HeadlinesBriefing favicon HeadlinesBriefing.com

UK Proposes L-Plates for AI Health Tools

Financial Times Companies •
×

New AI healthcare tools should be given provisional “L-plates” style approval until manufacturers demonstrate real-world safety and effectiveness, according to UK’s National Commission into the Regulation of AI in Healthcare. The proposals, announced Thursday, also call for continuous monitoring after approval and easier public access to safety incident information. Led by two NHS doctors, the Commission’s conclusions were based on evidence from 12,000 people including patients, clinicians, healthcare leaders, and technology developers.

MHRA chief executive Lawrence Tallon said the UK aims to be “the best place in the world for innovators to build and test AI, for healthcare professionals to use it, and for patients to benefit from it.” Jennifer Dixon of the Health Foundation warned that the NHS must have the capacity, skills, and systems to implement and monitor AI safely at scale. Tallon noted AI differs from traditional medical devices as it continues to evolve after licensing, requiring ongoing monitoring for both improvement and potential drift. The Commission recommended a searchable safety incident database, routine patient disclosure when AI is used in care, and stronger MHRA enforcement powers.

With WHO projecting a global shortage of 11 million healthcare workers by 2030, Tallon stressed the need to use AI to enhance care with existing staff.