Molecular genetic testing has increasingly been incorporated into clinical medicine, and this trend is likely to accelerate in the future. The introduction of genetic testing into medical practice is beginning to collide head on with patents that claim ownership of correlations between human genetic variants and predisposition to disease, response to therapeutic drugs, and susceptibility to pharmacologic side effects. Patent holders or licensees of genes, genetic variants, and their genotype-phenotype correlations are already using the threat of litigation to monopolize genetic tests for important well-known syndromes like Duchenne Muscular Dystrophy and inherited breast and ovarian cancer, in addition to a host of less commonly discussed conditions.

The words of Paul Simon capture the essence of what the courts are called upon to deal with when adjudicating matters of health. Wealthier and healthier neighbors living in the upstairs apartment are, all things being equal, not overly interested in raising the floor of their apartment in order to create more space for those in the apartment below. The floor is tangible, measurable and movable, and thus a subject where science can contribute much. However, where to locate the floor is a matter of values and thus largely in the realm of politics.

Resorting to the courts in matters of public policy can be seen as the residual of the inability of the remaining two branches of government, the legislature and the executive, to succeed in allocating resources and regulating the system. When the combination of science (bureaucracy) and politics (legislation) falters, enter the judiciary.

Analysis in bioethics has relied primarily on the identification and application of general principles and on the examination of particular paradigmatic cases. Principalism and casuistry depend on an assumption of generalizability; that is, that learning and insights gained from an understanding of the principles or the case may be effectively applied to other similar situations. For the most part, the particular characteristics of the institutional setting have not played a central role in these approaches. It would appear, then, that what has been learned in the context of one health care setting is transferable, with some few adjustments, to another.

The institutional context does make both a practical and a substantive difference, however, and shifting ethical analyses from one context to another has sometimes proven difficult. This has been so, for example, in the context of nursing home care.

Developing ethical standards for clinical use of large-scale genome and exome sequencing has proven challenging, in part due to the inevitability of incidental or secondary findings. Policy of the American College of Medical Genetics and Genomics (ACMG) has evolved but remains problematic. In 2013, ACMG issued policy recommending mandatory analysis of 56 extra genes whenever sequencing was ordered for any indication, in order to ascertain positive findings in pathogenic and actionable genes. Widespread objection yielded a 2014 amendment allowing patients to opt-out from analysis of the extra genes. In 2015, ACMG published the amended policy, providing that patients could opt out of the full set of extra genes, but not a subset. In 2016, ACMG enlarged the set and indicated planned expansion of the roster of extra genes to include pharmacogenetic findings. ACMG policy does not protect the respect for patient choice that prevails in other domains of clinical medicine, where informed consent allows patients to opt in to desired testing. By creating an expanding domain of genomic testing that will be routinely conducted unless patients reject the entire set of extra tests, ACMG creates an exceptional domain clinical practice that is not supported by ethics or science.

This article seeks to outline a viewpoint on the study of the legal, ethical and policy considerations raised by DNA tests and databases (from here on, DNA usages). It does not delve into the specifics involved. It outlines a way of thinking that has proven productive elsewhere1 and seems promising in dealing with DNA usages in the United States, but little more. Given that this essay is about a communitarian approach that draws on specific communitarian values, I turn next to briefly present the approach here followed.

Communitarianism is a social philosophy that maintains that society should articulate what is good, and asserts that such articulations are both necessary and legitimate. Communitarianism is often contrasted with classical liberalism, a philosophical position that holds that individuals should formulate their idea of good on their own. Communitarians examine the ways shared conceptions of the good (values) are formed, transmitted, justified, and enforced.

Employers of all types, including group practices, health maintenance organizations (HMOs), and university and other hospital practices, commonly include noncompetition clauses in physician employment contracts. The clauses only apply in the event physicians leave their employers, and typically only limit activities in relatively narrow geographic areas. Consequently, physicians often agree to the clauses without much thought or analysis. This is a mistake, as the clauses may have broad adverse ramifications for both physicians and patients.

This article identifies the standard components of noncompetition clauses, addresses the ethical and practical concerns they raise, and reviews recent court decisions on point. The article concludes that despite public policy concerns, courts can and often do enforce the clauses. The purpose of the article, therefore, is to increase physicians’ awareness of the potential impact of these clauses, and to encourage physicians to carefully consider whether to accept contracts that contain them, or at the very least to negotiate for the least restrictive terms possible.

Preventable diseases not only cause suffering and physical harm, they also impose financial costs on private individuals and public authorities. By disregarding evidence of the safety and effectiveness of vaccines and choosing not to vaccinate their children, some parents are increasing the risk of outbreaks and their attendant costs. In a very real sense, since those families are not currently required to cover the full costs of outbreaks, they are externalizing those costs onto others – individuals affected and society at large. Since non-vaccinating can directly lead to costly outbreaks, this paper argues that it is both fair and desirable to impose those costs upon those making the choice not to vaccinate. There are, in fact, strong policy reasons to support doing so regardless of whether we use an approach based on fault or a no-fault framework. Not only can the decision not to vaccinate be seen as culpable, aside from the culpability consideration, it is appropriate to compel those deciding not to vaccinate to internalize the costs in order to prevent free riding and to mitigate harms to others.

This essay describes an interdisciplinary educational experiment in health law. The experiment was funded by the National Science Foundation (NSF), received Institutional Review Board approvals, incorporated inter-disciplinary faculty and graduate students from several universities in Atlanta, and employed problem-based learning (PBL). After discussing my motivation to undertake this experimental approach to teaching health law, I explain how the course was developed and structured and how we are assessing its results. I also offer some reflections on why other health law teachers might be motivated to incorporate some features of our experimental approach into their own classes, and some thoughts on how they might do so based on lessons learned.

I undertook this experiment to test in an educational setting an approach to problem solving that I have developed for addressing certain kinds of seemingly intractable policy problems. I call this a “navigational approach” to “fractious problems.”

On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (PPACA), a major piece of health care reform legislation. This comprehensive legislation includes provisions that focus on prevention, wellness, and public health. Some, including authors in this symposium, question whether Congress considered public health, prevention, and wellness issues as mere afterthoughts in the creation of PPACA. As this article amply demonstrates, they did not.

This article documents the extent of congressional consideration on public health issues based on personal experience working on the framework for health care reform — specifically, my experience as a Fellow for a member of the Health Subcommittee of the Senate Finance Committee from 2008-2009. I also include a review of congressional activity in the United States House of Representatives. Analysis of the congressional meetings and hearings reveals that Congress had a deep understanding about the critical need to reform the U.S. public health and prevention system.

Recent reforms in state nursing home regulations have created an-array of enforcement tools that relate the severity of the penalty to the severity of the violation. These intermediate sanctions, intended to be flexible and effective in enforcing state standards, include civil fines, receiverships, public disclosure, monitors. and suspension of admissions. As supplements to the more traditional remedy of license revocation, intermediate sanctions can enforce standards without closing facilities unnecessarily, thus avoiding trauma to the residents, aggravation of the shortage of nursing home beds, and lengthy administrative proceedings and litigation.

The study of nursing home regulation by the Institute of Medicine of the National Academy of Sciences offers a unique opportunity to evaluate the implementation of intermediate sanctions by the states over the past decade. Because of the high degree of similarity among the state statutes authorizing these sanctions, comparisons can be drawn.

New coverage of the recent wars in Afghanistan and Iraq, and the ensuing public education campaigns by the Department of Veterans Affairs and private veterans advocacy groups combine to call the public's attention to the many potential mental health problems associated with traumatic event exposure. Indeed, since 2001, Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) combat and peacekeeping missions have been characterized by high levels of exposure to acts of extreme violence, with often gruesome effects. Less publically discussed is the fact that a surprisingly large number of United States civilians also report exposure to traumatic events, such as severe interpersonal violence, natural disasters, and serious automobile accidents. In fact, approximately 70% of randomly sampled respondents indicated that they have experienced an incident characterized by significant perceived life threat at some point during their lives.

Efforts to ensure greater transparency in the regulation of “drugs” (used here as a catch-all for pharmaceuticals, biologics, medical devices, and biomarker-based technologies such as genetic testing paired with a pharmaceutical or biologic) are well underway. For example, laws in the United States and Europe now require registration of most clinical trials beyond phase 1. Yet instances of avoidable harm to patients continue to arise. In response, calls for disclosure of clinical trial data in the form of “clinical study reports,” not just trial designs and basic results, are growing. In this paper, I argue that disclosure of clinical trial data is necessary but insufficient. Rather, the regulatory decisions that flow from those trial data —whether positive (i.e., product approvals) or negative (i.e., abandoned products, product refusals, and withdrawals) —should also be open to outside scrutiny provided they are final in nature.

The environment, particularly, land and water, play a powerful role in sustaining and supporting American Indian and Alaska Native communities in the United States. Not only is water essential to life and considered — by some Tribes — a sacred food in and of itself, but environmental water resources are necessary to maintain habitat for hunting and fishing. Many American Indian and Alaska Native communities incorporate locally caught traditional subsistence foods into their diets, and the loss of access to subsistence foods represents a risk factor for food security and nutrition status in indigenous populations. Negative health outcomes, including obesity, diabetes and cancer, have accompanied declines in traditional food use in indigenous communities throughout the United States.

It is often thought that there is a “crisis” or something akin to this in the field of medical malpractice in the USA and from time to time, as will be shown, there are suggestions that a similar situation could exist in the UK. This paper will examine what might be meant by the expressions “malpractice” and “crisis” in relation to the UK. It will be argued that there is no evidence to suggest that anything as dramatic as a crisis exists, and that what current concerns exist about medical malpractice and litigation are not based upon an existing or impending crisis. Further, it will suggest that evidence points to medical litigation had reached a plateau, and that, due to a number of factors, if there were a serious problem it is likely to be on the wane.

The traumatic stress experienced by our black healthcare colleagues is often overlooked. This work contextualizes workplace racism, identifies some interpersonal barriers limiting anti-racist growth, and calls for solidarity.

Various kinds of consumer-driven reforms have been attempted over the last 20 years in an effort to rein in soaring costs of health care in the United States. Most are based on a theory of moral hazard, which holds that patients will over-utilize health care services unless they pay enough for them. Although this theory is a basic premise of conventional health insurance, it has been discredited by actual experience over the years. While ineffective in containing costs, increased cost-sharing as a key element of consumer-driven health care (CDHC) leads to restricted access to care, underuse of necessary care, lower quality and worse outcomes of care. This paper summarizes the three major problems of U.S. health care urgently requiring reform and shows how cost-sharing fails to meet that goal.

This article defines the problem of the uninsured. It begins with an overview of why health insurance matters and presents a profile of the uninsured. It then discusses the roles and limits of private and public health insurance as sources of coverage for the nonelderly population. The article concludes with reflections on the current health insurance environment and prospects for reform.

The large and growing number of uninsured people is of concern because health coverage makes a difference in whether and when people get necessary medical care, where they get their care, and ultimately how healthy people are. About a quarter of uninsured adults (26 percent) say that they have postponed seeking care in the past year because of its cost, compared to about 6 percent of privately insured adults (Figure 1). In addition, more than half of uninsured adults (54 percent) have no usual source of care, compared to 1 in 10 adults (10 percent) with other types of coverage. Similarly, uninsured children are more likely to lack a usual source of care, delay care, or to have unmet medical needs than children with insurance. The uninsured are less likely to receive timely preventive and outpatient care and are more likely to be hospitalized for avoidable health problems. Improved access to care through health insurance ultimately has an impact on people’s health and lives: an estimated 22,000 excess deaths occurred among adults aged 25-64 in 2006 as a result of lack of health coverage.