UK commission sets out a staged licence regime for medical AI

The National Commission into the Regulation of AI in Healthcare published its recommendations on 10 September 2026. The Medicines and Healthcare products Regulatory Agency set the commission up in September 2025 under Professor Alastair Denniston, an NHS consultant, with Patient Safety Commissioner Professor Henrietta Hughes as deputy chair. Over a year it took evidence from more than 12,000 people, and the Health Foundation ran deliberative sessions with 78 members of the public across three UK locations in March and April 2026.

The central proposal is a staged authorisation the commission likens to a learner plate: a new model goes into service under close supervision and tight guardrails, demonstrates real-world safety and performance there, and only then receives fuller authorisation. Alongside it: monitoring of AI devices across their whole working life rather than at approval alone, a public route to search the safety and adverse-incident record of a specific device, stronger MHRA enforcement powers, and a proportionate duty to tell patients when AI is used in their care.

A medical device is normally judged once, on a fixed specification. A model that keeps learning, or that meets a population it was not trained on, is not fixed. The commission’s answer is to regulate the deployment rather than the artifact. The government and the MHRA say a formal response will follow.