UK watchdog urges new rules for AI in healthcare

The Medicines and Healthcare Products Regulatory Agency says the UK needs updated regulations for AI tools used in the NHS and other healthcare settings as adoption accelerates. The agency, which oversees medical devices and licenses medicines, has published 44 recommendations developed by an independent commission with input from more than 12,000 people, including patients and clinicians.

MHRA chief Lawrence Tallon said patients are likely to increasingly encounter AI as part of routine NHS care, but trust will depend on clearer safeguards. The proposals include continuous monitoring of approved AI products, removing approval when systems malfunction or lose effectiveness, giving patients the right to know when AI is involved in their care, and creating penalties for developers that fail to meet required standards.

The recommendations also propose an AI “L plate” system that would let healthcare professionals trial new models under close supervision. Tallon said existing medical device rules were designed for products such as hip replacements, stethoscopes and plasters, not tools that keep learning from new data after authorisation.

AI scribes powered by LLMs are reportedly used by 40% of UK-based GPs to record consultations and generate reports, though research found patients may disclose less personal information if they know AI is processing the conversation. Clinicians involved in the commission said patients should be able to opt out, while doctors remain responsible for correcting errors.