UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has published 44 recommendations to update its policies following an increase in the deployment of artificial intelligence (AI) in the country’s medical sector.
The MHRA is the agency that regulates all medical devices and licences treatment drugs in the UK.
Speaking to the BBC, chief executive officer of the agency, Lawrence Tallon said the technology would soon be routinely used within the NHS.
“What I would expect is that patients will… increasingly see AI as part of the way that normal NHS healthcare is delivered.
“That should happen in a way that they can maintain their trust and their confidence in what’s happening,” Tallon said.
The report was compiled by an independent commission and involved input from more than 12,000 people, including patients and clinicians.
Among the recommendations include the need to continuously monitor AI products and remove 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; power to penalise the developers of an AI product if it fails to meet required standards; and an AI “L plate” system which would make it easier for new AI models to be trialled by healthcare professionals under close supervision.
“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 added that while current guidelines may work for simple AI products trained to spot known symptoms on scans, for example, the rules do not apply to more complex models.
“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,” he added.
He, however, acknowledged trying to regulate 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 added.
AI note-takers known as scribes, which are powered by LLMs, are reportedly used by 40 percent of UK-based GPs to record consultations and generate reports.
But a recent study from the University of Edinburgh found patients could be less likely to share personal information such as substance abuse history if they knew the conversation was being processed by AI.
Professor Henrietta Hughes, a GP who was part of the report commission, said many of her patients were happy for AI being used during their consultations, but some chose to opt out. “Some say, ‘I don’t want to talk to a robot’, and that is also fine,” she said.
