UK needs new laws for AI in healthcare, says watchdog

The UK's industry watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), has urged the government to introduce new regulations for artificial intelligence (AI) products used in healthcare settings. The agency, which currently oversees medical devices and licenses treatment drugs, has published 44 recommendations to update its policies as AI use in the sector grows.

MHRA chief Lawrence Tallon believes AI will become commonplace in the NHS, stating that patients will increasingly encounter AI as part of routine care. The report, compiled by an independent commission, included input from over 12,000 individuals, including patients and healthcare professionals. It suggests continuously monitoring AI products and removing them from regulatory approval if they malfunction or become less effective over time.

Patients should also be informed about AI involvement in their care and have easy access to relevant information.

A key proposal is the implementation of an "AI L plate" system, allowing new AI models to be trialled by healthcare professionals under close supervision. The current medical devices regulatory framework primarily dates back to simpler technologies like hip replacements and stethoscopes, and may not be effective for more complex AI systems that adapt and evolve after authorization.

While AI note-takers, or scribes, powered by large language models (LLMs) are currently used by 40% of UK-based GPs, a University of Edinburgh study found patients may be less likely to share sensitive information if they know their consultations are being processed by AI. Professor Henrietta Hughes, part of the report commission, noted that some patients prefer not to interact with AI during consultations.

Despite potential benefits, there are concerns about AI models making incorrect decisions due to biased data or providing inaccurate medical advice.