time of cost restraint,
increasing technological potential, the public expectation

of universal access to health care, and the assumption that
everyone will live a healthy and long life. Health status has
always been linked with socioeconomic status and, despite
enormous gains, this remains true even in the most egalitar-
ian countries. Expansion of market mechanisms, such as
controlling the supply of hospital beds, doctors, and access
to referrals, competition and incentives/disincentives in
payment systems for hospital and managed care systems,
contribute to a need for dynamic health policy management
capacity. The New Public Health assumes a social responsi-
bility for health for all, using community and personal care
modalities as effectively as possible to achieve that overall
goal.

NOTE

For a complete bibliography and guidance for student
reviews and expected competencies please see companion
web site at http://booksite.elsevier.com/9780124157668

http://booksite.elsevier.com/9780124157668

http://publicationethics.org/

Mattress Review – Which is the best mattress of 2018?

Chapter 15 Health Technology, Quality, Law, and Ethics

BIBLIOGRAPHY

Health Technology
Agosti J.M., Goldie S.J. 2007. Introducing HPV vaccine in developing

countries–key challenges and issues. N. Engl. J. Med. 356:1908–1910.
Available at: http://www.nejm.org/doi/full/10.1056/NEJMp078053
(accessed 10.01.14).

Alliance, G.A.V.I., 2011. GAVI alliance secures lower price for rotavi-
rus vaccine. Available at: http://www.gavialliance.org/library/news/
press-releases/2012/gavi-secures-lower-price-rotavirus-vaccine/
(accessed 15.12.12).

American Cancer Society, 30 July 2013. US task force makes recommen-
dations for lung cancer screening. Available at: http://www.cancer.org/
cancer/news/us-task-force-makes-recommendations-for-lung-cancer-
screening (accessed 12.08.13).

American Congress of Obstetricians and Gynecologists, 2012. ACOG
practice bulletin no. 131: screening for cervical cancer. Obstet.
Gynecol. 120, 1222–1238. http://www.acog.org/About%20ACOG/
Announcements/New%20Cervical%20Cancer%20Screening%20
Recommendations.aspx (accessed 22.5.13).

Brenzel L., Wolfson L.J., Fox-Rushby J., Miller M., Halsey N.A. 2006.
Vaccine-preventable diseases. In: Jamison D.T., Breman J.G.,
Measham A.R., Alleyne G., Claeson M., Evans DB, et al., (Ed.) Dis-
ease control priorities in developing countries, second ed. World Bank
Washington, DC. Available at: http://www.ncbi.nlm.nih.gov/
pubmed/21250343 (accessed 7.10.2012).

Campbell, B., 2013. Regulation and safe adoption of new medical devices
and procedures. Br. Med. Bull. 1–14. Available at: http://www.ncbi.
nlm.nih.gov/pubmed/23896485 (accessed 10.01.14).

Canadian Council of Health Services Accreditation. http://www.accredita-
tion.ca/ (accessed 10.01.14).

Centers for Disease Control and Prevention. Healthcare associated infec-
tions (HAI) [updated 23 September 2013]. Available at: http://www.
cdc.gov/hai/ (accessed 10.01.14).

Centers for Disease Control and Prevention, 2009. The direct medical costs
of healthcare-associated infections in US hospitals and the benefits of
prevention. CDC, Atlanta, GA. Available at: http://www.cdc.gov/HAI/
pdfs/hai/Scott_CostPaper (accessed 14.12.12).

Centers for Disease Control and Prevention. Vaccine price list. Available
at: http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-
management/price-list/index.html (accessed 19.09.12).

Centers for Disease Control and Prevention, 2013. Percentage of women
Aged 50–64 years who reported receiving a mammogram in the past
2 years, by health insurance status – National Health Interview Sur-
vey, United States, 1993–2010. MMWR. Morb. Mortal. Wkly. Rep.
62, 651. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/
mm6232a5.htm?s_cid=mm6232a5_w (accessed 10.01.14).

Danish Centre for Health Technology Assessment, 2008. Health technology
assessment handbook, second ed. National Board of Health. Available
at: http://sundhedsstyrelsen.dk/~/media/C0ED080616D7410E8B-
6020B903AD0339.ashx (accessed 10.01.14).

Deyo, R.A., 2002. Cascade effects of medical technology. Annu. Rev.
Public Health 23, 23–44. Available at: http://www.annualreviews.
org/doi/abs/10.1146/annurev.publhealth.23.092101.134534 (accessed
10.01.14).

Fitzpatrick, C., Floyd, K., 2012. A systematic review of the cost and cost
effectiveness of treatment for multidrug-resistant tuberculosis. Phar-
macoeconomics 30, 63–80. Available at: http://www.ncbi.nlm.nih.
gov/pubmed/22070215 (accessed 13.12.12).

817

Flahault, A., Martin-Moreno, JM., 2013. Why do we choose to address health
2020? Public Health Reviews. 2013;35: epub ahead of print. Available
at: http://www.publichealthreviews.eu/upload/pdf_files/13/00_Edito-
rial (accessed 04.01.14).

Greenberg, M.R., 2006. The diffusion of public health innovations. Am.
J. Public Health 96, 209–210. Available at: http://www.ncbi.nlm.nih.
gov/pmc/articles/PMC1470490/ (accessed 10.11.14).

Harris, R.P., Helfand, M., Woolf, S.H., Lohr, K.N., Mulrow, C.D., Teutsch,
S.M., et al., 2001. Current methods of the US Preventive Services Task
Force. A review of the process. Am. J. Prev. Med. 20, 21–35. Avail-
able at: http://www.ncbi.nlm.nih.gov/pubmed/11306229 (accessed
10.01.14).

Health Services/Technology Assessment (HSTAT). Available at: http://
www.ncbi.nlm.nih.gov/books/NBK16710/ (accessed 17.08.12.).

Institute of Medicine, 1985. Assessing medical technologies. National
Academies Press, Washington, DC. Available at: http://www.nap.edu/
openbook.php?record_id=607 (accessed 10.01.14).

International Network of Agencies for Health Technology Assessment
(INAHTA). http://www.inahta.org/ (accessed 17.08.12).

Ikeda, N., Sapienza, D., Guerrero, R., Aekplakorn, W.,et al. 2914, Con-
trol of hypertension with medication: a comparative analysis of
national surveys in 20 countries. Bull. World Health Organ.; 92(1):
10–19. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/
PMC3865548/ (accessed 10.01.14).

Lancet, 2011. Financing HPV vaccination in developing countries. Lan-
cet 377, 1544. Available at: http://www.thelancet.com/journals/lancet/
article/PIIS0140-6736(11)60622-3/fulltext (accessed 10.01.14).

Larson, E.L., Quiros, D., Lin, S.X., 2007. Dissemination of the CDC’s
hand hygiene guideline and impact on infection rates. Am. J. Infect.
Control. 35, 666–675. Available at: http://www.ncbi.nlm.nih.gov/
pubmed/18063132 (accessed 10.01.14).

Lehoux, P., Tailliez, S., Denis, J.L., Hivon, M., 2004. Redefining health tech-
nology assessment in Canada: diversification of products and contextu-
alization of findings. Int. J. Technol. Assess 20, 325–336. Available at:
http://www.ncbi.nlm.nih.gov/pubmed/15446762 (accessed 10.01.14).

Martelli, F., La Torre, G., Di Ghionno, E., Neroni, M., Cicchetti, A., Von
Bremen, K., et al., 2007. Health technology assessment agencies:
an international overview of organizational aspects. Int. J. Technol.
Assess 23, 414–424. Available at: http://www.ncbi.nlm.nih.gov/
pubmed/17937828 (accessed 10.01.14).

Murray, A., Lourenco, T., de Verteuil, R., Hernandez, R., Fraser, C.,
McKinley, A., et al., 2006. Clinical effectiveness and cost-effectiveness
of laparoscopic surgery for colo-rectal cancer: systematic reviews and
economic evaluation. Health Technol. Assess 10, 1–141. Available at:
http://www.ncbi.nlm.nih.gov/books/NBK62293/ (accessed 10.01.14).

National Library of Medicine, 2007. National information center on health
services research & health care technology. Etext on health technology
assessment (HTA) information resources. Available at: http://www.nlm.
nih.gov/archive//20060905/nichsr/ehta/ehta.ht (accessed 10.01.14).

Nixon, J., Stoykova, B., Glanville, J., Christie, J., Drummond, M., Klei-
jnen, J., 2000. The UK NHS economic evaluation database. Eco-
nomic issues in evaluations of health technology. Int. J. Technol.
Assess 16, 731–742. Available at: http://www.ncbi.nlm.nih.gov/
pubmed/11028129 (accessed 10.01.14).

Noorani, H.Z., Husereau, D.R., Boudreau, R., Skidmore, B., 2007. Pri-
ority setting for health technology assessments: a systematic review
of current practical approaches. Int. J. Technol. Assess 23, 310–315.
Available at: http://www.ncbi.nlm.nih.gov/pubmed/17579932 (accessed
10.01.14).

http://www.nejm.org/doi/full/10.1056/NEJMp078053

http://www.gavialliance.org/library/news/press-releases/2012/gavi-secures-lower-price-rotavirus-vaccine/

http://www.cancer.org/cancer/news/us-task-force-makes-recommendations-for-lung-cancer-screening

http://www.acog.org/About%20ACOG/Announcements/New%20Cervical%20Cancer%20Screening%20Recommendations.aspx

http://www.ncbi.nlm.nih.gov/pubmed/21250343

http://www.ncbi.nlm.nih.gov/pubmed/23896485

Home

http://www.cdc.gov/hai/

http://www.cdc.gov/HAI/pdfs/hai/Scott_CostPaper

http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6232a5.htm?s_cid=mm6232a5_w

http://sundhedsstyrelsen.dk/%7e/media/C0ED080616D7410E8B6020B903AD0339.ashx

http://www.annualreviews.org/doi/abs/10.1146/annurev.publhealth.23.092101.134534

http://www.ncbi.nlm.nih.gov/pubmed/22070215

http://www.publichealthreviews.eu/upload/pdf_files/13/00_Editorial

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1470490/

http://www.ncbi.nlm.nih.gov/pubmed/11306229

http://www.ncbi.nlm.nih.gov/books/NBK16710/

http://www.nap.edu/openbook.php?record_id=607

Home

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3865548/

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60622-3/fulltext

http://www.ncbi.nlm.nih.gov/pubmed/18063132

http://www.ncbi.nlm.nih.gov/pubmed/15446762

http://www.ncbi.nlm.nih.gov/pubmed/17937828

http://www.ncbi.nlm.nih.gov/books/NBK62293/

http://www.nlm.nih.gov/archive//20060905/nichsr/ehta/ehta.ht

http://www.ncbi.nlm.nih.gov/pubmed/11028129

http://www.ncbi.nlm.nih.gov/pubmed/17579932

818

Sassi, F., 2003. Setting priorities for the evaluation of health interven-
tions: when theory does not meet practice. Health Policy 63, 141–
154. Available at: http://www.ncbi.nlm.nih.gov/pubmed/12543527
(accessed 10.01.14).

Soto, J., 2002. Health economic evaluations using decision analytic model-
ing. Principles and practices – utilization of a checklist to their devel-
opment and appraisal. Int. J. Technol. Assess 18, 94–111. Available at:
http://www.ncbi.nlm.nih.gov/pubmed/11987445 (accessed 10.01.14).

Upshur, R.E.G., 2002. Principles for the justification of public health inter-
ventions. Can. J. Public Health 93, 101–103. Available at: http://journal.
cpha.ca/index.php/cjph/article/download/217/217 (accessed 10.01.14).

Williams, I., Bryan, S., McIver, S., 2007. How should cost-effectiveness
analysis be used in health technology coverage decisions? Evi-
dence from the National Institute for Health and Clinical Excellence
approach. J. Health Serv. Res. Policy 12, 73–79. Available at: http://
www.ncbi.nlm.nih.gov/pubmed/17407655 (accessed 10.01.14).

Woods, K., 2002. Health technology assessment for the NHS in England
and Wales. Int. J. Technol. Assess 18, 161–165. Available at: http://
www.ncbi.nlm.nih.gov/pubmed/12053415 (accessed 10.01.14).

Quality
Agency for Healthcare Research and Quality. http://www.ahrq.gov/

(accessed 14.12.12).
AHRQ. U.S. Preventive Services Task Force USPSTF), an introduction.

Available at: http://www.ahrq.gov/professionals/clinicians-providers/
guidelines-recommendations/uspstf/index.html.

American College of Cardiology (ACC), http://www.cardiosource.org/
science-and-quality.aspx (accessed 20.08.12).

Cancer Research UK, October 2012. Who is screened for breast cancer? Avail-
able at: http://www.cancerresearchuk.org/cancer-help/type/breast-cancer/
about/screening/who-is-screened-for-breast-cancer (accessed 10.01.14).

Centers for Disease Control and Prevention, 2013. Quick stats. MMWR.
Morb. Mortal. Wkly. Rep. 62, 651. Available at: http://www.cdc.gov/
mmwr/pdf/wk/mm6232 (accessed 17.08.13).

Reviews, Cochrane, http://www.cochrane.org/cochrane-reviews (accessed
14.12.12).

Dannenberg, A.L., Bhatia, R., Cole, B.L., Dora, C., Fielding, J.E., Kraft, K.,
et al., 2006. Growing the field of health impact assessment: an agenda
for research and practice. Am. J. Public Health 96, 262–270. Avail-
able at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1470491/
(accessed 10.01.14).

Deeks, J.J., 2001. Systematic reviews in health care: systematic
reviews of evaluations of diagnostic and screening tests. BMJ 323,
157–162. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/
PMC1120791/ (accessed 10.01.14).

European Society of Cardiology, Guidelines. Available at: http://www.
escardio.org/GUIDELINES-SURVEYS/ESC-GUIDELINES/Pages/
GuidelinesList.aspx (accessed 17.08.12).

Epstein, A.J., Polsky, D., Yang, F., Yang, L., Groeneveld, P.W., 2011.
Coronary revascularization trends in the United States, 2001–2008.
JAMA 305, 1769–1776. Available at: http://www.ncbi.nlm.nih.gov/
pubmed/21540420 (accessed 13.08.13).

Fielding, J.E., Briss, P.A., 2006. Promoting evidence-based public
health policy: can we have better evidence and more action? Health
Aff. 25, 969–978. Available at: http://content.healthaffairs.org/con-
tent/25/4/969.full (accessed 10.01.14).

Institute of Medicine, 2007. State of quality improvement and imple-
mentation research: expert views. Workshop summary. Institute of
Medicine of the National Academies of Science. National Academies
Press, Washington, DC. Available at: http://www.nap.edu/catalog.
php?record_id=11986 (accessed 10.01.14).

The New Public Health

International Guideline Network Library. http://www.g-i-n.net/library/
international-guidelines-library/ (accessed 14.12.12).

Kohn, L.T., Corrigan, J.M., Donaldson, M. (Eds.), 1999. Institute of
Medicine. Committee on quality of health care in America. To err is
human: building a safer health system. National Academies Press,
Washington, DC. Available at: http://www.nap.edu/openbook.
php?isbn=0309068371 (accessed 10.01.14).

Krech, L.A., El-Hadri, L., Evans, L., Fouche, T., et al., 2014. The
medicines quality database: a free public resource. Available at:
h t t p : / / w w w. w h o . i n t / bu l l e t i n / vo l u m e s / 9 2 / 1 / 1 3 – 1 3 0 5 2 6 . p d f
(accessed 10.01.14).

National Council for Quality Assurance. http://www.ncqa.org/ (accessed
10.01.14).

Pilkington, H., Blondel, B., Drewniak, N., Jennifer Zeitlin, 2014.
Where does distance matter? Distance to the closest maternity unit
and risk of foetal and neonatal mortality in France. Eur. J. Public
Health, 1–6. Available at: http://eurpub.oxfordjournals.org/content/
early/2014/01/01/eurpub.ckt207.full (accessed 10.01.14).

Shortell, S.M., Gillies, R., Wu, F., 2010. United States innovations in
health care delivery. Public Health Rev. 32, 190–212. Available at:
http://www.publichealthreviews.eu/show/f/26 (accessed 26.10.12).

The National Audit Office, 2012. Healthcare across the UK: A compari-
son of the NHS in England. Wales and Northern Ireland, Scotland.
Available at: http://www.officialdocuments.gov.uk/document/hc1213/
hc01/0192/0192 (accessed 10.01.14).

UK National Institute for Health and Care Excellence (NICE). Available
at: http://www.nice.org.uk/ (accessed 17.08.12).

US Department of Health and Human Services, August 2008. Office of
Inspector General. Adverse events in hospitals: overview of key
issues. Available at: http://oig.hhs.gov/oei/reports/oei-06-07-00470.
pdf (accessed 17.08.13).

US Food and Drug Administration, 2007. Department of Health and
Human Services. Amendment to the current good manufacturing prac-
tice regulations for finished pharmaceuticals. Direct final rule. Federal
Register 72, 68064–68070. Available at: http://www.ihi.org/Pages/
default.aspx (accessed 17.08.12).

US National Library of Medicine. Available at: http://www.nlm.nih.gov/
(accessed 13.02.14).

US National Information Center on Health Services Research. https://www.
nlm.nih.gov/nichsr/ (accessed 13.02.14).

US Preventive Services Task Force. Guide to preventive services. Report
of the US Preventive Services Task Force (USPSTF). http://www.ahrq.
gov/professionals/clinicians-providers/guidelines-recommendations/
uspstf/index.htm. Available at: http://www.ahrq.gov/clinic/USpstfix.
htm (accessed 13.02.14).

Law
American Society of Law, Medicine and Ethics. The public’s health and

the law in the 21st century: Second annual partnership conference on
public health law. J. Law. Med. Ethics. Special Suppl. 31 (4). Avail-
able at: http://www.stacks.cdc.gov/view/cdc/6751/cdc_6751_DS1
(accessed 10.1.14).

Annas, G., 1998. Human rights and health – the universal declaration
of human rights at 50. N. Engl. J. Med. 339, 1778–1781. Available
at: http://www.nejm.org/doi/full/10.1056/NEJM199812103392411
(accessed 10.01.14).

Burris, S., Wagenaar, A.C., Mello, M.M., 2010. Making the case for laws
that improve health: A framework for public health law research. Mil-
bank. Q. 88 (2), 169–210. Available at; http://www.ncbi.nlm.nih.gov/
pmc/articles/PMC2980343/ (accessed 10.01.14).

http://www.ncbi.nlm.nih.gov/pubmed/12543527

http://www.ncbi.nlm.nih.gov/pubmed/11987445

http://journal.cpha.ca/index.php/cjph/article/download/217/217

http://www.ncbi.nlm.nih.gov/pubmed/17407655

http://www.ncbi.nlm.nih.gov/pubmed/12053415

http://www.ahrq.gov/

http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/uspstf/index.html

http://www.cardiosource.org/science-and-quality.aspx

http://www.cancerresearchuk.org/cancer-help/type/breast-cancer/about/screening/who-is-screened-for-breast-cancer

http://www.cdc.gov/mmwr/pdf/wk/mm6232

http://www.cochrane.org/cochrane-reviews

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1470491/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1120791/

http://www.escardio.org/GUIDELINES-SURVEYS/ESC-GUIDELINES/Pages/GuidelinesList.aspx

http://www.ncbi.nlm.nih.gov/pubmed/21540420

http://content.healthaffairs.org/content/25/4/969.full

http://www.nap.edu/catalog.php?record_id=11986

http://www.g-i-n.net/library/international-guidelines-library/

http://www.nap.edu/openbook.php?isbn=0309068371

http://www.who.int/bulletin/volumes/92/1/13-130526

http://web.ncqa.org/tabid/577/Default.aspx

http://eurpub.oxfordjournals.org/content/early/2014/01/01/eurpub.ckt207.full

http://www.publichealthreviews.eu/show/f/26

http://www.officialdocuments.gov.uk/document/hc1213/hc01/0192/0192

http://www.nice.org.uk/

http://oig.hhs.gov/oei/reports/oei-06-07-00470

http://www.ihi.org/Pages/default.aspx

http://www.nlm.nih.gov/

https://www.nlm.nih.gov/nichsr/

http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/uspstf/index.htm

http://www.ahrq.gov/clinic/USpstfix.htm

http://www.stacks.cdc.gov/view/cdc/6751/cdc_6751_DS1

http://www.nejm.org/doi/full/10.1056/NEJM199812103392411

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2980343/

Chapter 15 Health Technology, Quality, Law, and Ethics

Centers for Disease Control and Prevention, Collaborating Center for the
Law and the Public’s Health. Available at: http://www.publichealthlaw.
net/ (accessed 17.08.12).

Fox, D., Kramer, M., Standish, M., 2003. From public health to population
health: how can law redefine the playing field? J. Law Med. Ethics.
31, 21–29. Available at: http://www.stacks.cdc.gov/view/cdc/6751/
cdc_6751_DS1 (accessed 10.01.14).

Goodman, R.A., Moulton, A., Matthews, G., Shaw, F., Kocher, P., Mensah,
G., et al., 2006. Law and public health at CDC. MMWR. Morb. Mor-
tal. Wkly. Rep. 55, 29–33. Available at: http://www.cdc.gov/mmwr/
preview/mmwrhtml/su5502a11.htm (accessed 10.01.14).

Gostin, L.O., 2000. Public health law in a new century. Part II: Public
health powers and limits. JAMA 283, 2979–2984. Available at: http://
www.ncbi.nlm.nih.gov/pubmed/10865277 (accessed 10.01.14).

Gostin, L.O., 2000. Public health law in a new century: Part III: Public
health regulation: a systematic evaluation. JAMA 283, 3118–3122.
Available at: http://www.ncbi.nlm.nih.gov/pubmed/10865307
(accessed 10.01.13).

Ruhl, S., Stephens, M., Locke, P., 2005. The role of NGOs in public health
law. J. Law Med. Ethics. 31, 76–77. Available at: http://www. stacks.cdc.
gov/view/cdc/6751/cdc_6751_DS1 (page 76). (accessed 10.01.14).

Thiel, K.S., 2003. New developments in public health case law. J. Law
Med. Ethics. 31, 86–87.

Zasa, S., Clymer, J., Upmeyer, L., Thacker, S., 2003. Using science-based
guidelines to shape public health law. J. Law Med. Ethics. 31, 65–67.

Ethics
Aceijas, C., Brall, C., Schröder-Bäck, P., Otok, R., Maeckelberghe, E.,

Stjernberg, L., et al., 2012. Teaching ethics in schools of public
health in the European Region: findings from a screening survey.
Public Health Rev. 34. Epub ahead of print. Available at: www.publi-
chealthreviews.eu (accessed 05.12.12).

American College of Epidemiology, 2000. Ethics guidelines. Ann. Epidemiol.
10, 487–497. Available at: http://acepidemiology.org/content/ethics.

American Public Health Association, Principles of the ethical prac-
tice of public health. Available at: http://www.apha.org/NR/
rdonlyres/1CED3CEA-287E-4185-9CBD-BD405FC60856/0/ethics-
brochure (accessed 17.08.12).

Bachrach, S., 2004. In the name of public health – Nazi racial hygiene. N.
Engl. J. Med. 351, 417–420. Available at: http://content.nejm.org/cgi/
content/full/351/5/417?ijkey=8bee5b41cf11cadc3a826ad16fc2deef59
aa8f32&keytype2=tf_ipsecsha (accessed 05.12.12).

Bayer, R., Fairchild, A., 2004. The genesis of public health ethics. Bio-
ethics 18, 473–492. Available at: http://www.ncbi.nlm.nih.gov/
pubmed/15580720 (accessed 10.01.14).

Birn, A.E., Molina, N., 2005. In the name of public health. Am. J. Pub-
lic Health 95, 1095–1097. Available at: http://www.ncbi.nlm.nih.gov/
pmc/articles/PMC1449322/ (accessed 10.01.14).

Carter, S.M., Cribb, A., Allegrante, J.P., 2012. How to think about health
promotion ethics. Public Health Rev. 34. Epub ahead of print. Avail-
able at: www.publichealthreviews.eu (accessed 05.12.12).

Centers for Disease Control and Prevention, US Public Health Service
syphilis experiment at Tuskegee. Available at: http://www.cdc.gov/
tuskegee/timeline.htm (accessed 17.08.12).

Centers for Disease Control, Advancing excellence and integrity of CDC
science. Available at: http://www.cdc.gov/od/science/integrity/pheth-
ics/ (accessed 10.01.14).

Coleman, C.H., Bouësseau, M.-C., Reis, A., 2008. The contribution of
ethics to public health. Bull. World Health Org. 86, 578–579. Avail-
able at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2649472/
(accessed 10.01.14).

819

Coughlin, S.S., Barker, A., Dawson, A., 2012. Ethics and scientific integ-
rity in public health, epidemiological and clinical research. Pub-
lic Health Rev. 34 (1). Available at: www.publichealthreviews.eu
(accessed 05.12.12).

Coughlin, S.S., 2006. Ethical issues in epidemiologic research and public
health practice. Emerg Themes Epidemiol 3, 3–16. Available at: http://
www.ncbi.nlm.nih.gov/pmc/articles/PMC1594564/ (accessed 10.01.14).

Dawson, A., Paul, Y., 2006. Mass public health programs and the obliga-
tions of sponsoring and participating organizations. J. Med. Ethics 32,
580–583. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/
PMC2563318/ (accessed 10.01.14).

Dawson, A., 2004. Vaccination and the prevention problem. Bioethics 18,
515–530. Available at: http://onlinelibrary.wiley.com/doi/10.1111/
j.1467-8519.2004.00414.x/abstract?deniedAccessCustomisedMessag
e=&userIsAuthenticated=false (accessed 10.01.14).

El Amin, A.N., Parra, M.T., Kim-Farley, R., Fielding, J.E., 2012. Ethical
issues concerning vaccination requirements. Public Health Rev. 34
(1). Available at: www.publichealthreviews.eu (accessed 05.12.12).

Kass, N., 2004. Public health ethics: from foundations and frameworks
to justice and global public health. J. Law Med. Ethics. 32, 232–
242. Available at: http://www.ncbi.nlm.nih.gov/pubmed/15301188
(accessed 10.01.14).

Lee, L.M., 2012. Guest editorial: Public health ethics theory: review and
path to convergence. Public Health Rev. 34 (1). Available at: www.
publichealthreviews.eu (accessed 05.12.12).

Lynch, H.F., 2012. Ethical evasion or happenstance and hubris? The US
Public Health Service STD Inoculation Study. Hastings Cent. Rep.
42, 30–38. Available at: http://onlinelibrary.wiley.com/doi/10.1002/
hast.17/abstract (accessed 10.01.14).

Nuremberg Code, 1949. Trials of war criminals before the Nurem-
berg military tribunals under control council law no. 10, Vol. 2. US
Government Printing Office, Washington, DC. pp. 181–182. Organ-
isation for Economic Co-operation and Development, 2007. Global
Science Forum. Best practices for ensuring scientific integrity and
preventing misconduct. OECD, Available at: http://www.oecd.org/
dataoecd/37/17/40188303 (accessed 19.5.2012).

Reverby, S.M., 2012. Ethical failures and history lessons: the US
Public Health Service research studies in Tuskegee and Guatemala.
Public Health Rev. 34. Epub ahead of print. Available at: http://
www.publichealthreviews.eu/upload/pdf_files/11/00_Reverby
(accessed 10.01.14).

Thieren, M., Mauron, A., 2007. Nuremberg Code turns 60. B World Health
Organ 85, 573. Available at: http://www.publichealthreviews.eu/
upload/pdf_files/11/00_Reverby (accessed 10.01.14).

Thomas, J.C., Sage, M., Dillenberg, J., Guillory, V.J., 2002. A code of
ethics for public health. Am. J. Public Health 92, 1057–1060. Avail-
able at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1447186/
(accessed 10.01.14).

US Presidential Commission for the Study of Bioethical Issues, 2011.
Creation of the commissions. Available at: http://bioethics.gov/cms/
creation-of-the-commission (accessed 05.12.12).

United Nations Programme on HIV/AIDS (UNAIDS), 2013. Ending
overly broad criminalisation, non-disclosure, exposure and transmis-
sion: Critical scientific, medical and legal considerations. Available
at: http://www.unaids.org/en/media/unaids/contentassets/documents/
document/2013/05/20130530_Guidance_Ending_Criminalisation
(accessed 20.1.14).

Zusman, S.P., 2012. Water fluoridation in Israel, 1968–2012. Public Health
Rev. 34. Epub ahead of print. Available at: http://www.publichealthre-
views.eu/upload/pdf_files/11/00_Zusman (accessed 10.01.14).

Centers for Law and the Public’s Health

http://www.stacks.cdc.gov/view/cdc/6751/cdc_6751_DS1

http://www.cdc.gov/mmwr/preview/mmwrhtml/su5502a11.htm

http://www.ncbi.nlm.nih.gov/pubmed/10865277

http://www.ncbi.nlm.nih.gov/pubmed/10865307

http://www.stacks.cdc.gov/view/cdc/6751/cdc_6751_DS1

http://refhub.elsevier.com/B978-0-12-415766-8.00015-X/ref0300

http://refhub.elsevier.com/B978-0-12-415766-8.00015-X/ref0305

Mattress Review – Which is the best mattress of 2018?

http://acepidemiology.org/content/ethics

http://www.apha.org/NR/rdonlyres/1CED3CEA-287E-4185-9CBD-BD405FC60856/0/ethicsbrochure

http://content.nejm.org/cgi/content/full/351/5/417?ijkey=8bee5b41cf11cadc3a826ad16fc2deef59aa8f32%26keytype2=tf_ipsecsha

http://www.ncbi.nlm.nih.gov/pubmed/15580720

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1449322/

Mattress Review – Which is the best mattress of 2018?

http://www.cdc.gov/tuskegee/timeline.htm

http://www.cdc.gov/od/science/phec/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2649472/

Mattress Review – Which is the best mattress of 2018?

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1594564/

http://onlinelibrary.wiley.com/doi/10.1111/j.1467-8519.2004.00414.x/abstract?deniedAccessCustomisedMessage=%26userIsAuthenticated=false

Mattress Review – Which is the best mattress of 2018?

http://www.ncbi.nlm.nih.gov/pubmed/15301188

Mattress Review – Which is the best mattress of 2018?

http://onlinelibrary.wiley.com/doi/10.1002/hast.17/abstract

http://www.oecd.org/dataoecd/37/17/40188303

http://www.publichealthreviews.eu/upload/pdf_files/11/00_Reverby

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1447186/

http://bioethics.gov/cms/creation-of-the-commission

http://www.unaids.org/en/media/unaids/contentassets/documents/document/2013/05/20130530_Guidance_Ending_Criminalisa%20

http://www.publichealthreviews.eu/upload/pdf_files/11/00_Zusman

15 – Health Technology, Quality, Law, and Ethics

Introduction
Innovation, Regulation, and Quality Control
Appropriate Health Technology
Priority Interventions in Low- and Medium-Income Countries
Priority Selection in High-Income Countries
Health Technology Assessment
Technology Assessment in Hospitals
Technology Assessment in Prevention and Health Promotion
Technology Assessment in National Health Systems
Dissemination of Technology
Diffusion of Technology
Quality Assurance
Adverse Events and Negligence
Licensure and Certification
Health Facility Accreditation
Peer Review
Tracer Conditions
Setting Standards
Algorithms and Clinical Guidelines
Organization of Care
Diagnosis-Related Groups
Managed Care
Performance Indicators
Consumerism and Quality
The Public Interest
Total Quality Management
Public Health Law
Environmental Health
Public Health Law Reform
Ethical Issues In Public Health
Individual and Community Rights
Tragic Deviations in Public Health Ethics
Human Experimentation
Ethics in Public Health Research
Ethics in Patient Care
Sanctity of Life Versus Euthanasia
The Imperative to Act or Not Act in Public Health
Summary
Note
Bibliography
Health Technology
Quality
Law
Ethics