The UK government confirmed on October 6, 2026 that it will accept all 44 recommendations of the National Commission into the Regulation of AI in Healthcare and set out how they will be delivered across the UK. Alongside the response, the Medicines and Healthcare products Regulatory Agency (MHRA) opened the call for applications for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices.
Delivery Commitments and Key Dates
The Commission’s report, published on September 10, 2026, concluded that the current regulatory approach must evolve into a more proportionate, lifecycle-based framework, with AI-enabled medical devices assessed and monitored throughout their working life rather than through over-reliance on one-time assessments.
Among the first steps, the response commits the MHRA to issue draft guidance by December 2026 on a new approach to managing changes to AI-enabled medical devices as they adapt and improve over time. The MHRA will also begin next year by consulting on how to qualify and classify AI-enabled devices, the Commission’s first recommendation. Further commitments include exploring staged authorisation pathways that would allow promising AI tools to be used in the NHS earlier under close supervision while further real-world evidence is gathered.
The government also committed to work 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. The response adds new commitments to keep patients informed about when AI is used in their care.
AI Airlock Phase 3 Opens for Applications
The MHRA published the Phase 3 application guidance on October 6, 2026. Following a pilot and Phase 2 programme, AI Airlock has secured three years of additional government funding, and the guidance states the current phase is funded until April 2029. Phase 3 focuses specifically on post-market surveillance and lifecycle regulation, working with developers, regulators and healthcare partners to test how AI devices can be monitored and managed safely after deployment, generating evidence intended to inform future MHRA guidance and policy.
A webinar for prospective applicants takes place on October 22, 2026, at 10:00, and the first wave of innovators will be selected in November 2026. Applications are evaluated in scheduled review waves with rolling onboarding; candidates seeking the current review wave should apply before October 31, 2026, and a subsequent shortlisting period will take place in Spring 2027.
The guidance sets three priority topics: ongoing assurance across the lifecycle, including how surveillance captures deployment-context factors such as local infrastructure, workflow integration, data quality and user interaction; surveillance suited to settings with varying levels of clinical or organisational oversight, such as remote, direct-to-consumer or higher-autonomy systems; and effective communication of performance, safety, update and rollback information to regulators, providers, professionals and patients. Proposals outside these areas may be submitted as expressions of interest, but priority goes to aligned applications.
Each testing plan is bespoke and generally scoped to six to 12 months across three environments: a simulation airlock of roundtable workshops, a virtual airlock digital testing space using real or synthetic data, and a real-world airlock observing devices in actual use environments outside patient pathways, such as shadow deployment. Eligibility requires potential patient benefit, an innovative product or concept, a regulatory challenge to address, and readiness to be trialled. Organisations of all sizes may apply, and a lead applicant may partner with others. There is no fee for application or participation, but candidates are expected to fund their own studies and testing. The Information Commissioner’s Office will support the programme through a referral service offering data protection by design advice.
The Commission Behind the Recommendations
The MHRA established the National Commission in September 2025 as an independent expert advisory body. It was chaired by Professor Alastair Denniston, Professor of Regulatory Science and Innovation at the University of Birmingham and an honorary consultant ophthalmologist, with Deputy Chair Professor Henrietta Hughes, a practising GP and Patient Safety Commissioner for England. The Commission brought together expertise from healthcare, technology, law, patient groups, government, the NHS and partners across England, Scotland, Wales and Northern Ireland, and invited stakeholders from the United States, Europe and Singapore.
Its recommendations report organises the 44 recommendations around three connected areas: proportionate lifecycle regulation; system-wide responsibility and safe management; and trust, transparency and predictability. The recommendations were grounded in a research and engagement programme that included an open Call for Evidence, public deliberation events delivered with The Health Foundation, engagement with seldom-heard groups supported by National Voices, professional and industry roundtables and specialist working groups. According to the report, 77% of healthcare professional respondents called for a complete overhaul or significant reform of the regulatory framework, two-thirds of industry respondents and half of healthcare providers viewed the current framework as restricting innovation, and 65% of respondents disagreed that current post-market surveillance approaches are sufficient.
Reactions From Ministers, the MHRA and the Devolved Nations
Health Innovation Minister James Frith said the government wants all patients to benefit from AI with confidence that it is safe, effective and properly overseen, adding: “But innovation must never come at the expense of patient safety.” MHRA Chief Executive Lawrence Tallon described the Commission’s blueprint as clear and ambitious and said the government is accepting its recommendations in full while setting out a plan and oversight structure to deliver them.
Denniston welcomed the response and said the government had listened not just to the Commission “but to the more than 12,000 patients, clinicians and members of the public who shaped our recommendations,” describing AI Airlock Phase 3’s priorities as an early sign of the lifecycle-based approach being put into action from day one. Hughes welcomed the commitment to monitoring AI throughout its use in practice, strengthening patient involvement in decision-making and ensuring clear routes to redress when things go wrong.
AI Minister Kanishka Narayan said the government is working to make promising new tools available to people across the country sooner, while Lord Willetts, Chair of the Regulatory Innovation Office, welcomed the response and referenced momentum from the MHRA’s recent ambient scribe guidance. Welsh Government Cabinet Minister for Health and Care Mabon ap Gwynfor and Northern Ireland Health Minister Robbie Butler both welcomed the recommendations and pledged continued collaboration with the MHRA and partners across the UK. Sir Andrew Goddard, AI Airlock Governance Board Chairman, said that over the next three years the programme will focus on understanding how AI products can be monitored effectively once they are in use. The Office for Life Sciences and ABHI also welcomed the decision.
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 covering timelines and responsibilities across all 44 recommendations will follow by Spring 2027, with regular progress updates.
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