For years, people living in rural areas have struggled unsuccessfully to attract and retain primary care physicians to supply basic medical care to their residents. Rural areas continue to suffer from chronic shortages of physicians and mid-level practitioners, as well as high rates of hospital closures and increased levels of uninsurance and underinsurance, reducing both the physical and financial health of these communities. Physical and economic barriers unique to rural areas block the adequate delivery of health care and contribute to this shortage of health care personnel.

Although Congress has made some progress in identifying where health care shortages occur, it has not adequately identified the source of the shortages, and thus, it has not been able to find adequate solutions to rural health care ills. Past legislative action has involved identifying shortage areas and then providing financial incentives to attract physicians and increase the financial health of hospitals by subsidizing the difference between rural America's ability to pay and what physicians are willing to accept.

What is the value of a human face? It is a vexing question with no simple answer. The question, however, is no longer fanciful given the trajectory of biomedical science that simultaneously captures our imagination and challenges our essence. Essential to each of us and to the whole of humanity, the face is primal in its individuated image and identity. It is intrinsically connected with us in a way that defied question—until now, given the highly anticipated next step in transplant science and technology, facial transplantation. This Article examines the value of the face in this context, along with a range of related issues.

The human face has rich significance. It is intrinsic and instrumental to the ontology of a person. A portal for emotions and expressions, the face reveals an inner-self essential to identity and is inscribed with an inherent dignity of human life.

In 1977, the Supreme Judicial Court of Massachusetts held in the Saikewicz case that the probate court is the proper tribunal for making decisions whether to give or to withhold “life-prolonging treatment” for terminally ill incompetent patients. This ruling provoked debate in the medical and legal communities. Dr. Arnold Relman, Editor of The New England Journal of Medicine, argues that Saikewicz encroaches on existing sound medical practice and requires decision-making machinery that is impractical and inhumane. Relman contends that treatment decisions for terminally ill incompetents in Saikewicz-type cases should be made by the physician in consultation with the patient's family. Law professor Charles Baron, in contrast, defends Saikewicz's judicialization approach, arguing that such decisions must be made in an adversary framework that approximates the ideal of the rule of law.

In the present Article, Professor Buchanan argues that Relman's criticism of Saikewicz rests on a defective, medical paternalist view of the physician-patient relationship, and that Baron's support of Saikewicz is based on an unjustifiable, legal imperialist view of decision making for incompetents. In Buchanan's view, Relman's approach fails to distinguish appropriately between the making of medical judgments and the making of moral judgments and wrongly assumes that the patient's family typically cannot understand the elements of the decision, while Baron's approach unjustifiably extends the sphere of the legal process by ignoring the special moral relationship that usually exists between the family and its incompetent member.

Buchanan proposes an alternative decision-making approach that he believes incorporates the merits, while remedying the defects, of both Baron's and Relman's approaches. The alternative is based on three propositions. (1) The proper presumption in Saikewicz-type cases is that the family of an incompetent is to make decisions concerning treatment. (2) This presumption of the family's dominant role in decision making is defeasible: protection of the patient's rights requires that decisions be made within a framework that allows vigorous discussion and accountability through impartial review and that provides for legal intervention when necessary. (3) The institutional framework for implementing the features listed in the preceding proposition will rely heavily upon an ethics committee that is neither an all-medical prognosis committee nor an administrative agency of the hospital.

Besides evaluating and responding to the Relman and Baron approaches, Buchanan examines the contribution to the Saikewicz debate made by law-and-medicine professor George Annas. In essence, Buchanan rejects Annas's argument that, taken together, the Saikewicz opinion and the Quinlan opinion of the Supreme Court of New Jersey delineate a proper division of medical and legal decision-making responsibility concerning terminally ill incompetents. Buchanan concludes that, contrary to Annas's view, those two cases are not reconcilable.

This Article reviews recent case and statutory law concerning patients who refuse medical treatment. Among the special cases considered are: 1) the competent adult patient who refuses treatment on religious or privacy grounds; 2) the incompetent patient whose own wishes were never expressed, but whose family refuses treatment; 3) the incompetent patient who expressed the wish not to be treated before becoming incompetent; and 4) parents who refuse treatment on behalf of their child.

It is pointed out that recent court decisions have blurred the distinctions between “extradordinary” care and “ordinary” care and between withholding and withdrawing life-sustaining treatment. Reference is made to the recent trend toward allowing the family of an incompetent patient to assert the patient’s rights without court intervention either in the form of direct court order or through guardianship proceedings.

Finally, the implications of these legal developments for health care institutions are discussed. A protocol pertaining to incompetent patients is proposed. Health care institutions are encouraged to develop formal policies for dealing with patients who refuse treatment, and to work with their professional associations in lobbying for legislation which will clarify the law in this area.

This Article explores the connections between emerging infectious diseases, domestic disease panics, global health, and the law by comparing the American response to Ebola to the initial American response to the AIDS epidemic. We demonstrate that in both cases the arrival of a new deadly disease was initially met with fear, stigma and the use of law to “other” those associated with the disease. We begin by reviewing the initial responses to the AIDS epidemic. We then offer a brief history of emerging infectious disease scares over the past few decades, highlighting the problematic rhetoric that paved the way for the Ebola panic. We then review the 2014 Ebola outbreak, noting its similarities and distinctions from the early AIDS epidemic. Finally, we examine United States policies regarding HIV and Ebola in Africa. We conclude with some tentative observations about the relationship between germ panics, law, and public health.

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as ‘natural.’ This leads many consumers to fail to question the supplements' safety, and some consumers even equate ‘natural’ with safe. But, ‘natural’ does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco—a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food.

Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful.

The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.

Courts in a number of jurisdictions have recently confronted questions of legal parentage concerning children conceived by alternative insemination. Typically, the biological mother is contesting the right of either the sperm donor or a non-biological co-parent to custody or visitation. This Note surveys the current state of the law and demonstrates a lack of protection for the rights of unmarried biological mothers and their co-parents. This Note then proposes a new paradigm for establishing the parties’ rights and obligations, one that reflects the parties’ pre-insemination, mutual intent regarding parenting responsibilities and encourages legal acknowledgement of and protection for the families people are creating with the help of AI.

This article identifies twenty-six jurisdictions where nurses have been granted legal authority to prescribe drugs. The jurisdictions are divided into two groups: those where nurses have authority to prescribe without the supervision of a physician and can therefore function as substitutes for physicians; and those where nurses may prescribe only in collaboration with a supervising physician, and are thereby limited to functioning in a complementary role.

The issue of prescriptive authority is discussed within the context of regulating the practice of nursing, and more generally, the health care professions. The article reviews the history of Nurse Practice Acts, focusing upon the Connecticut statute and the economic implications of this statutory approach. It is argued that the law should promote the use of nurses as substitutes for physicians whenever appropriate.

The article concludes with a two-part proposal for reform: an “authorized prescriber” statute requiring health care professionals desiring to prescribe drugs to pass an examination testing their knowledge of pharmacology and drug therapy; and the elimination of the “unauthorized practice” provisions of the statutes regulating all health care professions. The proposal promotes economic efficiency by eliminating artificial constraints on the substitutability of labor in the provision of health services.

This Article examines the content-related liability exposure of health care providers operating in cyberspace (cybermedicine). The Article maps real space theories of liability such as professional negligence, misrepresentation and products liability to cybermedicine fact patterns.

This Article examines cybermedicine in contrast to the more widely discussed but narrower issue of telemedicine. The latter typically refers to technologies, primarily preconvergence telephony, satellite and video, used to patch geographical holes in health coverage. Thus, telemedicine is to medicine what distance learning is to education. Just as telemedicine technologies and goals have been more limited, so too have the legal issues been analyzed in a narrower regulatory or licensure issues.

Legal and ethical questions regarding existing organ transplant procurement policies and practices are numerous and unsettling. They arise because transplantable organs are scarce. The scarcity of such organs has been the hue and cry of several medical and legal scholars. For example, the scarcity creates competition among those who wait, necessitating equitable organ allocation procedures and guidelines. Medical obstacles surround the determination of when, how, and on whom such procedures can be performed successfully. Other obstacles range from finding a suitable donor for proper “matching” with the intended donee, to the time constraints involved in preserving excised organs until transplantation, to the donee's ability to fight off rejection of transplanted organs. There is also the obstacle of locating available organs. As medical technology continues to advance, the number of possible organ sources increases. Currently, these sources have included live human donors, cadavers, mechanical devices, animals, fetuses, anencephalic infants, and “brain-dead” donors.

The issue of online prescribing through the use of telemedicine raises ethical concerns. In particular, several studies suggest a correlation between telemedicine and overprescribing. Meanwhile, new developments in the law also have the potential to significantly impact online prescribing using telemedicine. In the absence of concrete federal guidance and a continued delay in issuing required federal regulations, states have developed their own laws, which vary considerably, regarding the ability of physicians to engage in online prescribing through telemedicine. As legal developments open doors for physicians to prescribe through telemedicine, current evidence of overprescribing, although limited, suggests the need to carefully balance access to health care and quality of care in this context, especially when crafting innovative legislative responses.

This article attempts to explore this dynamic issue by closely evaluating the research on overprescribing involving telemedicine and the ethical issues surrounding online prescribing. It will continue by analyzing the current legal landscape for online prescribing for telemedicine at both the federal and state levels. Next, this article will examine ethics opinions offered by medical groups that touch this issue. Finally, this article will suggest several recommendations for law and policy moving forward by shedding light on the ethical issues surrounding telemedicine and online prescribing and how to strike a balance between access and quality of care.

Developments in medicine and constitutional law dictate modification of public health legislation in the United States. Traditionally overlooked by legislators, present public health laws provide inadequate decisionmaking criteria and inappropriate procedures for dealing with issues. Revised legislation should provide health care officials and agencies with the tools to balance individual rights against public health necessities. This Article makes four recommendations for legislative reform: (1) remove artificial legislative distinction between venereal and other communicable diseases; (2) provide criteria denning “public health necessity” to limit discretionary exercise of police power by health officials; (3) provide strong confidentiality protections in the collection and storage of public health information; (4) empower public health officials to select from a graded series of less restrictive alternatives in dealing with public health problems.

Since ancient times, people have yearned to attribute human behaviors to a physical source within the head. Recently, neuroimaging technologies have given us the technical ability to look at the living brain, its structures, and some of its functions without the need for invasive procedures. However, the science has a long way to go before these technologies can allow us fully to appreciate the anatomical and physiologic underpinnings of human thoughts, states of mind, motives, will, or behaviors.

In this Article, we use an historical overview to introduce the various new technologies for imaging the brain. Today, the goal of medical science is the same as it has always been: to make medical technologies valid, useful, effective, and safe; and to guide appropriate uses while protecting the public from the misuse of them. Brain images are particularly vulnerable to misuse because they are so visually attractive. This visual power can easily result in misunderstanding about what the images show and what they mean.

Millions of people in developing countries die of diseases for which treatments exist that can relieve suffering and save, or at least prolong, people’s lives. High-profile pandemics like HIV/AIDS understandably attract considerable attention. Millions of people have died of this terrible disease - 2.6 million in 2003 and 2.8 million in 2005, of which Sub-Saharan Africa contributed 1.9 million and 2.0 million respectively. As the above quote makes clear, there are a whole host of diseases that have particularly devastating impacts on the poor.

The social movement surrounding autism in the U.S. has been rightly defined a ray of light in the history of social progress. The movement is inspired by a true understanding of neuro-diversity and is capable of bringing about desirable change in political discourse. At several points along the way, however, the legal reforms prompted by the autism movement have been grafted onto preexisting patterns of inequality in the allocation of welfare, education, and medical services. In a context most recently complicated by economic recession, autism-driven change bears the mark of political and legal fragmentation. Distributively, it yields ambivalent results that have not yet received systemic attention. This article aims to fill this analytical vacuum by offering, first, a synoptic view of the several legal transformations brought about or advocated for by the autism movement and, second, a framework for investigating their distributive consequences.

This Article discusses the rights of prisoners, pretrial detainees, and the involuntarily committed to receive high-cost medical treatments. More specifically, the Article analyzes U.S. Supreme Court and lower court case law dealing with the medical care rights of those in state custody and argues that, under a proper understanding of this case law, the financial considerations of states should play no role in determining the rights of these people to receive high-cost medical care. Finally, the Article defends the current medical care standard against various critiques.

Parts and products of the human body are increasingly important to biomedical research. Tumors removed in surgery help researchers map the molecular progression of cancer. Blood samples matched to clinical profiles suggest the role of genes and other factors in disease. Both hospital patients and visitors to the World Wide Web may be approached to provide tissues for study.

Sometimes this research results in commercial developments that produce substantial financial rewards for researchers, biotechnology companies and pharmaceutical or medical device makers. Frequently, the use of human tissue is crucial to the scientific discoveries on which those products rely. Yet, the individual sources of tissue seldom share in the ensuing profits.

The Human Genome Project (HGP) provides information about the human genome that will forever alter society and the way we view ourselves. The genetic age offers great potential, including a future where gene and germ-cell therapy may virtually eliminate genetic disease. However, genetic information may also result in a world characterized by genetic discrimination and genetic determinism. Although genetic information will be used to develop revolutionary treatments, such as gene therapy and other molecular medicine, it will also bring genetic discrimination and heretofore unrealized invasions into the privacy of our genetic codes.

Foods and beverages marketed for infants, babies, and toddlers through 3 years of age is a $7 billion industry in the United States, incorporating a wide range of products, including infant formula and other types of drinks, foods, and snacks. The World Health Organization (“WHO”) found that mothers “are often inundated with incorrect and biased information” from direct advertising, health claims on products, information packs from sales representatives, and the distribution of samples of infant formula and “educational materials” by infant formula manufacturers. To address these problematic practices, in 1981, the WHO established the International Code of Marketing of Breast-milk Substitutes (the “Code”) to end the inappropriate marketing of infant formula and other food and drinks intended for children up to age two. In 2016, WHO expanded the definition of breastmilk substitutes to include milk and milk products specifically marketed for feeding infants and young children up to age three. However, the United States is one of a minority of countries that has not passed any legislation or regulation to implement the Code. Furthermore, U.S. regulation and enforcement actions have not kept pace with the introduction of new products and product categories and the profusion of labeling and marketing claims questionably implying nutritional and developmental benefits from these products.

Writing in 1988, Arnold Relman heralded the dawning of the “third revolution“ in medical care. The first revolution, at the end of World War II, had inaugurated an Era of Expansion, with an explosion of hospitals, physicians, and research. Medicare and Medicaid were passed, and medicine experienced a golden age of growth. Inevitably, according to Relman, this yielded to an Era of Cost Containment starting in the 1970s. The federal government and private employers revolted against soaring costs, brandishing the weapons of prospective payment, managed care, and global budgeting. Yet these blunt instruments of cost-cutting eventually produced concern over how to evaluate the quality of health care, to promote the good while trimming the bad. Thus Relman announced the arrival of the Era of Assessment and Accountability.

This chronology helps explain the current importance of quality. Quality assessment and more recently, quality improvement techniques, occupy a central place in this new era.