New Legal Paradigms Regulating of Artificial Intelligence in Healthcare: The Advances, Deficits and Pitfalls of Laws in the United States and the European Union

This chapter examines the governance of artificial intelligence (AI) in healthcare in the United States (US) and the European Union (EU) through an analysis of ‘integrated governance’ and ‘digital exceptionalism’. The developments exemplify a shift towards digital exceptionalism, but that approach may not ultimately help protect patients against the potential harms of AI. The early responses toward AI regulation prioritised explorations of how to adapt existing laws to overcome the unique challenges posed by AI. Those early responses have since evolved into an approach premised on digital exceptionalism that emphasises the need for novel legal solutions to govern AI. This evolution can be explained by the ‘AI to Law’ framework which describes the rise of new technology posing new legal challenges, the inadequacy of existing law to solve those challenges, and the need for new laws to rectify that gap. To decipher this framework, the chapter outlines the uses of AI in healthcare, and highlights the ethical and legal challenges that arise from its use, such as data privacy, informed consent, and medical liability. While some existing legal doctrine can be adapted, those adaptations may be insufficient for the unique challenges proposed by AI. Digital exceptionalism reflects how novel laws are being devised to deal with those challenges, such as the EU’s Artificial Intelligence Act (AI Act), alongside the AI and Product Liability Directives. However, a dichotomy in approach remains between the EU hard law and the US soft law focus, resulting in an uncertain path forward.