Faculty Bibliography
-
Type:
Categories:
Sub-Categories:
Links:
This Viewpoint discusses new guidance on responsible use of artificial intelligence.
-
Type:
Categories:
Sub-Categories:
Links:
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.
-
Type:
Categories:
Sub-Categories:
Links:
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.
-
Type:
Categories:
Sub-Categories:
Links:
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.
-
Type:
Categories:
Sub-Categories:
Links:
This Viewpoint reviews employer protection initiatives for family caregivers in Illinois and other states.
-
Type:
Categories:
Sub-Categories:
Links:
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.
-
Type:
Categories:
Sub-Categories:
Links:
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.
-
Type:
Categories:
Sub-Categories:
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.
-
Type:
Categories:
Sub-Categories:
Links:
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.
-
Type:
Categories:
Sub-Categories:
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.
-
Type:
Categories:
Sub-Categories:
Links:
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.
-
Type:
Categories:
Sub-Categories:
Links:
This Viewpoint discusses prospects for populating the regulatory landscape for health and health care AI in the coming years.
-
Type:
Categories:
Sub-Categories:
Links:
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.
-
Type:
Categories:
Sub-Categories:
Links:
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.
-
Type:
Categories:
Sub-Categories:
Links:
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.
-
Type:
Categories:
Sub-Categories:
Links:
Research on psychedelic medicines is experiencing a revival. Some clinicians, scientists, and ethicists believe that psychedelics are so different from other treatments that they warrant special consideration in how they are researched, regulated, commercialized, and administered. Others argue that psychedelic medicines show clinical potential, but they should be treated like other medical interventions. In other words, identical standards should apply. This article analyzes whether psychedelic medicines warrant special consideration from a regulatory and ethical perspective.
-
Type:
Categories:
Sub-Categories:
Links:
On April 26, 2024, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) issued a Final Rule titled “HIPAA Privacy Rule to Support Reproductive Health Care Privacy.” As per the attendant Federal Register, the Final Rule was to become effective on June 25, 2024. In so doing, HHS was complying with President Biden’s Executive Order 14076 the sole focus of which was “Securing Access to Reproductive and Other Healthcare Services.” The newly (announced Final Rule bolsters the Health Insurance Portability and Accountability Act of 1996 [HIPAA; Public Law No: 104–191) which “provides penalties” for “wrongful disclosure of individually identifiable health information.” Among its leading objectives, the Final Rule seeks to protect women who cross state lines in search of an abortion. Data reported by the Guttmacher Institute suggest that nearly one in five abortion patients sought out-of-state care during the first 6 months of 2023, a two-fold increase when compared with the same period in 2020. The Final Rule also protects those who provide or facilitate lawful reproductive health care who might otherwise be targeted by state prosecutors with criminal probes or lawsuits in mind. The administration and enforcement of the newly issued Final Rule will be the designated responsibility of the OCR. In a clear reference to Dobbs v. Jackson Women’s Health Organization, HHS Secretary Xavier Becerra made note of the reality that “with reproductive health under attack by some lawmakers, these protections are more important than ever.” It is the objective of this Commentary to review the multiple facets of the reproductive privacy imperative and the projected oversight thereof.
-
Type:
Categories:
Sub-Categories:
-
Type:
Categories:
Sub-Categories:
This article examines how emerging quantum technologies, when combined with artificial intelligence (AI), could reshape precision medicine, offering hyper-personalized healthcare solutions. By leveraging quantum phenomena like superposition and entanglement, second-generation quantum technologies (2G QT) can tackle complex medical challenges beyond the reach of classical computers. These advancements, ranging from quantum computing and sensing to quantum networking, can enhance drug discovery workflows, improve diagnostic imaging, accelerate genome sequencing, and even enable real-time health monitoring. For instance, quantum simulations may aid in modeling molecular interactions to produce more effective drugs, while quantum dots could deliver targeted cancer treatments or bypass the blood-brain barrier to help fight neurodegenerative diseases. Quantum sensors can also refine surgical precision and boost diagnostic accuracy. Yet, the introduction of quantum medical devices raises significant regulatory questions, as existing frameworks are not fully equipped to handle quantum’s unique capabilities and risks. In the European Union, no dedicated quantum healthcare regulations exist, so devices likely must comply with existing EU medical device and AI rules. In the United States, quantum medical devices will operate under the current FDA framework, supplemented by other relevant laws and standards. Both regions face quantum-specific concerns, including data security threats once classical encryption is broken (Q-Day), and the need for tailored clinical trial guidelines to account for quantum’s novel biological interactions. Ultimately, the article advocates for proactive, adaptive, and harmonized policy approaches. Policymakers should learn from previous technological experiences, promote quantum literacy, and adopt principles-based, forward-looking regulations. By doing so, they can support innovation while ensuring the safe, ethical, and equitable integration of quantum technologies into global healthcare.
-
Type:
Categories:
Sub-Categories:
Links:
This Viewpoint discusses potential benefits and obstacles regarding US Food and Drug Administration (FDA) oversight of laboratory-developed tests.
-
Type:
Categories:
Sub-Categories:
Links:
This Viewpoint discusses whether the federal EMTALA act requires that hospitals provide abortions when needed to protect the health of the pregnant person, even if prohibited by state law.