The Consequences of the AI Act and Proposed AI Liability Directive on Medical Negligence

The European Union (EU) has initiated a two-fold approach to regulating AI, consisting of the Artificial Intelligence Act (AI Act) and the proposed AI Liability Directive. This paper takes an exploratory approach to critically evaluate the new regulation and proposals in resolving medical negligence claims, through using example case studies to highlight the realities and applicability of the regulations in ʻreal world’ scenarios. Through assessment of the England and Wales common law, this paper argues that the duty of care owed by physicians when collaborating with AI is currently not fit for purpose. In addition, this paper highlights that enforcement of the new Act and proposed Directive will lead to physicians falling victim to ʻred tape’ rules, and in turn, stifle innovation and reduce the benefits AI can bring to the healthcare sector. Finally, the paper argues that the legislative stance leaves many questions regarding the practicalities of medical negligence unanswered, highlighting the future difficulties the courts will face in applying the new rules once approved.