Since the anthrax attacks of 2001 and the severe acute respiratory syndrome (SARS) outbreak of 2003, significant efforts have been made to develop and revise a range of legal tools designed to strengthen public health emergency responses. The 2009 H1N1 pandemic provided an unprecedented opportunity to implement and exercise many of these mechanisms. At the global level, the World Health Organization (WHO) declared a public health emergency of international concern (PHEIC) pursuant to the revised International Health Regulations [IHR (2005)], and many governments declared national or regional emergencies. At the U.S. federal level, the Secretary of Health and Human Services (HHS) made public health emergency and Public Readiness and Emergency Preparedness (PREP) Act declarations. In addition, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) (to allow the emergency use of certain antiviral medications, diagnostic tests, and respirators during the pandemic), and President Obama declared a National Emergency (to authorize the use of temporary waivers or modifications of certain federal requirements related to health care facility responses). Select state and local governments also declared emergencies.

As a result of health care reform, medicine has entered a new era of comparative effectiveness. The Patient Protection and Affordable Care Act (PPACA) created the nation’s first comprehensive comparative effectiveness research (CER) program, investing in CER at record levels and establishing a new regulatory framework for oversight of the research. CER attracts considerable enthusiasm as a tool for reform because it compares competing interventions to determine which works best, supplying critical information for medical decision-making and health policy. In theory, better evidence of how treatments fare relative to one another will translate to better medical care. According to some optimistic accounts, CER can lead to a “revolution” in clinical practice, has transformative power “to reshape major portions of the practice of medicine,” and represents a major “turning point” for the health care system.

On April 13, 2010, Nebraska enacted a new state ban on abortion in the Pain-Capable Unborn Child Protection Act that ha caught the attention of many on both sides of the abortion debate, and has inspired other states to attempt similar measures. The statute requires the referring or abortion-providing physician to make a “determination of the probable postfertilization age of the unborn child” (defined as, “the age of the unborn child as calculated from the fertilization of the human ovum”) and makes it illegal to induce or attempt to perform or induce an abortion upon a woman when the “probable postfertilization age” of the fetus is “twenty or more weeks” unless the doctor determines in “reasonable medical judgment (1) she has a condition which so complicates her medical condition as to necessitate the abortion of her pregnancy to avert her death or to avert serious risk of substantial and irreversible physical impairment of a major bodily function or (2) it is necessary to preserve the life of an unborn child.”

Communicable diseases, especially those that are readily contagious, are on the rise as evidenced by the emergence of viruses like severe acute respiratory syndrome (SARS), the global resurgence of resistant forms of ancient mycobacteria such as extensively drug resistant tuberculosis (XDR TB), and the 2009 swine flu outbreak in Mexico. Moreover, each of us, no matter who we are or where we live, is just as likely to transmit contagious diseases to others as we are to contract such diseases from others. As cogently described in the title of a recent book by Margaret Battin et al., we are all potential “victims and vectors.”

Just as contagious diseases are readily passed person to person, so too can they readily be passed across local and national boundaries. We therefore all have a stake in the development of effective infectious disease control policies on a national scale, with “effective” being the operative term: regulations and statutes that are neither enforceable nor likely to be complied with may do more harm than good.

Offering cash payments to research subjects is a common recruiting method, but this practice continues to be controversial because of its potential to compromise the protection of human subjects. Some critics question whether researchers should be allowed to offer money at all, citing concerns about commodification of the research subject, invalidation of study results, and increased risks to subjects. Other critics are comfortable with the idea of monetary payments but question how much researchers can pay their subjects, citing concerns about undue inducement, crowding out, and monetary exploitation. Focusing only on the amount researchers can pay their subjects, this paper argues that the federal regulations and guidelines should implement a standard payment formula. It argues for a wage payment model, and critically examines three candidates for a base wage: the nonfarm production wage, the FLSA minimum wage, and a living wage.

Physicians' duties to their patients traditionally have been construed narrowly in time and scope to focus on the specific episode of care or clinical encounter. Physicians generally have had no ethical or legal duty to notify patients about new medical information discovered after a visit, notwithstanding the health care benefits to patients that might flow from receiving the information. The rule was based on the relatively high burdens that notification would impose on physicians compared with the likelihood of benefits to patients. This established view, however, no longer may be appropriate in light of new physician-patient relationships and the reduced burden of patient notification using new types of health information technology (HIT). This article explores the duty to inform patients and former patients about relevant, medical developments subsequent to their episode of care. It concludes by recommending the recognition in ethics and law of a limited, ongoing duty to notify patients of significant information relevant to their health.

On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (ACA or the Act) into law. ACA aims to improve access to care and health outcomes through a number of mechanisms, including requiring most individuals to carry health insurance, prohibiting insurers from denying health insurance coverage based on pre-existing conditions, and creating exchanges through which individuals and families not eligible for employer- or government-sponsored health insurance may purchase coverage. While the Act is aimed primarily at improving individual health by increasing access to health insurance, it also contains a number of provisions targeted directly at improving health at the population level. Most of these provisions, which encompass a variety of disease prevention and access-to-care initiatives, are found in ACA Title IV.

Individuals can often take steps to preserve or improve their own health. They can eat appropriate quantities of healthy foods, exercise, and refrain from smoking. They can obtain preventive care and adhere to their physicians’ advice about how best to manage their health. But they often fail to take these steps.

A widespread failure to adopt healthy behaviors can significantly erode public health while increasing health care costs. Obesity, for example, increases the risk of heart disease, stroke, liver disease, and certain cancers. By one estimate, it is responsible for almost 10 percent of medical spending in the United States, or about $147 billion per year. Smoking increases the risk of heart disease, stroke, lung disease, and cancer; it accounts for nearly 20 percent of deaths each year in the United States and about $96 billion in health care expenditures.

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.”

The passing of the Patient Protection and Affordable Care Act (ACA) is a triumph for the field of public health. Its inclusion of many provisions intended to prevent illness and promote health endorses the core belief of public health as expressed by Dr. Georges Benjamin, the long-time executive director of the American Public Health Association, in a Washington Post opinion piece praising ACA for “provid[ing] care as far upstream as possible… [in order to] reduce costs by identifying problems early and then managing them to reduce or eliminate the need for more costly care in the future.” In this article, I consider the conflict between ACA’s adoption of public health goals seeing population health and societal interests in protecting individuals from discrimination based on their health. The article focuses on one aspect of ACA which seeks to lower the costs to employers who provide health insurance for their employees by making it easier for them to offer their employees substantial incentives for participating in and meeting the goals of employer-sponsored Wellness Programs.

The ethics sections of Critical Care Societies have issued position statements and proposed a variety of position papers and policies describing the appropriate use of critical care services. These policies describe the goals of critical care provision — to support a patient through an acute, potentially reversible, life-threatening illness — and provide broad guidance on physiological and hemodynamic criteria that require the specialized care of an ICU environment. In recent years, many critical care professionals have, however, reported providing care they felt was inappropriate or futile even though most felt they should not have done so. Futile care encompasses treatments that will not work or treatments that have no chance of providing any benefit. ICU teams define care as inappropriate when it fails to restore a person to an awareness of self, and an ability to interact with their environment particularly when a lot of critical care resources are required. When patients experience significant amounts of pain and suffering, such care seems even more inappropriate.

The Affordable Care Act1 (ACA) promises to improve access to coverage and care for two vulnerable groups: low-income persons who are excluded by a lack of resources and chronically ill and disabled people who are excluded by the dysfunction of our existing insurance and care delivery systems. ACA’s sprawling provisions raise a wealth of implementation challenges that are exacerbated by the compromises required to move reform through Congress. In particular, the compromise between regulatory/public program advocates and advocates for private, market-driven programs requires thoughtful regulatory coordination between public and private health systems.

The Patient Protection and Affordable Care Act (ACA) represents the most significant reform of the United States health care system in decades. ACA also substantially amplifies the federal role in health care regulation. Among other provisions, ACA expands government health care programs, imposes detailed federal standards for commercial health insurance policies, creates national requirements on employers and individuals, and enlists state administrative capacity to implement various federal reforms. In response, a persistent voice in the protracted, contentious debate surrounding ACA was, and continues to be, resistance from states. The rhetoric of federalism — states’ rights, reserved powers, state sovereignty, limited government, and local diversity — resonates deeply even around provisions of ACA that do not specifically implicate state interests. For example, the loudest and most persistent state objections target the new mandate that individuals maintain health insurance, a requirement imposed by ACA and enforced through federal tax penalties.

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services (whose regulations appear at 45CFR46), to require that investigators follow the same rules for conducting human research. (The Food and Drug Administration [FDA] has its own rules (at 21CFR50 and 21CFR56), though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter the National Commission). The National Commission was appointed in 1974 as part of the National Research Act (P.L. 93-348) in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study.

The least infringement principle has been widely endorsed by public health scholars. According to this principle, public health policies may infringe upon “general moral considerations” in order to achieve a public health goal, but if two policies provide the same public health benefit, then policymakers should choose the one that infringes least upon “general moral considerations.” General moral considerations can encompass a wide variety of goals, including fair distribution of burdens and benefits, protection of privacy and confidentiality, and respect for autonomy.

In this article, we argue that the Center for Disease Control and Prevention's (CDC) 2006 HIV screening recommendations (“Recommendations”) may violate the least infringement principle. This is a concern because, although not legally binding, the Recommendations appear to have already influenced state laws and will likely continue to do so as legislative proposals continue to be passed. At a minimum, therefore, the Recommendations have important implications for HIV screening within the United States.

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.

As genetic and genomic research has progressed since the sequencing of the human genome, scientists have continued to struggle to understand the role of genetic and socio-cultural factors in racial and ethnic health disparities. Recognition that race and ethnicity correlate imperfectly with differences in allele frequency, environmental exposures, and significant health outcomes has made framing the relationship between genetic variation, race, ethnicity, and disease one of the most heated debates of the genome era. Because racial and ethnic identities reflect a complicated mix of social and genetic factors, critics have argued that use of racial and ethnic categories as analytical variables in biomedical research lacks rigor, leads to potentially dangerous stereotyping in medical practice, and sends harmful messages of innate racial difference to the broader public.

Concerns over the current lack of diversity in human genetic and genomic studies have developed in parallel to discussions of the appropriate use of racial and ethnic categories during the research process.