The government has today, 6 October 2026, confirmed it will accept all 44 recommendations made by the National Commission into the Regulation of AI in Healthcare, published 10 September, and has set out how they will be delivered across the UK. Alongside the response, the MHRA is opening the call for applications for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices, with testing themes directly informed by the Commission’s recommendations.
A new approach to regulating AI in healthcare
The Commission concluded that the current regulatory approach must evolve for AI technologies by designing a more proportionate, lifecycle-based framework.
Today’s response commits the UK to developing a world-leading agile approach to AI device regulation that supports innovation while maintaining patient safety and public trust. The reforms aim to ensure patients can benefit from safe, effective and trusted AI more quickly, while maintaining robust safeguards as technologies evolve.
One of the Commission’s central conclusions was that AI-enabled medical devices should be assessed and monitored throughout their working life to better understand true performance, instead of over-relying on one-time assessments. AI Airlock Phase 3 puts this principle into practice immediately, working with developers, regulators and healthcare partners to test how AI devices can be safely monitored and managed for post-market surveillance after they are deployed, generating insights, evidence and solutions that will directly inform future MHRA guidance and policy. Applications are now open for developers of eligible AI-enabled medical devices, with a webinar for prospective applicants taking place on 22 October.
Among the first steps set out in today’s response, the MHRA is also committed to issue draft guidance by December 2026 on a new approach to managing changes to AI-enabled medical devices as they adapt and improve over time, moving towards a regulatory system that is designed to maintain safety while supporting timely access to innovative devices. The MHRA will also begin next year by consulting on how to qualify and classify AI-enabled devices, the first recommendation of the National Commission.
Other commitments include exploring new staged authorisation pathways, allowing promising AI tools to be used in the NHS earlier under close supervision while further real-world evidence is gathered. A full implementation roadmap, setting out timelines and responsibilities across all 44 recommendations, will be published by Spring 2027, with regular progress updates to follow.
In addition, the Government has committed to working with partners across the health system to strengthen patient engagement in decision-making, improve access to redress where standards of care fall below expectations, and ensure the benefits of AI are shared fairly across all communities, including underserved groups.
AI Airlock Phase 3: applications open today
Alongside today’s response, the MHRA is opening applications for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices. Following a successful pilot and Phase 2 programme, AI Airlock has secured three years of additional government funding.
Phase 3 will focus specifically on post-market surveillance and lifecycle regulation, the themes at the heart of both the Commission’s recommendations and today’s response. Working with real products and technologies, the programme brings together innovators, regulators and healthcare partners to explore how AI-enabled medical devices can be monitored and managed safely throughout their working life, generating evidence and insights that will directly inform future MHRA guidance and policy.
Eligible developers of AI-enabled medical devices can apply now at [gov.uk]. A webinar for prospective applicants will take place on 22 October 2026, 10:00, with full details available on the same page. The first wave of innovators will be selected in November 2026.
Moving from one-off assessment to lifecycle-long monitoring
Together, the government’s response and the opening of AI Airlock Phase 3 confirm a shift towards more continuous, real-world monitoring of AI technologies throughout their working life, rather than over-relying on a single point in time assessment, alongside new commitments to keep patients informed about when AI is used in their care.
Health Innovation Minister James Frith said:
“We want all patients to benefit from the life-saving potential of AI, with the confidence that it is safe, effective and properly overseen. We also want to see the NHS harness the best new technologies to give patients faster, better care and give staff more time to focus on patients. But innovation must never come at the expense of patient safety.
“This will be a continually-evolving process as the technology itself develops, but we are acting now by accepting in full all 44 recommendations of the Independent Commission, which will provide a foundation to embrace the opportunities AI brings while putting strong safeguards, transparency and public confidence at the heart of its use.”
Lawrence Tallon, the MHRA’s Chief Executive, said
“The independent National AI Commission, led by NHS doctors, has given us a clear and ambitious blueprint for how we make the UK the best place to get AI products to patients safely, quickly and in a way that maintains public trust. I am pleased that today the Government is accepting its recommendations in full, whilst setting out a clear plan and oversight structure to deliver them. The MHRA’s AI Airlock is already opening its doors to more innovators who want to help us understand how these technologies can be implemented and monitored safely throughout their working life. This is about making sure patients can benefit from safe, trusted AI more quickly, while never losing sight of the safeguards that maintain public confidence.”
Professor Alastair Denniston, Chair of the National Commission, said:
“I am delighted to welcome the Government’s response to the National AI Commission, and its full acceptance of all our recommendations. This response shows that government has listened, not just to the Commission, but to the more than 12,000 patients, clinicians and members of the public who shaped our recommendations.
The Government’s response is a welcome confirmation that it is committed to the Commission’s guiding principles namely that our approach to AI should be people-centred, and be underpinned by a regulatory system that is safe, fast, and trusted. The regulatory challenges being prioritised by AI Airlock Phase 3 is an early sign of that shift in practice, putting the lifecycle-based approach we recommended into action from day one.”
What happens next ?
The newly established Programme Board will convene with work already under way across government, the MHRA, NHS partners and the devolved authorities on the nine priority areas set out in the response. A full implementation roadmap will follow by Spring 2027. AI Airlock Phase 3 applications close in November 2026, with a webinar for prospective applicants on 22 October.
Supporting quotes
AI Minister Kanishka Narayan said:
“AI has huge potential to help doctors deliver better care and improve outcomes for patients.
“We’re working to make promising new tools available to people across the country sooner, so everyone has the chance to benefit.”
Lord Willetts, Chair, Regulatory Innovation Office, said:
“The National Commission has set out a clear vision for how regulation can evolve to support innovation, whilst protecting patient safety and public trust throughout the technology lifecycle. I welcome the Government’s response and look forward to seeing these recommendations translated into real-world action, building on the momentum created by the MHRA’s recent ambient scribe guidance. With the right regulatory leadership we can accelerate access to transformational technologies safely and make the UK a global leader in AI for healthcare.”
Steve Bates, OLS Executive Chair, said:
“I welcome the government’s decision to accept all the recommendations made by the Commission, demonstrating its commitment to a world-leading regulatory framework that is pro-innovation, proportionate and trusted. By providing innovators, investors and the health system with greater clarity and confidence, these reforms will help accelerate the safe development, scaling and adoption of AI technologies. This will drive investment and growth across the life sciences sector, support better outcomes for patients and help position the UK as a global leader in AI-enabled healthcare.
“The Office for Life Sciences looks forward to continuing its close collaboration with the MHRA to deliver on these recommendations for the benefit of patients, innovators, the health system and the economy.”
Professor Henrietta Hughes OBE, Deputy Chair of the National Commission and Patient Safety Commissioner for England, said:
“Patients have told us they want artificial intelligence that improves care without compromising safety, transparency or accountability. The Government’s commitment to implement all 44 recommendations is an important step towards ensuring that innovation and patient safety go hand in hand. I particularly welcome the commitment to monitoring AI throughout its use in practice, strengthening patient involvement in decision-making and ensuring there are clear routes to redress when things go wrong. Patients must remain at the heart of how these technologies are developed, regulated and used across healthcare.”
The Welsh Government Cabinet Minister for Health and Care, Mabon ap Gwynfor, said:
“Patients in Wales stand to benefit from a regulatory system that is safer, faster and more trusted, and I welcome the Commission’s recommendations.
“We will continue to work closely with the MHRA and partners across the health system to ensure AI technologies are introduced safely and responsibly, with appropriate safeguards in place and patients kept informed as new innovations become available.”
Northern Ireland Health Minister, Robbie Butler, said:
“Artificial Intelligence has the potential to improve outcomes for patients, enhance the experience of our workforce and help transform the delivery of health and social care services.
“I welcome the publication of the recommendations of the National Commission into the Regulation of AI in Healthcare and the Government’s commitment to taking them forward. As AI becomes increasingly important within healthcare, it is essential that innovation is supported by appropriate safeguards, evidence and public trust.
“I am particularly pleased that Northern Ireland’s perspectives have been reflected throughout this work, and I look forward to continued collaboration with the MHRA and partners across the UK as these recommendations are implemented.”
Sir Andrew Goddard, AI Airlock Governance Board Chairman and Consultant Gastroenterologist at Royal Derby Hospital, said:
“The AI Airlock was set up to test AI technologies in a safe environment, and over its first two years has shown the value of bringing industry, healthcare partners and regulators together to generate practical insights for the responsible adoption of AI. Over the next three years, the programme will build on this learning, with a focus on understanding how AI products can be monitored effectively once they are in use. We look forward to this next phase and to contributing to expectations of the National Commission into the Regulation of AI in Healthcare.”
Steve Lee, Executive Director, Regulation, ABHI, said:
“We welcome the Government’s response and were pleased to contribute to the Commission via its Technology Working Group. There is a lot here that we support, particularly the focus on proportionate regulation that reflects how AI technologies develop and perform over time.
“There is also significant international interest in the UK’s approach to AI regulation, and getting implementation right will be important in helping patients access new technologies faster and making the UK an attractive place for innovation and investment. Building on, and aligning with, international best practice will be key. We look forward to working with the MHRA to turn these principles into reality.”
Notes to Editors
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The National Commission into the Regulation of AI in Healthcare published its independent recommendations on 10 September 2026, following a year-long UK-wide programme of evidence gathering involving more than 12,000 people, the largest engagement of its kind on the regulation of healthcare technology. The full report is available at [National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework - GOV.UK].
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The government’s full response, including its response to each individual recommendation, is available at [Government response ].
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AI Airlock is the MHRA’s regulatory sandbox for AI as a Medical Device (AIaMD), providing a collaborative environment for innovators, regulators and healthcare partners to explore regulatory challenges using real products and technologies. Full details on Phase 3, including eligibility criteria and how to apply, are set out above and available at [gov.uk].
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The Commission was established by the MHRA in September 2025 as an independent, non-statutory advisory body, in line with commitments in the 10-Year Health Plan for England, the Life Sciences Sector Plan and the AI Opportunities Action Plan.
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The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.