The UK’s medical devices regulator has called for new rules governing AI in healthcare, including greater patient transparency and ongoing monitoring of products.
The UK needs new regulations for artificial intelligence products used in healthcare as the technology becomes increasingly common across the NHS, according to the industry watchdog.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has published 44 recommendations for updating its regulatory framework following a review involving more than 12,000 patients, clinicians and other people.
MHRA chief executive Lawrence Tallon told the BBC that AI would soon become a routine part of NHS healthcare, but said its use needed to maintain patients’ trust.
Under the proposals, patients would have the right to know when AI is involved in their care and would be given easier access to information about the technology being used.
AI products would also be monitored continuously, with regulators able to withdraw approval if a system malfunctioned or became less effective over time.
Developers could also face penalties if their products failed to meet required standards.
Another recommendation is an AI “L plate” system, allowing new models to be trialled by healthcare professionals under close supervision.
Tallon said existing medical device regulations were largely designed for products such as hip replacements, stethoscopes and plasters rather than software that can evolve after being approved.
He said: “Unlike most of the medical products we’re used to regulating, these products continue to change after the point of authorisation.
“As new data gets fed in, they learn, they adapt, they drift.”
AI scribes, which use large language models to record medical consultations and produce notes, are already reportedly used by about 40 per cent of UK GPs.
However, research from the University of Edinburgh found some patients may be less willing to discuss sensitive subjects, including substance abuse, if they know AI is processing their conversation.
Professor Henrietta Hughes, a GP who contributed to the report, said some patients were comfortable with AI while others chose not to use it.
There are also concerns about errors and bias in healthcare AI, particularly where systems are trained on incomplete or unrepresentative patient data.
Professor Alastair Denniston, an ophthalmologist involved in the review, described AI as an “exceptional opportunity” for healthcare, potentially ranking alongside breakthroughs such as antibiotics and MRI.
But Tallon said no country had yet found a perfect regulatory model for the rapidly evolving technology.
He said: “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.”
Watchdog calls for new regulations for AI products used in UK healthcare
