This policy brief identifies critical challenges for the current liability arrangements for AI-enabled health technologies and proposes measures to strengthen accountability and patient protection.
A clear and balanced liability framework should ensure appropriate protection and compensation for patients, allocate responsibility according to the roles, responsibilities and degree of control of relevant actors, and enable those involved in the development and deployment of AI to innovate within a clear and predictable legal environment.
This requires consideration not only of liability when harm occurs but also of postmarket surveillance and life cycle monitoring, which are essential to identify and address risks that may emerge after deployment and to ensure that AI systems remain safe, effective and reliable in real-world health-care settings.
Artificial intelligence and liability in health systems across the WHO European Region. Data and digital health policy brief series. Copenhagen: WHO Regional Office for Europe; 2026.