The UK's medical devices regulator has called for new rules governing artificial intelligence in healthcare, including giving patients the right to know when AI is involved in their care. The Medicines and Healthcare Products Regulatory Agency (MHRA) published 44 recommendations on 14 September 2026 following a review that involved more than 12,000 patients, clinicians and other stakeholders.
MHRA chief executive Lawrence Tallon told the BBC that AI would soon become a routine part of NHS healthcare, but said its use needed to maintain patients' trust. "Unlike most of the medical products we're used to regulating, these products continue to change after the point of authorisation," Tallon said. "As new data gets fed in, they learn, they adapt, they drift."
Continuous monitoring and the 'L plate' proposal
Under the proposed framework, AI products would face ongoing scrutiny rather than the one-off approvals typical for physical medical devices. Regulators could withdraw authorisation if a system malfunctioned or its performance degraded over time. Developers could also face penalties if their products failed to meet required standards.
One recommendation introduces an AI "L plate" system, allowing new models to be trialled by healthcare professionals under close supervision before wider deployment. Tallon noted that existing regulations were designed for products such as hip replacements, stethoscopes and plasters, not software that evolves after approval.
Transparency and patient trust
Patients would gain the right to know when AI is involved in their care, with easier access to information about the specific technology being used. The push for transparency comes as AI scribes - large language models that record consultations and produce clinical notes - are reportedly used by about 40 per cent of UK GPs.
Research from the University of Edinburgh found some patients may be less willing to discuss sensitive subjects, including substance abuse, if they know AI is processing their conversation. Professor Henrietta Hughes, a GP who contributed to the report, said some patients were comfortable with AI while others chose not to use it. Concerns also persist about errors and bias, particularly where systems are trained on incomplete or unrepresentative patient data.
The regulatory challenge
Professor Alastair Denniston, an ophthalmologist involved in the review, described AI as an "exceptional opportunity" for healthcare, potentially ranking alongside breakthroughs such as antibiotics and MRI. But Tallon said no country has yet found a perfect regulatory model for the rapidly evolving technology.
"I don't think at this moment in time we can point to a single country, a single regulatory framework, and say that they have absolutely cracked it," he said. For healthcare professionals navigating these changes, understanding how AI systems are regulated and deployed is becoming part of the job. Resources on AI for Healthcare can help clinicians stay current with the tools entering their workplaces.
Why this matters for healthcare professionals
The MHRA's recommendations signal a shift toward greater accountability for AI tools in clinical settings. If adopted, the rules will require clinicians to inform patients when AI is part of their care - a conversation many will need to prepare for. The proposed continuous monitoring also means systems used today could be pulled tomorrow if performance slips, making it essential to stay informed about the regulatory status of the tools you rely on. For those in administrative roles, the spread of AI scribes and data-handling systems touches on workflows covered in training paths like AI for Medical Billers, where understanding compliant AI use is increasingly relevant.
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