This chapter explores this last possibility but discounts the role federalism plays in forcing private ordering. Courts have generally proved unreceptive to arguments that the federal government lacks power to regulate the practice of medicine. Even if courts were receptive to such arguments, federalism merely divides responsibilities between federal public ordering and state public ordering; it is agnostic on whether private ordering is superior to both those alternatives. Federalism thus cannot explain the outsized role private ordering plays in health care. This chapter focuses instead on constitutional speech protections, which bind the federal and state governments alike and which leave room for private actors to oversee medical speech and information flows in ways public agencies cannot do.

Digital tools to diagnose and treat patients evoke four conceptualizations of privacy. An interest in spatial privacy feels violated as the home becomes a site of digital observation and surveillance, inviting a scheme of protections geared to the traditional privacy of the home. Yet many information theorists reject location-based privacy schemes and favor control-over-information theory, stressing people’s rights to notice and consent before disclosing or using their identifiable information. US medical privacy law, including the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, rejects control-over- information theory and is more aptly portrayed as a Nissenbaumian contextual privacy scheme directed at one specific context: Clinical health care (as opposed to health-related transactions outside the clinical context). A fourth alternative would be a uniform scheme of content-based privacy regulations that stratifies the level of privacy protection based on inherent data characteristics (e.g. data about health) without regard to where in the overall economy the data are generated and stored. The European Union (EU)’s General Data Protection Regulation (GDPR) and the California Consumer Privacy Act aspire (with partial success) to extend uniform protections. This chapter examines these four visions of privacy and considers their advantages and possible drawbacks when applied to home health care. After comparing the four alternatives, the chapter recommends norms of privacy and data access for digital tools used in home care settings.

The 21st Century Cures Act preserved the FDA’s authority to regulate several categories of software that incorporate artificial intelligence/machine learning (AI/ML) techniques. The agency’s draft guidance on Clinical Decision Support Software proposed an approach for regulating CDS software and shed light on the FDA’s approach to genomic software. This chapter explains why the FDA’s proposed approach to regulating software is unlikely to preempt failure-to-warn suits. It then turns to design-defect suits, focusing on adaptive AI/ML software that continues to redesign itself throughout the product lifecycle. How will common defenses work when the state of the art is in the robotic “mind” of an AI/ML algorithm? We also reflect on broader impacts on patients, clinicians, software developers, and healthcare systems and ask whether the FDA is the “right” regulator to address the unresolved ethical and medical practice concerns that surround this software.

Genetic testing and gene editing are rapidly becoming – indeed, already are – consumer Genetic testing and gene editing are rapidly becoming – indeed, already are – consumer technologies that people can experiment with and apply on their own, potentially without any involvement by traditional payers and research funding agencies, professional scientists and healthcare providers, regulators, and medical product manufacturers. This chapter explores the challenges of regulating direct-to-consumer and do-it-yourself genomic technologies that disrupt the traditional funding, supply arrangements, and roles. It is widely understood that the U.S. Coordinated Framework for biotechnology regulation, even after a 2017 update, is a patchwork of old federal statutes that were never designed for some of the genetic technologies now emerging. This chapter explores four problems that are less well understood: First, consumer genetics poses a fundamental challenge, also seen in the sharing economy exemplified by ride-sharing platforms such as Uber and Lyft. This challenge is one of scale, and the need for regulators to oversee a massive number of small-scale transactions and individual actors. A second challenge is that consumer genetics forces a rethinking of the goals of regulation – specifically, how paternalistic is it appropriate for regulators to be? A third conundrum is whether top-down regulatory approaches can be effective and, if not, how to motivate bottom-up, citizen-led norm-setting and compliance. A final challenge concerns the fact that the human genome itself is, ultimately, software, and many of the consumer products for interpreting and manipulating it also are in the nature of software, yet traditional consumer safety regulators struggle when confronted with the task of regulating software. The chapter concludes that merely expanding the jurisdiction of existing regulatory bodies and granting them new tools and powers will not suffice. A more sweeping redesign of consumer safety regulation will be required.