Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released a comprehensive set of policy recommendations designed to address the regulatory gap created by increasing artificial intelligence deployment in healthcare. The independent commission that developed these 44 recommendations incorporated feedback from more than 12,000 stakeholders, including patients, clinicians, and industry representatives.
The MHRA chief noted that AI will soon become a routine component of NHS care delivery, but emphasized the need for frameworks that preserve patient confidence. Current medical device regulations were developed for products like joint implants and diagnostic tools that remain static after approval. AI systems, by contrast, continue to evolve after authorization as they are exposed to new data, learn from it, and adapt their behavior over time—a characteristic that existing rules do not adequately address.
The proposed recommendations include mechanisms for continuous monitoring of AI products with provisions to withdraw regulatory approval if performance deteriorates, patient rights to be informed of AI involvement in their care and to access information about the systems used, authority to penalize developers whose products fail to meet standards, and an “L plate” system to facilitate supervised trials of new AI models by healthcare professionals. The MHRA acknowledged that AI regulation represents a global challenge with no country having definitively established best practices.
AI-powered note-taking systems, known as scribes and powered by large language models, are reportedly used by 40% of UK general practitioners. Research from the University of Edinburgh found that some patients became less willing to disclose sensitive personal information when aware that AI would process their conversations. Healthcare professionals involved in the commission indicated that while many patients accepted AI use in consultations, others exercised the option to decline such systems.
While current applications predominantly assist with administrative tasks and symptom identification under human supervision, the healthcare sector views AI as offering substantial potential. Some experts described the technology as comparable in significance to major medical advances such as antibiotics and magnetic resonance imaging. However, concerns persist regarding algorithmic bias affecting clinical decision-making and the provision of inaccurate medical guidance through AI chatbots.
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