Pay-for-performance (P4P) represents an effort to improve the quality of health care by paying physicians more if they meet specified target measures. There are both empirical and theoretical reasons to be deeply suspicious of P4P schemes applied at the level of the individual physician or health provider. Most P4P programs were implemented before there were any good data to demonstrate that they achieved the desired results. Once such schemes were in use, the available data are far from reassuring. Common findings are that providers may do more of the specific procedure that is being measured, but in the process may neglect to do other things that equally affect quality of care. Payers often find that the cost of implementing a P4P program far exceeds the value of the very modest resulting improvements; and payments may unfairly benefit providers who are already meeting quality targets while disadvantaging those who make the most strenuous efforts to improve.

Suppose that someone has a serious illness. The illness will likely lead to significant disabilities, and may even cause death. Existing treatments are unsatisfactory. The patient learns about a clinical trial, in which some allegedly promising new treatment for that illness is being tested.

Such seriously ill patients for whom existing treatments are unsatisfactory have sometimes been categorized as medically vulnerable in the literature. Should these patients indeed be considered vulnerable subjects and be provided with special protections? And if the answer is yes, then what are those special protections? This article explores the possible answers to these questions.

The federal regulations for the protection of research subjects have several provisions addressing the concept of vulnerability. The three subparts Subparts B (pregnant women, fetuses, and neonates), C (prisoners), and D (children) deal with specific categories of vulnerable subjects, but do relatively little to address broader issues relating to vulnerability that might apply to a category such as the medically vulnerable. The Common Rule (Subpart A) is the only section containing general discussions of vulnerability.

This article introduces and defines the Health in All Policies (HiAP) concept and examines existing state legislation, with a focus on California. The article starts with an overview of HiAP and then analyzes the status of HiAP legislation, specifically addressing variations across states. Finally, the article describes California's HiAP approach and discusses how communities can apply a HiAP framework not only to improve health outcomes and advance health equity, but also to counteract existing laws and policies that contribute to health inequities.

United States public health experts have long expressed concern about the prevalence of the human immunodeficiency virus (HIV) among injection drug users (IDUs). The United States has the largest reported IDU population in the world: 1.1 to 1.5 million. Recent estimates from the Centers for Disease Control and Prevention (CDC) suggest that 50 percent of incident HIV infections occur among IDUs, with additional infections occurring among their sex partners and offspring. More than 33 percent of new AIDS cases occur in IDUs, their sexual partners, and their children. Almost one half of all women diagnosed with AIDS in the United States are IDUS. Many of the remaining infected women were infected as a result of sex with a male IDU.

While public health agencies, legislators, community leaders, and religious groups have engaged in vigorous debate over the merits of needle exchange programs (NEPs) as an intervention to reduce HIV transmission, the programs, some legal and some illegal, have been implemented in fifty-five cities across the country.

It is doubtful that any feature of the American health care system in the last several decades has had as profound an effect on the way Americans pursue their perceived health needs as complementary and alternative medicine (CAM). Almost half of all Americans take care of some of their health care needs outside of contemporary scientific medicine. The number of visits to CAM practitioners was estimated 6 years ago to be 629 million a year, with expenditures of $27 billion a year. The use of CAM has been expanding rapidly despite little objective evidence of its safety or effectiveness. Little more than a decade ago CAM was viewed by the traditional medical community as a nuisance that offered unproven treatments at best and as outright quackery at worst. In any case, alternative medicine, as it was known at that time, seemed unworthy of serious attention.

In the development of a rights-based approach to global health governance, international organizations have looked to human rights under international law as a basis for public health. Operationalizing human rights law through global health policy, the World Health Organization (WHO) has faced obstacles in efforts to mainstream human rights across the WHO Secretariat. Without centralized human rights leadership in an increasingly fragmented global health policy landscape, regional health offices have sought to advance human rights in health governance and support states in realizing a rights-based approach to health. Examining the efforts of the Pan American Health Organization (PAHO), this article explores the evolution of human rights in PAHO policy, assesses the mainstreaming of human rights in the Pan American Sanitary Bureau (Bureau or PASB), and analyzes the future of the rights-based approach through regional health governance.

The contributions of Professor Bernard Dickens to health law and bioethics span the era in which these fields have emerged as distinct domains of teaching, scholarship and professional and public conversation. Neither field exists in a vacuum. The concerns of bioethics, like the content of health law, are a product of social forces. The bureaucratization of medical care, the possibilities and uncertainties created by developments in medical technology, not to mention glaring health inequalities, have been destabilizing forces in medicine. Writing in 1974, American sociologist Renée Fox noted that medicine had reached “a stage of development characterized by diffuse ethical and existential self-consciousness.” This new medical introspection was evidenced by intense engagement with issues of biomedical regulation, and with the growth of professional codes and processes for resolving value-laden issues within clinical settings.

While sometimes described as a process or site for discussion and “engagement,” bioethics evolved rapidly into a domain of governance, with direct implications for clinical practice.

The regulation of narcotic medications used in narcotic addiction treatment is unique in medical therapeutics. Physicians who want to use narcotics for this indication must obtain a separate annual registration from the Drug Enforcement Administration (DEA). Annual registration is contingent on compliance with both the DEA's security regulations (inventory, record-keeping, and physical security) as well as treatment regulations jointly promulgated by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA).

During the last decade, a number of events have occurred that persuaded NIDA that it is time to reevaluate the current method by which the Department of Health and Human Services (HHS) regulates methadone treatment. As a result of research during the past twenty years, we have learned about the effective components of methadone treatment. In comparison to other available treatment modalities for opioid addiction, methadone treatment is uniquely effective when administered by well-trained medical staffs.

As a worldwide economic crisis emerged at the end of 2008, international health agencies were quick to highlight its predictable impact on health in the poorest of communities. The World Health Organization (WHO) underscored the need for a multisectoral approach to the crisis, “seeking health gains through demonstrating the importance of health in all policies” and whether current investments in health addressed the broader social determinants of health. However, despite good intentions and decades of discussion addressing the need for transformative changes globally to reduce poverty and improve health equity, little progress has been made.

A recent report on progress towards the Millennium Development Goals (MDGs) indicates that many targeted goals have not been met, with some goals lagging many years behind schedule (“Four years after the target date, gender parity in education has yet to be achieved”). Although progress towards achieving the MDGs has been made for some specific conditions (e.g., malaria), where targeted interventions have had an immediate impact, limited progress is reported in more complex areas such as maternal child health. Such complex health issues require structural changes, strong political will, long-term funding, and consideration of other health determinants, such as education and exposure to environmental hazards.

A generation ago, we adopted a national system for the protection of human subjects in research. Today, that system is facing new challenges. Many argue that the system has failed to evolve in concert with dramatic changes in the research environment. Accordingly, efforts are underway to reform the existing process to make it both more efficient and more effective. At the same time, many are also reexamining the system in more fundamental ways — going well beyond considerations of policies and compliance and raising questions that go to the very foundations of what constitutes an ethical conduct of human research.

Experimentation involving human subjects is a necessary step in the process of translating scientific discovery and technological advancement into procedures and products that offer the prospect of better lives for all of us. It helps us to better understand why we do the things we do and believe what we believe.

Evaluating the risks and anticipated benefits of medical, behavioral and, social research is a central function of institutional review boards (IRBs). The calculation that IRBs undertake ultimately determines whether a particular research project involving human participants is permitted to proceed. In medical research the physical harms and even the anticipated benefits of a new procedure or drug are often apparent and quantifiable. In contrast, for social/behavioral research that may involve probing the most intimate feelings, thoughts, and actions of participants, the weighing of risks and anticipated benefits, the calculation of possible harms and the acceptability of that harm require a more intense level of scrutiny.

Even the early step of identifying and recruiting participants for a research endeavor may potentially cause harm, making participant selection a focus of IRB analysis.

American health policy today faces dual problems of too little coverage at too high a cost. The mix of private and public financing leaves about one seventh of the population without any insurance coverage. At the same time, the coverage Americans do have costs an ever-larger share of our country’s productive capacity. The U.S. pays well above what other countries pay and what many people, health plans, businesses, and governments want to pay. This “paradox of excess and deprivation” results from the incremental approach the U.S. has taken to promoting incompatible policy goals of increasing health insurance coverage and medical quality while trying to control costs, without squarely confronting tradeoffs. This essay examines the record of incremental developments and draws lessons for current efforts at reform.

Health information technology (HIT) is becoming increasingly prevalent in medical offices and facilities. Like President George W. Bush before him, President Obama announced a plan to computerize all Americans’ medical records by 2014. Computerization is certain to transform American health care, but to ensure that its benefits outweigh its risks, the federal government must provide appropriate oversight.

President Obama’s stimulus legislation, the American Recovery and Reinvestment Act of 2009 (ARRA), dedicated $27 billion to the promotion of health information technology. It provides payments of up to $44,000 per clinician under the Medicare incentive program and $63,750 per clinician under the Medicaid program.

Anti-selection occurs when information asymmetry exists between insurers and applicants. When an applicant knows they are at high risk of loss, but the insurer does not, the applicant may try to use this knowledge differential to secure insurance at a lower premium that does not match risk.

This article discusses (1) the ways in which law functions as a determinant of health, (2) historical collaborations between the health and legal professions, (3) the benefits of creating medical-public health-legal collaborations, and (4) how viewing law through a collaborative, population health lens can lead to health equity.

It has been seven years since the last major medical malpractice crisis, when the cost of liability insurance rose so astronomically that several important insurers withdrew from providing insurance coverage to physicians and health care institutions. Government and private policy groups at that time established committees to evaluate the medical malpractice crisis and to recommend changes that would bring about an amelioration of the adverse financial and health care features surrounding medical malpractice. The United States Department of Health, Education and Welfare published its Report of the Secretary's Commission on Medical Malpractice in 1973, documenting the extent of the crisis and recommending that alterations be made in the existing tort law to alleviate some of the financial burdens brought on by the increasing number of cases. In 1977, the Institute of Medicine of the National Academy of Sciences formed a Steering Committee on Medical injury Compensation that reviewed some of the special problems of the medical malpractice system and published its report.

How did surrogate motherhood evolve from a hare-brained, fly by night idea of the late 1970s into one that had at least some mainstream, middle-class support in the mid-1980s? Many explanations have been suggested. Although the rate of infertility has not increased, infertility is no longer a secret, and there are major public support groups, like RESOLVE, that advocate for infertile couples. New and powerful techniques like IVF (in vitro fertilization) have been developed, and although they help very few people, they have been widely publicized and approved. And babies are fashionable again. As one movie critic put it: Men and women do not fall in love with each other in the movies anymore. They fall in love with babies. Babies are the new lovers—unpredictable, uncontrollable, impossible and irresistible.

These explanations all have some merit. But the core of surrogate motherhood lies in the modern fairy tale that babies can properly be viewed as a consumer product for those with money to purchase them, and that by permitting this transaction we will all live happily ever after. As a product babies have been hyped by slick, white, middle-class professionals and advertised in the free-market environment of the 1980s. We are asked not to look behind the resulting children to see their lower-middle-class and lower-class mothers.

A large part of the everyday practice of medicine consists of prescribing drugs for the purpose of curing or alleviating patient ills. In most cases, a drug must be approved for specific uses by the federal government before it becomes available to be prescribed by a physician. However, once a drug has received regulatory approval for a specific medical use, the physician may prescribe it for any purpose, approved or not. The prescribing of drugs for nonapproved uses is a common medical practice. This article discusses the informed consent implications raised by this practice, and argues that the physician should disclose to the patient the legal status of a drug prior to prescribing it for a purpose which has not been governmentally approved.

Relying upon the Constitution's Commerce Clause, Congress has vested jurisdiction over all “drugs” involved in “interstate commerce” in the federal Food and Drug Administration (FDA), a division of the Public Health Service (PHS) of the Department of Health and Human Services (DHHS).

H5N1 avian influenza has reportedly claimed the lives of 186 persons worldwide, 77 of whom resided in Indonesia. On February 7, 2007, the government of Indonesia announced that it would withhold strains of H5N1 avian influenza virus from the World Health Organization (WHO). On the same day, Indonesia signed a memorandum of agreement with Baxter Healthcare, a United States-based company, to purchase samples and presumably ensure access to subsequent vaccines at a discount.