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:
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Continuously monitoring AI products and removing them from regulatory approval if they malfunction or become less effective over time
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Giving patients the right to know whether AI is involved in their care, and easy access to information about the products involved
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The power to penalise the developers of an AI product if it fails to meet required standards
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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.
