Just over a year has elapsed since the decision of the Supreme Court of the United States in Cruzan. In the year prior to and since the decision there have been a substantial number of articles in the medical literature that have discussed the possible impacts of the decision on medical care along with suggestions as to how to avoid the more onerous consequences. These analyses are constrained by the lack of any direct measurements, an activity that is itself complicated by other events such as the publicity surrounding episodes of assisted suicide and so-called mercy killing. In this paper we will limit our focus to how the decision in Cruzan is likely to affect the doctor-patient relationship, especially in the critical activities surrounding decision-making about the use of life sustaining treatments.

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.

When a disaster occurs, adults over age 65 may be disproportionately impacted due to sensory deficits, chronic health conditions, diminished social support and isolation, and financial limitations. Although older adults comprised approximately 15 percent of the New Orleans population, they accounted for over 70 percent of the fatalities associated with Hurricane Katrina in 2005. Disasters can also impact older adults’ morbidity, as a disaster may disrupt established habits and routines (e.g., timing of medication administration) and result in removal from a familiar environment, promoting disorientation. This may raise particular challenges for older adults with mental and physical co-morbidities, and subsequently for their formal and informal caregivers.

While some older adults may need care for physical health problems following a disaster, mental health needs are often overlooked or unmet. One study of Hurricane Katrina survivors found that, compared to older adults, middle-aged individuals were twice as likely to have received mental health services in the eight months after the hurricane.

Since AIDS was first identified in 1981, its rate of spread among a primarily young and vibrant population has chilled the medical and lay communities. Today, the public response is sober and oriented toward the examination of specific policies that could lessen the impact of the disease. After six years' experience it is now feasible to propose a strategy for combatting AIDS. Consensus around the following policies should form the nucleus of the public health strategy to combat AIDS before the intervention of an effective vaccine or treatment.

Unprotected sexual intercourse and use of contaminated needles are intentional activities. Voluntary changes in behavior to avoid a high risk of transmission is currently the overriding public policy objective. The first line of defense in controlling AIDS, therefore, is to inform and educate individuals about high-risk behavior and about methods of altering behavior to protect against transmission of the infection.

Biobank-based research in Mexico is mostly governed by research and data protection laws. There is no direct mention of biobanks in either statutory or regulatory law besides a requirement that the Federal Ministry of Health and a Mexican institution devoted to scientific research approve the transfer of biological materials outside of Mexico for population genetics research purposes. Such requirements are the basis of Genomic Sovereignty in Mexico, but such requirements have not prevented international collaboration. In addition, Mexican law singles out genetic research in informed consent provisions, but it does not specify whether all biobank-based research is genetic research. In order to facilitate international collaboration on biobank-based research, Mexico should directly address biobanking in its laws, building on the research framework and data protection framework already in place.

True revolutions turn the entire world upside down, in ways expected and surprising, profound and mundane. The revolution spawned by advances in molecular biology is no exception. Most of the attention has gone, deservedly, to the possible effects of these advances on medicine, on society, and on our understanding of what it means to be human. But the revolution has already had effects—large and small, good and bad—in other areas. This paper analyzes one aspect of the industry created by that revolution in molecular biology–biotechnology. Specifically, it surveys the various kinds of conflicting interests, both real and perceived, that develop among commercial enterprises, government, and institutions in biotechnology; and it examines the legal implications and public policy concerns of these conflicting interests.

The paper focuses on three different kinds of conflicting interests that confront private and public enterprises competing or collaborating in the biotechnology industry: (1) those among businesses involved within the industry; (2) those in relationships between industry and government; and (3) those in relationships between industry and universities. These types of conflicts raise very different issues, but each stems from circumstances unique to the young biotechnology industry.

Calls to abolish race as a proxy for biology or genetics in clinical care have reached a fever pitch in the latter half of 2020, including articles in the New England Journal of Medicine, and urgent letters from prominent Senators.

The home setting presents particular problems in assessing a client/patient's ability to refuse suggested medical care. Home is familiar; it is associated with relaxation and not with the mobilization required to combar anxiety, uncertainty, illness and pain. In the home family members may be overly involved or controlling. Especially in the situation of elderly siblings with long combined histories, there may be shared peculiarities or even shared personaliry disorders which complicate an individual's choice of care. The home, because it is familiar, may maximize patient orientation but may also support denial of illness; the patient/client may reason “If I'm home, I'm really not ill.” In contrast, hospitals and long-term care facilities are intimidating and infantilizing institutions that tend to undercut personal resolve and challenge denial.

In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.

Given the nature of scientific inquiry, biomedical and genomic researchers have forged innumerable ways to advance our understanding of human disease. In many cases, research requires the involvement of human subjects, and in a subset of these studies, the researcher may collect data and biospecimens from many participants, and even serially collect additional materials over time and across a number of geographically dispersed centers. The organized data and biospecimens are collectively known as research biobanks. Researchers have an obligation to disseminate findings from their research through publications and presentations to other professionals, and when possible, to the public. Sharing genomic data is increasingly being mandated; access to data can be obtained through collaborative or state-funded entities. For example, the database of Genotypes and Phenotypes (dbGAP) and the International Cancer Genome Consortium will grant approved research applicants access to de-identified individual level genomic data with accompanying demographic/clinical information.

Ensuring that life-saving antimicrobials remain available as effective treatment options in the face of rapidly rising levels of antimicrobial resistance will require a massive and coordinated global effort. Setting a collective direction for progress is the first step towards aligning global efforts on AMR. This process would be greatly accelerated by adopting a unifying global target — a well-defined global target that unites all countries and sectors. The proposed pandemic instrument — with its focus on prevention, preparedness and response — represents an ideal opportunity to develop and adopt a unifying global target that catalyzes global action on AMR. We propose three key characteristics of a unifying global target for AMR that — if embedded within the pandemic preparedness instrument — could rally public support, funding, and political commitment commensurate with the scale of the AMR challenge.

Disability rights law has made issues of access and accommodations much more visible in American life. Yet a byproduct of the increased awareness of disability rights has been “fear of the disability con,” that is, the common apprehension that people are abusing the law to gain an unfair advantage. Many times, this moral panic creates an invisible, oft-overlooked barrier for people with disabilities who desire to utilize their rights. They either are refused the right altogether or give up asking for it in the first place because they are afraid of being accused of being fakers. This Article shows how fear of the disability con surfaced along the progression of the COVID-19 pandemic. It describes the schism between the ways in which people with disabilities generally fared under the pandemic and some popular perceptions regarding the “privileges” they allegedly received because of their protected legal status. Those so-called privileges include mask exemptions, vaccination priority, and permission to continue remote work. The Article concludes with lessons the COVID-19 pandemic experience can teach us about the nature and scope of the fear of the disability con.

Immunization plays a crucial role in global health security, preventing public health emergencies of international concern and protecting individuals from infectious disease outbreaks, yet these critical public health benefits are dependent on immunization law. Where public health law has become central to preventing, detecting, and responding to infectious disease, public health law reform is seen as necessary to implement the Global Health Security Agenda (GHSA). This article examines national immunization laws as a basis to implement the GHSA and promote the public's health, analyzing the scope and content of these laws to prevent infectious disease across Sub-Saharan Africa. Undertaking policy surveillance of national immunization laws in 20 Sub-Saharan African countries, this study: (1) developed a legal framework to map the legal attributes relevant to immunization; (2) created an assessment tool to determine the presence of these attributes under national immunization law; and (3) applied this assessment tool to code national legal landscapes. An analysis of these coded laws highlights legal attributes that govern vaccine requirements, supply chains, vaccine administration standards, and medicines quality and manufacturer liability. Based upon this international policy surveillance, it will be crucial to undertake legal epidemiology research across countries, examining the influence of immunization law on vaccination rates and disease outbreaks.

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime.

Celebrations of playing through risk, skepticism of athletes perceived as faking injuries, unregulated training regimens, the mythos of amateurism, and lack of accountability for preventable health harms have long characterized many college football programs. Setting policies that effectively prioritize player health will require taking this history into account.

When adopted in 1991, the French Loi Evin was pioneering as one of the first in the world to regulate alcohol marketing as extensively. This short contribution assesses whether it remains fit for purpose over 30 years later. To this effect, it assesses its main provisions, considers the legislative amendments that have ensued as well as the extensive interpretation French courts have given of its scope, before concluding that the prospects for its revisions are limited in the near future.

This essay explores the long Western history of anxieties about feigned illness connected specifically to social policy. There is a remarkable consistency of such anxieties across time, as they appear in almost every major historical period in the West since the Middle Ages.

I want to begin by making the fundamental point that the question is not whether decisions to end human lives ought to be made but, rather, who makes these decisions, and on the basis of what principles or values. For the fact is that such decisions are already being made, and inevitably must be made, in modern hospitals.

For almost any life-threatening condition, modern medical technology can now delay the moment of death. Death will often not occur until and unless the decision has been made to withhold or withdraw life-sustaining treatment. In other words, when and how a patient dies is increasingly the outcome of a deliberate human decision. Such decisions—not to resuscitate a terminally ill patient, not to continue to sustain the life of a permanently comatose patient. or to withhold antibiotics from the deaf and blind octogenarian—are all instances of the intentional termination of life and, if done for the patient's sake, are cases of passive euthanasia.

Physicians and institutional providers face expanding liability exposure today, in spite of state tort reform legislation and public awareness of the costs of malpractice for providers. Standards of practice are evolving rapidly; new medical technologies are being introduced at a rapid rate; information is proliferating as to treatment efficacy, patient risk, and diseases generally. Tort standards mirror this change. As medical standards of care evolve, they provide a benchmark against which to measure provider failure. The liability exposure of physicians is affected by (1) the generation of data, including outcomes data usable to profile physician practice, and statistical data that allows for predictions as to treatment efficacy, and patient prognosis; (2) obligations to inform patients and third parties of risk created by contagious disease and other sources of harm; (3) obligations of physicians to disclose risks that the provider creates for the patient; (4) obligations to disclose conflicts of interest arising out of the practice setting; and (5) duties arising from new epidemiological knowledge.