As the public profile of bioethics rises, and as litigation about issues ranging from assisted reproduction to gene therapy multiplies, the presence of bioethics experts in a litigation context has become more common. Dozens of appellate opinions refer to bioethics testimony in the lower courts. Today's technical advisory services for attorneys advertise bioethics experts along with experts in scientific fields. A single bioethicist has served as an expert in more than fifty cases. In all likelihood, opportunities for bioethicists to fill the role of testifying expert will grow as medicine and biotechnology become more complex. Bioethics experts have also been involved in several other kinds of litigation-related activities, including investigation, consultation with attorneys, preparing reports that express expert opinions, and explaining and defending these opinions by deposition.

Despite the growth of these activities by bioethicists, they have never been free of controversy, have recently been received with little enthusiasm by the judiciary, and could become highly problematic in the future.

Effective November 1, 2002, the federal Department of Health and Human Services (DHHS) reclassified developing fetuses as “unborn children,” thereby providing health insurance benefits for prenatal care under the State Children's Health Insurance Program (SCHIP). By broadening the current definition of “child” —and thus expanding SCHIP insurance coverage — DHHS hopes to increase the number of low-income pregnant women who receive prenatal services. As noted by one commentator, the new rule represents the first time “any federal policy has defined childhood as beginning at conception.”

In an attempt to improve access to publicly funded health insurance for poor children not covered by Medicaid, Congress established SCHIP a 10-year, $40 billion program jointly funded by federal and state governments. Through a series of block grants, SCHIP allows states to either expand income-eligibility for their existing Medicaid program or to create a separate child health program to decrease the number of uninsured poor and near-poor children.

This paper is the companion to “Assessment of Information on Public Health Law Best Practices for Obesity Prevention and Control,” and the fourth of four action papers produced as part of the National Summit on Legal Preparedness for Obesity Prevention and Control, convened June 2008 by the Centers for Disease Control and Prevention, the Robert Wood Johnson Foundation, and the American Society for Law, Medicine Ethics. The four action papers present options to address gaps in the four core elements of public health legal preparedness as outlined in the relevant companion papers. The four core elements are: (1) laws and legal authorities; (2) legal competencies for public health professionals to apply those laws and authorities; (3) coordination of law-based efforts across jurisdictions and sectors, and (4) information on public health law best practices.

Not so very long ago - in historical terms - the politics of Medicare were thought to be stable and well-established. Medicare’s 1965 enactment culminated an epochal political battle that spanned fifteen years and involved mass mobilization, millions of dollars in lobbying expenditures (including the development of such techniques as “grass-roots lobbying” and targeted direct mail), and bitter partisan controversy. By the late 1980s those seemed to be distant birthing pains long since overshadowed by the program’s robust health and popularity. Medicare politics had devolved into a model of pluralist “normalcy” in which a relatively specialized and autonomous group of subject-matter experts in the federal bureaucracy, the Congress, and affected interest groups largely made policy by negotiating among themselves, primarily on issues of provider reimbursement. Even the extraordinary events involving the 1988 enactment of the “Medicare Catastrophic Coverage Act” legislation (which, among other things, established good coverage for prescription drugs), and the ensuing public firestorm that led to its partial repeal in 1989, could be seen as an aberrational deviation from a more placid pattern.

Health reform proposals tend to be rich with details and dimensions. The primary goal of health reform is typically to extend health coverage to people who lack it. Yet even the most similar of plans differ in terms of exactly who is targeted for assistance, the means by which assistance is delivered, and the type of health coverage promoted. Moreover, the Byzantine nature of the existing U.S. health system means that any reform plan can appear complex. The plan that aims for a new, simple health system will require radical changes to achieve it, while the plan that strives to be the least disruptive will have extensive rules that target assistance while maintaining the existing sources of coverage. Indeed, some have argued that the complexity inherent in meaningful reform is an impediment to reform itself.

Public health legal preparedness begins with effective legal authorities, and law provides a key foundation for public health practice in the United States. Laws not only create public health agencies and fund them, but also authorize and impose duties upon government to protect the public's health while preserving individual liberties. As a result, law is an essential tool in public health practice and is one element of public health infrastructure, as it defines the systems and relationships within which public health practitioners operate.

For purposes of this paper, law can be defined as a rule of conduct derived from federal or state constitutions, statutes, local laws, judicial opinions, administrative rules and regulations, international codes, or other pronouncements by entities authorized to prescribe conduct in a legally binding manner. Public health legal preparedness, a subset of public health preparedness, is defined as attainment of legal benchmarks within a public health system.

“Strict gun control”(SCG) has no clear meaning,so it is necessary to clarify it.I define SGC as an array of legally sanctioned restrictions designed to impose firearm scarcity on the general population. SGC’s public policy goal, gun scarcity, commonly rests on the predicates that “dangerous criminal control” is not the central problem for reducing the problem of criminal gun violence but rather that it is the social prevalence of the distinctively-lethal instruments (guns) by which both supposedly “good citizens” as well as violent criminals inflict a staggeringly high percentage of injury and death.

Professor Zimring (who also has an essay published in this issue) is one SGC’s most distinguished, prolific and comprehensive theorists. He has advocated for handgun scarcity among the general population since at least 1969.

The Trump Administration has exposed both the durability and vulnerability of the Patient Protection and Affordable Care Act's insurance reforms. One of the Administration's first strikes at “Obamacare” was to discontinue federal government payment of cost-sharing reductions, which insurers pay to low-income enrollees on the exchanges to reduce their out-of-pocket share of medical spending. The states struck back with a clever solution that could hold insurers and enrollees harmless. This article examines this strategy and why, while impressive, it reaffirms larger problems with the ACA's market-based approach to health reform and the need for new pathways forward.

The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally. Each area of research on human subjects has been the subject of a vast academic literature and extensive public policy debate, from issues of informed consent to that of regulatory structures. Professor Bernard Dickens has provided an outstanding contribution to this debate internationally through his many innovative and incisive papers in this area. This paper provides an English lawyer’s perspective upon the increasing regulation of clinical research practices and asks – does regulation equate with effective rights protection? From Nuremberg onwards, there has been concern to ensure that research practices are ethical and in accordance with legal principles. So, for example, there have been statements such as the Declaration of Helsinki, which was initially produced in 1964. In the European context in particular, notably influential statements have been the European Convention on Human Rights, which has been followed by the Council of Europe Convention on Human Rights and Biomedicine and, more recently, a Draft Additional Protocol on medical research.

This article aims to show how the changes to NEPA by the Trump Administration are an act of environmental racism, defined as “[i]ntentional or unintentional racial discrimination in environmental policy‐making, enforcement of regulations and laws, and targeting of communities for the disposal of toxic waste and siting of polluting industries.”

This article highlights and evaluates the role of CEPI and its contribution to global equitable access to COVID-19 vaccines through its established partnerships for vaccine development. The article adds to the understanding of how and when such partnerships can work for public health, especially under emergency citations.

Climate change exacts a devastating toll on health that is rarely incorporated into the economic calculus of climate action. By aligning health and environmental policy and collaborating across borders, governments and industries can develop powerful initiatives to promote both environmental and human health.

Prior to the recent introduction of generic TDF/FTC in the U.S., access to pre-exposure prophylaxis (PrEP) for HIV was greatly limited due to the downstream effects of the high cost of the medication. This article argues that despite drug copay cards and patient assistance programs, the promise of drastically reduced HIV diagnoses has never been fully realized, and more policy reforms on drug pricing are needed to make ending the HIV epidemic a reality.

In December 1998, the Office of Inspector General (OIG) and the Health Care Financing Administration (HCFA) solicited comments from health care providers regarding the federal anti-patient dumping statute, the Emergency Medical Treatment and Active Labor Act (EMTALA) (42 USCA §1395dd). EMTALA is a federal health care law of unprecedented breadth—the first universal benefit guaranteed by the federal government. It requires Medicare-participating hospitals with public emergency rooms, emergency physicians, and ancillary surgical and medical specialists to render adequate stabilizing treatment to whoever requests it. The 1998 Special Advisory Bulletin (63 FR 67486-01) sought input on four principal dimensions of EMTALA: (1) the statutory obligation to furnish adequate medical screening to anyone who visits an emergency room; (2) the responsibilities of health care providers towards enrollees of managed care organizations (MCOs); (3) the prior authorization and payment rules for Medicare and Medicaid; and (4) what practices would promote hospital compliance with EMTALA.

The risk of tort liability for health maintenance organizations (HMOs) and other managed care plans has dramatically increased in recent years. This is due in part to the growing percentage of health care rendered through managed care plans. The cost-containment mechanisms commonly used by managed care plans, such as limiting access to services and/or choice of providers, creates a climate ripe for disputes that may end up in court. As dissatisfied patients and providers seek recourse in the courts, tort doctrines are extended and new legal theories emerge as needed. For example, the concepts of direct and vicarious tort liability developed in the hospital context have been extended by courts to encompass HMOs. vicarious liability claims, based on ostensible agency or respondeat superior doctrines, have been brought against HMOs and managed care plans for negligent treatment by physicians selected to provide care to members.

Although data sharing platforms host diverse data types the features of these platforms are well-suited to facilitating biomarker research. Given the current state of biomarker discovery, an innovative paradigm to accelerate biomarker discovery is to utilize platforms such as Vivli to leverage researchers' abilities to integrate certain classes of biomarkers.