Click here for a full text transcript of the conversation.

Host Ira Flatow said in his introduction:

“Lost in the fray [of acronyms and actuarial tables] is the whole reason to have the health care debate in the first place…we’re going to try to reel it back in to talk about our values. What role do they play in shaping health care policy?”

Flatow noted that in its recent collection of essays, Connecting American Values with Health Reform, “The Hastings Center has tried to bring values back into the discussion.”

Len Nichols, health policy director at the New America Foundation, also participated in the show. Nichols, a health economist who wrote an essay on stewardship for the Hastings Center collection, said that passage of the final health care reform legislation is contingent on leadership that promotes shared values. “It is sometimes true is that those values seem to differ among political antagonists….but when you probe deeply and get in a dialogue you find out the values are actually shared,” Nichols said. “I believe most people share them and therefore we will end up with a bill that moves our country forward.”

There is a sacred realm of privacy for every man and woman where he makes his choices and decisions—a realm of his own essential rights and liberties into which the law, generally speaking, must not intrude.
—Geoffrey Fisher, Archbishop of Canterbury

This essay appears in the Hastings Center’s Connecting American Values with Health Reform Collection, available here.

Above all values, Americans prize freedom—the right of individuals to control all aspects of their lives, including the personal and the economic. In many ways, both major political parties embrace individual freedom, with Democrats stressing personal freedom and Republicans economic liberty. What is often absent in political discourse around freedom, however, is the common good and an appreciation of when rigid adherence to individualism is inimical to collective welfare.

A core American value—privacy—is closely linked to freedom and clearly illustrates the tensions between the individual good and the collective good. Privacy is a foundational individual good that respects personal dignity and protects patients from embarrassment, stigma, and discrimination. Privacy is also a collective good that has societal value because it encourages individuals to participate in socially desirable activities such as biomedical research, health care quality assurance, and public health surveillance and response. Taken too far, however, privacy can seriously harm activities necessary for the public good. Privacy relating to medical records, for example, encourages individuals to access treatment and participate in research. However, if taken too far, it can thwart valuable societal activities such as quality assurance, cost-effectiveness studies, and epidemiological research if essential data are withheld from clinicians, risk managers, and researchers.

The prevailing model of privacy, both as formulated in theory and as enshrined in national policy, is doubly harmful. This model purports to safeguard privacy but actually fails to fully protect personal health information. At the same time, it significantly undermines socially valuable activities. President Obama’s stimulus package, the American Recovery and Reinvestment Act (ARRA), authorizes $20 billion for health information technology, which is a cornerstone of the president’s health care reform proposals. Unfortunately, ARRA and accompanying health care reform proposals do little to change the current privacy paradigm and, if anything, reinforce its flaws.

Privacy and Consent

With regard to health information, the most well-accepted definition of privacy is the right of individuals to control the collection, use, and disclosure of their personal medical information. Thus, individuals retain the right to strictly limit others’ access to their personal data. Many scholars and policy-makers even assert that patients “own” everything to do with their body, including human tissue, DNA, future cell lines, and personal medical records.

The way modern laws and regulations assure these entitlements is to grant patients a right to fully informed consent. The Health Insurance Portability and Accountability Act, for example, adopts this model by giving patients the right to authorize most uses of their personally identifiable data.

Granting this right certainly makes sense when the data are to be used for purposes detrimental to the individual and society, such as discrimination in health care, employment, or insurance. However, it makes much less sense when each individual has the power to withhold information needed to achieve compelling public goods such as quality assurance, cost-effectiveness studies, medical records research, and public health investigations—even when potential harms to the individual are negligible.

I propose an entirely different conception of privacy. Privacy should be understood as an individual’s interest in avoiding embarrassing or harmful disclosures of personal information, while not significantly limiting equally valuable activities for the public’s health, safety, and welfare. This conception allows that individuals have an interest in limiting access to personal data sought by insurers, employers, commercial marketers, and family or friends. But they would have a much-reduced interest in limiting the access of those engaged in highly beneficial, well-defined activities for the public’s welfare.

This would require a fundamental shift in the way in which privacy is protected.  Instead of relying chiefly on strict individual control of data by means of informed consent, it would erect meaningful privacy and security safeguards.

The Failure of Consent

Although consent is a dominant theme in law and ethics, in practice it fails to adequately protect personal privacy and is detrimental to valuable social activities. Multiple studies have demonstrated that patients do not read or understand complex privacy notices and consent forms, which are mostly designed to shield institutions from liability. Patients are also often asked to give consent when they are sick and incapable of making complicated decisions.

This means that consent is a poorly designed tool to prevent the most common causes of privacy invasion. Most professionals who access medical records—such as health care workers, health plan administrators, and lab technicians—are already authorized to do so. At the same time, many of the most visible and worrying privacy invasions occur due to security breaches, such as when data are left on laptops or databases with inadequate security.

Relying heavily on consent rather than on strong privacy and security assurances shifts the focus from meaningful safeguards to conceptual and often toothless ones. It provides patients with few real choices and burdens the health system with a new level of bureaucracy and expense. Furthermore, the prevailing model fails to safeguard personal health information both because it leaves gaps and because it is inconsistent.

The gaps in federal regulation leave many patients without protection against privacy invasions. Consider the “HIPAA Privacy Rule,” which regulates “protected health information” held by “covered entities” such as health plans and health care providers. Personal data held by many entities that are not covered, such as pharmaceutical companies, remain unregulated. At the same time, the “Common Rule,” which regulates human subjects research, applies principally to investigations supported by the federal government. Research carried out with private funding is often unregulated. This is in sharp contrast to most other countries, in which privacy regulations are not limited to particular health care transactions or funding sources, but instead apply to all health data.

Federal regulation and oversight of privacy is also inconsistent because of the marked and confusing differences between the Privacy and Common Rules. The standards for future consent, anonymized data, and recruiting patients vary under the two rules, leading to contrary results. There is no ethically principled reason for this patchwork of regulation.

Undermining Socially Beneficial Activities

Aprimary focus on consent is also harmful to the social good. Investigators report a diminished ability to recruit participants, obstacles in accessing stored tissue and genetic datasets, and increased complexity in IRB procedures, causing some hospitals and physicians to opt out of research. A universal requirement for consent, moreover, creates selection bias, which significantly limits the generalizability of results and leads to invalid conclusions.

Rigid understandings of privacy also hamper quality assurance and public health activities. There is a lack of clarity about whether privacy and research regulations apply to these vital activities. As a result, clinics, hospitals, and public health agencies feel highly constrained when they seek access to or use personally identifiable health records.

The prevailing conceptualization of privacy as synonymous with strict individual control also defies common sense. We all have our own pet likes and dislikes, which is fine if each decision only affects the individual making it. However, allowing each person to make her own decisions in ways that disrupt the common good causes a deep social problem. Think of the consequences of granting individuals a virtual veto over each and every proposed use of their personal information for the foreseeable future. A patient might say, for example, that her information can be used for research on heart disease but not for research on AIDS or STDs. This effectively thwarts a great deal of health services research, and the same could be said for databases used for quality improvement or public health.

The perverse effects of privacy rules make life more difficult for investigators, physicians, and agency officials charged with carrying out research and public health activities. They undermine equally compelling individual and societal goods: scientific discovery, medical innovation, cost-effective health care, and methods of prevention that confront the nation’s most pressing health problems.  These are critical if health care reform is to succeed.

Policy Implications

What is urgently needed is a bold approach that would make federal regulations more effective in safeguarding privacy, more uniform and fairer in application, and less likely to impede socially beneficial activities. A new framework to the oversight of health records would emphasize data security, privacy, transparency, and accountability. Mandated security would include state-of-the-art systems with secure sign-on, encryption, and audit trails. Privacy safeguards would require that data be used only for well-defined and legitimate public purposes, with strict penalties for harmful disclosures. Security and privacy procedures would have to be transparent and actors held fully accountable. By focusing on fair informational practices, patients would gain strong privacy protection, with the assurance that their personal information would not be disclosed to their detriment and that data would be protected against security breaches.

To achieve public confidence, the new system would require careful ethical oversight focusing on measures to protect data privacy and security, harms that could result from data disclosure, and the potential public benefits. An alternative framework could also include a certification for entities that undertake large-scale data collection for defined health purposes or to link data from multiple sources for the purpose of providing more complete, anonymized datasets. Federal monitoring and enforcement would ensure regulatory compliance, and legal sanctions would prohibit unauthorized attempts to make donors of anonymized data identifiable again.

Information technology certainly will be a key component of national health care reform, but it will fail unless policy-makers safeguard privacy and facilitate responsible research, quality assurance, and public health. President Obama wants to achieve both cost-effective health care and strict privacy. But the stimulus package and his health care reform proposals do little to resolve the fundamental flaws of an antiquated model for safeguarding privacy. The success of health reform depends upon our ability to develop as rapidly and completely as possible our understanding of what works in health care, and an awareness that a false sense of privacy works against that urgent need.

Lawrence O. Gostin, JD, is the O’Neill Professor of Global Health Law, Georgetown University; professor of public health, Johns Hopkins University; fellow, Centre for Socio-Legal Studies, Oxford University; and a Hastings Center Fellow.

This is the introductory essay in the Hastings Center’s Connecting American Values with Health Reform Collection, available here.

The atmosphere was tense. Representatives of the insurance industry were huddled in one corner.  The other members of the Task Force on Genetic Information and Insurance, mostly academics and consumer representatives, were bunched across the room. As chair of the task force, I was in the middle, trying to make sense of the disagreement, which was growing more intense by the minute.

Our mandate was to provide recommendations about what health insurers should and should not do with genetic information. This was the early 1990s; there wasn’t much information available about an individual’s genes, but the avalanche of genetic information was gathering strength. The first few pebbles had arrived recently, and ever larger ones, such as the tests for genes linked to breast and ovarian cancer, would appear soon. We had time—not a lot, but some—to plan for how private health insurers would deal with information about our genetic risks for diseases, from the rare and inexorable progression of Huntington’s disease to far more common ones such as Parkinson’s, diabetes, and heart disease. Health insurers were accustomed to shaping policies according to the risks people presented. If someone with cancer was like a house afire, someone with a genetic risk of cancer was a house with a smoldering pile of rags in the corner.

The standoff in that room, though, was puzzling. We asked the insurers if they believed that everyone should have access to insurance whatever their risks: Yes, they agreed, everyone should have access to insurance. So, they were in favor of universal access, right? No, they adamantly insisted, universal access would be the death of the  industry. Finally, we understood what frightened them: to insurers, universal access meant that people could sail along without any insurance coverage until the day they became ill, when they could march into the insurer’s offices and demand to be covered.

That’s not what we had in mind, we explained. Everyone should have to pay their fair share and, when they needed care, their health insurance would be there to cover the cost. We described it as universal participation.  Fine, said the insurers, we can agree with that.

Among the lessons I learned from chairing the task force (including: Don’t fly from England to San Francisco and expect to control a contentious meeting), one stands out for this collection of provocative essays: understanding what’s at stake in a public policy debate is as vital as it can be elusive.

Connecting American Values with Health Reform is our effort to identify what is at stake amidst the swirling confusion of proposals for delivery systems, financing, cost control, and other details necessary for any practical reform. These details, though, are instruments carrying with them the impedimenta of history, habit, and interests.  To see things afresh, it helps to return to foundational questions: What do we want health reform to accomplish? What values should our institutions and practices be built upon, embody, and achieve?

The language of values has another virtue: Unlike health policy mavens, most Americans are baffled by the alphabet soup of program acronyms, economic models, and the difference between cost-benefit and cost-effectiveness analyses. Heck, most of us can’t explain the difference between Medicare and Medicaid. But we all understand what values are, and we can defend our preferences among them. Which leads to another reason The Hastings Center undertook this project.

Values can be wielded like cudgels to batter your opponents. That, unfortunately, has been all too common in recent political discourse. But values worth taking seriously — including all the values addressed in this collection of essays – are far more subtle, multifaceted, and interesting ideas that can cross political boundaries. Liberty, Bruce Jennings reminds us in an echo of Isaiah Berlin’s classic formulation, includes both freedom from and freedom to — and each of those meanings of liberty deserves attention in health reform. Liberty can mean the freedom from the imposition of a particular health plan and physicians; but it also demands a health care system that does not deny a would-be entrepreneur the freedom to pursue her vision, a freedom not available to the parent of a child with diabetes, for whom health insurance would be unaffordable outside the protective umbrella of a large group policy.

We chose the authors of these essays to represent a broad spectrum of beliefs. We assigned each of them a particular value to address, but we did not tell them what to say about it, other than to display the complexity residing within each value and spell out the policy implications of taking that value seriously for American health reform.

In reading these essays, I found moments of great illumination and insight along with occasional areas of disagreement; familiar ideas displayed in new and revealing aspects; new arguments, distinctions, and concepts. I was provoked, enlightened, and occasionally surprised. I hope that other readers will have a similar experience.

Most of all, I came away convinced that values are the beating heart of health reform, that these authors have begun a marvelous conversation about those values, and that the implications for American health reform are concrete and vitally important. A handful of ideas stand out.

First, simplistic understandings of values are deceptive and harmful to private insight and public discourse. Liberty, properly understood, is not the opposite of equality; justice, not the opposite of liberty; and responsibility, both personal and social, is crucial to the full realization of liberty and justice. Efficiency, an instrumental value rather than an end in itself, is intimately related to quality, solidarity, stewardship, and justice.  Core American values, rather than existing in ineluctable tension with one another, form a sturdy, mutually reinforcing foundation for health reform.

Second, when we acknowledge, as we must, that our goal is health, we are obliged to think much more broadly than our patchwork system of health care. Healthy children, healthy adults, and healthy communities are the outcome of many factors—from decent housing and safe areas for play and exercise to good jobs and schools.  Health care, crucial for episodes of acute illness and for the care of chronic diseases, is a significant but not dominant determinant of a community’s health. As responsible stewards of community resources, we should invest our finite public funds according to where they will do the most good. At times the best investment for health may be in education, job creation, or environmental protections, not in health care.

Third, the practice of individual underwriting in health insurance—making it harder to get the sicker you are — should be given a prompt funeral and buried with a stake through its heart. A concept such as actuarial fairness — which makes good moral sense in commercial insurance where risks are voluntary and the losses measured in money — has no place in deciding who gets access to the health care they need.

Fourth, efficiency and communal responsibility are essential if we are to have an affordable, effective, and sustainable health care system. This will require, at a minimum, systematically studying and improving the quality
and effectiveness of what we do in the name of health care. It will also require restructuring incentives so that providers are rewarded for results rather than for the numbers of procedures or tests they perform. There is good evidence that such changes would also lead to a higher quality of care.

Finally, the concept the task force developed more than fifteen years ago—universal participation—may be one whose time has finally come. The core idea is simple enough: everyone should be responsible for participating in whatever way is appropriate; when anyone needs health care that is reasonably effective and not financially ruinous, the care will be there for them. I was delighted to find the concept, if not the term, endorsed so often in these essays.

Whatever combination of private and public programs we choose, it’s a good time to connect American values with American health reform.

Thomas H. Murray is the President of the Hastings Center.