Over the past decade, a series of studies have found that physicians-in-training who work extended shifts (>16 hours) are at increased risk of experiencing motor vehicle crashes, needlestick injuries, and medical errors. In response to public concerns and a request from Congress, the Institute of Medicine (IOM) conducted an inquiry into the issue and concluded in 2009 that resident physicians should not work for more than 16 consecutive hours without sleep. They further recommended that the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission work with the Accreditation Council for Graduate Medical Education (ACGME) to ensure effective enforcement of new work hour standards.

The IOM's concerns with enforcement stem from well-documented non-compliance with the ACGME's 2003 work hour rules, and the ACGME's history of non-enforcement. In a nationwide cohort study, 84% of interns were found to violate the ACGME's 2003 standards in the year following their introduction.

It is axiomatic that tobacco smoking is hazardous to health. The statistics are well documented and often very grim. For example, the 2008 World Health Organization Report on the global tobacco epidemic presented the following statistics: a hundred million people died of tobacco-related diseases globally in the 20th century; there are approximately over five million tobacco-related deaths every year; and an estimated one billion could die of tobacco-related diseases in this 21st century.

Significantly, no other risky, self-indulgent addictive behaviors such as cocaine abuse directly endanger bystanders as much as cigarette smoking or tobacco use endangers nonsmokers through secondhand tobacco smoke or inhaled environmental tobacco smoke (ETS). Environmental tobacco smoke comprises sidestream smoke (smoke that emanates from the burning end of a tobacco product) and mainstream smoke (smoke exhaled by the smoker). About 85 percent of environmental tobacco smoke is sidestream smoke, while the remainder is mainstream smoke.

DNA profiling and databasing have become commonplace in criminal investigation and prosecution. There is a body of both state and federal legislation enabling the establishment and operation of profile databases for law enforcement purposes. Most legislation is specific as to who (or what evidence) may be profiled for inclusion in a database. The majority of state laws permit DNA profile databasing of offenders convicted of certain defined crimes, of missing persons and their relatives, and of DNA profiles from criminal-case evidence where the depositor is unknown. More recently, a few states have acted to permit databasing profiles of suspects of certain types of crimes, and there appears to be a trend toward wider adoption of this practice. The legislation adopted or proposed thus far defines whose DNA profiles can be databased, and under what circumstances. Less attention has been given to the matter of specimen retention following profiling and databasing.

The Flint water crisis demonstrates the importance of adequate legal preparedness in dealing with complicated legal arrangements and multiple statutory responsibilities. It also demonstrates the need for alternative accountability measures when public officials fail to protect the public's health and explores mechanisms for restoring community trust in governmental public health.

Health care cost considerations exert increasing influence today over clinical decision-making. One way to help contain costs while maintaining the quality of health care may be to increase among both physicians and patients an acknowledgment of, and tolerance for, a reasonahle degree of medical uncertainty. By medical uncertainty we mean here those clinical situations in which, based on available data, absolute scientific proof regarding some aspect of a patient's heallh status cannot be obtained.

To the extent that acceptance of medical uncertainty and a corresponding restraint among physicians can he encouraged without exposing the physicians to an undue risk of legal liability, all participants in the health care system would benefit from this tolerance. To help provide this encouragement. we will explore the legal implications of medical uncertainty, focusing on diagnostic testing, and argue that our legal system does now and will continue to recognize, tolerate, and perhaps even promote some medical uncertainty in the diagnostic realm.

More than 30 years have passed since the phrase informed consent was first uttered in a judicial opinion. Jay Katz's own ground-breaking work on informed consent is now more than 10 years old, and the insights of The Silent World of Doctor and Patient are so constantly fresh that it is easy to forget it too was not just recently published. While trying to develop some new thoughts about informed consent for this essay—a task made virtually impossible by Jay's work—I had reviewed an article by Professor Joseph Goldstein, one of Jay's frequent collaborators. Goldstein recounted discovering an index card he had written almost 30 years earlier (ironically for me, the year I was born) containing some notes about Harold Lasswell's work. Not only is law a seamless web, it is a timeless one.

Jay's work on informed consent is pervaded by a timeless theme that I wish to address here: how the dignity of the individual, the shining beacon of the idea of informed consent, is sorely neglected in the law of informed consent.

The subject of physician efforts to limit care by unilaterally withholding particular therapies, even if the patient, or the family of an incompetent patient, wishes continued care, plays an increasingly prominent role in discussions of clinical medical ethics. Some providers have described a professional duty to define the futility of care, and to act on the determination of futility even in the face of the patient’s, or a surrogate’s, resistance. This aggressive stance has gained intellectual momentum and may be percolating down into clinical practice.

Given the history of the medical profession's diffident attitude toward patients’ rights and its reliance on well-meaning paternalism, the notion that doctors should determine futility and limit access to specific interventions must be carefully scrutinized. Indeed, the emergence of two other themes in health policy and ethics, in particular the living will/power of attorney initiative on the one hand and the open discussion of rationing care in Oregon on the other, tends to undermine the key rationales for physician control over futile care.

The use of restraints on psychiatric patients has long been criticized, and the need for self-restraint of professionals in response to new technologies has been documented from the nineteenth century. Since the middle ages, when leprosy disappeared from civilized society, individuals with a “deranged mind” came to occupy the public space of outcast once reserved for the leper. This diminished social status conflicts with the ethical precept of respect for all patients and the need for humane treatment within the clinical care setting. Psychiatric patients may be presented as a physically dangerous presence in clinical care facilities. New technologies may seem to offer a solution to the problem of balancing the safety of staff with the ethical requirement to treat patients with respect and attention to their medical needs. The Taser, promoted as a safe method of law enforcement, has received notoriety in at least one case involving restraint of psychiatric patients.

The American health care system long has been distinctive in its embrace of market forces. For-profit private insurers play a major role in providing coverage, though they operate alongside public insurance programs that cover over one-third of the population. Historically, federal and state governments’ regulation of insurance markets was limited, leaving insurers to set premiums and coverage rules largely as they saw fit.

Government’s role in controlling health care spending has been even more circumscribed. Purchasing power is fragmented, with each insurer negotiating its own rates with physicians and hospitals. A formidable medical-industrial complex of for-profit providers, from hospitals to home-health care agencies, dialysis facilities, pharmaceutical companies and much more, has arisen to sell services.

The Canadian law governing informed consent was significantly influenced by the decision of its Supreme Court in Reibl v. Hughes, a case that involved a physician’s failure to warn the patient about the risk of stroke after carotid endarterectomy. Even though most Canadian plaintiffs after Reibl have continued to lose informed consent cases, it is likely that the judgement in this case has significantly influenced the manner in which physicians now approach the discussion of risk while obtaining consent not only in Canada but also in several other jurisdictions.

The development of informed consent law in the United States similarly became one of the drivers for change in physicians’ practices of information disclosure to their patients. The effect of Reibl on clinical practice is an outstanding example of the law’s positive influence on medical practice, especially in protecting patient autonomy during collaborative medical decision-making.

Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New England Journal of Medicine. The oversight system is based on a foundation, first implemented by the U.S. Public Health Service (PHS) in 1966 and by the U.S. Food and Drug Administration in 1971, of prior review and approval of a written experimental protocol by an independent committee. The World Medical Association articulated the ethical centrality of independent review in its 1975 revision of the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the requirement in its flagship Belmont Report.

While the importance of civil and political rights to health advocates is widely acknowledged, economic and social rights are not yet securely on advocates’ agenda. Health impact assessment is an approach that can promote an appreciation of their importance. This paper introduces health impact assessment, gives examples of how it is being used, links its development to a focus on inequalities in health status, indicates the insufficiency of civil and political rights to protect health, and shows that the use of health impact assessment draws attention to economic and social rights. While civil and political rights are an astonishing social achievement, they are not in themselves sufficient to promote health.

In discussions of health reform, the increased use of health information technology (health IT) is a common element of nearly every serious proposal on the table. Health IT includes electronic health records kept by providers, personal health records offered by health insurance plans or owned by consumers, and electronic health information exchanges. Although health reform initiatives being discussed contain little detail regarding health IT, in general they promote health IT to facilitate the electronic sharing of health information to improve individual and population health. During the 2008 presidential campaign, the health care proposals of both President Obama and Senator McCain discussed health IT. President Obama’s proposal invests $50 billion over the next five years to promote the adoption of health IT with privacy safeguards. Senator McCain’s plan also encouraged the adoption of health IT, with an emphasis on coordination.

Recent legislation, such as the Patient Self-Determination Act, establishes advance directives as an acceptable procedural means of incorporating patients’ preferences for life-sustaining treatments into their medical care. Advance directives can enhance medical decision making since they provide patients with an opportunity to communicate their preferences before suffering from an acute illness that may preclude their ability to do so.

Although patients expect discussions about life-sustaining therapies to be initiated by their physicians, very little is known about what prompts physicians to discuss advance directives with their patients. As in other areas of clinical decision making, there is evidence that patients’ sociodemographic factors influence whether discussions about advance directives occur between patients and their physicians. In one study of persons with the acquired immunodeficiency syndrome (AIDS), those who had not had discussions about advance directives with their physicians tended to be non-white, have no prior hospitalization, and were more likely to have been cared for in a health maintenance organization than in a teaching hospital.

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.

United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards (IRBs) to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses (Table 1).

It is often said that all human life, irrespective of its quality or kind, is equally valuable and that our life-and-death decisions for seriously ill or handicapped infants must not be based on the quality or kind of life in question. As the Protestant theologian Paul Ramsey has put it:

The view that all human life—irrespective of its quality or kind—has equal worth may well be the simplest answer to the difficult issues raised about the treatment of infants born seriously ill or with major handicaps; but there are two questions that need to be asked about this simple answer.