UK watchdog calls for new AI regulations in NHS and healthcare

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
• 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 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 authorization," he said.

"As new data gets fed in, they learn, they adapt, they drift."

And he 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 said.

'I don't want to talk to a robot'

AI note-takers known as scribes, which are powered by LLMs, are reportedly used by 40% 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 that 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.

Prof Hughes acknowledged that the scribes could make mistakes in their notes but said it was the responsibility of doctors to correct them.

While currently AI is more likely to be used to assist with administrative tasks, or carry out symptom spotting overseen by a human expert, there is a lot of excitement about its potential in the health and medical research industries.

Professor Alastair Denniston, an ophthalmologist who also worked on the report, described the technology as "an exceptional opportunity" for healthcare which was "likely to rank alongside step-changes such as antibiotics and MRI".

In September Rene Haas, the boss of chip designer Arm, told the BBC he believed the tech would come up with a cure for cancer "within our lifetime".

But there are also concerns about AI models making wrong decisions as a result of biases in the patient data used to train them, and incorrect medical advice being given by AI chatbots.