Now in its second decade, functional magnetic resonance imaging (fMRI) localizes changes in blood oxygenation that occur in the brain when an individual performs a mental task. Physicians and scientists use fMRI not only to map sensory, motor, and cognitive functions, but also to study the neural correlates of a range of sensitive and potentially stigmatizing conditions, behaviors, and characteristics. Poised to move outside the traditional clinical and research contexts, fMRI raises a number of ethical, legal, and social issues that are being explored within a burgeoning neuroethics literature.

In this Article, I place these issues in their proper historical context. The ethical, legal, and social issues raised by advances in functional neuroimaging are challenging and somewhat distinctive, but they are not entirely new. Earlier methods of body imaging and brain mapping, including phrenology, x-ray, positron emission tomography, and single-photon emission computed tomography, raised similar issues, and perhaps we can use our experiences with these sciences and technologies to help guide current functional neuroimaging policy.

The World Health Organization’s CHOICE program analyzes the cost effectiveness of various health interventions related to the Millennium Development Goals. The program identifies the best strategies for improving health in low-income countries, using a standard set of methodological assumptions. These studies evaluate interventions in many areas, including child health and HIV/AIDS.

For some of these treatments, drug costs are a significant variable: if the drug price doubles, the intervention becomes less cost effective. But if the drug price is reduced by 90%, then more therapies become affordable.

Drug prices are uniquely susceptible to radical price reductions through generic competition. Patented pharmaceuticals may be priced at more than 30 times the marginal cost of production; the excess is the patent rent collected by the drug company while the patent and exclusive marketing periods remain. Patent rents are significant. AIDS drugs which sell for US$10,000 per person per year in the US are sold generically for less than US$200. If patented drugs could be sold at the marginal cost of production, cost effective treatments would become even more attractive, and other interventions would become affordable.

The rapid growth of medical technology gives rise to difficult dilemmas concerning the appropriateness of, and access to, new equipment and devices capable of maintaining life or improving its quality. Such a dilemma already exists, for example, with regard to kidney dialysis machines. In 1972, Congress amended the Social Security Act to make such machines available under Medicare to all who needed them. But almost immediately the overwhelming cost of such equipment—in the billions of dollars—made the original appropriations totally inadequate, and prompted serious questions of whether access to kidney dialysis should be made available at public expense—and, if so, to whom.

This Comment takes the reader 25 years into the future through the medium of a hypothetical U.S. Supreme Court decision** regarding a federal health agency's regulations that establish a system for allocating artificial hearts to those whose lives can be lengthened by implantation. The author assumes that a national health insurance system has been enacted and implemented, that all physicians are employees of the federal government, and that the enabling legislation has placed broad powers in the hands of the federal government to regulate the development and allocation of scarce and expensive medical resources. The opinions of the various Supreme Court Justices reflect a broad range of legal and ethical viewpoints, and—in keeping with the difficult, indeed frightening, life-or-death issues involved—are often intensely personal in nature.

Until recently, physicians have been the primary health care providers in the United States. In response to the rising health care costs and public demand of the past decade, allied health care providers have challenged this orthodox structure of health care delivery. Among these allied health care providers are nurse practitioners, who have attempted to expand traditional roles of the registered nurse.

This article focuses on the legal issues raised by several major obstacles to the expansion of nurse practitioner services: licensing restrictions, third party reimbursement policies, and denial of access to medical facilities and physician back-up services. The successful judicial challenges to discriminatory practices against other allied health care providers will be explored as a solution to the nurse practitioners’ dilemma.

In recent years, many states have attempted to address the cost and access problems that face their health care systems. Such efforts, however, are significantly impeded by a variety of federalism doctrines that limit the ability of states to regulate the health care market. This Article surveys some of those federalism barriers, including the constitutional restraints imposed by the Commerce Clause, the Privileges and Immunities Clause, and the Fourteenth Amendment, and the statutory hurdles created by ERISA, the Social Security Act, and the Americans with Disabilities Act of 1990. This Article concludes that the restraints that these doctrines and statutes place on states reflect not only federalism concerns, but also deeper ambivalence about governmental regulation of the health care market. Only when that ambivalence is resolved can a proper division of labor between the states and federal government be determined.

Policy debates over medical malpractice in the United States involve a complex amalgam of legal doctrine, public demands to address the problem of medical errors, and the interests of various stakeholder groups. Most parties can agree, however, that the current system for compensating medical injury performs poorly. It falls short of achieving its two main goals: compensation and deterrence. The current system of tort liability is “neither sensitive nor specific in its distribution of compensation:” the vast majority of patients injured by negligent medical care do not receive compensation, yet the system compensates some cases that do not appear to involve negligence. Sometimes, it awards more in noneconomic damages than seems reasonable to many observers. Ultimately, tort liability appears to do little to improve health care quality and safety, yet it spurs costly defensive medicine. Physicians and health care organizations face burdensome insurance and legal costs, leading some to threaten to curtail their services. These concerns about the burden of medical injury and the malpractice “crisis” have sharpened calls for reform.

Since the demise of the last major health reform initiative in 1994, health coverage for the American people has deteriorated. Private insurance costs have risen, and coverage under private insurance became less comprehensive, with higher deductibles and copayments. Many new treatments for serious diseases and associated provider compensation have become more and more unaffordable, even for those with health insurance coverage. Recent reports document the challenges for cancer patients faced with the soaring cost of cancer treatment. Public programs, such as Medicare and Medicaid, have picked up some slack and have grown in numbers. But gaps remain. Approximately 16 percent of the U.S. population is uninsured. Annual U.S. spending for health care was $2 trillion in 2005, and is estimated to reach $4 trillion by 2015.

The emerging king of the new health care order is capitation. “Whoever controls the capitated revenue stream will be poised to dominate the emerging health care delivery system— and to reap an enormous windfall that could total hundreds of billions of dollars.” Accordingly, we are witnessing a tremendous struggle over the locus of capitation. Once firmly ensconced in the insurance and HMO industry, capitation is now spreading to organizations controlled by doctors and hospitals.

In a world littered with countless acronyms and organizational types—HMO, IDS, MCO, EPO, PHO, IPA, PSN, OWA—we are most reluctant to introduce yet another. But we must. None of the existing terms describes an important aspect common to all of them that is the subject of this article—providers bearing financial risk for medical expenses. We call these Risk-Bearing Provider Groups (RBPGs). The most prominent example of an RBPG is a physician-hospital organization (PHO), which consists of at least one hospital and one physician practice group that accepts partial or full capitation for at least some of its patients. Accepting capitation risk is not essential to being a PHO, but is a common characteristic. PHOs seek to maintain the financial center of gravity in a provider organization as insurers and employers increasingly come to dominate health care delivery. PHOs can do this by contracting directly with employers on a fully or partially capitated basis, thereby by-passing insurance companies. They can also subcontract with insurance companies or HMOs—so-called “downstream” capitation. Accepting treatment obligations under financial risk helps providers maintain their professional and institutional autonomy and offers the prospect of capturing some of the financial rewards created by the market restructuring that is presently sweeping the country.

There is a great deal of misinformation surrounding the economics of pharmaceutical importation and price regulation. Among economists, the principles governing the relationships between prices, innovation, and pharmaceutical research and development (R&D) investment are incontrovertible. Unfortunately, faulty, non-economic analyses abound on these fundamental relationships, reinforcing economic illiteracy and leading to unfounded U.S. public policy.

Effective public policy debate requires that all parties to the debate be informed and aware of the potential costs and benefits associated with new policies, or changes in existing policies. This has not yet occurred for pharmaceutical importation and price regulation policy. Therefore, the purpose of this paper is to provide a positive (in contrast to a normative) economic analysis of pharmaceutical importation and price regulation.

In its amendments to the Child Abuse Prevention and Treatment Act, Congress set forth a strict standard for treatment of impaired infants. The statute, shaped by right-to-life groups and certain medical organizations, calls for aggressive treatment in virtually all cases, regardless of the degree of suffering imposed and the burdens and risks involved. The federal rule evidences deep distrust of parental decisionmaking, relegating most parents to a nonparticipatory bystander role.

Congress did not make its rule binding on the states. Rather, it conditioned the receipt of federal funds upon incorporation of the rule into each state's law. Most states have accepted the condition, largely through rulemaking by state child abuse agencies.

This article challenges the authority of state administrators to promulgate these rules, and argues that state constitutions, little mentioned in the Baby Doe debate thus far, may prohibit many states from adopting the federal standard. Ordering medical interventions that perpetuate extreme conditions of physical and mental devastation, subjecting infants to grave suffering for uncertain benefits, and depriving parents of virtually all decisionmaking power violates the norm of governments constitutionally committed to individual liberty, human dignity and family autonomy. A constitutionally sound approach to this issue would permit careful, ethical deliberation, attention to the individual circumstances of each infant Doe and a reasonable degree of parental control.

Electronic fetal monitoring (EFM) has been criticized as ineffective, unsafe and costly. Despite existing controversy regarding the risks involved in using EFM, this monitoring procedure continues to be widely employed. In many jurisdictions, in fact, the use of EFM during labor may be considered the customary practice. This Article analyzes the medical and legal issues arising from a physician's use of or failure to use EFM. The Author argues that EFM subjects the mother and the fetus to risks which may be avoided if auscultation, a less intrusive monitoring technique, is employed. The ‘customary practice’ standard of care, the ordinary negligence standard of care, and the ‘best judgment’ and ‘duty to keep abreast’ standards of care are compared and applied to the physician's decision to use EFM. The Author contends that physicians who employ auscultation may not be liable for failing to use EFM; however, physicians who use EFM despite the evidence of its risks may be liable for failing to ‘keep abreast’ or to use their ‘best judgment’ or for negligence. Finally, the Author contends that both physicians and their patients are best protected when the physician elicits the mother's informed consent to employ a particular monitoring technique during labor.

Use of “natural” and “all natural” claims on food and beverage products has increased exponentially over the last decade. Studies have consistently found that the claims influence consumer behavior—consumers seek out and are willing to pay a premium for products that make Natural claims. Not surprisingly, the Natural market has grown significantly, surpassing $40 billion in annual revenues. Despite strong consumer demand for Natural products, a majority of consumers have mistaken beliefs about the meaning of Natural claims.

Informed consent matters — so does protecting people from infectious diseases. This paper examines what the appropriate informed consent process for vaccines should look like and how the process is conceptualized by law and health authorities. Drawing on the extensive theoretical and empirical literature on informed consent and vaccination, this article sets out what an ideal informed consent process for vaccination would consist of, highlighting the need for autonomous decisions. To be autonomous, decisions need to be based on full, accessible information and reached without coercion. We suggest that the information provided must address the nature of the procedure — including benefits to the child, benefits to society, and risks. Parents should have their concerns and misconceptions addressed. The information needs to be accessible and include an opportunity to ask questions. Based on this ideal model we examined in detail the legal framework surrounding informed consent to vaccination and the process as conceptualized by health authorities in two countries, Israel and the United States, to assess whether they meet the requirements. These two countries are similar in some of their values, for example, the importance of individual autonomy, and face similar problems related to vaccine hesitancy. At the same time, there are meaningful differences in their vaccine policies and the current structures of their informed consent processes, allowing for a meaningful comparison. We found neither country met our ideal informed consent process, and suggested improvements both to the materials and to the processes used to obtain informed consent.

When the government decides to assume a major role in providing and paying for healthcare, the government also has to decide exactly what constitutes appropriate, reasonable, or essential healthcare under its program. Congress, of course, recognized this necessity when it passed the Patient Protection and Affordable Care Act (ACA), and the statute itself provides authority to the Secretary of Health and Human Services (HHS) to determine the “essential health benefits” that must be covered under the ACA beginning in 2014, both by insurers offering plans within governmentally sponsored exchanges and on the individual and smallemployer markets outside the exchanges. In a decision that was hailed as both “politically astute” and problematic for the goals that the ACA itself was supposed to accomplish, HHS shunted off the task of defining the term “essential health benefits” to the individual states.

Scholars of differing political affiliation and the President's Council on Bioethics have called for regulation of assisted reproductive technology (ART) that would emulate many aspects of the regulatory system of the United Kingdom, in particular that of the Human Fertilisation and Embryology Authority. Specifically, scholars and the Council have argued that research in the U.S. involving gametes and human embryos lacks consistent oversight. While the Centers for Disease Control and Prevention (CDC) produces an annual ART success rate report, submission of data is guaranteed only by the promise that non-responders will be noted as such in the appendix of CDC's report, and most ART clinics publish success rates on the Internet in a much more recognized forum: website advertising. Moreover, U.S. law does not require licensing or accreditation of infertility programs and few regulations govern embryo research. While the large majority of clinics report their success rate data, and many follow practice standards and apply for accreditation from private agencies, these practices are strictly voluntary. Clinics failing to report their success rates face no legal consequence.

Nursing homes perform a vital function in the long-term care continuum by providing nursing care around the clock to the elderly and disabled. By entrusting these institutions with society's frailest members, the general population relies on government agencies and their regulations to ensure that the elderly receive quality care. States expect quality care, but providers often lack the financial support and regulatory guidance.

Recently, the conflict between reimbursement and quality care received national attention. Vencor, the U.S.'s second largest nursing home chain, attempted to terminate its Medicaid contracts and evict all its Medicaid residents. Executives explained that the contract terminations and resident evictions were strategies to make room for higher paying private pay residents. Faced with state, and potentially federal, fines, as well as a district court injunction and public outrage over the patient dumping, the company quickly abandoned its policy and apologized.

The backlash against managed care, in general, and Health Maintenance Organizations (“HMOs”), in particular, is a major health policy issue. It has led to the formation of major commissions at the national and state levels, and to a great outpouring of legislative activity. The U.S. Congress has been deadlocked over various versions of a Patients’ Bill of Rights for the past two years. As a nation, we are far from resolving the many problems consumers report experiencing with their HMOs. However, to prescribe an effective solution to the problem, it is important to understand the root causes of the consumer backlash. It is, after all, possible that a Patients’ Bill of Rights will do little if it is not targeted to correct what is really bothering people about HMOs.

Epidemics are among the greatest threats to humanity, and the International Health Regulations are the world's key legal instrument for addressing this threat. Since their revision in 2005, the IHR have faced two big tests: the 2009 H1N1 influenza pandemic and the 2014 Ebola epidemic in West Africa. Both exposed major shortcomings of the IHR, and both offered profound lessons for the future.

The objective of this Article is twofold. First, we seek to compare the lessons learned from H1N1 and Ebola for reforming the IHR in order to test the hypothesis that they are similar. Second, we seek to examine the barriers to implementing these lessons and to identify strategies for overcoming those barriers.

We find that the lessons from H1N1 and Ebola are indeed similar, and that opportunities to act on lessons from H1N1 were woefully missed. We identify many political barriers to global collective action and implementation of lessons for the IHR. On that basis, we describe strategies to overcome these barriers, which will hopefully be deployed now to reform the IHR before the policy window following Ebola closes, and before the inevitable next epidemic comes. The emerging threat of the Zika virus underscores that we have no time to waste.

While science does advance steadily over time, occasionally a scientific breakthrough occurs that does not merely augment current scientific explanations and understandings, but instead radically redirects the focus of the scientific inquiry, fundamentally reconfigures our conception of our world and community, and threatens our existing social and moral conventions. We are currently experiencing such a scientific revolution, precipitated by advances in decoding our genetic makeup. While the revolution began at least by 1952 with the discovery by James Watson and Francis Crick of the structure of the DNA molecule–the molecule that contains our genetic information–the pace of the revolution has accelerated most rapidly in the last ten years. The engine for this change is the Human Genome Project.