UK needs new laws on artificial intelligence in healthcare, says observer


The UK needs new rules for artificial intelligence products used in the NHS and other healthcare settings, says a British industry observer.

The Medicines and Healthcare Products Regulatory Agency (MHRA), which regulates all medical devices and licenses therapeutic products in the UK, has published 44 recommendations to update its policies as the use of AI in the sector grows.

The technology will soon be used routinely across the NHS, MHRA chief Lawrence Tallon told the BBC.

“I expect patients… will increasingly see AI as part of normal NHS care,” he said.

“It needs to happen in a way that they can maintain their trust and confidence in what’s going on.”

The report was compiled by an independent commission and involved more than 12,000 people, including patients and doctors.

Recommendations include:

  • 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 treatment, as well as easy access to information about the products they use.

  • The right to punish the developers of an artificial intelligence product if it does not meet the required standards.

  • An “L Plate” AI system that will make it easier for healthcare professionals to test new AI models under close supervision.

“The regulatory framework for medical devices largely came about during the period when we were thinking about things like hip replacements and knee replacements, or smaller things like stethoscopes and patches,” Tallon said.

He added that while current guidelines may work for simple AI products trained to detect known symptoms in a scan, for example, the rules do not apply to more complex models.

“Unlike most medical products that we are used to regulating, these products continue to change after approval,” he said.

“As new data comes in, they learn, adapt and drift.”

And he acknowledged that attempts to regulate AI are a global problem.

“I don’t think at this point we can point to one country, one single regulatory framework and say they’ve completely cracked it,” he said.

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