Faculty Bibliography
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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 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.
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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.
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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.
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This Viewpoint discusses potential benefits and obstacles regarding US Food and Drug Administration (FDA) oversight of laboratory-developed tests.
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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.
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Researchers and practitioners are increasingly using machine‐generated synthetic data as a tool for advancing health science and practice, by expanding access to health data while—potentially—mitigating privacy and related ethical concerns around data sharing. While using synthetic data in this way holds promise, we argue that it also raises significant ethical, legal, and policy concerns, including persistent privacy and security problems, accuracy and reliability issues, worries about fairness and bias, and new regulatory challenges. The virtue of synthetic data is often understood to be its detachment from the data subjects whose measurement data is used to generate it. However, we argue that addressing the ethical issues synthetic data raises might require bringing data subjects back into the picture, finding ways that researchers and data subjects can be more meaningfully engaged in the construction and evaluation of datasets and in the creation of institutional safeguards that promote responsible use.
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Medical devices diagnose disease, prolong life, and improve health. But when defective, they can injure, disable, and kill. To successfully sue manufacturers for injuries caused by medical devices, patients must overcome the defense that federal law preempts, or displaces, state law claims. The Supreme Court has provided a framework for answering this question with respect to most devices. However, it has never confronted how it would apply the framework to an innovative but growing class of devices—de novo devices—that may incorporate novel technologies like artificial intelligence and machine learning. This Essay tries to answer this question as a predictive and normative matter. From a predictive perspective, the Essay argues that the Court’s increasingly textualist orientation suggests it will reject preemption of claims against manufacturers of de novo devices, though the result is not certain. From a normative perspective, the Essay argues that allowing claims against de novo device manufacturers forces risk internalization, provides a regulatory failsafe for innovative technology, and preserves innovation without sacrificing patient health.
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Congressional hearings and public reports have drawn attention to problems afflicting Medicare Advantage (MA), the privatized version of Medicare. Private plans became a staple of Medicare through the passage of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA). Congress passed this law during a furor of privatization, when think tanks and powerful financial interests emphasized the power of corporations’ profit incentive to improve the efficiency and quality of social enterprise. Yet the surging criticism of MA suggests a misalignment between the financial interest of some MA plans and the well-being of their patient populations. The criticisms range from deceptive marketing, ghost networks, and patient cherry-picking to unethical prior authorization denials and defrauding the government. In total, MA plans cost the federal government 22% more per patient than if these patients in question were enrolled in traditional Medicare. Moreover, it is not clear that this additional funding is producing proportional benefits. These developments raise questions about the presence of a profit incentive in Medicare, and perhaps health care more broadly.
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In this Viewpoint, the authors refute recent suggestions that the US Food and Drug Administration (FDA) is not accountable for its decisions, pointing out the legal, legislative, and executive checks and balances on the agency.
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Women’s Health Research, barely 40-year-old in the United States has recently received an all-important boost from First Lady Jill Biden. The $100 million in question are bound to make a meaningful difference in this all-important arena. It was the view of the White House that “our nation must fundamentally change how we approach and fund women’s health research.” The White House expressed its hope that “congressional leaders, the private sector, research institutions, and philanthropy” will answer the call to “improve the health and lives of women throughout the nation.”
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Importance: As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice. Objective: To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice. Evidence Review: From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists convened at the Banbury Center at Cold Spring Harbor Laboratory. Prior to the meeting, attendees submitted key ethics and policy issues for psychedelic medicine. Responses were categorized into 6 broad topics: research ethics issues; managing expectations and informed consent; therapeutic ethics; training, education, and licensure of practitioners; equity and access; and appropriate role of gatekeeping. Attendees with relevant expertise presented on each topic, followed by group discussion. Meeting organizers (A.L.M., I.G.C., D.S.) drafted a summary of the discussion and recommendations, noting points of consensus and disagreement, which were discussed and revised as a group. Findings: This consensus statement reports 20 points of consensus across 5 ethical issues (reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping), with corresponding relevant actors who will be responsible for implementation. Areas for further research and deliberation are also identified. Conclusions and Relevance: This consensus statement focuses on the future of government-approved medical use of psychedelic medicines in the US and abroad. This is an incredibly exciting and hopeful moment, but it is critical that policymakers take seriously the challenges ahead.
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Artificial intelligence (AI)-enabled chatbots are increasingly being used to help people manage their mental health. Chatbots for mental health and particularly ‘wellness’ applications currently exist in a regulatory ‘gray area’. Indeed, most generative AI-powered wellness apps will not be reviewed by health regulators. However, recent findings suggest that users of these apps sometimes use them to share mental health problems and even to seek support during crises, and that the apps sometimes respond in a manner that increases the risk of harm to the user, a challenge that the current US regulatory structure is not well equipped to address. In this Perspective, we discuss the regulatory landscape and potential health risks of AI-enabled wellness apps. Although we focus on the United States, there are similar challenges for regulators across the globe. We discuss the problems that arise when AI-based wellness apps cross into medical territory and the implications for app developers and regulatory bodies, and we outline outstanding priorities for the field.
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Importance: Interest in administering psychedelic agents as mental health treatment is growing rapidly. As drugmakers invest in developing psychedelic medicines for several psychiatric indications, lawmakers are enacting legal reforms to speed access globally, and health agencies are preparing to approve these treatments. Meanwhile, US states, such as Oregon and Colorado, are making psychedelics available for supervised use outside the conventional health care system. Observations: Despite legal change and potentially imminent regulatory approval in some countries, standards for integrating psychedelics into health care have lagged, including norms for designing and implementing informed consent processes. Informed consent is complicated by the unique features of psychedelics and their means of administration. Because no governments have approved any classic psychedelics for general medical or psychiatric use, only clinical researchers have obtained informed consent from trial participants. Accordingly, there is an unmet need for informed consent processes tailored to the challenges of administering psychedelics in nonresearch settings. Conclusions and Relevance: Analysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks of data collection, relevant practitioner disclosures, and interactive patient education and comprehension assessment. Because publicly available informed consent documents for psychedelic clinical trials often overlook or underemphasize these essential elements, sample language and procedures to fill the gap are proposed.
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Health care delivery is shifting away from the clinic and into the home. Even prior to the COVID-19 pandemic, the use of telehealth, wearable sensors, ambient surveillance, and other products was on the rise. In the coming years, patients will increasingly interact with digital products at every stage of their care, such as using wearable sensors to monitor changes in temperature or blood pressure, conducting self-directed testing before virtually meeting with a physician for a diagnosis, and using smart pills to document their adherence to prescribed treatments. This volume reflects on the explosion of at-home digital health care and explores the ethical, legal, regulatory, and reimbursement impacts of this shift away from the 20th-century focus on clinics and hospitals towards a more modern health care model. This title is also available as Open Access on Cambridge Core.
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This Viewpoint discusses the Alabama Supreme Court’s opinion on in vitro fertilization and how it plays into a larger push for fetal and embryonic personhood.
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Health care workers are disproportionately at risk for workplace violence. They are 5 times more likely to experience violence at work than other workers, accounting for 73% of all nonfatal workplace injuries from violence. Attacks against health care workers are on the rise. A national survey of nurses found a 119% increase in nurses reporting worsening workplace violence between March 2021 and March 2022. This increase is part of a broader trend of rising violence against health care workers over the last decade. This Viewpoint seeks to understand the current legislative responses at the state level to this outburst of deadly violence and analyze how the law is adapting to protect health care personnel.
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Upon the release of the Dobbs decision, the public and legal academic conversation quickly shifted to implications for other rights closely connected to substantive due process. Justice Alito’s opinion attempts to argue that abortion’s involvement of “potential life” is what distinguishes abortion from other substantive due process rights. This chapter argues that reproductive technologies, specifically those that involve embryo destruction, are directly implicated by Alito’s language. The Dobbs decision erects a barrier to a federal constitutional right to engage in reproductive technologies involving embryo destruction, raises the possibility that states that prohibit abortion could restrict embryo destruction (though data on public opinion suggests few will), and creates normative questions about embryo destruction that turn on particular theories of embryonic/fetal personhood. The chapter concludes that some who believe abortion should be restricted should also oppose embryo destruction, and that some who oppose abortion restrictions should not oppose restrictions on embryo destruction.
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The expected societal impact of quantum technologies (QT) urges us to proceed and innovate responsibly. This article proposes a conceptual framework for Responsible QT that seeks to integrate considerations about ethical, legal, social, and policy implications (ELSPI) into quantum R&D, while responding to the Responsible Research and Innovation dimensions of anticipation, inclusion, reflection and responsiveness. After examining what makes QT unique, we argue that quantum innovation should be guided by a methodological framework for Responsible QT, aimed at jointly safeguarding against risks by proactively addressing them, engaging stakeholders in the innovation process, and continue advancing QT (‘SEA’). We further suggest operationalizing the SEA-framework by establishing quantum-specific guiding principles. The impact of quantum computing on information security is used as a case study to illustrate (1) the need for a framework that guides Responsible QT, and (2) the usefulness of the SEA-framework for QT generally. Additionally, we examine how our proposed SEA-framework for responsible innovation can inform the emergent regulatory landscape affecting QT, and provide an outlook of how regulatory interventions for QT as base-layer technology could be designed, contextualized, and tailored to their exceptional nature in order to reduce the risk of unintended counterproductive effects of policy interventions. Laying the groundwork for a responsible quantum ecosystem, the research community and other stakeholders are called upon to further develop the recommended guiding principles, and discuss their operationalization into best practices and real-world applications. Our proposed framework should be considered a starting point for these much needed, highly interdisciplinary efforts.
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This Viewpoint discusses the litigation strategy of state-initiated lawsuits alleging illegal and immoral conduct regarding the pricing of insulin by pharmaceutical companies and pharmacy benefit managers.
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When medical AI systems fail, who should be responsible, and how? We argue that various features of medical AI complicate the application of existing tort doctrines and render them ineffective at creating incentives for the safe and effective use of medical AI. In addition to complexity and opacity, the problem of contextual bias, where medical AI systems vary substantially in performance from place to place, hampers traditional doctrines. We suggest instead the application of enterprise liability to hospitals—making them broadly liable for negligent injuries occurring within the hospital system—with an important caveat: hospitals must have access to the information needed for adaptation and monitoring. If that information is unavailable, we suggest that liability should shift from hospitals to the developers keeping information secret.
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This chapter examines the role of liability in shaping the use of artificial intelligence (AI) in medicine. It examines various forms of liability—physician medical malpractice, lack of informed consent, corporate liability for hospitals, and developer liability. Finally, it turns to the preemption of liability and regulation. This chapter focuses primarily on US law, with some reference to EU law.