Faculty Bibliography
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This paper proposes a set of guiding principles for responsible quantum innovation. The principles are organized into three functional categories: safeguarding, engaging, and advancing (SEA), and are grounded in the values of responsible research and innovation (RRI). Utilizing a global equity normative framework, we link the Quantum-SEA categories to promise and perils specific to quantum technology. The paper operationalizes the Responsible Quantum Technology framework by proposing ten actionable principles to help address the risks, challenges, and opportunities associated with quantum technology. Our proposal aims to catalyze a much-needed interdisciplinary effort within the quantum community to establish a foundation of quantum-specific and quantum-tailored principles for responsible quantum innovation. The overarching objective of this interdisciplinary effort is to steer the development and use of Quantum Technology (QT) in a direction not only consistent with a values-based society but also a direction that contributes to addressing some of society’s most pressing needs and goals.
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We examine perceived and idea ownership of US patient medical data as governed by HIPPA in a survey of three stakeholder groups: patients, primary care physicians, and medical administrators. Current and ideal unbundled ownership were measured with six questions about the rights to access, control access, profit, modify, destroy and transfer rights. First, we find that there is an underestimation of the patients’ rights in their medical data across all three samples of stakeholders. Second, all stakeholders agree on expanding patients’ rights and curtailing rights afforded to health systems.
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Regulation of mitochondrial replacement therapy (MRT) in the United States must be understood against the backdrop of the regulation—and, in some cases, lack thereof—of other reproductive technologies. Moreover, given the proximity between MRT and sensitive ethical concerns, political debates over the right to procreate, access to abortion, and concern for fetal personhood provide crucial context. This chapter situates MRT in these larger contexts and juxtaposes the National Academies of Medicine’s proposal for MRT regulation in the United States with the way Congress has thus far regulated the technology by essentially enacting a prohibition via an appropriations rider. The authors also discuss the regulatory scheme surrounding funding for MRT research as the United States lags behind other jurisdictions in nationally available funding. A final part of this chapter considers additional legal and ethical issues raised by the prospect of MRT, including the threat of medical tourism to circumvent US prohibitions.
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On April 13, 2022, the Food & Drug Administration (FDA) issued a new draft guidance for industry for "developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials ." In so doing, the FDA reaffirmed the reality that racial and ethnic minorities remain underrepresented in clinical trials. FDA Commissioner Robert M. Califf, MD offered that the "U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health." Commissioner Califf went on to pledge that "achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities." This Commentary is dedicated to a thorough review of the new FDA policy and the implications thereof.
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This Viewpoint reviews California’s recently proposed CalRx initiative to manufacture biosimilar insulin, highlights challenges facing the initiative, and suggests ways in which, if successful, the initiative could serve as a model for state-managed development of drugs other than insulin, reduce drug prices, and provide other benefits.
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This Viewpoint examines the future role of the Administration for Strategic Preparedness and Response in light of the COVID-19 pandemic.
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Microdosing psychedelic substances (“microdosing”) is a growing trend that has gained significant media and scientific attention. The practice typically involves consuming low doses of psychedelics, such as psilocybin or lysergic acid diethylamide (“LSD”), two or three times per week, over the course of weeks or months. Many claim that microdosing improves attention, creativity, or mood. Some say it reduces pain as well as symptoms of anxiety, depression, and migraine or cluster headaches. Others fear it has not been proven safe or effective by randomized controlled trials. Nevertheless, the microdosing trend is growing against the backdrop of a broader psychedelic renaissance characterized by increasing interest in researching, legalizing, consuming, and commercializing psychedelics. This Article is the first to address the legal status of microdosing under local, state, and federal law. It analyzes the national trend toward psychedelic legal reform and how it affects the legal status of people who microdose. Since 2019, over a dozen U.S. cities have decriminalized psychedelics, making their possession in each city a low priority for law enforcement. The following year, during the 2020 presidential election, the psychedelic renaissance reached a turning point. Through ballot initiatives, the District of Columbia partially decriminalized psychedelics, and Oregon became both the first state to decriminalize psychedelics and the first to legalize the production, sale, and supervised adult use of psilocybin. In 2022, Colorado became the second state to partially decriminalize psychedelics and create a legal market for their supervised administration. Related legislation has been proposed in about a dozen other states, including California, New York, Massachusetts, Illinois, and New Hampshire. However, despite the growing popularity of microdosing, these jurisdictions have largely overlooked the practice and thus raised numerous equity and public health concerns. This Article analyzes available scientific evidence for microdosing, summarizes its risks and benefits, and analyzes how existing and proposed legislation affect the practice. It concludes with recommendations for the safe and equitable integration of microdosing into existing, proposed, and future psychedelics regulation. As more jurisdictions decriminalize or legalize psychedelics, they can use the Article as a resource and guide.
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This Viewpoint discusses the controversy surrounding the FDA’s efforts to withdraw Makena from the market and the broader implications for the accelerated approval pathway.
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It is a huge pleasure to engage with Prof. Shaw’s careful and close reading of my article. Though almost a decade old, many of the issues are becoming only more relevant as it seems that Roe v Wade will be overruled in the U.S. and travel for abortion will become a sad reality. I appreciate how deeply Prof. Shaw interacts with my article and am full of praise for his work, but given the small space allocated here I only focus on our few places of disagreement.
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The sobering realization that little has changed in the scope of inpatient harm makes it plain that efforts intent on improving patient safety must be redoubled if the status quo is to be reversed. Living up to the recommendations of the iconic Institute of Medicine (IOM) Report (To Err Is Human: Building a Safer Health System) must remain top of mind. Much can and must be done to assure to the degree possible the safety of the inpatient population.
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This JGIM Perspective discusses new and emerging challenges with accessing controversial medical therapies like medical aid in dying and abortion. While some states permit these therapies for only their residents, other states prohibit these therapies for their own residents. We summarize recent developments and growing challenges for clinicians treating “medical tourism” patients from other jurisdictions.
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This Viewpoint discusses the new Colorado law prohibiting anonymous gamete donation and other debates over reproductive technologies and secrecy.
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This Viewpoint examines the murky legal treatment of various health-related wearable or other general wellness products for patients, physicians, and manufacturers, and recommends solutions.
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Hospital-at-Home (HaH) is a home-based alternative for acute care that has expanded significantly under COVID-19 regulatory flexibilities. The post-pandemic policy agenda for HaH will require consideration of multistakeholder perspectives, including patient, caregiver, provider, clinical operations, technology, equity, legal, quality, and payer. Key policy challenges include reaching a consensus on program standards, clarifying caregivers’ issues, creating sustainable reimbursement mechanisms, and mitigating potential equity concerns. Key policy prescriptions include creating a national surveillance system for quality and safety, clarifying legal standards for care in the home, and deploying payment reforms through value-based models.
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In the past two years, in 25 US states, bills have been introduced to restrict access to gender-affirming medical care for minors. Some have already become law. We show how these bills, while purporting to “protect” trans youth, are really an assault on their ability, along with their parents’ and physicians’, to make healthcare choices and to receive medically necessary care. We discuss the evidence-based guidelines for the care of these patients, the positions taken by major medical societies against these bills, and the landscape of legal challenges that are being brought against these enacted laws.
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Professor Jennifer Hochschild’s Genomic Politics: How the Revolution in Genomic Science Is Shaping Society is a must-read for anyone interested in where our politics about genetics in America has been and where it is going. It is also an exemplar of how to do mixed-methods social science work: Hochschild combines theory with database searches and coding of congressional acts and social science journal articles, open-ended interviews with authors of leading peer-reviewed articles and other experts (semi-structured with genomic experts),1 and two sets of relatively lengthy online surveys (one administered in 2011 and one in 2017, nicely allowing some opportunity to detect change) to arrive at a much more complete picture than I have seen anywhere in the extensive literature. Part I summarizes the book and highlights its main contributions. Part II engages with three questions on which the book has something to say, but where I think a longer conversation is warranted: (1) What explains the lack of partisan politicization on these topics? (2) How should equality theorists think about obligations of justice that stem from genetic bad luck and the possibility of redistribution? (3) What would it mean to take seriously the critiques of race as a genetic category and what would that mean for equality discourse?
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We appreciate the comments by Dr Genzen and colleagues about our recent Viewpoint1 on SARS-CoV-2 LDTs. The FDA has long asserted its authority to regulate LDTs even while using its enforcement discretion to largely leave LDTs alone. Although many FDA law scholars believe the FDA’s authority to regulate at least some LDTs is well supported by the relevant statutory language,2,3 Dr Genzen and colleagues are correct that this view is not universally shared and that the issue has never been resolved in court. Although there have been past attempts to clarify this question through acts of Congress, the aftermath of the COVID-19 pandemic may underscore the importance of doing so.
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Voice-based AI-powered digital assistants, such as Alexa, Siri, and Google Assistant, present an exciting opportunity to translate healthcare from the hospital to the home. But building a digital, medical panopticon can raise many legal and ethical challenges if not designed and implemented thoughtfully. This paper highlights the benefits and explores some of the challenges of using digital assistants to detect early signs of cognitive impairment, focusing on issues such as consent, bycatching, privacy, and regulatory oversight. By using a fictional but plausible near-future hypothetical, we demonstrate why an “ethics-by-design” approach is necessary for consumer-monitoring tools that may be used to identify health concerns for their users.
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On June 24, 2002, the US Supreme Court ended the constitutional right to abortion in Dobbs v Jackson Women’s Health Organization. The Court’s majority decision authored by Justice Samuel Alito was substantially the same as a draft opinion leaked a month earlier. The regulation of abortion will now be decided by the states. In this Viewpoint, we explain the Dobbs ruling and what it means for physicians, public health, and society.
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The Consumer Operated and Oriented Plans (CO-OPs), the subject of Section 1322 of the Affordable Care Act (ACA), were to constitute “qualified nonprofit health insurance issuers.” Designed with an eye toward increasing competition with the extant commercial and nonprofit insurance sector, the CO-OPs were to enhance consumer choice as well as hold down prices on the state and federal exchanges. To achieve these ends, the consumer-governed state-licensed CO-OPs were to target the individual and small-group markets. At least one qualified CO-OP was to be established in each and every state. By the fall of 2013, however, coincident with the first open enrollment period of the ACA, only 23 CO-OPs were on tap. At the time of this writing, only three of these CO-OPs remain operational in the states of Maine, Montana, and Wisconsin. Viewed in hindsight, the thorough dissolution of the CO-OPs was the product of incremental financial privation effectuated by congressional opponents of the ACA. In this Commentary, we revisit the ontogeny of the CO-OP construct, review its partisan dismantling, and explore the potential resurrection thereof.
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Health technology is advancing at a rapid clip, with many of these technologies appearing on consumer products like smartphones and tablets. Federal regulators have responded to these changes with a flexible approach that allows firms to manufacture a ‘general wellness product’ (‘GWP’) without being subject to regulation typically applied to ‘devices’ that diagnose or treat a disease or condition. Using currently available medical products and devices from across a spectrum of diseases, we describe how firms can use this existing regulatory framework to develop innovative products by ‘skating the line’ between mostly unregulated GWPs and regulated devices. On the one hand, we find that skating the line offers a variety of benefits, including potential improvements to product development, innovation, and patient access to medical technologies. On the other hand, we show that this technique has potential costs to patient safety, competition, and data sharing. Skating the regulatory line between GWP and devices, in other words, offers important benefits but is not without risks. Any further regulatory action to address such risks should be careful to leave significant unregulated space for product development.
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A substantial portion of the US population faces infertility — the National Institutes of Health reports that 15 percent of heterosexual couples are unable to conceive after one year of trying.
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Rapid developments in artificial intelligence (AI) promise improved diagnosis and care for patients, but raise ethical issues. Over 6 months, in consultation with the American Academy of Ophthalmology Committee on Artificial Intelligence, we analyzed potential ethical concerns, with a focus on applications of AI in ophthalmology that are deployed or will be deployed in the near future. We identified 3 pressing issues: (1) transparency, paradigmatically through the explanation or interpretation of AI models; (2) attribution of responsibility issues for particular harms arising from the use or misuse of AI; and (3) scalability of use cases and screening infrastructure.
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While artificial intelligence has substantial potential to improve medical practice, errors will certainly occur, sometimes resulting in injury. Who will be liable? Questions of liability for AI-related injury raise not only immediate concerns for potentially liable parties, but also broader systemic questions about how AI will be developed and adopted. The landscape of liability is complex, involving health-care providers and institutions and the developers of AI systems. In this chapter, we consider these three principal loci of liability: individual health-care providers, focused on physicians; institutions, focused on hospitals; and developers.
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The COVID-19 pandemic has highlighted that leveraging medical big data can help to better predict and control outbreaks from the outset. However, there are still challenges to overcome in the 21st century to efficiently use medical big data, promote innovation and public health activities and adequately protect individuals’ privacy. The metaphor that property is a “bundle of sticks” applies equally to medical big data. Understanding medical big data in this way raises a number of questions, including: Who has the right to make money off its buying and selling, or is it inalienable? When does medical big data become sufficiently stripped of identifiers that the rights of an individual concerning the data disappear? How have different regimes such as the General Data Protection Regulation in Europe and the Health Insurance Portability and Accountability Act in the US answered these questions differently? In this chapter, we will discuss three topics: (1) privacy and data sharing, (2) informed consent, and (3) ownership.
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Digital applications (apps) are commonly used across the research ecosystem. While apps are frequently updated in the course of clinical and behavioral research, there is limited guidance as to when an app update should trigger action related to human research participant protections and who should be responsible for monitoring and reviewing these updates. We term this the “update problem” and argue that, while it is the principal investigator's duty to track all relevant updates, the level of involvement and re-review by the institutional review board (IRB) of an approved research protocol should vary depending on whether the update may be classified as minor, not minor, or significant. Minor updates require at most annual notification of the IRB, updates that are not minor require prompt notification of the IRB, and significant updates may require full board re-review or another response. We also suggest how these policies might be implemented.
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The distribution of crucial medical goods and services in conditions of scarcity is among the most important, albeit contested, areas of public policy development. Policymakers must strike a balance between multiple efficiency and fairness objectives, while reconciling disparate value judgments from a diverse set of stakeholders. We present a general framework for combining ethical theory, data modeling, and stakeholder input in this process and illustrate through a case study on designing organ transplant allocation policies. We develop a novel analytical tool, based on machine learning and optimization, designed to facilitate efficient and wide-ranging exploration of policy outcomes across multiple objectives. Such a tool enables all stakeholders, regardless of their technical expertise, to more effectively engage in the policymaking process by developing evidence-based value judgments based on relevant tradeoffs.
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The Federation of State Medical Boards defines physician sexual misconduct as any ‘behavior that exploits the physician-patient relationship in a sexual way.’ Although several attempts have been made in recent years to clarify its incidence in the United States, physician sexual misconduct is almost certainly underreported. Physician sexual misconduct represents a severe and irreversible violation of the compact underlying the patient–physician relationship and can have far-reaching consequences on the lives of patients and their families. In addition, the credibility of and trust in physicians, both essential to the provision of medical care, could well erode in the eyes of the public at large if egregious cases of physician sexual misconduct are perceived as having gone unpunished. Although all physician licensees accused of sexual misconduct are entitled to the presumption of innocence and due process, complaints made by patients must be taken seriously and vigorously pursued. In this article, we discuss the ongoing challenge of physician sexual misconduct and provide recommendations to improve its reporting and curb its incidence.
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Once-daily oral tenofovir/emtricitabine is highly effective as pre-exposure prophylaxis (PrEP) against HIV but is dependent on adherence, which may be challenging for men who have sex with men (MSM) and use substances. Digital pill systems (DPS) permit the direct, real-time measurement of adherence, though user perceptions of data privacy in this context are unknown. Thirty prospective DPS users – HIV-negative MSM with non-alcohol substance use – completed in-depth qualitative interviews exploring preferences around privacy, access, and sharing of DPS adherence data. Participants discussed some concerns about the impact of DPS use on personal privacy, and emphasized the need for robust data protections in the technology. Participants were interested in having on-demand access to their adherence data, and were most willing to share data with primary care providers and long-term relationship partners. Future investigations exploring bioethical frameworks around DPS use are warranted, and user preferences should inform best practices for protecting DPS data.
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When applied in the health sector, AI-based applications raise not only ethical but legal and safety concerns, where algorithms trained on data from majority populations can generate less accurate or reliable results for minorities and other disadvantaged groups.
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On November 15, 2021, the US Department of Health and Human Services (HHS) rescinded a Trump-era policy that had directed the US Food and Drug Administration (FDA) to discontinue the premarket reviews of laboratory-developed tests (LDTs), including those for SARS-CoV-2.1 In a statement detailing the reversal, HHS Secretary Xavier Becerra noted that the policy “limited FDA’s ability to address certain problematic COVID-19 tests.”1 Secretary Becerra also noted that restoring the integrity of the regulatory process required that the FDA reinstate its “longstanding approach” to the oversight of the LDTs.1 Given the ever-growing demand for LDTs for detecting SARS-CoV-2, the restoration of integrity to the FDA review process could not be more timely. In this Viewpoint, we review the regulatory oversight of the LDTs, discuss its recent policy permutations, and explore potential future considerations.