In theory, a competent patient may refuse any and all treatments, even those that sustain life. The problem with this theory, confidently and frequently asserted, is that the circumstances of real patients may so confound us with their complexity as to shake our confident assumptions to their core.

For instance, it is not the case that one may always and easily know which patients are competent. Indeed, evaluation of decision-making capacity is notoriously difficult. Not only may reasonable and experienced evaluators, say a judge and a psychiatrist, disagree, but also a person's capacity may change from hour to hour and may extend to some decisions yet not to others. And yet it is on this subtle art of capacity evaluation that life and death decisions often turn, especially when patients decline life-sustaining treatment.

An evaluation of capacity may consider the impact of serious medical or psychiatric illness, as well as the patient's life circumstances.

Genetic testing poses fundamental questions for insurance. Testing can predict a low probability of future illness and disability, which can help promote the insurability of individuals with a family history of genetic risk, but it can also invite insurers to reject applicants, increase premiums, exclude people with certain illnesses and disabilities, and otherwise adjust the underwriting processes for individuals with certain genotypes. In the workplace, these issues may cause employers who offer or pay for insurance to alter their hiring behavior, either by selecting those with desirable genetic makeup or rejecting, dismissing, or reassigning those who carry an unwanted risk, ultimately threatening employability and the safety net that insurance is intended to provide.

In the foundational piece in this issue of the journal, “Integrating Law and Social Epidemiology,” Burris, Kawachi, and Sarat present a model for understanding the relationship between law and health. This article uses the case of a specific health condition, the human immunodeficiency virus (HIV) infection, as an opportunity to flesh out this schema and to test how the model “fits” the world of the HIV pandemic. In applying the model to this communicable disease, we hope to illustrate the multitude of ways that laws affect the course of the pandemic as well as the course of an individual’s vulnerability or resilience to the disease, and how the complexities of an individual’s life dealing with the virus interface with the world of laws and legal institutions.

On June 28, 1993, the United States Supreme Court ruled on the admissibility of expert scientific opinion and evidence in federal court cases. The importance of the case can be measured by the interest it stimulated. The scientific community turned out in particular force to register its views. At the heart of the controversy was a debate over the nature of scientific knowledge and its relation to law. More than any other Supreme Court case in recent memory, the amici seemed to view the Daubert case both as posing a potential challenge to basic scientific premises and as an opportunity to reclaim a lost prerogative to determine how science is applied in courts.

Three years ago, I was invited by the Hastings Center to prepare a position paper asserting that patients had the right to be protected against exposure to HIV in health care settings. Believing, rather naively I fear, that I was being asked to defend the rights of patients, I happily accepted. My paper examined such areas as the patient's right to be informed if her surgeon was HIV-infected, along with the prevailing professional duty of health care providers to protect patients from avoidable harms.

When I arrived at the debate forum, I looked up to see my friends—humane public health officials, civil libertarians, and AIDS activists—on the other side of the table. It dawned on me that the debate was not about patients’ rights at all, but about restricting the employment rights of HIV-infected health care professionals. Still, I argued at that time, and have continued to assert in the Centers for Disease Control review process, that HIV-infected health care professionals ought to refrain from the practice of seriously invasive procedures.

Professor Hall is to be congratulated on his thoughtful analysis of an issue that, as he rightly suggests, “is one of the most important issues that will confront health care tort law throughout the remainder of the century.”’ He argues that malpractice law currently can accommodate considerable latitude both for a conservative streamlining of medical practices in general and for a cost-sensitivity in individual treatment decisions. And he further argues that existing tort principles, such as the locality rule, can comfortably be stretched to embrace still greater room for economics in the medical standard of care. I quite agree.

Unfortunately, Hall's arguments do not go nearly far enough, for they are framed around a seriously oversimplified picture of the economic changes that are revolutionizing medicine in the United States. He envisions a fairly uniform, global set of resource constraints that generally pressure physicians to conserve on care—pressures that tort law can then encompass equally globally as it accepts more cost-efficient standards of care. However, neither the changing economics of medicine nor the resulting jurisprudential challenges are anywhere near this generalized.

With breathtalung speed, traditional criminal prohibitions against assisted suicide have been declared unconstitutional in twelve states, including California and New York. This poses great promise and great peril. The promise is that competent terminally ill patients, as a compassionate measure of last resort, will have the option of putting an end to their suffering by physician-assisted suicide (PAS). More sigmficant, legally permitting this controversial option may be a catalyst for doctors, health care institutions, and society to improve the care of the dying. PAS should be limited only to those relatively few competent patients who continue to suffer intolerably despite unrestrained efforts to palliate and who face a continued existence that they regard as worse than death. When dying patients know they will not be abandoned to miserable and pointless suffering if palliative care fails, they will be fortified to cope better with the process of dying.

The immediate peril is that PAS will become a quick fix, available on demand to any patient diagnosed as terminally ill, thus bypassing palliative care and producing premature deaths.

There is likely to be widespread agreement with much of the FDA’s rationale for approving BiDil (a combination of hydralazine hydrochloride and isosorbide dinitrate; H-I) as a treatment for heart failure. In particular, most would agree that the evidence of effectiveness provided by the African American Heart Failure Trial (A-HeFT) is compelling. Likewise, few health scientists would believe that it is either necessary or responsible to withhold therapies such as BiDil from those who might benefit until there is a full understanding of how they work. And although there is substantial concern that biomedical differences between racial groups are routinely misinterpreted as evidence of innate genetic differences (hence Jonathan Kahn’s call for all such claims to be supported by genetic evidence), most would concede that using race as a “descriptive” variable can help identify differences in health and access/response to treatment that might warrant further investigation or intervention.

Despite evidence that social factors can result in poor health outcomes, and the emergence of payment models that encourage the use non-medical interventions to improve health, many health care providers do not identify the social determinants of health within patient populations through routine screening. This Article explores the possible reasons for this inconsistency by considering screening practices in medical-legal partnerships (MLPs), the health care approach most concerned with identifying and treating the social determinants of health. Through an analysis of the results of a national survey and qualitative interviews with MLPs, we discovered that screening is not operationalized or consistent within many MLPs. We conclude that although health care providers may recognize the value of screening, they are not yet embracing the practice, perhaps because of an unspoken fear that fulsome screening identifies so many unmet social and legal needs that community-based resources cannot satisfy demand. This fear is unfounded. Approaches such as MLP demonstrate that social and legal needs can be efficiently treated through collaboration with other professionals, often within the health care setting. Nevertheless, providers must first operationalize screening to truly understand the scope of the need in their patient populations and collaborate to address those needs.

Several prominent cases have recently highlighted tension between the interests of individuals and those of the broader population in gaining access to health care resources. The care of Helga Wanglie, an elderly woman whose family insisted on continuing life support long after she had lapsed into a persistent vegetative state (PVS), cost approximately $750,000, the majority of which was paid by a Medi-gap policy purchased from a health maintenance organization (HMO). Similarly, Baby K was an anencephalic infant whose mother, believing that all life is precious regardless of its quality, insisted that the hospital where her daughter was born provide mechanical ventilation, including intensive care, whenever respiratory distress threatened her life. Over the hospital's objections, courts ruled that aggressive care must be provided. Much of Baby K's care was covered by her mother's HMO policy. In the 1993 case of Fox v. HealthNet, a jury awarded $89 million to the family of a woman whose HMO had refused, as experimental, coverage for autologous bone marrow transplant in treating her advanced breast cancer.

Reflecting on the tension of which he was aware between the imperial West and the still-mysterious East, Victorian writer Rudyard Kipling (1865-1936) penned the above phrase to express the incommensurable situation wherein the Westerner never understands the Asian, as the latter’s culture differs too greatly from his own. However, aware that East and West nevertheless cannot remain separated forever, the author ends the poem with an eventual encounter between the two.

Over 100 years have passed since this poem was written, yet the ambivalent encounter between East and West that it depicts still exists and is currently playing out within the field of pharmaceuticals. On one side of the divide are the many people in the industry who want to standardize global acceptance of drugs; on the other are the local authorities who want to maintain the overruling legal need not to compromise on health care at a national level. In this sense, the divergence and unity that Kipling captures is what this paper aims to discuss as it addresses how race is debated at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

This article examines the privacy and security issues associated with mobile application-mediated health research, concentrating in particular on research conducted or participated in by independent scientists, citizen scientists, and patient researchers. Building on other articles in this issue that examine state research laws and state data protection laws as possible sources of privacy and security protections for mobile research participants, this article focuses on the lack of application of federal standards to mobile application-mediated health research. As discussed in more detail below, the voluminous and diverse data collected by some independent scientists who use mobile applications to conduct health research may be at risk for unregulated privacy and security breaches, leading to dignitary, psychological, and economic harms for which participants have few legally enforceable rights or remedies under current federal law. Federal lawmakers may wish to consider enacting new legislation that would require otherwise unregulated health data holders to implement reasonable data privacy, security, and breach notification measures.

And yet:

It has long been recognized that an understanding of at least some core legal rules and concepts is an important piece of medical training. To address this, law is now typically part of the core medical school curriculum, often incorporated into bioethics and/or practice of medicine coursework — whether as part of a distinct course or series of courses or threaded through the curriculum (or both). While often this education focuses on rules, some have recommended that it also include fundamentals of legal reasoning, and go beyond knowledge to include skills, attitudes, and behaviors vis-à-vis the law.

Every September, millions of parents around the country herd their children into pediatricians’ offices with school immunization forms in hand. Their kids have already received a dozen or more shots before the age of two, and, depending on the state in which they live, a dozen more may await them over the ensuing decade. To protect public health, states require that parents have their children immunized before they are permitted to attend public or private school, but the rules vary for homeschooled children. With the spectacular growth in the number of homeschooled students, it is becoming more difficult to reach these youth to ensure that they are immunized at all. These children are frequently unvaccinated, leaving them open to infection by diseases that have been all but stamped out in the United States by immunization requirements. States should encourage parents to have their homeschooled students vaccinated by enacting the same laws that are used for public school students, enforcing current laws through neglect petitions, or requiring that children be immunized before participating in school-sponsored programs.

The laws and ethical guidelines governing decision making for incompetent patients evolved from controversies in which family members refused life-sustaining interventions. These cases led to a consensus that advance directives to limit interventions should be respected and that a surrogate designated by the patient or specified by statute could refuse interventions, even when other relatives disagreed. Surrogate decision-making statutes and ethical principles about respect for delegated autonomy promote an active role for family members or other surrogates in medical decisions for incompetent patients. Inviting surrogates to participate actively in medical decisions recognizes the importance of the patient's personal community and assures that decisions will reflect the patient's own preferences and values.

The standard approach to decisions for incompetent adults gives advance directives priority over a surrogate's substituted judgment, which in turn has priority over assessments of the patient's best interest. A patient may express advance directives by appointing a proxy, stating specific preferences, or articulating general values. We use case examples to illustrate the limitations of all three types of advance directives.

Circe directed Ulysses to fill the ears of his seamen with wax, so that they should not hear the strain [of the Sirens]; and to cause himself to be bound to the mast, and his people to he strictly enjoined, whatever be might say or do, by no means to release him till they should have passed the Sirens’ island. His men obeyed… . At the sound of the Sirens Ulysses struggled to get loose, and by cries and signs to his people begged to be released; but they, obedient to his previous orders, sprang forward and bound him still faster. They held on their course, and the music grew fainter till it ceased to be heard, when with joy, Ulysses gave his companions the signal to unseal their ears, and they relieved him from his bonds.

For decades, medicine has been dominated by a “spare-no-expense’’ philosophy that fostered an ethic of providing all care that is of any conceivable benefit, regardless of the cost. This extended financial honeymoon has now ended. Sweeping reimbursement reform is limiting payment for health care under both public programs and private insurance. As physicians respond to this emerging cost consciousness in health care by declining to perform procedures once considered necessary, will they be exposed to liability or will legal standards shift to accommodate the new constraints? This dilemma is one of the most important issues that will confront health care tort law throughout the remainder of the century.

The potential conflict between malpractice law and cost containment has received considerable scholarly attention over the past dozen years, particularly following the 1983 reform of the Medicare program and the 1986 California appellate decision in Wickline v. State of California concerning that state's Medicaid program.

Debate over the proper use of racial and ethnic categories in biomedical research has raged in recent years. With the Human Genome Project showing that human beings are overwhelmingly alike genetically, exhibiting more genetic variation within supposed “races” than between them, many have come to doubt the scientific utility of such categories. Yet federal authorities use Directive 15 from the Office of Management and Budget (OMB) to mandate the continued use of such categories in research. Moreover, researchers studying health disparities argue that data collection using racial and ethnic categories is necessary to determine whether conditions and care vary by race and ethnicity. Epidemiologists also defend the use of racial and ethnic categories to understand contributors to disease such as the stress of experiencing racial prejudice and reduced access to care because of bias.

The need for new “pull” incentives to stimulate antibiotic R&D is widely recognized. Due to the global diversity of health systems, combined with different challenges faced by antibiotics used in different types of healthcare settings, there is no one-size-fits-all solution. Instead, different “pull” incentives should be tailored to local contexts, priorities, and antibiotic types. Policymakers and industry should collaborate to identify appropriate solutions at the local, regional, and global levels.