Understanding the Role of and Conceptualizing Health Policy and Law


By the end of this chapter, you will be able to:

c Describe generally the important role played by policy and law in the health of individuals and populations

Describe three ways to conceptualize health policy and Law

In this chapter, we introduce the role played by policy and

law in the health ofindividuals and populations and describe

three conceptual frameworks with which you can approach

the study ofhealth policy and law. Later, we narrow our focus,

providing a measure ofclarity in an area that is neither readily

discernable-even to those who use and work in the health care and public health systems-nor easily redrawn by those who shape them through policy and law.

The goals of this chapter are to describe why it is impor­

tant to include policy and law in the study of health care and

public health and how you might conceptualize health policy

and law ·when undertaking your studies. To achieve these

goals, we first briefly discuss the va§l.~!!fl~-~I~~~-?iP?~~”cy_~IJ-d law in health -~are and public health. You will have a much better feel for how far policy and law reach into these areas

as you proceed, but we dedicate a few pages here to give you

a sense ofwhy it is critical to examine policy and lawmaking as part ofyour broader health studies. We then describe three

ways to conceptualize health policy and law. As you will dis­ cover, the three conceptual frameworks are interwoven, with

no one framework dominating the discussion.


The forceful influence of policy and law on the health of in­

dividuals and populations is undeniable. Policy and law have

always been fundamentalin shaping the practice ofindividual

health care in the United States and to achieving both every­

day and landmark public health improvements.

Centuries-old legal principles have, since this country’s

inception, provided the bedrock on which healthcare quality

laws are built, and today the healthcare industry is regulated

in many different ways. Indeed, federal and state policy and

law shape virtually all aspects of the healthcare system, from

structure and organization, to service delivery, to financing,

and to administrative and judiciaroversight. Whether per­

taining to the accreditation and certification ofindividual or

institutional healthcare providers, requirements to provide care under certain circumstances, the creation ofpublic insur­

ance programs, the regulation ofprivate insurance systems, or

any other number of issues, policy and law drive the health­

care system to a degree unknown by most people. In fact, professional digests that survey and report on

the subjects ofhealth policy and law typically include in their

pages information on topics like the advertising and market­

ing of health services and products, the impact of health ex­

penditures on federal and state budgets, antitrust concerns,

health care contracting, employment issues, patents, taxation,

healthcare discrimination and disparities, consumer protec­

tion, biot~rrorism, health insurance, prescription drug regula­

tion, physician-assisted suicide, biotechnology, human subject

research, patient privacy and confidentiality, organ availabil­ ity and donation, and more. Choices made by policymakers and decisions handed down through the legal system impact how we approach, experience, analyze, and research all of

these and other specific aspects ofthe healthcare system. Once you have read the next four preparatory chapters­

one on policy and the policymaking process, one on law and the legal system, and one each covering the structure and or­ ganization ofthe healthcare and public health systems-and begin to digest the substantive chapters that follow them, the full force of policy and law in shaping the individual health­ care system will unfold. For now, simply keep in the back of your mind the fact that policy and law heavily influence the way in which health care is accessed, medicine is practiced, treatments are paid for, aild much more.

The role ofpolicy and law in public health is no less im· portant than in individual health care, but the influence of policy and law in the field of public health is less frequently articulated. In fact, policy and law have long played a seminal role in everyday public health activities (think, for example, offuod establishment inspections, occupational safety stan­ dards, policies related to health services for persons with chronic health conditions such as diabetes, and policies and laws affecting the extent to which public health agencies are able to gauge whether individuals in a community suffer from certain health conditions), as well as in many historic public health accomplishments such as water and air puri· fication, reduction in the spread of communicable diseases

through compulsory immunization laws, reduction in the number of automobile-related deaths through seatbelt and consumer safety laws, and several others.’ Public health professionals and students quickly learn to appreciate that combating public health threats requires both vigorous poli· cymaking and adequate legal powers. Additionally, in re· cent years, enhanced fears about bioterrorism and new and

emerging infectious diseases have only increased the public’s belief that policy and law are important tools in creating an environment in which people can achieve optimal health and safety.

Ofcourse, policies and laws do not always cut in favor of what many people believe to be in the best interests of pub· lie health and welfare. A policy or law might, for example, favor the economic interests of a private, for-profit company

over the residents of the community in which the company is located.b Why? Because one main focus of policy and law in the realm of public health is on locating the appropriate balance between public regulation ofprivate individuals and corporations and the ability of those same parties to exercise

rights that allow them to function free of overly intrusive gov· ernment intervention. Achieving this balance is not easy for policymakers. Not all interested parties agree on things like the extent to which car makers should alter their operations to reduce environmentally harmful auto emissions, or the

degree to which companies should be limited in advertising cigarettes, or whether gun manufacturers should be held liable in cases where injuries or killings result from the negligent use of their products.

How do policyrnakers and the legal system reach a (hope· fully) satisfactory public health/private right balance? The competing interests ~t the heart of public health are mainly addressed through two types of policies and laws: those that define the functions andpowers ofpublic health agencies, and those that aim to directly protect and promote health.’ State· level policymakers and public health officials create these types of policies and laws through what are known as their police powers. These powers represent the inherent authority of state and local governments to regulate individuals and private business in the name ofpublic health promotion and pro tee· tion. The importance ofpolice powers cannot be overstated; it is fair to say that they are the most critical aspect of the sovereignty that states retained at the founding ofthe country, when the colonies agreed to a governmental structure consist­ ing of a strong national government. Furthermore, the reach of police powers should not be underestimated, particularly since they permit public health authorities to coerce private interests to engage in (or refrain from) activities in the name of public health and welfare. However, states do not need to · exercise their police powers in order to affect or engage in pub­ lic health-related policymaking. Because the public’s health is impacted by many social, economic, and environmental factors, public health agencies also conduct policy-relevant research, disseminate information aimed at helping people

engage in healthy behaviors, and establish collaborative rela· tionships with healthcare providers and purchasers and with other government policymaking agencies.

Federal policy and law also play a role in public health.

Although the word “h.”!’]!.~.:_pey.!’Lill’P.Ci’Esin the U.S. (;()n· stitutig_n,_the document confers powers on th:~fedel:a1 go~ern­ ,;;:;;t-to tax and spend, for example-that allow it to engage

in public h_~alth 2~~!!W!1Ql1 aT!~ d_is~_?-§~_pl:;y(ifl:{~~iCtivitie_~ For.ex~,;pl~th~ p~wer t~ !;,~(or establish exemptions from taxation) allows Congress to incentivize healthy behaviors, as

witnessed by the heavy taxes levied on packages of cigarettes; the power to spend enables Congress to establish executive branch public health agencies and to allocate public health· specific funds to states and localities.

– – —


You have just read about the importance oftaking policy and law into account when studying health care and public health. The next step is to begin thinking about how you might con­ ceptually approach the study of health policy and law.

There are multiple ways to conceptualize the many im­ portant topics that fall under the umbrella of health policy and law. We introduce three conceptual frameworks in this

section: one premised on the broad topical domains ofhealth policy and law, one based on prevailing historical factors, and

one focused on the individuals and entities impacted by a particular policy or legal determination (see Box 1·1).

FrameWork l• Study based on the broad ToPiCAl DOMAiNS of:

a; HeBtth- care

b: Public health

c; Bioethics-

Framework 2.Stiidy -ba_Sed-on._ HISTORICALLY: DoMINAkr SonAL, – PoLiTICAL; -:ANO. -Ec’ONOMIC -PERSPECTIVEs;

a~ PrOfes_Sibri<H”autOriorriY_

b. Social contract

c.- Fre_e inarket

Framework 3. Study based on the perspectives of Kcv 5TAi<EHOL0ERs;

. ‘- __ ,___ ­

a. Individuals

b. The public – .-<_·,

c; He·qtthc~re.·profe:s_Si_OnalS

d. :Fect-erat’and·s:fate .g·oye·rnm-erits

e. M~na9~d-~are and: traditio~al iitsurance -¢o~pani-~·s f. Employers

g·. The p’hal-mateutlcal ‘i_ndustry

. h, The research community

i. ll]te_rest group~

j: Others

Conceptualizing Health Policy

We draw on these frameworks to various degrees in this text. For example, the topical domain approach of Frame­ work I is on display in the sections about individual rights in health care and public health and healthcare quality policy and law. Framework 2’s focus on historical perspectives is highlighted in the health reform section and the government health insurance programs section. Finally, Framework 3, which approaches the study ofhealth policy and law from the perspectives ofkey stakeholders, is discussed in the policy and the policymaking process section. We turn now to a descrip­

tion of each framework.

The Three Broad Topical Domains of Health Policy and Law

One way to conceptualize health policy and law is as consist· ing of three large topical domains. One domain is reserved for policy and law concerns in the area ofhealthcare, another

for issues arising in the public health arena, and the last for controversies in the field ofbioethics. As you contemplate these topical domains, bear in mind that they are not individual silos whose contents never spill over into the others. Indeed, this sort of spillage is common (and, as noted, is one reason

why fixing health policy problems can be terribly compli· cated). We briefly touch on each domain below.

Health Care Policy and Law

In the most general sense, this domain is concerned with an

individual’s access to care (e.g., what policies and laws impact an individual’s ability to access needed care?), the quality of the care the person received (e.g., was it appropriate, cost­ effective, and non-negligent?); and how the person’s care is going to be financed (e.g., is the person insured?). However, “access,” “quality,, and “financing” are themselves rather

large sub-domains, with their own sets of complex policy and legal issues, and in fact it is common for students to take semester-long policy and/or law courses focused on just one of these sub-domains.

Public Health Policy and Law

The second large topical domain is that ofpublic health policy and law. A central focus here is on why and how the gov· ernment regulates private individuals and corporations in the name of protecting the health, safety, and welfare of the general public. Imagine, for example, that the federal govern· rnent was considering a blanket policy decision to vaccinate individuals across the country against the deadly smallpox disease, l;>elieving that the decision was in the best interests ofnational security. Would this decision be desirable from a

····—–3 Ch;mf,er t Understanding the Role of and Conceptualizing Health Policy and Law

national policy perspective? Would it be legal? Ifthe program’s desirability and legality are not immediately clear, how would you go about analyzing and assessing them? These are the kinds of questions with which public health policy and law practitioners and scholars grapple.


Finally, there is the bioethics domain to health policy and law. Strictly speaking, the term “bioethics” is used to describe

ethical issues raised in the context of medical practice or biomedical research. More comprehensively, bioethics can be thought of as the point at which public policy, law, individual morals, societal values, and medicine intersect. The bioeth­ ics domain houses some of the most explosive questions in health policy, including tl’i.e morality and legality ofabortion,

conflicting values around the meaning ofdeath and the rights ofindividuals nearing the end oflife, and the policy and legal consequences of mapping the human genetic code.

Social, Political, and Economic Historical Conte>tt

Dividing the substance of health policy and law into broad topical categories is only one way to conceptualize them. A second way to consider health policy and law is in historical terms, based on the social, political, and economic views that dominate a particular erad Considered this way, health policy

and law have been influenced over time by three perspectives, all ofwhich are technically active at any given time, but each of which has eclipsed the others during specific periods in terms ofpolitical, policy, and legal outcomes. These perspec· tives are termed professional autonomy, social contract, and free market.’

Professional Autonomy Perspective

The first perspective, grounded in the notion thatthe medical profession should have the authority to regulate itself, held sway from approximately 1880 to 1960, making it the most dominant ofthe three perspectives in terms ofboth the length of time it held favored status and its effect in the actual shaping of health policy and law. This model is premised on the idea that physicians’ scientific expertise in medical matters should translate into legal authority to oversee essentially all aspects of delivering health care to individuals-in other words, ac­

cording to proponents ofthe physician autonomy model, legal oversight of the practice of medicine should be delegated to the medical profession itself. While this perspective remained dominant, policy· and lawmakers were generally willing to allow physicians to control the terms and amount ofpayments

for rendered healthcare services, the standards under which medical licenses would be granted, the types ofpatients they would treat, the type and amount ofinformation to disclose to patients, and the determination as to whether their colleagues

in the medical profession were negligent in the treatment of their patients.

So’cia/ Contract Perspective

The second perspective that informs a historical conceptu­ alization of health policy and law is that of the “modestly egalitarian social contract.”fThis paradigm overshadowed its competitors, and thus guided policy decision making, from roughly 1960 to 1980, a time notable in U.S. history for so·

cial progressiveness, civil rights, and racial inclusion. At the center of this perspective is the belief that complete physician autonomy over the delivery and financing ofhealth care is po· tentially dangerous in terms ofpatient care and healthcare ex· penditures, and that public policy and law can and sometimes should enforce a “social contract” at the expense ofphysician

controL Put differently, this perspective sees physicians as just one of several stakeholders (including but not limited to. patients, employers, and society) that lay claim to important rights and interests in the operation of the healthcare system.

Health policies and laws borne ofthe social contract era cen­ tered on enhancing access to health care (e.g., through the Examination and Treatment for Emergency Medical Condi· tions and Wmnen in Labor Act), creating new health insur­ ance programs (Medicare and Medicaid were established in 1965), and passing anti-discrimination laws (one ofthe specific

purposes of Title VI of the federal1964 Civil Rights Act was wiping out health care discrimination based on race).

Free Market Perspective The final historical perspective-grounded in tbe twin no· lions of the freedom of the marketplace and of market com· petition-became dominant in the 1990s and continues with force today. It contends that the markets for healthcare ser·

vices and for health insurance operate best in a deregulated environment, and that commercial competition and con­ sumer empowerment will lead to the most efficient healthcare system. Regardless of the validity of this claim, this perspec· live argues that the physician autonomy model is falsely pre· 1nised on the idea of scientific expertise, when in fact most healthcare services deemed “necessary” by physicians have never been subjected to rigorous scientific validation (think of the typical treatments for the common cold or a broken leg). It further argues that even the modest version of the social contract that heavily influenced health policy and law

during the civil rights generation is overly regulatory. Fur­ thermore, market competition proponents claim that both

other models are potentially inflationary, since in the first case self~interest will lead autonomous physicians to drive up

the cost of their services, and in the second instance public insurance programs like Medicare would lead individuals to

seek unnecessary care.

To tie a couple of these historical perspectives together and examine (albeit in somewhat oversimplified fashion) how evolving social and economic mores have influenced health

policy and law, consider the example of Medicaid, the joint federal-state health insurance program for low-income in­ dividuals. In 1965, Medicaid was borne out ofthe prevailing societal mood that it was an important role of government

to expand legal expectations among the poor and needy. Its creation exemplified a social contract perspective, which in the context of health promotes the view that individuals and society as a whole are important stakeholders in the healthcare and public health systems. Medicaid entitled eligible individu­ als to a set of benefits which, according to courts during the era under consideration, was the type oflegal entitlement that could be enforced by beneficiaries when they believed their rights under the program were infringed.

These societal expectations and legal rights and protec­ tions withstood early challenges during the 1970s, as the costs associated with providing services under Medicaid resulted in

state efforts to roll back program benefits. Then, in the 1980s, Medicaid costs soared higher, as eligibility reforms nearly doubled the program’s enrollment and some providers (e.g., community health centers) were given higher payments for the Medicaid services they provided. Still, the social contract perspective held firm, and the program retained its essential egalitarian features.

As noted above, however, the gravitational pull of the social contract theory weakened as the 1980s drew to a close. This, coupled with the fact that Medicaid spending contin­ ued to increase in the 1990s, led to an increase in the number

of calls to terminate program members’ legal entitlement to

benefits.g Also in the 1990s, federal and state policymakers dramatically increased the role ofprivate managed care cop­

parries in both Medicaid and Medicare, an example of the trend toward free market principles described above.

Key Stakeholders

A third way to conceptualize health policy and law issues is in terms of the stakeholders whose interests are impacted by

certain policy choices or by the passage or interpretation of a

law. For example, imagine that in the context ofinterpreting a

state statute regulating physician licensing, your state’s highest court ruled that it was permissible for a physician to not treat

a patient even though the doctor had been serving as the pa­ tient’s family physician. What stakeholders could be impacted by this result? Certainly the patient, and othel’ patients whose treatment may be colored by the court’s decision. Obviously the doctor, and other doctors practicing in the same state,

could be impacted by the court’s conclusion. What about the state legislature? Perhaps it unintentionally drafted the licensing statute in ambiguous fashion, which led the court

to determine that the law conferred no legal responsibility on the physician to respond to a member of a family that was part of the doctor’s patient load. Or maybe the legislature is implicated in another way-maybe it drafted the law with such clarity that no other outcome was likely to result, but the citizenry of the state was outraged because its elected of­

ficials have created public policy out ofstep with constituents’ values. Note how this last example draws in the perspective

of another key stakeholder-the broader public. Of course, patients, healthcare providers, governments,

and the public are not the only key stakeholders in important matters ofhealth policy and law. Managed care and traditional insurance companies, employers, the pharmaceutical indus­

try, the medical device industry, the research community,

interest groups, and others all may have a strong interest in

various policies or laws under debate.


The above descriptions ofthe roles played by policy and law in the health of individuals and populations, and ofthe ways to conceptualize health policy and law, were cursory by design. But what we hope is apparent to you at this early stage is the fact that the study ofpolicy andlaw·is essential to the study of both health care and public health. Consider the short list of major problems with the U.S. health system as described in a 2005 book edited and written by a group ofleading scholars: the coverage and financing of health care, healthcare qual­ ity, health disparities, and threats to population healthh All of the responses and fixes to these problems-and to many other healthcare- and public health-related concerns-will invariably and necessarily involve creative policyrnaking and

rigorous legal reform (and indeed, the 2010 Patient Protec­ tion and Affordable Care Act, about which you will read in various sections, addressed each ofthese topics to one degree

or another). This fact is neither surprising nor undesirable:

Policy and law have long been used to effectuate positive social change. Since the founding ofthis country, the fields ofhealth care and public health have experienced this phenomenon,

and given the many serious problems playing out in these arenas right now, there is little reason to expect that policy

and law will not be two of the primary drivers ofhealth-related reform in the years ahead.

Policy and legal considerations are not only relevant in

the context of major healthcare and public health problems going forward, however-they are critical to the daily func­ tioning of the health system, and to the health and safety of individuals and communities across a range of everyday life

events. Consider pregnancy and childbirth, for example. There are approximately 11,000 births each day in this country, and society views pregnancy and childbirth as more or less nor­

mal and unremarkable events. In fact, the process ofbecom­

ing pregnant, accessing and receiving high-quality prenatal health care, and experienCing a successful delivery is crucial

not only to the physical, mental, and emotional health and well-being of individuals and families, but to the long-term economic and social health of the nation. It also implicates a dizzying number of interesting and important policy ques­ tions. Consider the following:

• Should there be a legal right to health care in the con­ text of pregnancy and, if so, should that right begin at the point of planning to get pregnant, at the moment of conception, at the point of labor, or at some other point? Regardless oflegal rights to care, how should the nation finance the cost of pregnancy care? Should individuals and families be expected to save enough money to pay out-of-pocket for what is a predictable event? Should the government help subsidize the cost of prenatal care? If so, in what way? Should care be subsidized at the same rate for everyone, or should subsidy levels be based on financial need?

• Regarding the quality of care, what is known about the type ofobstetrical care women should receive, and

how do we know they are getting that care? Given the importance of this type of care, what policy steps are taken to assure that the care is sound? What should the law’s response be when a newborn or pregnant woman

is harmed through an act ofnegligence? When should clinician errors be considered preventable and their

commission thus tied to a public policy response? And what should the response be? What should the legal and social response be to pro­ spective parents who act in ways risky to the health of a fetus? Should there be no societal response because

the prospective parents’ actions are purely a matter of

individual right? Does it depend on what the actions

are? • Is it important to track pregnancy and birth rates

through public health surveillance systems? Why or why not? Ifit is an important function, should the data tracking be made compulsory or voluntary?

, • How well does the public health system control known risks to pregnancies, both in communities and in the

workplace? Finally, who should answer these questions? The fed­ eral government? States? Individuals? Should courts

play a role in answering some or all of them and, ifso, which ones? Whose interests are implicated in each

question, and how do these stakeholders affect the policymaking process?

There are scores of topics-pregnancy and childbirth among them-that implicate a range of complex health pol­ icy questions, and these are the types of questions this text prepares you to ask and address. Before you turn your at­

tention to the essential principles, components, and issues

of health policy and law, however, you must understand something about policy and law generally, and about the or­ ganization and purposes ofthe healthcare and public health systems. The next two chapters provide a grounding in policy and law and supply the basic information needed to study policy and law in a health context. There, we define policy and law; discuss the political and legal systems; introduce the administrative agencies and functions at the heart ofthe

government’s role in health care and public health; and more. With this information at your disposal, you will be better equipped to think through some of the threshold questions common to many policy debates, including: which sector­

public, private, or not-for-profit (or some combination of

them)-should respond to the policy problem?; if govern­ ment responds, at what level-federal or state-should the problem be addressed?; what branch of government is best­

suited to address-or more attuned to-the policy issue?;

when the government takes the lead in responding to a policy concern, what is the appropriate role of the private and not­ for-profit sectors in also attacking the problem?; and what legal barriers might there be to the type of policy change being contemplated? Once you have the knowledge to be able to critically assess these types of questions, you will be able to focus more specifically on how the healthcare and public health systems operate in the United States, and on the application of policy and law to critical issues in health care and public health.

ENDNOTES a, See, e.g., Wendy E. Parmet, “Introduction: The Interdependen~y of

Law and Public Health,” in Law in Public Health Practice, eds. Richard A. Goodman et al. (Oxford, England: Oxford University Press, 2003).

b. For a non-fictional and utterly engrossing example of the ways in which law and legal process might stand in the way ofeffective public health regulation, we recommend Jonathan Harr, A Civil Action (New York, NY: Vintage Books, 1995).

c. See, e.g., Larry 0. Gostin, Jeffrey P. Kaplan, and FrankP. Grad, “The Law and the Public’s Health: The Foundations,” in Law in Public Health Practice, eds. Richard A. Goodman et al. (Oxford, England: Oxford Uni­ versity Press, 2003).

d. The particular historical framework described here was developed to apply to health care, rather than public health. We do not mean to imply, however, that it is impossible to consider public health from an historical, or evolutionary, vantage point. In fact, it is fair to say that public health practice may have just entered its third historical phase. Throughout the 1800s and most of the 1900s, protection of the public’s health occurred mainly through direct regulation of private behavior. In the latter stages of the 20th century, strict reliance on regulation gave way to an approach that combined regulation with chronic disease management and public health promotion, an approach that necessitated a more active collaboration between public health agencies and healthcarc providers and purchasers.

Now, it appears that public health professionals are adding to this revised practice model another strategic initiative: building collaborative relation­ ships with policymaking agencies whose responsibilities are not directly related to public health-for example, agencies whose primary fields are transportation or agriculture.

c. The discussion ofthese perspectives is guided by Rand E. Rosenblatt, Sylvia A. Law, and Sara Rosenbaum, Law and the American Health Care System (Westbury, CT: The Foundation Press, Inc., 1997), 24-35; and Rand E. Rosenblatt, “The Four Ages of Health Law,” Health Matrix: Journal of Law-Medicine. 2004;14:15.

f. Rand E. Rosenblatt, Sylvia A. Law, and Sara Rosenbaum, Law and the American Health Care System, 2. The authors write that the American social contract lags behind those of other developed countries, and thus use the phrase “modestly egalitarian” in describing it.

g. By 2005, proponents of weakening Medicaid-enrolled persons’ en­ titlement to program benefits had made significant strides: Congress passed a law called the Deficit Reduction Act that, among other things, granted states the ability to redefine the benefits and services to which Medicaid beneficiaries are entitled.

h. David Mechanic, Lynn B. Rogut, David C. Colby, and James R. Knick­ man, eds., Policy Challenges in Modern Health Care (New Brunswick, NY: Rutgers University Press, 2005), 10.

  1. undefined:
  2. between public health agencies and healthcarc providers and purchasers:

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