Faculty Bibliography
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Same-sex couples, not unlike their heterosexual counterparts, would prefer having a genetically related child.However, assisted same-sex human reproduction has heretofore been deemed infeasible absent haploid cellularanalogs of human gametes. Recent developments, however, may have overcome this limitation through thederivation of haploid embryonic stem cells (hapESCs). Undifferentiated, pluripotent, self-renewing, and stablyhaploid, hESCs have also displayed germline competence. It is in this capacity that murine hESCs, doubling upas de facto gametes, gave rise to bimaternal and bipaternal progeny. Herein we argue that assisted same-sexhuman reproduction, although potentially attainable at this time, is still years away from the clinic. In support ofthis perspective, we note the significant technical, regulatory, statutory, and societal hurdles that stand in theway of near-term implementation.
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The melding of human genetics with clinical assisted reproduction, now all but self-evident, gave flight to diagnostic and therapeutic approaches previously deemed infeasible. Preimplantation genetic diagnosis, mitochondrial replacement techniques, and remedial germline editing are particularly noteworthy. Here we explore the relevant disruption brought forth by coalescence of these mutually enabling disciplines with the regulatory and legal implications thereof.
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June Medical Services v. Russo is the U.S.Supreme Court’s first abortion case since President Donald Trump appointed two new conservative justices—leading many to predict the end of Roe v. Wade. Yet Chief Justice John Roberts joined his four more liberal colleagues to strike down the restriction by a 5-4 majority. But the distinct reasoning of his separate opinion could give shelter to a wide range of abortion laws. Chief Justice Roberts may be playing the long game. His vote ensures that a woman's basic constitutional right to decide the fate of her pregnancy will live to fight another day. But his opinion should leave advocates wary of counting on the judiciary alone to protect against state restrictions on abortion access and providers. This article analyzes the Supreme Court's case and its multiple opinions, the significance of the Roberts concurrence for future abortion challenges, and next steps for both lower court judges and lawmakers at the state and federal level.
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Mitochondrial replacement techniques (MRTs, also referred to as mitochondrial replacement therapies) have given hope to many women who wish to have genetically related children but have mitochondrial DNA mutations in their eggs. MRTs have also spurred deep ethical disagreemensts and led to different regulatory approaches worldwide. In this review, we discuss the current regulation of MRTs across several countries. After discussing the basics of the science, we describe the current law and policy directions in seven countries: the United Kingdom, the United States, Canada, Australia, Germany, Israel, and Singapore. We also discuss the emerging phenomenon of medical tourism (also called medical travel) for MRTs to places like Greece, Spain, Mexico, and Ukraine. We then pull out some key findings regarding similarities and differences in regulatory approaches around the world.
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There has been increasing interest in the use of home monitoring technologies during the COVID-19 pandemic to decrease interpersonal contacts and the resultant risks of exposure for people to the coronavirus SARS-CoV-2. This Perspective explores how the accelerated development of these technologies also raises major concerns pertaining to safety and privacy. We make recommendations for needed interventions to ensure safety and review best practices and US regulatory requirements for privacy and security. We discuss, among other topics, Emergency Use Authorizations for medical devices and privacy laws of the USA and Europe.
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In February, 2020, the European Commission published a white paper on artificial intelligence (AI) as well as an accompanying communication and report. The paper sets out policy options to facilitate a secure and trustworthy development of AI and considers health to be one of its most important areas of application. We illustrate that the European Commission's approach, as applied to medical AI, presents some challenges that can be detrimental if not addressed. In particular, we discuss the issues of European values and European data, the update problem of AI systems, and the challenges of new trade-offs such as privacy, cyber-security, accuracy, and intellectual property rights. We also outline what we view as the most important next steps in the Commission's iterative process. Although the European Commission has done good work in setting out a European approach for AI, we conclude that this approach will be more difficult to implement in health care. It will require careful balancing of core values, detailed consideration of nuances of health and AI technologies, and a keen eye on the political winds and global competition.
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This chapter will map the ethical and legal challenges posed by artificial intelligence (AI) in health care and suggest directions for resolving them. Section 1 will briefly clarify what AI is and Section 2 will give an idea of the trends and strategies in the United States (U.S.) and Europe, thereby tailoring the discussion to the ethical and legal debate of AI-driven health care. This will be followed in Section 3 by a discussion of four primary ethical challenges, namely (1) informed consent to use, (2) safety and transparency, (3) algorithmic fairness and biases, and (4) data privacy. Section 4 will then analyze five legal challenges in the U.S. and Europe: (1) safety and effectiveness, (2) liability, (3) data protection and privacy, (4) cybersecurity, and (5) intellectual property law. Finally, Section 5 will summarize the major conclusions and especially emphasize the importance of building an AI-driven health care system that is successful and promotes trust and the motto “Health AIs for All of Us”.
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Contact investigations have been a vital public health strategy, most recently in controlling tuberculosis and sexually transmitted infections including HIV. Yet, the sheer scale of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections poses major challenges to contact investigations. Strategies in China, Singapore, South Korea, and Taiwan have supplemented traditional manual approaches with digital surveillance through smartphone applications. The US has not used digital surveillance as a tool, but Google, Apple, the Massachusetts Institute of Technology (MIT), as well as 2 pan-European consortia and a variety of independent efforts are developing Bluetooth smartphone technology to enable rapid notification of users that they have had a close exposure to individuals diagnosed with medically verified coronavirus disease 2019 (COVID-19). How does digital tracking differ from manual tracing? Although digital surveillance has the distinct advantages of scale and speed, does it confer sufficient public health benefit to justify adoption given privacy concerns? How do the design choices of digital contact tracing systems affect public health and privacy?
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FGM can cause short-term complications such as severe pain, hemorrhage, tetanus infection, and urine retention.2 Long-term consequences include recurrent urinary tract infections, cyst formation, sexual difficulties, and increased risk of childbirth complications and newborn deaths.2 While some claim religious or ethnographic reasons for the practice, others view it as sustained by myths of femininity and virginity, and intended to cure vaginal "uncleanliness," prevent "deviant" premarital sexual activity, preserve "purity," and hinder sexual pleasure.2 FGM is a globally recognized human rights violation rendered unlawful under several international treaties. THE COURT'S DECISION On November 20, 2018, Judge Bernard A. Friedman of the US District Court for the Eastern District of Michigan found in Nagarwala that the statute exceeded the federal government's enumerated powers and thus declared the statute unconstitutional.3 The federal government, the court made clear, has no authority to police local or state criminal activity; such authority should be left to the states.3 The Department of Justice declined to prosecute its appeal and the US Sixth Circuit Court of Appeals refused a request by the House of Representatives to intervene, making Judge Friedman's opinion the final word.4,5 Most criminal laws are passed and enforced by states, as Congress has the power to pass legislation only in areas in which the Constitution grants it authority. "4(p31) It also accords with the interpretation of Congress, which passed the FGM ban after finding that no "single State or local jurisdiction [could] control [FGM]" or protect against the physical, psychological, and civil injury it causes.5 Second, the district court mischaracterized FGM as a noncommercial "form of physical assault" rather than as a paid-for health care service within the national market of licensed medical providers. 3(p22) As federal prosecutors argued, "FGM is usually performed by trained practitioners," and the statute "contemplates criminalizing FGM undertaken by medical practitioners in a commercial healthcare setting, which is in and of itself economic activity.
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This chapter focuses on the right (or rights) to procreate in the United States, with a focus on reproductive technology use. The United States has been too often described as the “wild west” of reproductive technology use. When measured against many of its comparators — Canada, Australia, the UK, Germany, etc. — it is undoubtedly true that more forms of reproductive technology use are permitted in the United States than elsewhere. It is for this reason that the United States has been a frequent destination for “circumvention tourism” or “fertility tourism.” At the same time, it would be wrong to think that reproductive medicine is unregulated in the United States. The chapter argues that it is just that the regulation is more fragmented, both in terms of the locus of control (federal vs. state authority, governmental vs. professional self-regulation, etc.) and also of the legal sources involved (more of a focus on tort law and family law than direct regulation at the statutory or constitutional level).
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With an anticipated shortage of ventilators for patients with coronavirus disease 2019 (COVID-19), hospitals, physicians, and nurses may have to make an unprecedented decision: should they withdraw or withhold ventilators from some patients and use them for other patients who have a better chance of survival? It is not uncommon for care teams to decide against initiating or continuing mechanical ventilation when such treatment would not achieve a patient’s goals or directives. COVID-19 presents a different case: patients who do not receive a ventilator could benefit, perhaps living for many additional years, if they receive short-term mechanical ventilation. Denying patients such treatment, against their wishes, most likely will result in their death, but it will also make this scarce resource available to other patients who are more likely to survive if they receive ventilator support. Recently developed protocols expressly call for the rationing and reallocation of ventilators, in a manner that aims to save the greatest number of lives.1 These protocols are broadly accepted by medical ethicists.1,2 But ethics aside, there are potential legal ramifications of either withholding or withdrawing a ventilator from a patient who would ordinarily receive such aid in the absence of a public health emergency. In this Viewpoint, we assess the legal risks that physicians, other health care workers, and hospital systems confront in such scenarios and recommend that states explicitly and immediately adopt legal protections for health care workers, modeled on provisions in place in Maryland.
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Imagine you are a patient who has been diagnosed with prostate cancer. The two main approaches to treating it in the United States are active surveillance versus the surgical option of radical prostatectomy. Your physician recommends the surgical option, and spends considerable time explaining the steps in the surgery, the benefits of (among other things) eliminating the tumor and the risks of (among other things) erectile dysfunction and urinary incontinence after the surgery. What your physician does not tell you is that she has arrived at her recommendation of prostatectomy over active surveillance based on the analysis of an Artificial Intelligence (AI)/Machine Learning (ML) system, which recommended this treatment plan based on analysis of your age, tumor size, and other personal characteristics found in your electronic health record. Has the doctor secured informed consent from a legal perspective? From an ethical perspective? If the doctor actually chose to “overrule” the AI system, and the doctor fails to tell you that, has she violated your legal or ethical right to informed consent? If you were to find out that the AI/ML system was used to make recommendations on your care and no one told you, how would you feel? Well, come to think of it, do you know whether an AI/ML system was used the last time you saw a physician? This Article, part of a Symposium in the Georgetown Law Journal, is the first to examine in depth how medical AI/ML interfaces with our concept of informed consent. Part I provides a brief primer on medical Artificial Intelligence and Machine Learning. Part II sets out the core and penumbra of U.S. informed consent law and then seeks to determine to what extent AI/ML involvement in a patient’s health should be disclosed under the current doctrine. Part III examines whether the current doctrine “has it right,” examining more openly empirical and normative approaches to the question. To forefront my conclusions: while there is some play in the joints, my best reading of the existing legal doctrine is that in general, liability will not lie for failing to inform patients about the use of medical AI/ML to help formulate treatment recommendations. There are a few situations where the doctrine may be more capacious, which I try to draw out (such as when patients inquire, when the medical AI/ML is more opaque, when it is given an outsized role in the final decision-making, or when the AI/ML is used to reduce costs rather than improve patient health), though extending it even here is not certain. I also offer some thoughts on the question: if there is room in the doctrine (either via common law or legislative action), what would it be desirable for the doctrine to look like when it comes to medical AI/ML? I also briefly touch on the question of how the doctrine of informed consent should interact with concerns about biased training data for AI/ML.
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Safe and effective heritable editing of the human genome is years away from the clinic because of formidable technical, statutory, regulatory, and societal challenges. In particular, we note the fledgling state of the science, the imperatives of editing efficiency, specificity, and uniformity, and the extant legal roadblock.
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Companies and healthcare providers are developing and implementing new applications of medical artificial intelligence, including the artificial intelligence sub-type of medical machine learning (MML). MML is based on the application of machine learning (ML) algorithms to automatically identify patterns and act on medical data to guide clinical decisions. MML poses challenges and raises important questions, including (1) How will regulators evaluate MML-based medical devices to ensure their safety and effectiveness? and (2) What additional MML considerations should be taken into account in the international context? To address these questions, we analyze the current regulatory approaches to MML in the USA and Europe. We then examine international perspectives and broader implications, discussing considerations such as data privacy, exportation, explanation, training set bias, contextual bias, and trade secrecy.
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Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates challenges, which regulators must pay attention to. Which medical AI/ML-based products should be reviewed by regulators? What evidence should be required to permit marketing for AI/ML-based software as a medical device (SaMD)? How can we ensure the safety and effectiveness of AI/ML-based SaMD that may change over time as they are applied to new data? The U.S. Food and Drug Administration (FDA), for example, has recently proposed a discussion paper to address some of these issues. But it misses an important point: we argue that regulators like the FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition.
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Disability, Health, Law, and Bioethics (I. Glenn Cohen, Carmel Shachar, Anita Silvers & Michael Ashley Stein eds., 2020).
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The importance of evidence-based policy rooted in experimental methods is increasingly recognized, from the Oregon Medicaid experiment to the efforts to address global poverty that were awarded a 2019 Nobel Prize. Over the past several decades, there have been attempts to extend this scientific approach to legal systems and practice. Yet, despite progress in empirical legal studies and experimental social policy research, judges, lawyers, and legal services providers often fail to subject their own practices to empirical study or to be guided by empirical data, with a particular aversion to randomized controlled trials (RCTs) (1). This is troubling, as many questions fundamental to legal practice and those it affects, such as allocation of attorney services, bail decisions, and use of mandatory mediation, could and should be informed by a rigorous evidentiary foundation. Although there are practical obstacles to undertaking legal practice RCTs, they have also been stymied by cultural barriers...
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Readings in Comparative Health Law and Bioethics examines how different countries around the world approach the same challenges in health care law and ethics: how to finance care for as many people as possible; how to ensure quality care; how to best secure patients' rights; how to regulate abortion, end of life decision-making, and assisted reproduction; and how to manage infectious diseases, tobacco use, and human subject research. The new edition considers a broader array of countries, particularly from Asia, Latin America, Africa, and the Middle East.
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In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and non-traditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits that would benefit from extension of current paradigms. Discussion of such potential paradigms should be undertaken by the development community.
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Like many other elite athletes, National Football League (“NFL”) players typically have a short playing career, often leaving the league due to injury or lack of interest from teams before they have been able to prepare sufficiently for life after the league. This qualitative study examines the experiences of NFL players related to preparing for the transition out of professional sports. We completed interviews with a total of 25 players including both current and former players, as well as 27 family members of former and current players. Factors that affected their career preparation included features of the NFL work environment which necessitated an emphasis on football over other interests, identity foreclosure that made it difficult to consider other career options, limited exposure to other professions, and challenges with financial planning. Social contacts had both positive and negative effects on players’ preparation but family, particularly wives, provided important support. Our findings point to policies that might guide players in their preparation for life as former players including instituting mandatory training and counseling concerning these issues, beginning in a player’s rookie year, and continuing throughout players’ tenures in the league.
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On May 5, 2019, Indiana became the first state to legislate against a doctor’s failure to obtain his fertility patient’s consent before inseminating her using his own sperm. Less than a month later, Texas passed an even stricter law against fertility fraud, as the practice is called. The explosion of at-home DNA testing has recently uncovered dozens of doctors who conceived scores of offspring using their own sperm instead of the samples provided by a spouse, an unknown donor, or a donor that the patients had selected. This revelation has upended families, revealed webs of biological half-siblings, and confounded the legal system. Fertility fraud is a pressing case study about the demands of informed consent and modern struggles between patient wellbeing and autonomy in the clinical practice of obstetric and fertility medicine. The answers to these hard questions are also giving rise to new criminal and civil penalties that are codifying those developments in medical ethics into law.
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Medical crowdfunding has raised many ethical concerns, among them that it may undermine privacy, widen health inequities, and commodify health care. One motivation for medical crowdfunding has received particular attention among ethicists. Recent studies have shown that many individuals are using crowdfunding to finance access to scientifically unsupported medical treatments. Recently, GoFundMe prohibited campaigns for antivaccination groups on the grounds that they “promote misinformation about vaccines” and for treatment at a German clinic offering unproven cancer treatments due to “the need to make sure people are equipped to make well-informed decisions.” GoFundMe has not taken any additional actions to regulate the much larger presence of campaigns seeking to fund unproven medical interventions on the platform. In this article, we make the ethical case for intervention by GoFundMe and other crowdfunding platforms.
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There are two distinct problems about bystander effects raised by organ donor intervention research. The first is the problem of “bystander organs”—sometimes called “non-target organs”—which Kimmelman discusses in his case presentation. How do we treat the recipients of organs that are not the subject of the intervention research but nonetheless might be directly affected by the research? The second problem is not about altering the organ but the pattern of distribution of organs. Each of these cases shows bystander effects that matter for real people. This article examines how research ethics should approach each of these cases.
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The market for patient data has never been more active. Technology companies, from startups to giants, are eager to access electronic health record (EHR) data to build the next generation of health-focused products. Medical artificial intelligence (AI) is particularly data-hungry; large, representative data sets hold promise for advancing not only AI companies’ growth, but also the health of patients. Companies’ overtures to major hospitals about data sharing have highlighted legal and ethical uncertainties as to whether and how to undertake these relationships. One such partnership is now being challenged in court. In June 2019, a patient sued the University of Chicago Medical Center and Google for alleged misuse of patient EHR data. This Viewpoint discusses the case and what it signals about the need for thoughtful governance of data sharing between health care organizations and technology companies.
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While genetic testing may be the gateway to the future of medicine, it also poses challenges for individuals, especially in terms of differentiated treatments on the basis of their genetic characteristics. The fear of unwanted disclosure to insurers and the possibility of genetic discrimination can hamper the recruitment of individuals for clinical research that involves genetic testing. Precision medicine initiatives, such as All of Us, are proliferating in the United States. In order to succeed, however, they must ensure that the millions of Americans recruited to share their genetic data are not penalized with regard to life, disability and long-term insurance coverage. In this Perspective, we discuss several initiatives adopted by countries around the world, such as the United Kingdom and France, that better balance the interests of insurers and research subjects, and explain how the United States might learn from them. We call for regulatory and industry leadership to come together to establish a voluntary moratorium on insurance pricing with the aim of protecting research participants.
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Ingestible electronic sensors are a promising technology for improving health outcomes that may, for example, be useful in monitoring and promoting the taking of medication. However, these sensors also raise ethical and legal challenges that need to be considered by all stakeholders—notably, the creators of such products—at the earliest stages of the development process. Here, we examine selected ethical and legal issues related to ingestible electronic sensors. We first briefly describe sensors that are already available on the US and European markets as well as potential future sensor combinations. We then focus on ethical aspects, discussing patient, provider, and social issues. Finally, we provide a comparative analysis of legal regulation of ingestible electronic sensors in the US and Europe.
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The Football Players Health Study at Harvard University (FPHS) is a unique transdisciplinary, strategic initiative addressing the challenges of former players’ health after having participated in American style football (ASF). The whole player focused FPHS is designed to deepen understanding of the benefits and risks of participation in ASF, identify risks that are potentially reversible or preventable, and develop interventions or approaches to improve the health and wellbeing of former players. We are recruiting and following a cohort of former professional ASF players who played since 1960 (current n = 3785). At baseline, participants complete a self‐administered standardized questionnaire, including initial reporting of exposure history and physician‐diagnosed health conditions. Additional arms of the initiative are addressing targeted studies, including promising primary, secondary, and tertiary interventions; extensive in‐person clinical phenotyping, and legal and ethical concerns of the play. This paper describes the components of the FPHS studies undertaken and completed thus far, as well as those studies currently underway or planned for the near future. We present our initiatives herein as a potential paradigm of one way to proceed (acknowledging that it is not the only way). We share what we have learned so that it may be useful to others, particularly in regard to trying to make professional sports meet the needs of multiple stakeholders ranging from players to owners, to fans, and possibly even to parents making decisions for their children.
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This Introduction summarizes the contributions of the chapters and introduces the main themes of the edited volume Transparency in Health and Health Care in the United States: Law and Ethics (Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, Barbara J. Evans, eds., Cambridge University Press 2019). It also provides the front matter for the volume, including its table of contents.