Faculty Bibliography
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The revival of psychedelic medicalization is often narrated as a story of scientific legitimacy and neurotherapeutic promise, yet the unusual sensitivity of psychedelics to environmental conditions has encouraged research on music, therapy, setting, and other contextual factors. Treating setting and context as the building blocks of felt atmospheres, this article examines how regulation actively shapes atmospheres of consumption for substances that alter affective and sensory perception. Debates over drug-centric versus therapy-centered models are situated within the broader issue of how law shapes contexts and settings of psychedelic consumption. Policy developments in the United States and Australia show how emerging legal pathways have variably defined personnel, setting, access, substance, and the permitted forms of “holding space” or providing support or therapy. We introduce the concept of regulatory atmospheres to describe the diffuse and sometimes invisible ways in which policy shapes the contextual conditions of psychedelic use. Although policy rarely addresses atmospheres directly, we argue that it powerfully conditions them, which the case of psychedelic drug policy makes particularly clear. Alongside emerging legal pathways, the persistent shadow cast by prohibition over underground and traditional contexts reveals how some ontologies of risk and efficacy are privileged over others.
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This Viewpoint discusses the executive order supporting the development and approval of psychedelic drugs and outlines issues surrounding their ethical and evidence-based integration into clinical care.
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This Viewpoint discusses the potential benefits and risks, such as privacy violations, discrimination, and exacerbation of health disparities, that may accompany the unfiltered upload of electronic health records to large language models.
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The Genetic Information Nondiscrimination Act (GINA) became law almost two decades ago, when genomic medicine was still in its infancy. One reason for its passage was to ensure that individuals and society would reap the benefits of emerging advances in genetic medicine, and would be able to benefit from genetic testing and research without fear of employment or health insurance discrimination. Since then, genomics has matured into a complex probabilistic science that increasingly allows for individualized estimates of genetic risk derived from large-scale population studies. Polygenic risk scores (PGSs), which provide genome-wide estimates of disease liability and may help indicate effective preventive care for an individual, raise new benefits but also concerns. PGS testing may become common in clinical practice, particularly to mitigate common complex diseases such as cardiac conditions and cancer. But are existing antidiscrimination protections adequate for a world where polygenic risk scoring is the norm? In this paper, we consider how existing laws apply and whether new legal and policy approaches are needed to support widespread, beneficial clinical use of PGSs. We also propose avenues for potential action by policymakers.
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As recently as November 2024, the National Center for Health Workforce Analysis (NCHWA) of the Health Resources and Services Administration (HRSA) made note of the latest census data of U.S. physicians [1]. It was the conclusion of the NCHWA that the U.S. is presently home to a total of 933,788 “professionally active” physicians of whom 800,355 are “reported as patient care practicing physicians [1].” The NCHWA went on to project a “shortage of 187,130 full-time equivalent (FTE) physicians in 2037” as well as the possibility that “nonmetro areas will experience greater shortages of physicians than metro areas [1].” The NCHWA further estimates that “75 million people live in a primary care Health Professional Shortage Area (HPSA)” and that “a total of 122 million people live in a mental health HPSA [1].” Note was also made of the reality that “the maldistribution of the health care workforce results in severe shortages in rural communities [1].” Seeking to address the extant challenges, a bipartisan group of members of the Senate Committee on Finance stepped into the breach [2]. Led by Sen. Ron L. Wyden (D-OR), it was the intent of the Senators to introduce legislation that will assist teaching hospitals in the training of more physicians by reforming Medicare's Graduate Medical Education (GME) rules [2]. In this Commentary, we review the evolution of the aforementioned draft legislation as well as assess the likelihood of the materialization thereof.
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Patent applications indicate a trend toward completely integrating artificial intelligence (AI) with drugs, whereby AI applications will be so tightly linked to drugs that the drugs could be effectively unusable without the AI.
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This Viewpoint discusses new guidance on responsible use of artificial intelligence.
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In this Viewpoint, a California artificial intelligence law is described, including its positive contributions to making these companion chatbots safer for minor and adult users and the limits of the law, and recommends further steps California and other states can adopt to improve protections for mental health and chatbot safety, especially for minors.
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This Viewpoint explores the US Food and Drug Administration’s plan to approve leucovorin for patients with autism and the potential implications for evidentiary standards.
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A new Section 1557 rule bans discrimination by AI-based clinical decision tools, with compliance required by May 2025. This paper explores challenges in identifying and mitigating algorithmic bias, especially where outcome disparities exist. We emphasize the need to audit high-risk tools, address proxy discrimination, and provide standardized guidance. Political uncertainty around enforcement complicates long-term planning, making expanded regulatory support essential for health systems and developers alike.
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The notion of medical aid in dying dates back to 1994 and the approval of the Death with Dignity Act by the citizens of Oregon. Therein was incorporated the notion of competent terminally ill patients being permitted to resort to the self administration of lethal physician-prescribed drugs. Several other states followed suit. Medical aid in dying is now broadly applied in the US under strict legal oversight in an ever-growing number of states.
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This Viewpoint reviews employer protection initiatives for family caregivers in Illinois and other states.
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Medication shortages constitute an ongoing threat to patient care across the United States and affect nearly every aspect of health care. National drug shortages have been a recurring challenge of the US health care system but were markedly aggravated during the COVID-19 pandemic. Federal executive and legislative efforts to bolster the resiliency of the pharmaceutical supply chain have thus far fallen short. This Commentary reviews the leading executive and legislative initiatives proposed during the 118th Congress and the Biden administration to protect the national drug supply in the hope of avoiding future shortages. It will be up to the new (119th) Congress and presidential administration to take up this issue again and pursue remediation of the nation’s drug shortage problem. The health of the nation demands action by policy makers to mitigate drug shortages that give rise to discontinuity of care and thereby to a compromise of the national state of health.
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We propose that AI-driven wellness apps powered by large language models can foster extreme emotional attachments and dependencies akin to human relationships — posing risks such as ambiguous loss and dysfunctional dependence — that challenge current regulatory frameworks and necessitate safeguards and informed interventions within these platforms.
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This chapter considers where law and bioethics intersect as to the 100-year life. It tackles two different issues. The first is an exploration of the bioethics of life extension and whether such extension is something that should be pursued. The second considers attempts to extend reproduction into the late period of life and the ethics thereof.
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Artificial Intelligence (AI) presents unprecedented opportunities to transform healthcare worldwide, from improving diagnostic accuracy to expanding access in underserved regions. Despite this potential and growing investment, a significant gap persists between AI's theoretical promise and its realised benefits in healthcare settings. This article examines the complex barriers impeding AI benefits realization in global health contexts, including ethical uncertainties, data infrastructure limitations, evidence quality concerns, and regulatory ambiguities. We analyze current initiatives addressing these challenges and highlight how technological solutions alone cannot resolve fundamental healthcare inequities. Drawing on the interdisciplinary perspectives and insights presented at the Global Health in the Age of AI Symposium hosted by the Cini Foundation and Yale Digital Ethics Center, 1 we propose five core infrastructure requirements necessary for ethical AI implementation: robust data exchange; epistemic certainty with staff autonomy; actively protected healthcare values; validated outcomes with meaningful accountability; and environmental sustainability. These requirements form the foundation for a systems approach that balances technological advancement with ethical imperatives, contextual adaptability, and global equity considerations. We conclude that the successful integration of AI into healthcare demands coordinated action across sectors and borders, with careful attention to avoiding technological colonialism and ensuring AI serves as a force for health equity rather than widening existing disparities.
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Maternal care deserts, defined as counties where there are no hospitals offering obstetric services or birth centers and no obstetricians, gynecologists, or certified nurse midwives, have a significant adverse effect on the quality of maternity care afforded women in the United States, especially Black women and women in rural areas. The maternal mortality rate for Black women in 2022 was 2.6 times higher than the rate for White women. The rate in the most rural counties is 1.6 times higher than the rate in large metropolitan counties. Across the nation, 36% of all US counties qualify as maternal care deserts, contributing to the country's poor placement globally among high-income nations. A recent report by the March of Dimes draws attention to the crisis in maternal health care. A number of interventions have been proposed by federal government entities to address the persistent problem. Family physicians in particular have a potential role in improving the situation as they represent the broadest geographic coverage of all maternity care providers.
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In longer-form writing with Larry Gostin, especially on global health, I have been particularly struck by how careful he is not to lose the narrative voice, especially of the vulnerable. He truly believes that these stories are “on loan” to us, and that there is an almost holy reverence and devotion we owe to the lives of those whose stories we tell.
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This Viewpoint discusses prospects for populating the regulatory landscape for health and health care AI in the coming years.
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This article discusses legal and ethical issues raised by in vitro gametogenesis, including safety, Food and Drug Administration review, embryo destruction, eugenics, enhancement, unauthorized parenthood, inequitable access, and evolving conceptions of parenthood.
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This study reports a comprehensive environmental scan of the generative AI (GenAI) infrastructure in the national network for clinical and translational science across 36 institutions supported by the CTSA Program led by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) at the United States. Key findings indicate a diverse range of institutional strategies, with most organizations in the experimental phase of GenAI deployment. The results underscore the need for a more coordinated approach to GenAI governance, emphasizing collaboration among senior leaders, clinicians, information technology staff, and researchers. Our analysis reveals that 53% of institutions identified data security as a primary concern, followed by lack of clinician trust (50%) and AI bias (44%), which must be addressed to ensure the ethical and effective implementation of GenAI technologies.
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The field of artificial intelligence (AI) has entered a new cycle of intense opportunity, fueled by advances in deep learning, including generative AI. Applications of recent advances affect many aspects of everyday life, yet nowhere is it more important to use this technology safely, effectively, and equitably than in health and health care. Here, as part of the National Academy of Medicine’s Vital Directions for Health and Health Care: Priorities for 2025 initiative, which is designed to provide guidance on pressing health care issues for the incoming presidential administration, we describe the steps needed to achieve these goals. We focus on four strategic areas: ensuring safe, effective, and trustworthy use of AI; promotion and development of an AI-competent health care workforce; investing in AI research to support the science, practice, and delivery of health and health care; and promotion of policies and procedures to clarify AI liability and responsibilities.