Liability Issues in Data-driven Healthcare and Harmonisation Efforts in Europe

The article examines the process of digital transformation in healthcare and the implications for liability rules and compensation. Digitalisation in healthcare is leading to improved eHealth services and better patient care and outcomes, including across borders. While data and AI are undoubtedly transforming healthcare, they also raise legal and liability issues for manufacturers, care providers, healthcare professionals and insurers. The need to adapt liability rules to the digital age has been recognised. Emerging concerns about 'black box medicine' due to the opacity and complexity of AI have been addressed in the recent Artificial Intelligence Act, and two new proposed Directives also aim to cover compensation for damage caused by AI systems (AI Liability Directive) and to extend the Product Liability Directive to AI-based medical devices. Protecting patients' right to health and adequate compensation requires health authorities to adopt a 'best risk avoidance' and precautionary approach to liability rules.