Healthcare AI Safety Gap · Don't break patients
    Peer-reviewed / official10 Sep 2026·UK

    UK commission says a single AI approval isn't enough — and proposes L-plates

    The MHRA's independent National Commission, after a year and more than 12,000 contributors, recommends staged 'L-plate' authorisation for new healthcare AI, continuous real-world monitoring for a device's whole working life, and a public, searchable record of AI safety incidents.

    12,000+
    people consulted over a year — the largest engagement ever undertaken in the UK on regulating healthcare technology

    What the research found

    The Commission, set up by the MHRA in September 2025 and chaired by practising NHS doctors, gathered evidence from patients, clinicians, healthcare leaders and developers over a year before publishing its recommendations. It proposes that new AI models be given staged authorisations — deployed first under close supervision and tight guardrails, like L-plates for learner drivers, before earning fuller approval; that AI-enabled devices be monitored continuously in the real world rather than cleared once at a point in time; that the public be able to search safety information and adverse incidents for a specific device; and that the MHRA get stronger enforcement powers. Companion deliberative research by the Health Foundation, published the same day, found public support for AI in care is real but conditional, with accuracy the top priority and human oversight treated as a precondition rather than a nice-to-have.

    Why it matters for providers

    A national regulator is now formally proposing what providers have had to improvise: that an AI tool earns trust in stages and stays monitored for its whole working life, rather than being declared safe once and left alone.

    Original source
    National Commission into the Regulation of AI in Healthcare (established by the MHRA)
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