Artificial intelligence and liability in health systems across the WHO European region: policy brief

The rapid adoption of artificial intelligence (AI) in health systems across the WHO European Region is introducing technologies with increasing levels of complexity, opacity and autonomy, creating new challenges for patient safety, accountability and liability. While liability frameworks traditionally provide protection and compensation for harm and incentivize responsible behavior, existing rules may not adequately address situations where AI contributes to clinical decisions. The complexity of AI systems can make it difficult for patients to establish faults and causations, while uncertainty over responsibility between manufacturers, healthcare professionals and organizations may create gaps in accountability. This policy brief examines challenges and gaps in liability frameworks for AI in health and proposes measures to strengthen accountability, clarify responsibilities, and improve access to redress across the WHO European Region.