Report: UK National Commission into the Regulation of AI in Healthcare
The UK’s National Commission into the Regulation of AI in Healthcare recommends a future regulatory framework that is proportionate, lifecycle-based, and system-wide, recognizing that AI-enabled technologies can change over time, perform differently across settings, and require ongoing evaluation beyond initial approval. The recommendations call for risk- and benefit-based regulation, stronger use of real-world evidence, flexible mechanisms for updating technologies, regulatory sandboxes, enhanced enforcement, and greater international harmonization. The framework also emphasizes that responsibility for safe AI use should be shared among developers, manufacturers, healthcare providers, professionals, regulators, and policymakers, with clear accountability, governance, workforce capability, and AI literacy. Transparency and public trust are identified as additional priorities, including clearer information about AI use in care, patient and public involvement, mechanisms for reporting concerns, and more predictable engagement between innovators and regulators. For professional regulatory organizations, the report highlights the need to consider how professional regulation, product regulation, organizational governance, and patient safety systems interact as AI becomes more integrated into healthcare, while recognizing that regulatory approaches and professional expectations will need to evolve as the technology and evidence change.