STORY
The Government has accepted all 44 recommendations made by the National Commission into the Regulation of AI in Healthcare as part of plans to introduce a new regulatory framework for the technology. Ministers said the changes would allow patients to benefit from AI enabled medical devices more quickly while maintaining safeguards, transparency and public confidence.
The recommendations include moving away from relying principally on assessments conducted at a single point in time and towards monitoring AI medical devices throughout their working lives. The Government will also explore staged authorisation arrangements under which promising technology could be introduced into the NHS under close supervision while further evidence about its performance is collected. Patients would be given clearer information about when AI is being used as part of their care.
The Medicines and Healthcare products Regulatory Agency has opened applications for the third phase of its AI Airlock regulatory programme, which will test how devices can be monitored after they enter use. Draft guidance on managing changes made to adaptive AI devices is expected by December 2026, followed by a consultation on their classification next year. The Government plans to publish a complete implementation timetable covering all 44 recommendations by spring 2027.