Faculty Bibliography
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After performing an abortion in 1973, Dr. Kenneth Edelin was indicted and convicted of manslaughter. Dr. Edelin’s conviction was reversed 50 years ago. However, the conflict between the medical and legal systems, the use of abortion prosecution to control patients and providers, and the framing of a fetus as a person feel just as relevant to today’s abortion landscape.
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Reported instances of AI-assisted, blanket denials of coverage have increased in recent years, particularly for Medicare Advantage plans, resulting in insurers facing criticism, class action lawsuits, investigations from Congress, and key providers leaving their networks. To ensure a fair healthcare system, action is needed to improve transparency in how AI tools approve or deny claims, and address provider burnout and patient burden due to navigating prior authorization requests and appeals.
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The Healthy Technology Act of 2025, a bill being considered by Congress, would permit artificial intelligence (AI) systems to prescribe medications without human sign-off. While allowing AI to practice independently may still be a stretch, large language models are already being used to support diagnosis and treatment.1 These applications challenge the current regulatory framework for clinical AI, which has focused on software as a medical device (SaMD). The US Food and Drug Administration (FDA) has cleared more than 1000 AI tools using this framework, mostly for narrow, well-defined tasks. However, generative models can be applied across domains, straining the SaMD framework. In this Viewpoint, we explore the application of a licensure paradigm to clinical AI systems, arguing that this offers a more reliable regulatory framework.
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The convergence of Artificial Intelligence (AI), drug discovery, and genomics represents one of the most transformative shifts in biomedical science. Traditional drug development is costly, slow, and fraught with uncertainty, yet AI-driven methodologies now promise to accelerate discovery, improve precision, and reduce attrition rates across the pharmaceutical pipeline. This paper provides an in-depth exploration of how AI enables predictive modeling of molecular interactions, target identification, and genomic-driven precision medicine. Machine learning algorithms, generative models, and systems biology frameworks are redefining the speed and scope of therapeutic innovation—allowing researchers to model diseases at the molecular level and design novel compounds with unprecedented accuracy. The study further examines the integration of genomics, transcriptomics, and proteomics data with AI, enabling stratified medicine and individualized therapy design. Ethical, regulatory. and data governance dimensions are critically assessed, including issues of data privacy, algorithmic bias, and explainability in medical AI systems. By analyzing current case studies and future trends, this paper reveals how AI not only accelerates drug discovery but also redefines the paradigm of innovation itself—ushering in an era of intelligent, personalized, and predictive medicine.
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Reproductive tracking technologies are widely used by women to track their menstrual cycles or fertility. While there are many benefits to reproductive tracking technologies, there are also risks with respect to privacy and quality assurance. This commentary outlines the current US regulatory landscape of reproductive tracking technologies following the Supreme Court ruling that eliminated the constitutional right to abortion. There is a risk that information from reproductive tracking technologies regarding cessation in menstruation can be investigated as an aborted pregnancy and used against a defendant in a lawsuit. There is also risk that poor quality technologies can have adverse implications on users’ health and well-being. Individual clinicians can find it challenging to safeguard patients from these legal and health risks. Sexual and reproductive health providers and researchers have an important opportunity to provide guidance on the safe use of reproductive tracking technologies. This guidance can include the implementation of an app evaluation model, curating a database of reproductive tracking technologies or developing an evidence-based app to be the “gold standard.”
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In response to rising health, economic, and equity burdens of suboptimal nutrition, health care stakeholders are increasingly integrating nutritional supports into health care delivery and financing. In January 2023, federal guidance clarified that states may use “in lieu of services and settings” (ILOS) authority to address health-related social needs, including nutrition, in Medicaid managed care. However, few data are available regarding ILOS implementation. This analysis reviewed ILOS policies based on managed care documents from forty states as of October 1, 2024. Thirty-five states have authorized ILOS to address behavioral health, and fourteen states have authorized ILOS to address general medical needs. Twelve states use ILOS to address health-related social needs; of these, only ten address nutrition. In addition, fewer than half of the forty states provide robust guidance regarding evaluation or establishment of new ILOSs. We examine the policy implications of these findings and provide recommendations to strengthen the role of ILOS in improving nutrition, health care costs, and health equity.
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Effective scientific research relies heavily on data sharing, particularly in collaborative projects spanning multiple African countries. Researchers must be cognisant of data protection laws, especially regarding secondary data use and cross-border data sharing. In this article, we examine how the terms ‘anonymisation’, ‘de-identification’, and ‘pseudonymisation’ are employed in data protection legislation across 12 African nations and compare them with two prominent regulatory frameworks—the Health Insurance Portability and Accountability Act of the United States of America and the General Data Protection Regulation of the European Union. While 10 of the selected African countries have enacted data protection laws, only six explicitly incorporate these terms, often without clear definitions. Despite this, our analysis reveals that the terms ‘de-identification’ and ‘anonymisation’ are distinct legal concepts in the selected jurisdictions, underscoring that researchers must employ these terms carefully and not assume they are interchangeable. Our study highlights the necessity for researchers to use terminology which is consistent with an individual African country’s choice to ensure internal consistency, legal compliance, and respect for legislative preferences. It is imperative for researchers involved in international health projects to be acutely aware of how terms are interpreted within each jurisdiction and the possible legal ramifications for data sharing.
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Policy Points The reinstitution of pre–COVID-19 pandemic licensure regulations has impeded interstate telehealth. This has disproportionately impacted patients who live near a state border; geographically mobile patients, such as college students; and patients with rare diseases who may need care from a specialist outside their state. Several promising and feasible reforms are available, at both state and federal levels, to facilitate interstate telehealth. For example, states can offer exemptions to licensure requirements for certain types of telehealth such as follow-up care or create licensure registries that impose little reduced paperwork and fees on physicians. On the federal level, congressional interventions that mimic the Department of Veterans Affairs Maintaining Internal Systems and Strengthening Integrated Outside Networks (VA MISSION) Act of 2018 can waive provider licensing and geographic restrictions to telehealth within certain federal programs such as Medicare. Any discussion of medical licensure reform, however, must also consider the current political climate, one in which states are taking divergent stances on sensitive topics such as reproductive care, gender-affirming care, and substance use treatments.
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May 11, 2023, marked the end of the federal COVID-19 Public Health Emergency (PHE). During the PHE, regulatory flexibilities allowed telehealth to more effectively connect physicians providing care and patients seeking it. This paper discusses the implications of the end of the PHE on telehealth coverage, payment, reimbursement, and licensure, and exposes inconsistencies and inequities in extant state regulations.
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This Viewpoint explores the various types of state laws establishing fetal personhood and the potential implications of these laws on health care, patients, and clinicians.
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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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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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Background: Clinicians and their employers, concerned with privacy and liability, are often hesitant to support the recording of clinical encounters. However, many people wish to record encounters with healthcare professionals. It is therefore important to understand how existing law applies to situations where an individual requests to record a clinical encounter. Methods: We searched for and reviewed relevant legal documents that could apply to recording clinical encounters. We limited the scope by purposefully examining relevant law in nine countries: Australia, Brazil, Canada, France, Germany, India, Mexico, the United Kingdom and the United States. We analyzed legal texts for consents needed to record a conversation, whether laws applied to remote or face-to-face conversations and penalties for violations. Findings: Most jurisdictions have case law or statutes, derived from a constitutional right to privacy, or a wiretapping or eavesdropping statute, governing the recording of private conversations. However, little to no guidance exists on how to translate constitutional principles and case law into advice for people seeking to record their medical encounters. Interpretation: The law has not kept pace with people’s wish to record clinical interactions, which has been enabled by the arrival of mobile technology.
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Data is an integral part of healthcare delivery. A growth in digital technologies has produced large swaths of health data that contain individuals’ personal, and often sensitive, information. A key question for policymakers is how to regulate the collection, storage, sharing, and disclosure of this information. In this chapter, the authors evaluate two different types of regulatory enforcement mechanisms: public rights of action (where the government sues) and private rights of action (where private persons sue). They use a recent case to illustrate the advantages and drawbacks of private rights of action in health data privacy cases, and then use this analysis to contrast them with public rights of action. Their analysis suggests that public and private rights of action should be viewed as complementary regulatory tools, rather than competing alternatives. In short, both public and private rights of action have important roles in regulating health data. To ensure private rights are effective regulatory tools, policy makers should pay particular attention to how those rights of action are designed and implemented.
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Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants’ locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant’s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas.
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The Council of Europe, Europe's most important human rights organization, is developing a legally binding instrument for the development, design, and application of AI systems. This “Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law” (AI Convention) aims to protect human rights against the harms of AI. The AI Convention may become the first legally-binding international treaty on AI. In this article, we highlight the implications of the proposed AI Convention for the health and human rights protection of patients. We praise the following characteristics. Global regulation for technology that easily crosses jurisdictions. The human rights-based approach with human rights assessment. The actor-neutral, full-lifecycle approach. The creation of enforceable rights through the European Human Rights Court. We signal the following challenges. The sector-neutral approach. The lack of reflection on new human rights. Definitional issues, and The process of global negotiations. We conclude that it is important for the Council of Europe not to compromise on the wide scope of application and the rights-based character of the proposed AI Convention.
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This Viewpoint discusses why the legality of calling patients located in another state has suddenly been called into question.
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Patients, physicians, and hospital administrators in the USA are often unaware of how legislation governs medical data—but agree that rights over such data should be expanded for patients and curtailed for health systems.
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This Viewpoint lists the top 3 pediatric drugs and product shortages, considers the federal government’s and manufacturers’ ethical duty to protect children, reviews the causes for the shortages, and suggests policy changes that could help fill in the gap.
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This Viewpoint discusses the legal risks physicians and health care facilities may incur by miscoding a surgical or chemical abortion as a miscarriage to conceal an abortion procedure.