UK watchdog says AI in the NHS needs its own rulebook

Key points

• The Medicines and Healthcare Products Regulatory Agency (MHRA) published 44 recommendations in 2025 to update UK rules for AI used in healthcare settings.
• An independent commission gathered input from more than 12,000 people, patients and clinicians alike, to shape the report.
• AI note-taking tools, called scribes, are now used by roughly 40% of UK-based GPs to record patient consultations.
• A University of Edinburgh study found patients may withhold sensitive information if they know AI is processing their conversation.
• MHRA chief Lawrence Tallon told the BBC that no country has yet fully solved the problem of regulating AI medical products.

Britain's medical products regulator says the rules that govern AI used in healthcare are out of date, and patients need stronger protections before the technology becomes a routine part of NHS care.

The Medicines and Healthcare Products Regulatory Agency, known as the MHRA, oversees medical devices and drug approvals in the UK. It has published a report, compiled by an independent commission with input from more than 12,000 patients and clinicians, calling for 44 changes to how AI health products are regulated.

What would the new rules actually change?

The four headline proposals are concrete and patient-facing. First, AI products would face continuous monitoring and could be pulled from use if they stop working properly. Second, patients would gain the right to know when AI is involved in their care. Third, regulators would get the power to fine developers whose products fall short of required standards. Fourth, a proposed "L plate" system, borrowing the learner-driver symbol, would let new AI tools be tested by healthcare professionals under close supervision before wider rollout.

MHRA chief Lawrence Tallon explained the problem clearly to the BBC. Current rules were written for things like hip replacements and stethoscopes. A hip replacement does not keep changing after it is fitted. Many AI systems do.

"Unlike most of the medical products we're used to regulating, these products continue to change after the point of authorization," Tallon told the BBC. "As new data gets fed in, they learn, they adapt, they drift."

That last word is the one that matters. An AI tool approved as safe today may quietly become less accurate months later, and existing rules have no mechanism to catch that.

Should patients be worried right now?

The technology is already in NHS consulting rooms. AI scribes, note-taking tools powered by large language models (the same underlying technology that drives chatbots like ChatGPT), are used by around 40% of UK GPs to record appointments and produce written summaries. Professor Henrietta Hughes, a GP who sat on the commission, said most of her patients accept the tools, but some opt out and are entitled to do so.

The honest concern is not the note-taking itself. It's what patients do differently when they know a machine is listening. A University of Edinburgh study found people are less likely to disclose sensitive details, such as substance abuse history, when they know AI is processing the conversation. That gap in information could affect the care they receive. Our story on 31 August found that AI scribes were already making serious medical errors that GPs were missing, according to Healthwatch England, and a GP writing for AI2Day on 7 September described the notes as riddled with errors and contradictions.

Professor Alastair Denniston, an ophthalmologist on the commission, called AI an "exceptional opportunity" for healthcare that could "rank alongside step-changes such as antibiotics and MRI". Tallon, meanwhile, was candid that regulators globally are still catching up: no country, he told the BBC, has fully cracked it yet.

Watch for: any letter or message from your GP surgery mentioning AI note-taking tools. You have every right to ask whether AI was used during your appointment and, under the proposed rules, you'd be entitled to information about the specific product involved. For now, ask your doctor directly if you're uncertain.