Despite historic efforts to enact the Patient Protection and Affordable Care Act (PPACA) in 2010, national health reform is threatened by multiple legal challenges grounded in constitutional law. Premier among these claims is the premise that PPACA’s “individual mandate” (requiring all individuals to obtain health insurance by 2014 or face civil penalties) is constitutionally infirm. Attorneys General in Virginia and Florida (joined by 25 other states) allege that Congress’ interstate commerce powers do not authorize federal imposition of the individual mandate because Congress lacks the power to regulate commercial “inactivity.” Stated simply, Congress cannot regulate individuals who choose not to obtain health insurance because they are not engaged in a commercial venture. Several courts initially considering this argument have rejected it, but two federal district courts in Virginia and Florida have concurred, leading to numerous appeals and the near promise of United States Supreme Court review.

Providing care for a baby born at 24 weeks of gestation in a neonatal intensive care unit (NICU) is one of the most expensive medical treatments in the United States today. The cost can easily run over $300,000 for one baby. Furthermore, many extremely premature babies who survive are left with chronic diseases or disabilities that require further medical expenses and other specialized services throughout childhood or throughout life. When all these expenditures are totaled up, it can seem that neonatal intensive care is just not worth it.

Concerns about the cost-effectiveness of NICUs have led to persistent critical scrutiny of these specialized units by physicians, economists, and epidemiologists. These analysts have examined NICUs and the patients in them in order to determine whether there are subpopulations of babies for whom neonatal intensive care is so demonstrably ineffective or so costly that it should not be provided. Such examinations have been carried out in many different countries, at many times over the last 30 years, and have analyzed outcomes for babies by gestational age, birthweight, and illness severity.

Perhaps the most significant law affecting the provision of health services to the American Indian and Alaska Native (AI/AN) population is the Indian Self-Determination and Education Assistance Act of 1975 (ISDEAA, PL 93-638). This Act allows tribes to assume the management and control of health care programs from Indian Health Service (IHS) and to increase flexibility in health care program development. Under ISDEAA, tribes have the option to contract or compact with IHS to deliver health services using pre-existing IHS resources (formula-based shares tables determine funding for various IHS sites), third party reimbursements, grants, and other sources. Typically, tribes develop their own non-profit health care corporations to provide services to their community, and as a result are eligible for grants and other types of funding not available to federal agencies like IHS.

Medical records contain important clues about the history of medicine. These documents, which ostensibly describe the course of a patient's illness, are “unique constructions that allow us to observe the social and technical structure of contemporary healing.” As such, the 21st-century hospital medical record reflects the many components of inpatient care: medical interventions, billing, legal documentation, research, and education. It is comprised of a wide array of elements: professionals' notes; vital signs and other descriptive information; laboratory data and test results; demographic information; orders, charges, diagnostic and treatment codes; and other utilization data. It is well understood that many people share and need this information. Current controversies over records involve not control, but computerization, security, and accessibility. Although health professionals offer input, decisions about hospital medical records have been considered largely an administrative responsibility.

Pandemics challenge the law and often highlight its strengths or expose its limits. The novel strain of influenza A (H1N1) virus that emerged in the spring of 2009 and rapidly spread around the globe was no exception. The H1N1 pandemic prompted the first significant application of a number of international legal and policy mechanisms that have been developed in the last decade to respond to this kind of event. Furthermore, it presented a considerable test for public health systems at all levels, from global to local.

Although initial predictions forecasting high morbidity and mortality from this virus overestimated its eventual impact, the human toll of the pandemic was nevertheless significant. The World Health Organization (WHO) reported approximately 1.5 million people were infected worldwide in 214 countries, resulting in over 25,000 confirmed deaths, but the actual health impact of the outbreak was certainly much higher.

No provision of the Patient Protection and Affordable Care Act (PPACA) has proven to be more contentious than the so-called “individual mandate.” Starting in 2014, the mandate will impose a penalty on non-exempt individuals who lack health insurance. According to Congress, the mandate is essential to ensuring near universal coverage. Without it, PPACA’s insurance reforms will lead healthy individuals to delay purchasing health insurance until they require medical care, resulting in risk pools with a disproportionate share of high-risk people. The price of insurance will then climb, causing more and more not-so-sick people to forego health insurance. The resulting “death spiral” will make insurance unaffordable to many more Americans.

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.

FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation.

As is evident from the other articles in this special issue, end-of-life treatment has engendered a vigorous dialogue in the United States over the past few decades because decision making at the end of life raises broad and difficult ethical issues that touch on health professionals, patients, and their families. This concern is exacerbated by the high cost related to the end of life in the U.S. Moreover, in light of demographic patterns, progressively scarce health care resources, and an expanding array of life-saving technologies, decisions at the end of life are becoming problematic matters of public and, thus, scholarly concern in most countries. Issues at the end of life are central not only to bioethics but also raise important ancillary policy dimensions.

A major obstacle to broad support of clinical ethics consultation (CEC) is suspicion regarding the nature of the moral expertise it claims to offer. The suspicion seems to be confirmed when the field fails to make its moral expertise explicit. In this vacuum, critics suggest the following:

1. (1) Clinical ethics consultation's legitimacy depends on its ability to offer an expertise in moral matters.

2. (2) Expertise in moral matters is knowledge of a singular moral truth which applies to everyone.

3. (3) The claim that a clinical ethics consultant can offer knowledge of a singular moral truth in virtue of her professional training is absurd, false, or gravely immoral.

   Therefore,

4. (4) The field is illegitimate.

The detection and spread of pandemic 2009 H1N1 influenza in the United States led to a complex and multi-faceted response by the public health system that lasted more than a year. When the first domestic case of the virus was detected in California on April 15, 2009, and a second, unrelated case was identified more than 130 miles away in the same state on April 17, 2009, the unique combination of influenza virus genes in addition to its emergence and rapid spread at the end of the typical Northern Hemisphere influenza season suggested the potential for a high morbidity, high mortality event. In response, federal, state, and local public health officials conducted epidemiologic investigations with federal and state laboratory support to help to determine the scope of the H1N1 pandemic. On April 26, the Secretary of the U.S. Department of Health and Human Services (HHS) declared a public health emergency that was renewed through June 23, 2010. The pandemic that ensued tested virtually every aspect of U.S. public health preparedness and response systems, from laboratory capabilities and capacities to social distancing plans.

“The thing about life is that one day you’ll be dead.” Indeed. But even total and honest acceptance of this brute fact about our relationship to death does not diminish the value we see in short remaining life at the end of life. Few just “give in” and no more fight for life because death is seen as an inherent part of life. They still invest small amounts of additional life with huge value. How high may that value plausibly be? What is the value of a relatively short extension of life when death is inevitably near?

Post-industrial societies confront common problems in pharmaceutical industry-physician relations. In order to promote sales, drug firms create financial relationships that influence physicians' prescriptions and sometimes even reward physicians for prescribing drugs. Three main types exist: (1) kickbacks, (2) gifts, and (3) financial support for professional activities. The prevalence of these practices has evolved over time in response to changes in professional codes, law, and markets. There are certainly differences among these types of ties, but all of them can compromise physicians' independent judgment and rational prescribing.

Drug firms have paid kickbacks for prescribing drugs, purchasing drugs, switching brands prescribed, adding a drug to a hospital formulary, enrolling patients in post-marketing clinical trials, and writing practice guidelines that encourage the use of certain drugs.

Since the first phase of the formal effort to sequence the human genome, geneticists, social scientists and other scholars of race and ethnicity have warned that new genetic technologies and knowledge could have negative social effects, from biologizing racial and ethnic categories to the emergence of dangerous forms of genetic discrimination. Early on in the Human Genome Project (HGP), population geneticists like Luigi Luca Cavalli-Sforza enthusiastically advocated for the collection of DNA samples from global indigenous populations in order to track the history of human ancestry, migration, and languages, while social scientists like Troy Duster insisted that the new genetics was in danger of ushering in insidious practices of eugenics. The Human Genome Diversity Project's 1991 proposal to archive human genetic variation around the world quickly came under intense scrutiny by indigenous peoples and advocacy groups who worried that such measures could exploit indigenous groups as research populations and even resurrect racist taxonomies from the nineteenth century.

The Patient Protection and Affordable Care Act of 2010 (PPACA) purportedly assures almost all Americans of the right to health insurance coverage. The long-term success of this legislation in improving the public’s health in the United States will likely hinge in no small part on the degree to which statutorily establishing a right to health insurance coverage translates into actual timely, meaningful access to health services, particularly physician services, for specific individuals.

The public safety, human services, health, and relief workers who comprise the first wave of a response to natural or man-made disasters play a critical role in emergency preparedness. These first responders provide care and services in the immediate aftermath of emergencies and may remain in affected communities for weeks or months. They often work long hours under stressful conditions, witnessing the human harms, physical destruction, and psychological devastation that can accompany disasters.

In a paper that has recently attracted discussion, David Shaw has attempted to criticize the distinction the law has drawn between withdrawing and withholding life-sustaining measures on the one hand, and euthanasia on the other, by claiming that the body of a terminally ill patient should be seen as akin to life support. Shaw compares two cases that we might, at least at first, regard as distinct, and argues that they are not. In the first case, Adam, who is dying of lung cancer, is connected to a ventilator and requests to be disconnected. In the second case, Brian, also dying of cancer, is not connected to anything, and so he requests his doctor to provide him with a lethal injection. In the first case, Shaw contends, Adam is being kept alive by a ventilator. In the second case, Brian is being kept alive by his body.

The hospice movement in the United States is approximately 40 years old. During these past four decades, the concept of holistic, multidisciplinary care for patients (and their families) who are suffering from a terminal illness has evolved from a modest, grassroots constellation of primarily volunteer-run and community-governed endeavors to a multimillion dollar industry where the surviving nonprofits compete with for-profit providers, often publicly traded, managed by M.B.A.-trained executives, and governed by corporate boards. The relatively recent emergence of for-profit hospice reflects an increasing commercialization of health care in the United States, the potentially adverse impact of which has been well documented.

The unsustainable growth in U.S. health care costs is in large part attributable to the rising costs of pharmaceuticals and medical devices and to unnecessary medical procedures. This fact has led health reform advocates and policymakers to place considerable hope in the idea that increased government support for research on the comparative effectiveness of medical treatments will eventually help to reduce health care expenses by informing patients, health care providers, and payers about which treatments for common conditions are effective and which are not. Comparative effectiveness research (CER) has shown in some cases that expensive but commonly used treatments are significantly less effective than relatively inexpensive alternatives. Critics warn, however, that CER will homogenize patient care, limit patient choices, and lead to improper health care rationing and even to the denial of lifesaving treatments.