MHRA Calls for 44 New AI Healthcare Regulations — SkimNews

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- MHRA published 44 recommendations to update policies for AI in NHS and healthcare settings, compiled by an independent commission with input from more than 12,000 patients and clinicians.
- MHRA chief Lawrence Tallon said the existing framework 'predominantly dates from a period' of regulating hip replacements and stethoscopes, and doesn't address complex AI models that 'continue to change after the point of authorization.'
- The recommendations include continuous monitoring and removal of malfunctioning AI products, a patient right to know when AI is involved in their care, powers to penalize non-compliant developers, and an AI 'L plate' system for supervised trialling.
- AI scribes powered by LLMs are reportedly used by 40% of UK-based GPs to record consultations, but a University of Edinburgh study found patients were less likely to disclose personal information like substance abuse history when they knew AI was processing the conversation.
- Professor Henrietta Hughes said some patients tell her 'I don't want to talk to a robot' and opt out of AI-assisted consultations, while others are comfortable with the technology — and acknowledged that scribes can make mistakes that doctors must correct.
- Professor Alastair Denniston called AI 'an exceptional opportunity' for healthcare 'likely to rank alongside step-changes such as antibiotics and MRI.'
Why it matters: The MHRA blueprint lands as 40% of UK GPs already use AI scribes — patients would gain a legal right to know when AI is involved in their care, and developers face potential penalties for underperforming products, while Tallon conceded no country has 'absolutely cracked' AI healthcare regulation yet.
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