GoKawiilMHRA proposes 44 rules to govern AI use across NHS services
Britain's medicines regulator, the MHRA, has published 44 recommendations for overseeing artificial intelligence tools used in healthcare, following input from over 12,000 patients and clinicians. The proposals include ongoing monitoring of AI systems, patient rights to know when AI is used in their care, penalties for developers whose products underperform, and a supervised 'L plate' trial phase for new AI tools.
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Existing medical device rules were built for static products like implants, not software that continually updates itself based on new data, leaving a regulatory gap as AI becomes embedded in NHS diagnostics and treatment. Establishing clear accountability and transparency standards now could shape how safely and quickly AI is adopted across public healthcare systems worldwide.
- MHRA wants 44 new rules to regulate evolving AI tools in NHS care.
- Patients would gain rights to know when AI is used and access information about it.
- A supervised 'L plate' system would let new AI models be trialled cautiously before full approval.
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Published there as: “UK needs new laws for AI in healthcare, says watchdog”
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