This article addresses the data protection and product safety regulatory models currently applied to consumer-facing health technologies. It explains how the design and structures of existing data protection and safety regulation in the U.S. have resulted in exceptionally thin protection for the users of consumer-facing devices and products that rely on or that facilitate consumer collection or aggregation of health and wellness data. It also examines some appealing legislative alternatives to the current thin model used in the U.S. and suggests a framework for prioritizing ameliorative regulation. To better understand existing regulatory models, their deficiencies, and how they should be reformed, the article employs an analytical model describing these regulatory systems across two axes. The vertical axis describes the quantity or depth of regulation, such as, for example, the strictness of the rules imposed by the regulatory model. The horizontal axis describes the reach of the regulation, the behaviors, products, or industries to which the regulation applies.

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.

A key feature of unregulated mHealth research is the diversity of participants in this space. Applying an approach drawn from user experience design, we describe a set of archetypal unregulated mHealth researcher “personas,” which range from individuals who seek empowerment or have philanthropic objectives to those who are primarily motivated by financial gain or have misanthropic objectives. These descriptions are useful for evaluating policies applicable to mHealth to understand how they will impact various stakeholders.

The promises of precision medicine are often heralded in the medical and lay literature, but routine integration of genomics in clinical practice is still limited. While the “last mile” infrastructure to bring genomics to the bedside has been demonstrated in some healthcare settings, a number of challenges remain — both in the receptivity of today's health system and in its technical and educational readiness to respond to this evolution in care. To improve the impact of genomics on health and disease management, we will need to integrate both new knowledge and new care processes into existing workflows. This change will be onerous and time-consuming, but hopefully valuable to the provision of high quality, economically feasible care worldwide.

In this article, we consider the possible application of the European General Data Protection Regulation (GDPR) to “citizen scientist”-led health research with mobile devices. We argue that the GDPR likely does cover this activity, depending on the specific context and the territorial scope. Remaining open questions that result from our analysis lead us to call for lex specialis that would provide greater clarity and certainty regarding the processing of health data by for research purposes, including these non-traditional researchers.

The use of decision-making capacity assessments (DMCA) in clinical medicine is an underdeveloped yet quickly growing practice. Despite the ethical and clinical importance of these assessments as a means of protecting patient autonomy, clinicians, philosophers, and ethicists have identified a number of practical and theoretical hurdles which remain unresolved. One ethically important yet largely unaddressed issue is whether, and to what extent physicians ought to inform and obtain consent from patients prior to initiating a capacity assessment. In what follows, I address the following question: Must, or should, physicians obtain consent for capacity assessments? I argue that physicians have an ethical obligation to obtain express patient consent for capacity assessments, and in doing so, I challenge the predominant view which requires physicians to merely inform patients without obtaining consent. I then identify an underlying philosophical paradox that complicates the clinician's duty to obtain consent: in short, consent is needed for an assessment of one's ability to consent. Finally, I recommend a practical solution to this paradox of consent for capacity assessments by proposing a model of double consent from both the patient and health care representative.

Between 2010 and 2016, the percentage of uninsured higher education students dropped by more than half. All the Affordable Care Act's key access provisions contributed, but the most important factor appears to be the Medicaid expansion. This article is the first to highlight this phenomenon and ground it in data. It explores the reasons for this dramatic expansion of coverage, links it to theoretical frameworks, and considers its implications for the future of health reform. Drawing on Medicaid universality scholarship, I discuss potential consequences of including the educationally privileged in this historically stigmatized program. Extending this scholarship, I argue that the student experience and its reverberating effects portend support for emerging proposals to make Medicare a more common option. Woven into both analyses is the role of the Trump-era retrenchment, notably the administration's promotion of Medicaid “work or community engagement” requirements and of cheap, skimpy plans. Higher education students were an afterthought in the ACA's debates, and yet the law has profoundly impacted their coverage options. Students are now much more likely to have health insurance, and for it to be comprehensive. Looking to the next decade, the student experience harbingers support for both Medicaid universality and Medicare commonality.

This essay argues that feminist legal theory offers an important, and underutilized, perspective to examine health law and policy. We use several theoretical frameworks developed by feminist legal theorists including relational autonomy, intersectionality, vulnerability theory, and the feminist critique of the public-private divide to demonstrate the utility of these theories to health law analysis. These frameworks provide insights relevant not only to issues that obviously relate to gender, but also to matters of choice, quality, and access that are less obviously gender-related. We map three key areas of existing scholarship and future inquiry at the intersection of health law and feminist legal theory: (I) patient choice and relational autonomy, (II) patriarchy, power and patient safety, and (III) access to health care and healthy living conditions at the public-private divide. Uniting these areas of inquiry is a nagging question central to the relationship between critical legal scholarship (including feminist scholarship) and pragmatic action to combat injustice: Can we use legal rights to achieve our aims even as we recognize them as tainted tools that have propped up oppressive social structures? A feminist agenda for health law and policy must grapple with this dilemma.

In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system.