MHRA calls for new AI regulations in UK healthcare

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued 44 recommendations to update regulations for artificial intelligence products used within the UK healthcare sector, including the NHS.

MHRA chief Lawrence Tallon noted that current medical device frameworks are outdated, having been designed for static products like hip replacements rather than AI models that learn, adapt, and drift after authorization. The watchdog emphasized the need for new policies to maintain patient trust as AI becomes a routine part of healthcare delivery.

Key recommendations from the independent commission include:

• Continuous monitoring of AI products with the ability to revoke approval if they malfunction or lose effectiveness. • Granting patients the right to know when AI is involved in their care. • Implementing a system to penalize developers if products fail to meet standards. • Creating an AI ‘L plate’ system to allow healthcare professionals to trial new models under close supervision.