The administration of Pre-Mortem Interventions (PMIs) to preserve the opportunity to donate, to assess the eligibility to donate, or to optimize the outcomes of donation and transplantation are controversial as they offer no direct medical benefit and include at least the possibility of harm to the still-living patient. In this article, we describe the legal analysis surrounding consent to PMIs, drawing on existing legal commentary and identifying key legal problems. We provide an overview of the approaches in several jurisdictions that have chosen to explicitly address PMIs within codified law. We then provide, as an example, a detailed exploration of how PMIs are likely to be addressed in one jurisdiction where general medical consent law applies because there is no specific legislation addressing PMIs — the province of Ontario in Canada.

Patients and physicians do not know the cost of medical procedures. Opaque medical billing thus contributes to exorbitant, rising medical costs, burdening the healthcare system and individuals. After criticizing two proposed solutions to the problem of opaque medical billing, I argue that the Centers for Medicare and Medicaid Services should pursue a rule requiring that patients be informed by the physician of a reasonable out-of-pocket expense estimate for non-urgent procedures prior to services rendered.

Physician-based transparency approaches have been advanced as a strategy for informing patients of the likely financial consequences of using services. The structure of health care pricing and insurance coverage, and the low uptake of existing tools, suggest these approaches are likely to be unwieldy and unsuccessful. They may also generate new ethical challenges.

Federally Qualified Health Centers (FQHCs) proved to be critical points of access for people of color and other underserved populations during the COVID-19 pandemic, administering 61% of their COVID-19 vaccinations to people of color, compared to the 40% rate for the overall United States’ vaccination effort. To better understand the approaches and outcomes of FQHCs in pandemic response, we conducted semi-structured interviews with FQHC health care providers and outreach workers and analyzed them using an inductive qualitative methodology.

With disparate rates of morbidity and mortality among minoritized communities, COVID-19 illuminated the need for equity-informed practices in public health. Pacia et al posit FQHCs as entities that addressed inequity when others failed. This commentary further situates how FQHCs address the public health crisis of institutional racism and related health inequities every day and presents a FQHC-led Ethics and Equity Framework and Workflow Checklist to guide ethical and equitable engagement with FQHCs.

Women are the fastest-growing population of people who use drugs in the US. As a group, they are more likely than men to experience stigma, poverty, and negative mental health outcomes. This article discusses the unique needs of women drug users in the US and provides suggestions on how to leverage national attention — and federal funding — to make harm reduction services in the US more gender sensitive, and, as a result, more effective in reducing harm for women who use drugs in this country.

This paper challenges historically preconceived notions surrounding a minor’s ability to make medical decisions, arguing that federal health law should be reformed to allow minors with capacity as young as age 12 to consent to their own Centers for Diseases Control and Prevention (CDC)-approved COVID-19 vaccinations. This proposal aligns with and expands upon current exceptions to limitations on adolescent decision-making. This analysis reviews the historic and current anti-vaccination sentiment, examines legal precedence and rationale, outlines supporting ethical arguments regarding adolescent decision-making, and offers rebuttals to anticipated ethical counterarguments.

Policies allowing some minors to consent to receive recommended vaccines are ethically defensible. However, a policy change at the federal level expanding minor consent for vaccinations nationwide risks triggering a political backlash. Such a move may be perceived as infringing on the rights of parents to make decisions about their children’s health care. In the current post-COVID environment of heightened anti-vaccination activism, changes to minor consent laws may be unadvisable, and policy makers should proceed with caution.

Despite significant scholarship, research, and funding dedicated to implementing criminal diversion programs over the past two decades, persons with serious mental illness and substance use disorders remain substantially overrepresented in United States jails and prisons. Why are so many U.S. adults with behavioral health problems incarcerated instead of receiving treatment and other support to recover in the community? In this paper, we explore this persistent problem within the context of “relentless unmet need” in U.S. behavioral health (Alegría et al., 2021).

The opioid epidemic demands the development, implementation, and evaluation of innovative, research-informed practices such as diversion programs. Aritürk et al. have articulated important bioethical considerations for implementing diversion programs in resource-constrained service environments. In this commentary, we expand and advance Aritürk et al.’s discussion by discussing existing resources that can be utilized to implement diversion programs that prevent or otherwise minimize the issues of autonomy, non-maleficence, beneficence, and justice identified by Aritürk et al.

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021.

The case of clinical trials for convalescent plasma during COVID-19 illustrates important lessons for realizing public sector approaches to biomedical research and development. These lessons, centering on mission, transparency, and spillover effects, can be translated to wider efforts to develop a “public option” for clinical trials.

Secondary use of clinical data in research or learning activities (SeConts) has the potential to improve patient care and biomedical knowledge. Given this potential, the ethical question arises whether physicians have a professional duty to support SeConts. To investigate this question, we analyze prominent international declarations on physicians’ professional ethics to determine whether they include duties that can be considered as good reasons for a physicians’ professional duty to support SeConts. Next, we examine these documents to identify professional duties that might conflict with a potential duty of physicians to support SeConts.

U.S. law imposes strict recording and reporting requirements on all entities that manufacture and distribute controlled substances. As a result, the prescription opioid crisis has unfolded in a data-saturated environment. This article asks why the systematic documentation of opioid transactions failed to prevent or mitigate the crisis. Drawing on a recently disclosed trove of 1.4 million internal records from Mallinckrodt Pharmaceuticals, a leading manufacturer of prescription opioids, we highlight a phenomenon we propose to call data diversion, whereby data ostensibly generated or collected for the purpose of regulating the distribution of controlled substances were repurposed by the industry for the opposite aim of increasing sales at all costs. Systematic data diversion, we argue, contributed substantially to the scale of drug diversion seen with opioids and should become a focus of policy intervention.

More than twenty-five years after the first signs of potential harm, the US remains locked in the grip of an opioid epidemic, with more Americans dying from overdoses than ever before.1 Diversion of prescription opioids plays an important role in opioid-related harms. Much of the scientific and public health focus on diversion has been on end-users, given how commonly non-medical prescription opioid use occurs, as well as the proportion of individuals who report that their source of non-medical opioids was friends or family. However, diversion of opioids, as well as their rampant oversupply, can be discerned higher up the supply chain, including among wholesalers, pharmacies and rogue prescribers whose behavior may trigger well-described “flags” warranting further evaluation and action.

Medical legal partnerships address individual legal needs that can create impediments to health. Little is known about outcomes from medical legal partnerships and their relationship to access to justice. This paper reports outcomes from one medical legal partnership from the perspective of the client, with specific emphasis on impact on health and concepts related to access to justice. We suggest a conceptual model for incorporating medical legal partnerships into a broader framework about access to justice.

As a legal aid union president in New Haven, laboring within shouting distance of a different large research university, I recall how our membership rolled our eyes when Professors Greiner, Pattanayak, and Hennesy of Harvard published their study providing evidence, through a randomized control trial, that law clinic housing work made no difference for clients.1 Representing, as I was, “lawyers, secretaries, and paralegals who have dedicated their careers to serving poor clients in crisis,”2 the authors’ conclusion generated first shock, then denial, and then an anxious realization that somebody’s job was to research and disseminate such conclusions. In a 2013 United States where there was one legal aid lawyer for every 8,893 people who qualified,3 where federal Legal Services Corporation funding had dropped 40% over ten years in real dollars,4 and in an America that spends as much on Halloween costumes for its pets as it does legal aid for the poor,5 the inquiry felt like a pile-on. It made no more sense to us than asking if a teacher is “good for students,” a nurse “good for the sick,” or a chef “good for the hungry.”6

Industry-funded religious liberty legal groups have sought to undermine healthcare policy and law while simultaneously attacking the rights of sexual and gender minorities. Whereas past scholarship has tracked religiously-affiliated healthcare providers’ growing political power and attendant transformations to legal doctrine, our account emphasizes the political donors and visionaries who have leveraged religious providers and the U.S. healthcare system’s delegated structure to transform social policy and bureaucratic agencies more generally.

Catholic hospitals and health systems have proliferated and succeeded in American healthcare; they now operate four of the largest health systems and serve nearly one in six hospital patients. Like other religious entities that Wuest and Last write about in this issue, in their article Church Against State, they have benefited by and supported the long reach of conservative efforts to undermine the administrative state.