Hospitals as AI Deployers: Organisational Failures and Direct Liability Risks

Abstract The present study aims to investigate the direct liability risk borne by hospitals (fault-based liability, hinging on the organisational failures of the hospital) when they deploy an AI-based medical device, with particular attention to clinical decision support systems. To do so, the article analyses the choices that hospitals make when deploying new medical devices, their sphere of control and the concrete likelihood of having to pay for damages. The study first reconstructs the lifecycle of deployment of AI systems by hospitals, through five different phases, and identifies the related organisational decisions that may generate foreseeable risks if inadequately performed and thus may lead to direct liability. The analysis then shifts to reconstructing the relevant spheres of control: it is highlighted how hospital and AI provider both contribute to the creation of the clinical environment, within which the physician exercises clinical discretion. The study further examines the concrete exposure of hospitals to direct liability on the basis of structural obstacles that claimants face and the circumstances under which recognising such liability becomes more realistic.