The Evolving Law and Ethics of Digital Health

Abstract

Given the novelty of digital health technologies, there remains significant confusion over which laws and regulations might apply to these technologies, and how. This chapter describes the major bodies of state and federal law that can apply, including medical device regulation by the FDA, state and federal consumer protection laws, data privacy and security laws, and potential legal liability for physicians, hospitals, manufacturers, and developers. The chapter examines how awkwardly these laws have adapted to the novel features of digital health, and vice versa. It concludes by detailing how, in the absence of quality screening by the FDA, four alternative methods of quality screening have emerged, including (1) due diligence by venture capital firms, (2) hospital guidelines for users and developers, (3) review by third-parties, such as app review web sites, and (4) coverage policies by health insurers. I call these “surrogate” or “proxy” regulation.