AI Minister Kanishka Narayan has welcomed the government’s decision to accept in full all 44 recommendations of the National Commission into the Regulation of AI in Healthcare, a shift that will see AI-enabled medical devices monitored throughout their working life instead of being judged on a single, one-off assessment.
The government published its response on Tuesday, less than a month after the independent commission, led by NHS doctors and set up by the Medicines and Healthcare products Regulatory Agency (MHRA) in September 2025, delivered its report. More than 12,000 patients, clinicians and members of the public contributed to its work, the largest engagement of its kind on the regulation of healthcare technology.
Narayan: ‘Huge potential to help doctors’
“AI has huge potential to help doctors deliver better care and improve outcomes for patients,” Narayan said. “We’re working to make promising new tools available to people across the country sooner, so everyone has the chance to benefit.”
Health Innovation Minister James Frith said ministers wanted every patient to benefit from the life-saving potential of AI with confidence that it is safe and properly overseen, adding that “innovation must never come at the expense of patient safety”.
What changes
At the heart of the response is a move to proportionate, lifecycle-based regulation. The MHRA will publish draft guidance by December on how AI devices can be updated and improved over time without compromising safety, and will consult next year on how AI-enabled products should be qualified and classified as medical devices.
Ministers will also explore staged authorisation, allowing promising AI tools to be used in the NHS earlier under close supervision while real-world evidence is gathered. A full implementation roadmap covering all 44 recommendations is due by spring 2027, with a new programme board overseeing delivery across the UK.
Alongside the response, the MHRA has opened applications for the third phase of AI Airlock, its regulatory sandbox for AI medical devices, which has secured three more years of funding. Phase 3 will test how devices can be monitored safely once they are in use, with the first wave of innovators chosen in November.
The government has also committed to stronger patient involvement in decisions, clearer routes to redress when care falls short and action to ensure the benefits of AI reach underserved communities. For Labour, the package is about giving NHS staff more time with patients while keeping public trust at the centre of the technology’s rollout.
