UK Watchdog Calls for New Rules for AI in NHS and Healthcare
The UK needs a new regulatory playbook for AI products used in the NHS and other healthcare settings, the country’s medical watchdog says.
The Medicines and Healthcare Products Regulatory Agency (MHRA), which oversees medical devices and licenses treatments in Britain, has published 44 recommendations aimed at updating its policies as AI spreads across the health system.
MHRA chief Lawrence Tallon told the BBC that the technology will soon become a routine part of NHS care.
“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 put together by an independent commission and drew on input from more than 12,000 people, including patients and clinicians. Its recommendations include:
- Continuously monitoring AI products and pulling 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, along with easy access to information about the products used.
- Giving regulators the power to penalize developers when an AI product fails to meet required standards.
- Creating an AI “L plate” system that would make it easier for healthcare professionals to trial new AI models under close supervision.
Tallon said the existing medical device framework largely dates from an era focused on hip and knee replacements, stethoscopes, and adhesive bandages.
While current rules may work for simple AI tools trained to spot known symptoms on scans, he added, they do not fit more complex models.
“Unlike most of the medical products we’re used to regulating, these products continue to change after the point of authorization,” he said. “As new data gets fed in, they learn, they adapt, they drift.”
He acknowledged that regulating AI is a global challenge. “I don’t think at this moment in time we can point to a single country, a single regulatory framework, and say that they have absolutely cracked it,” he said.
The stakes are already visible in everyday practice. AI note-takers known as scribes, powered by large language models, are reportedly used by 40% of primary care doctors in the UK to record consultations and generate reports.
But a recent University of Edinburgh study found patients could be less willing to share personal information, such as a history of substance abuse, if they knew the conversation was being processed by AI.
Professor Henrietta Hughes, a GP who served on the report commission, said many of her patients were happy for AI to be used during consultations, while some chose to opt out. “Some say, ‘I don’t want to talk to a robot,’ and that is also fine,” she said.
Hughes acknowledged that scribes could make mistakes in their notes, but said doctors are responsible for correcting them.
For now, AI is more likely to assist with administrative tasks or carry out symptom spotting under the supervision of a human expert. Still, there is considerable excitement about its potential in healthcare and medical research.
Professor Alastair Denniston, an ophthalmologist who also worked on the report, described the technology as “an exceptional opportunity” for healthcare, one that is “likely to rank alongside step-changes such as antibiotics and MRI.”
In September, Rene Haas, chief executive of chip designer Arm, told the BBC he believed the technology would produce a cure for cancer “within our lifetime.”
But concerns remain. AI models can make wrong decisions because of biases in the patient data used to train them, and AI chatbots can offer incorrect medical advice.
The recommendations are designed to shape how regulators, developers, and clinicians handle AI as it becomes a more common feature of patient care. The challenge will be balancing faster adoption with safeguards strong enough to preserve public trust.
Related coverage:
- What is AI and how does it work?
- AI will cure cancer in our lifetime, claims boss of UK chip giant
- Anthropic researcher believes more than 10% chance AI could kill all humans
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