The UK’s National Commission into the Regulation of AI in Healthcare published its recommendations on 10 September, setting out how the National Health Service should approve, monitor and police AI tools used in patient care.
The independent Commission was created by the Medicines and Healthcare products Regulatory Agency (MHRA) in September 2025. It gathered evidence from more than 12,000 patients, clinicians, industry figures and technology developers over a year, the largest public engagement of its kind in the UK on health technology regulation.
Its central proposal is staged authorization. New AI models would launch under close supervision and tight guardrails, similar to learner drivers’ L-plates, and would earn fuller approval only after proving real-world safety. The Commission also wants continuous oversight across a device’s working life rather than a single approval at launch, arguing that models can drift and evolve after deployment.
Other recommendations include a public, searchable register of AI device safety information and adverse incidents, a duty to tell patients when AI is involved in their care, and stronger enforcement powers for the MHRA.
Chairs Alastair Denniston and Henrietta Hughes, both practicing NHS doctors, said regulation should shape a system that is increasingly tech-enabled and always people-centered. MHRA chief executive Lawrence Tallon called for a modern, dynamic regulatory framework that accelerates safe adoption.
Ministers and the MHRA will now weigh the report and issue a formal response. The Health Foundation’s parallel research, drawn from workshops with 78 members of the public, found accuracy was the public’s top priority and that AI must not produce worse care for any group.
