Interoperability in a Post-Roe Era: Sustaining Progress While Protecting Reproductive Health Information.

This Viewpoint proposes a solution to better safeguard reproductive health information in patient records that are now more complete owing to the interoperability of health information exchange networks.

The Emerging Hazard of AI-Related Health Care Discrimination.

Artificial intelligence holds great promise for improved health-care outcomes. But it also poses substantial new hazards, including algorithmic discrimination. For example, an algorithm used to identify candidates for beneficial "high risk care management" programs routinely failed to select racial minorities. Furthermore, some algorithms deliberately adjust for race in ways that divert resources away from minority patients. To illustrate, algorithms have underestimated African Americans' risks of kidney stones and death from heart failure. Algorithmic discrimination can violate Title VI of the Civil Rights Act and Section 1557 of the Affordable Care Act when it unjustifiably disadvantages underserved populations. This article urges that both legal and technical tools be deployed to promote AI fairness. Plaintiffs should be able to assert disparate impact claims in health-care litigation, and Congress should enact an Algorithmic Accountability Act. In addition, fairness should be a key element in designing, implementing, validating, and employing AI.

Physician Burnout Calls for Legal Intervention.

Physician burnout is receiving more attention in the medical literature, and deservedly so. For example, in October of 2019, the National Academies of Sciences, Engineering, and Medicine published a lengthy report called Taking Action against Clinician Burnout: A Systems Approach to Professional Well-Being. The report is comprehensive and well worth reading, and it offers a series of sound recommendations for addressing the burnout problem. However, the recommendations are quite ambitious, and implementing them would require a considerable investment of time, staffing, and financial resources. The medical community should not be left to grapple with the phenomenon of physician burnout alone. The law has a significant role to play in addressing the problem. As a first step, it is useful to consider a few concrete interventions that regulators could realistically implement in the short term.

Improving Regulatory Enforcement in the Face of Inadequate Resources.

This exercise is designed to focus students' attention on the challenges of regulatory enforcement. The case example is drawn from Oregon's regulation of in-home care agencies (IHCA). Students are asked to formulate suggestions for enhancing compliance with IHCA regulations in the absence of additional funding. The author includes her own suggestions, which she developed during her fellowship.

Big bad data: law, public health, and biomedical databases.

The accelerating adoption of electronic health record (EHR) systems will have far-reaching implications for public health research and surveillance, which in turn could lead to changes in public policy, statutes, and regulations. The public health benefits of EHR use can be significant. However, researchers and analysts who rely on EHR data must proceed with caution and understand the potential limitations of EHRs. Because of clinicians' workloads, poor user-interface design, and other factors, EHR data can be erroneous, miscoded, fragmented, and incomplete. In addition, public health findings can be tainted by the problems of selection bias, confounding bias, and measurement bias. These flaws may become all the more troubling and important in an era of electronic "big data," in which a massive amount of information is processed automatically, without human checks. Thus, we conclude the paper by outlining several regulatory and other interventions to address data analysis difficulties that could result in invalid conclusions and unsound public health policies.

The use and misuse of biomedical data: is bigger really better?

Very large biomedical research databases, containing electronic health records (EHR) and genomic data from millions of patients, have been heralded recently for their potential to accelerate scientific discovery and produce dramatic improvements in medical treatments. Research enabled by these databases may also lead to profound changes in law, regulation, social policy, and even litigation strategies. Yet, is "big data" necessarily better data? This paper makes an original contribution to the legal literature by focusing on what can go wrong in the process of biomedical database research and what precautions are necessary to avoid critical mistakes. We address three main reasons for approaching such research with care and being cautious in relying on its outcomes for purposes of public policy or litigation. First, the data contained in biomedical databases is surprisingly likely to be incorrect or incomplete. Second, systematic biases, arising from both the nature of the data and the preconceptions of investigators, are serious threats to the validity of research results, especially in answering causal questions. Third, data mining of biomedical databases makes it easier for individuals with political, social, or economic agendas to generate ostensibly scientific but misleading research findings for the purpose of manipulating public opinion and swaying policymakers. In short, this paper sheds much-needed light on the problems of credulous and uninformed acceptance of research results derived from biomedical databases. An understanding of the pitfalls of big data analysis is of critical importance to anyone who will rely on or dispute its outcomes, including lawyers, policymakers, and the public at large. The Article also recommends technical, methodological, and educational interventions to combat the dangers of database errors and abuses.

Balancing Privacy, Autonomy, and Scientific Needs In Electronic Health Records Research.

The ongoing transition from paper medical files to electronic health records will provide unprecedented amounts of data for biomedical research, with the potential to catalyze significant advances in medical knowledge. But this potential can be fully realized only if the data available to researchers is representative of the patient population as a whole. Thus, allowing individual patients to exclude their health information, in keeping with traditional notions of informed consent, may compromise the research enterprise and the medical benefits it produces. This Article analyzes the tension between realizing societal benefits from medical research and granting individual preferences for privacy. It argues for a shift in the conceptual and regulatory frameworks that govern biomedical research. When studies involve electronic record review rather than human experimentation, the traditional, autonomy-dominated model should give way to one that emphasizes the common good. In record-based studies, the limited benefits of individual informed consent come at too high a cost-difficult administrative burdens, significant expenses, and a tendency to create selection biases that distort study outcomes. Other mechanisms can better protect data subjects' privacy and dignitary interests without compromising research opportunities. In this Article, we formulate a novel, multi-faceted approach to achieve these ends. This approach recognizes that technical means for achieving identity concealment and information security are necessary but not sufficient to protect patients' medical privacy and to foster public trust while facilitating research. Hence, we call for supplementing such means with (1) an oversight process that is tailored to record-based research and applies even to de-identified patient records, which are currently exempt from scrutiny, and (2) public notice and education about the nature and potential benefits of such research.

The drugs stop here: a public health framework to address the drug shortage crisis.

Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend of legislative, regulatory, and private-sector interventions that should deter undesirable conduct on the part of manufacturers and provide appropriate incentives to combat the drug shortage phenomenon.

Improving health care outcomes through personalized comparisons of treatment effectiveness based on electronic health records.

Comparative effectiveness research (CER) is one of the Patient Protection and Affordable Care Act's significant initiatives that aims to improve treatment outcomes and lower health care costs. This article takes CER a step further and suggests a novel clinical application for it. The article proposes the development of a national framework to enable physicians to rapidly perform, through a computerized service, medically sound personalized comparisons of the effectiveness of possible treatments for patients' conditions. A treatment comparison for a given patient would be based on data from electronic health records of a cohort of clinically similar patients who received the treatments previously and whose outcomes were recorded. This framework has unique potential to simultaneously improve the quality of health care, reduce its cost, and alleviate public concerns about rationing and "one size fits all" medicine.

Breach notification and the law.

The American Medical Association Council on Ethical and Judicial Affairs (CEJA) has written a position paper on physicians' ethical responsibilities in the event that the security of patients' electronic health information has been breached. The report offers compelling ethical and practical justifications for notification requirements and articulates guidelines for clinicians. This commentary addresses a gap in the report. It outlines the new legal duty to disclose security breaches, established by the 2009 HITECH Act, which is only briefly mentioned in the report. The commentary also analyzes the CEJA recommendations in light of the legal mandate and suggests that the guidance would benefit from further clarification.

Law, liability, and public health emergencies.

According to many experts, a public health emergency arising from an influenza pandemic, bioterrorism attack, or natural disaster is likely to develop in the next few years. Meeting the public health and medical response needs created by such an emergency will likely involve volunteers, health care professionals, public and private hospitals and clinics, vaccine manufacturers, governmental authorities, and many others. Conducting response activities in emergency circumstances may give rise to numerous issues of liability, and medical professionals and other potential responders have expressed concern about liability exposure. Providers may face inadequate resources, an insufficient number of qualified personnel, overwhelming demand for services, and other barriers to providing optimal treatment, which could lead to injury or even death in some cases. This article describes the different theories of liability that may be used by plaintiffs and the sources of immunity that are available to public health emergency responders in the public sector, private sector, and as volunteers. It synthesizes the existing immunity landscape and analyzes its gaps. Finally, the authors suggest consideration of the option of a comprehensive immunity provision that addresses liability protection for all health care providers during public health emergencies and that, consequently, assists in improving community emergency response efforts.