Faculty Bibliography
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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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This Viewpoint discusses how some pulse oximeters can provide incorrect oxygen saturation data for dark-skinned patients compared with light-skinned patients, describes the reasons that biased oximeters remained in use, and highlights why a rule recently proposed by the US Department of Health and Human Services may bring about needed change in the use of pulse oximetry for patients with dark skin.
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The drug-scheduling system, particularly the approach to rescheduling, should be reformed to ensure all beneficial medicines, including marijuana and psilocybin, are available to scientists and patients.
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This Viewpoint discusses a proposed DHHS rule to address discrimination in clinical algorithms and the need for additional considerations to ensure the burden of liability for biased algorithms is not disproportionately placed on health care professionals.
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Dobbs v. Jackson Women’s Health Organization radically revised the constitutional “right to privacy,” declaring that such a right does not protect the decision to have an abortion. Less appreciated is that it expressly left intact the constitutional right to “informational privacy.” In so doing, Dobbs became the next in a line of cases establishing constitutional protections for privacy alongside, and distinct from, both the substantive due process caselaw on intimate decision-making and the Fourth Amendment. This right to informational privacy has deep roots in our legal order, notwithstanding its vaguer history at the Supreme Court. It appears in the jurisprudence of all but one federal circuit as well as most state courts, and in an array of doctrinal settings, reflecting its intuitive cultural and normative force. This Article explores the surprisingly robust constitutional right to informational privacy post-Dobbs, and in particular its implications for abortion-related medical records—a particularly potent source of potential evidence, and deep privacy concerns, in a post-Dobbs world. Whatever else Dobbs is, it is also an invitation to take this value seriously—and for scholars and advocates to press the development of an “informational privacy” jurisprudence that survives, and to some extent counteracts, the erosion of decisional privacy.
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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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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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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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The development of autonomous artificial intelligence (A-AI) products in health care raises novel regulatory challenges, including how to ensure their safety and efficacy in real-world settings. Supplementing a device-centered regulatory scheme with a regulatory scheme that considers A-AI products as a ‘physician extender’ may improve the real-world monitoring of these technologies and produce other benefits, such as increased access to the services offered by these products. In this article, we review the three approaches to the oversight of nurse practitioners, one type of physician extender, in the USA and extrapolate these approaches to produce a framework for the oversight of A-AI products. Under the framework, the US Food and Drug Administration would evaluate A-AI products and determine whether they are allowed to operate independently of physician oversight; required to operate under some physician oversight via a ‘collaborative protocol’ model; or required to operate under direct physician oversight via a ‘supervisory protocol’ model.
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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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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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Telehealth has the potential to address health disparities, but not without deliberate choices about how to implement it. To support vulnerable patients, health policy leaders must pursue creative solutions such as public-private partnerships, broadband infrastructure, and value-based payment. Without these initiatives or others like them, health disparities are likely to persist despite telehealth’s tantalizing potential.
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For the average person, genetic testing has two very different faces. The rise of genetic testing is often promoted as the democratization of genetics by enabling individuals to gain insights into their unique makeup. At the same time, many have raised concerns that genetic testing and sequencing reveal intensely personal and private information. As these technologies become increasingly available as consumer products, the ethical, legal, and regulatory challenges presented by genomics are ever looming. Assembling multidisciplinary experts, this volume evaluates the different models used to deliver consumer genetics and considers a number of key questions: How should we mediate privacy and other ethical concerns around genetic databases? Does aggregating data from genetic testing turn people into products by commercializing their data? How might this data reduce or exacerbate existing healthcare disparities? Contributing authors also provide guidance on protecting consumer privacy and safety while promoting innovation.
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Employers and governments are interested in the use of serological (antibody) testing to allow people to return to work before there is a vaccine for SARS-CoV-2. We articulate the preconditions needed for the implementation of antibody testing, including the role of the U.S. Food & Drug Administration.
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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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Artificial intelligence surveillance can be used to diagnose individual cases, track the spread of Covid-19, and help provide care. The use of AI for surveillance purposes (such as detecting new Covid-19 cases and gathering data from healthy and ill individuals) in a pandemic raises multiple concerns ranging from privacy to discrimination to access to care. Luckily, there exist several frameworks that can help guide stakeholders, especially physicians but also AI developers and public health officials, as they navigate these treacherous shoals. While these frameworks were not explicitly designed for AI surveillance during a pandemic, they can be adapted to help address concerns regarding privacy, human rights, and due process and equality. In a time where the rapid implementation of all tools available is critical to ending a pandemic, physicians, public health officials, and technology companies should understand the criteria for the ethical implementation of AI surveillance.
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Context: The opioid epidemic is a major US public health crisis. Its scope prompted significant public outreach, but this response triggered a series of journalistic articles comparing the opioid epidemic to the crack cocaine epidemic. Some authors claimed that the political response to the crack cocaine epidemic was criminal justice rather than medical in nature, motivated by divergent racial demographics. Methods: We examine these assertions by analyzing the language used in relevant newspaper articles. Using a national sample, we compare word frequencies from articles about crack cocaine in 1988–89 and opioids in 2016–17 to evaluate media framings. We also examine articles about methamphetamines in 1992–93 and heroin throughout the three eras to distinguish between narratives used to describe the crack cocaine and opioid epidemics. Findings: We find support for critics' hypotheses about the differential framing of the two epidemics: articles on the opioid epidemic are likelier to use medical terminology than criminal justice terminology while the reverse is true for crack cocaine articles. Conclusions: Our analysis suggests that race and legality may influence policy responses to substance-use epidemics. Comparisons also suggest that the evolution of the media narrative on substance use cannot alone account for the divergence in framing between the two epidemics.
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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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Vaccine refusal is a serious public health problem, especially in the context of diseases with potential to spark global pandemics, such as Ebola virus disease in the Democratic Republic of the Congo. This article examines whether and when compelling vaccination through mandates and criminalization, for example, are appropriate. It argues that some legal approaches are ethical when they preserve social stability, trust in government, therapeutic research opportunities, or when they diminish disease severity.
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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.
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The practice of paying research participants has received significant attention in the bioethics literature, but the focus has been almost exclusively on consideration of factors relevant to determining acceptable payment amounts. Surprisingly little attention has been paid to what happens once the payment amount is set. What are the ethical parameters around how offers of payment may be advertised to prospective participants? This article seeks to answer this question, focusing on the ethical and practical issues associated with disclosing information about payment, and payment amounts in particular, in recruitment materials. We argue that it is permissible—and indeed typically ethically desirable—for recruitment materials to disclose the amount that participants will be paid. Further, we seek to clarify the regulatory guidance on “emphasizing” payment in a way that can facilitate design and review of recruitment materials.
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This term the Supreme Court will decide whether states can require all health insurers – including employers who self-insure – to submit health care claims data to the state’s All-Payer Claims Database (APCD). Because of the importance of the data compiled in APCDs, this case, Gobeille v. Liberty Mutual Insurance Company , could have serious ramifications for health services research.
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In order for the Food and Drug Administration (FDA) to receive the trust and deference it needs to accomplish its mission, it must be seen as relatively impervious to political manipulation. For most of the FDA’s history, it has been seen as an institution driven by scientific expertise, not by political maneuvering. However, the FDA was increasingly criticized during the Bush administration for politicizing decisions such as rejecting an application to grant the “morning after pill,” known as Plan B, over-the-counter (OTC) status for women of all ages. After an atypical approval process, the FDA approved OTC Plan B use only for women over the age of 18. Because some groups perceive the morning after pill as a form of abortion, the politically appointed leadership of the FDA was suspected of dramatically departing from normal FDA procedures in order to ensure that the application would not be approved.
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The New Jersey Supreme Court has continually avoided making moral judgments about the value of life and emphasized that such decision making should be the province of the potential parents. Recently, in Acuna v. Turkish, the court elaborated on the limitations of the decision-making right of the potential parents, and its decision demonstrated that New Jersey courts were only willing to require physicians to disclose all relevant medical information, and not moral statements that had not been agreed upon by the state's medical community, people, or legislature. Acuna might be read as a departure from the trend displayed by New Jersey courts in “wrongful birth” and “wrongful life” actions toward empowering potential parents to decide if they want to bring the pregnancy to term. However, the decision actually fits squarely within this trend in that the reluctance to expand the information to which potential parents are entitled from their physicians can be directly tied to the reluctance of the New Jersey Supreme Court to weigh in on the value of life in wrongful birth and wrongful life suits.
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In May of 2006, the Abigail Alliance for Better Access to Development Drugs (Abigail) appeared to have won a victory when a divided panel of the Court of Appeals for the District of Columbia Circuit (D.C. Circuit) ruled that “terminally ill, mentally competent adult patients” had a constitutionally protected right to access investigational medications. This victory was short lived, however. On August 7, 2007, the D.C. Circuit sitting en banc reversed this earlier decision, marking a setback in Abigail's campaign for removal of the regulatory barriers that currently prevent terminally ill patients from gaining early access to investigational drugs (i.e., experimental drugs). This loss represents a big blow for Abigail's cause, because there is no guarantee that they will have another day in court, and attaining their goal through other branches of the government remains uncertain.