The UK's medicines regulator has called for new legislation to govern the use of artificial intelligence in healthcare, warning that existing rules were not designed for technology that continues to learn and change after approval. The Medicines and Healthcare Products Regulatory Agency (MHRA) says AI is set to become a routine part of NHS care, but current frameworks—built around static products such as hip replacements or stethoscopes—cannot adequately regulate AI systems that "learn, adapt and drift" as they process new data. The intervention matters because it highlights a growing gap between rapid AI adoption in medicine and the regulatory tools needed to keep patients safe and informed.

The MHRA's report, drawn up by an independent commission with input from more than 12,000 patients and clinicians, sets out 44 recommendations. These include continuous monitoring of AI products with the power to withdraw approval if they underperform, giving patients the right to know when AI is involved in their care, powers to penalise developers whose products fall short of standards, and an "L plate" scheme allowing new AI tools to be trialled under close supervision. The report notes AI scribes are already used by around 40% of GPs to record consultations, though research from the University of Edinburgh suggests some patients are less willing to disclose sensitive information when they know AI is involved. Officials acknowledged no country has yet "cracked" AI regulation, while also citing the technology's potential to rank alongside breakthroughs such as antibiotics and MRI.