Regulation of AI in healthcare

Medicine is a profession that is highly regulated by statute and case law and by various codes and guidelines, and the arrival of artificial intelligence (AI) in medicine has invoked much scrutiny, concern, and even resistance. This chapter examines how AI is likely to fit within existing regulatory frameworks around healthcare, the sort of regulatory challenges it could present, and the potential strategies available to lawmakers and regulators to address them. The chapter does not attempt to give a practical guide to navigating the complexities of any particular healthcare system, but instead focuses on the types of questions that are arising in all of them. Given that the regulatory landscape around AI in healthcare is still in a state of flux, with many new approaches still undergoing consultation or in draft form, it is likely to be some time before a clear picture of the regulatory terrain emerges. The chapter considers all the major issues and challenges that the various jurisdictions are currently grappling with.