The UK needs new regulations for AI products used in the NHS and other healthcare settings, according to the country’s industry watchdog.
The Medicines and Healthcare Products Regulatory Agency (MHRA), which oversees medical devices and licenses medicines in the UK, has published 44 recommendations for updating its regulatory framework as the use of AI across healthcare continues to grow.
The technology is expected to become a routine part of NHS services in the near future, MHRA chief Lawrence Tallon told the Press.
“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 produced by an independent commission, with contributions from more than 12,000 people, including patients and healthcare professionals.
The recommendations include:
- Continuously monitoring AI products and withdrawing regulatory approval if they malfunction or become less effective over time.
- Giving patients the right to know when AI is being used in their care, along with straightforward access to information about the technology involved.
- Giving regulators the power to penalise AI developers when their products fail to meet required standards.
- Introducing an AI “L plate” system to allow healthcare professionals to trial new AI models under close supervision before wider use.
“The medical devices regulatory framework predominantly dates from a period where we were thinking about things like hip replacements and knee replacements, or smaller things like stethoscopes and plasters,” Tallon said.
He said existing rules may be suitable for relatively simple AI products, such as systems trained to identify known symptoms in medical scans, but may not adequately cover more advanced and 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.”
Tallon also acknowledged that regulating artificial intelligence remains a major challenge for regulators worldwide.
“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.
‘I don’t want to talk to a robot’
AI note-taking tools known as scribes, which use large language models (LLMs), are reportedly already being used by 40% of UK-based GPs to record consultations and produce reports.
However, a recent University of Edinburgh study found that patients may be less willing to disclose sensitive information, including substance abuse histories, if they know their consultation is being processed by AI.
Professor Henrietta Hughes, a GP who was part of the commission behind the report, said many of her patients were comfortable with AI being used during consultations, although some decided to opt out.
