UK needs new laws for AI in healthcare, says watchdog

Britain’s medicines watchdog says the UK needs fresh rules for AI in healthcare, as the NHS and other services use more of it. The Medicines and Healthcare Products Regulatory Agency has put out 44 recommendations to update policies that were built for a very different era of medicine.

The agency’s chief, Lawrence Tallon, said AI is on track to become a routine part of NHS care. He also argued that patients need to trust it, not just tolerate it. That is the thread running through the whole report: let the technology in, but keep a close hand on it.

Some of the proposals are blunt. AI products would need continuous monitoring after approval, with the option to remove them if they start to fail or lose effectiveness. Patients would also have the right to know when AI is involved in their care and to get clear information about the tools being used. The agency also wants the power to penalise developers whose products fall short of required standards.

There is also a practical idea tucked into the recommendations: an AI “L plate” system for new models, so healthcare professionals can try them under close supervision. Tallon said the current medical devices framework was built for things like hip replacements, knee replacements, stethoscopes and plasters, not software that keeps changing after approval.

That point matters, because AI does not sit still. Tallon said these systems can learn, adapt and drift as new data is fed in. He also admitted no country has fully solved the regulatory problem yet. The report drew on input from more than 12,000 people, including patients and clinicians, and it lands as AI scribes are already being used by 40% of UK-based GPs. But the same technology raises awkward questions: an Edinburgh study found some patients may be less willing to share sensitive information if they know AI is processing the conversation.