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UK needs new laws for AI in healthcare, says watchdog

2026-09-10 | original

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Why This Matters

The MHRA is admitting that a medical device framework built for hip replacements and stethoscopes can't govern AI systems that keep learning and drifting after approval. Its 44 recommendations — including continuous post-approval monitoring, patient disclosure rights, developer penalties and an 'L plate' supervised trial regime — signal how the UK plans to let AI into routine NHS care without losing patient trust. For health-AI vendors, it points to ongoing compliance obligations rather than one-off certification.

Key Takeaways

UK regulator says existing medical device rules don't cover complex, adaptive AI models that change after authorisation.
Proposals include continuous monitoring with approval withdrawal, penalties for non-compliant developers, and an 'L plate' supervised trial route.
Patients would gain the right to know when AI is involved in their care and to access details of the products used.

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The UK needs new regulations for AI products used in the NHS and other healthcare settings, says Britain's industry watchdog.

The Medicines and Healthcare Products Regulatory Agency (MHRA), which regulates all medical devices and licenses treatment drugs in the UK, has published 44 recommendations to update its policies as the use of AI in the sector rises.

The technology will soon be routinely used within the NHS, MHRA chief Lawrence Tallon told the BBC.

"What I would expect is that patients will... increasingly see AI as part of the way that normal NHS healthcare is delivered," he said.

"That should happen in a way that they can maintain their trust and their confidence in what's happening."

The report was compiled by an independent commission and involved input from more than 12,000 people including patients and clinicians.

The recommendations include:

Continuously monitoring AI products and removing them from regulatory approval if they malfunction or become less effective over time

Giving patients the right to know whether AI is involved in their care, and easy access to information about the products involved

The power to penalise the developers of an AI product if it fails to meet required standards

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Explore topics: mhra nhs ai regulation medical devices lawrence tallon