Artificial Intelligence News

All 44 Recommendations Accepted: UK Shifts AI Healthcare Regulation From One-Off Approval to Lifecycle Monitoring

On 6 October 2026 the UK Government accepted all 44 recommendations of the National Commission into the Regulation of AI in Healthcare, setting 10 priority areas: draft PCCP guidance by December, a classification consultation and roadmap by Spring 2027, and AI Airlock Phase 3 focused on post-market surveillance.

grokbot October 7, 2026 7 min read

Cover: In a hospital ward at dawn, a doctor and an older patient look at a scan on a tablet while a soft ribbon of light runs from the AI-enabled device at the bedside out through the window and across a garden turning through the seasons — a metaphor for monitoring a product throughout its working life (editorial illustration — no text or logos

On 6 October 2026 the UK Government published its response to the National Commission into the Regulation of AI in Healthcare, accepting all 44 recommendations and setting out 10 priority areas for the year ahead along with initial next steps for every recommendation. On the same day, the Medicines and Healthcare products Regulatory Agency (MHRA) opened applications for Phase 3 of AI Airlock, its regulatory sandbox for AI-enabled medical devices, with testing themes drawn directly from the Commission’s recommendations.

The Commission and its report

A year of evidence gathering, more than 12,000 people

The MHRA established the Commission in September 2025 as an independent, non-statutory advisory body, chaired by Professor Alastair Denniston, with Professor Henrietta Hughes OBE, Patient Safety Commissioner for England, as Deputy Chair. The Commission published its 44 recommendations on 10 September 2026. According to the Government’s press release, the report followed 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.

Government: current regulations have not kept pace with AI

The response states that, because AI has developed considerably since the UK Medical Devices Regulations 2002 (UK MDR 2002) were drafted, the current medical device regulations are not fit for purpose. It cites stroke imaging as an example: AI tools are being used across NHS stroke services to help clinicians rapidly assess brain scans and identify patients who may be eligible for treatment. The document also notes that earlier in 2026 the Government committed up to £10 billion over three years to technology, digital and data initiatives, supporting the NHS’s transformation into a fully digitally enabled service.

Three themes, ten priority areas

The response groups the 44 recommendations under the Commission’s three themes and sets out the year’s priorities:

Theme	Priority areas (Government response)
Proportionate lifecycle regulation	1. Modernise the regulatory framework for AI-enabled medical devices; 2. Deliver equitable access and outcomes, with a special focus on underserved populations; 3. Shift towards stronger post-market assurance; 4. Enable safe iteration and earlier patient access
System-wide responsibility and safe management	5. Create the assurance conditions for safe real-world deployment, including risk controls; 6. Build system capability and workforce readiness; 7. Strengthen accountability through a culture of safety and reporting
Trust, transparency and predictability	8. Strengthen transparency and public confidence; 9. Improve regulatory clarity and navigability; 10. Strengthen regulatory capability and the evidence base

Timeline: the first concrete steps

By December 2026: draft guidance on Predetermined Change Control Plans

The MHRA intends to issue draft guidance on Predetermined Change Control Plans (PCCPs) for public comment by December 2026. The proposed approach would let manufacturers set boundaries defining the scope of allowable change, rather than only pre-specifying particular modifications, with clear approaches for adaptive AI-enabled devices, while maintaining a device’s intended use.

By Spring 2027: classification consultation and implementation roadmap

The MHRA intends to launch a consultation by Spring 2027 on a new, proportionate approach to the qualification and classification of software and AI-enabled devices. It would then use secondary legislation to introduce an updated definition of a medical device — including clarity on when certain administrative, general wellbeing and decision support software are not medical devices — and a more proportionate classification system. A full implementation plan and roadmap, setting out roles, responsibilities, timelines and key deliverables, will also be published by Spring 2027, with annual progress updates thereafter.

A cross-system Programme Board, meeting quarterly

The Government will establish a cross-system Programme Board with representatives from across the health, regulatory and research systems and the devolved authorities. It will convene quarterly to oversee progress and will report quarterly to the Life Sciences Delivery Board.

For patients and clinicians: transparency, reporting and redress

Publicly searchable adverse-incident information

The MHRA will work to introduce a public-facing database or tool where people can search reports of adverse incidents for medical devices, including software and AI-enabled devices, building on the Interactive Drug Analysis Profiles (iDAPs). It will also work to publish a regularly updated list of authorised AI-enabled medical devices in the UK.

A stronger Yellow Card scheme

The MHRA will improve the Yellow Card scheme, which could include additional adverse-incident reporting routes for software and AI-enabled devices, and will explore automating low-burden reporting by embedding it in electronic patient records and in the devices themselves.

Telling patients when AI is used

The Department of Health and Social Care (DHSC) will work with the devolved health departments on how patients should be informed when AI is used in their care and what choices they have, including when opt-out arrangements may be feasible and appropriate, balanced against clinical effectiveness, equitable access and patient safety.

Redress and AI literacy

DHSC will convene a working group, including the Patient Safety Commissioner, to ensure patients have access to redress if they receive a standard of care below what is reasonably expected. The Government will also support AI literacy for healthcare professionals and wider staff, and develop an AI Readiness Toolbox to help healthcare organisations assess and prepare for adopting AI.

For developers: general-purpose models, staged authorisation and sandboxes

“Master Files” for general-purpose models

For medical devices built on general-purpose platforms or foundation models, the MHRA will engage experts on what proportionate information would be useful, and may launch a Master File pilot focused on general-purpose models or platforms. It will also issue guidance on the information such devices must provide in a regulatory submission, including their dependencies on underlying general-purpose models, related risks and controls.

Staged authorisation and earlier access

The Government has committed to exploring new staged authorisation pathways, allowing promising AI tools to be used in the NHS earlier under close supervision while real-world evidence is gathered. The MHRA will also expand the use of regulatory sandboxes.

Direct-to-consumer products and population diversity

The MHRA will issue guidance on direct-to-consumer apps and wearables with medical device functions, and guidance to support manufacturers in demonstrating that their devices are safe and effective for groups including children, women and ethnic minorities, without creating or exacerbating disparities.

AI Airlock Phase 3 opens for applications

AI Airlock, launched by the MHRA in Spring 2024, is its first regulatory sandbox for AI-enabled medical devices and has completed a pilot and a second phase. In April 2026 the MHRA announced that DHSC had allocated £1.2 million a year for three years (2026–2029), £3.6 million in total; the current phase is funded until April 2029.

Phase 3 focuses on post-market surveillance and oversight across the lifecycle, with three priority topics:

Ongoing assurance across the lifecycle: how post-market surveillance can more proactively capture deployment-context factors such as local infrastructure, workflow integration, data quality and user interaction
Surveillance under varying levels of local oversight: how to detect and respond to performance or safety signals in remote, direct-to-consumer or higher-autonomy settings
Communicating across the system: how manufacturers can convey information on performance, safety, updates and rollbacks to regulators, providers, professionals and patients in a timely way

Figure: Left to right — developers and regulators test an AI-enabled medical device in a sandbox workshop, the device goes into use in a clinic and at home, and clinicians report their experience back into the next round of testing (editorial illustration — no text or logos; not an actual device or system screen).

Applications are open year-round; to be considered in the current review wave, applicants should apply before 31 October, with a further shortlisting period in Spring 2027. The MHRA will hold a webinar for prospective applicants on 22 October at 10:00 UK time, and the first wave of innovators will be selected in November 2026. Individual testing plans are generally expected to run for 6 to 12 months.

What they said

Health Innovation Minister James Frith said the Government wants all patients to benefit from the life-saving potential of AI with confidence that it is safe, effective and properly overseen. He described this as a continually evolving process as the technology develops, and said accepting all 44 recommendations in full provides a foundation to embrace AI’s opportunities while putting strong safeguards, transparency and public confidence at the heart of its use.

MHRA Chief Executive Lawrence Tallon said the Commission, led by NHS doctors, had provided a clear and ambitious blueprint for getting AI products to patients safely, quickly and in a way that maintains public trust. Commission Chair Professor Alastair Denniston said the response shows the Government has listened not just to the Commission but to the more than 12,000 patients, clinicians and members of the public who shaped its recommendations.

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