Britain's industry watchdog has called for new regulations governing the use of artificial intelligence (AI) products within the National Health Service (NHS) and other healthcare settings. The Medicines and Healthcare Products Regulatory Agency (MHRA), responsible for regulating medical devices and licensing treatments in the UK, has released 44 recommendations aimed at updating its policies to address the rising use of AI in the sector.
MHRA chief Lawrence Tallon indicated that AI is expected to become a routine part of healthcare delivery 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," he told the BBC. "That should happen in a way that they can maintain their trust and their confidence in what's happening."
The recommendations stem from a report compiled by an independent commission that gathered input from over 12,000 individuals, including patients and clinicians. Key proposals include continuously monitoring AI products, removing them from regulatory approval if their performance degrades over time, and granting patients the right to know if AI is involved in their care, along with accessible information about these products.
The agency also suggests empowering itself to penalize AI product developers whose products fail to meet required standards. Furthermore, an AI "L plate" system is proposed to facilitate the supervised trial of new AI models by healthcare professionals.
Tallon explained that the current medical device regulatory framework was primarily designed for physical devices like hip replacements or stethoscopes. While these guidelines may suffice for simpler AI applications, such as those trained to identify known symptoms in scans, they are inadequate for more complex AI models. "Unlike most of the medical products we're used to regulating, these products continue to change after the point of authorization," he noted. "As new data gets fed in, they learn, they adapt, they drift."
Regulating AI presents a global challenge, Tallon acknowledged, stating that no single country or regulatory framework has definitively solved the issue.