The UK's 44 recommendations on regulating AI in healthcare (October 2026)
Reviewed by Dr. Ram Kumar G, MBBS, MD (Internal Medicine), MPH (USA), on · Last updated
In short
The National Commission into the Regulation of AI in Healthcare, set up by the MHRA in September 2025, published 44 recommendations on 10 September 2026 after evidence gathering involving more than 12,000 people. On 6 October 2026 the UK government accepted all of them and set ten priority areas. The first concrete steps are draft MHRA guidance on change control for AI devices by December 2026 and a consultation on a new way of qualifying and classifying software and AI devices in spring 2027.
Why the UK is reforming
AI medical devices in Great Britain are regulated under the UK Medical Devices Regulations 2002, written long before modern AI. The MHRA has been modernising software regulation through its Software and AI as a Medical Device programme and testing approaches in its AI Airlock sandbox, whose second phase finished in May 2026. The Commission was asked to recommend a framework fit for AI that keeps changing, is used at scale in the NHS, and is increasingly built on general-purpose models.
The ten priority areas
| Priority area | In brief |
|---|---|
| Modernise the framework for AI-enabled devices | Clearer qualification and classification; legislative reform |
| Equitable access and outcomes | Attention to underserved populations |
| Stronger post-market assurance | More weight on monitoring real-world performance |
| Safe iteration and earlier access | Ways to update AI safely, such as change-control plans |
| Assurance for real-world deployment | Conditions for safe use in services, not just approval |
| System capability and readiness | Skills and infrastructure in the health system |
| Accountability and safety culture | Reporting and learning from problems |
| Transparency and public confidence | Clear information for patients and the public |
| Regulatory clarity and navigability | Easier routes for developers to understand requirements |
| Regulatory capability and evidence base | Building the regulator's own expertise |
The timetable
| Step | When |
|---|---|
| Draft MHRA guidance on predetermined change control plans for AI devices | By December 2026 |
| Consultation on a new qualification and classification approach for software and AI devices | Spring 2027 |
| More detail on proportionate oversight, lifecycle evidence, master files for general-purpose models, cybersecurity, human factors and post-market surveillance | From spring 2027 |
| Full implementation plan and roadmap, with annual progress updates | After spring 2027 |
Nothing changes in law yet
- As of October 2026, AI devices are still regulated under the existing UK framework. The recommendations set direction; guidance, consultations and legislation will follow over the coming years.
What it means for different groups
- Developers: expect clearer rules on when software is a device and how it is classified, a route for planned updates through change-control plans, and more emphasis on post-market evidence.
- NHS organisations: deployment assurance, local monitoring and incident reporting will matter more, alongside existing clinical safety standards (DCB0129 and DCB0160).
- Clinicians and patients: more transparency about AI in care, and clearer channels to report problems.
- Outside the UK: the direction, towards lifecycle oversight and change-control plans, mirrors the US FDA and the EU AI Act, which helps developers working across countries.
FAQ
What is the National Commission into the Regulation of AI in Healthcare?
An independent advisory body set up by the MHRA in September 2025 to recommend how the UK should regulate AI in healthcare. It reported on 10 September 2026.
Did the government accept the recommendations?
Yes. On 6 October 2026 the government accepted all 44 recommendations and set ten priority areas.
What happens first?
The MHRA is due to issue draft guidance on predetermined change control plans for AI devices by December 2026, and to consult on qualification and classification of software and AI devices in spring 2027.
Do the current rules still apply?
Yes. Until new guidance and legislation are in place, AI devices are regulated under the UK Medical Devices Regulations 2002.
How does this compare with the EU and US?
All three are moving towards lifecycle oversight of AI devices, with plans for managing updates and stronger post-market monitoring, though their legal frameworks and timelines differ.
Sources
- GOV.UK. Government response to the National Commission's recommendations on the regulation of AI in healthcare (6 October 2026)
- GOV.UK. National Commission into the Regulation of AI in Healthcare: recommendations for a future regulatory framework (September 2026)
- GOV.UK. Government backs recommendations of NHS doctors-led AI Commission
- GOV.UK. AI Airlock: the regulatory sandbox for AIaMD
Educational content only. This material teaches methods; it is not clinical advice. Code, models and examples here are not validated medical devices and must not be used to make decisions about real patients without proper clinical validation, governance and any required regulatory approval. Examples use synthetic or openly licensed de-identified data only. Never paste identifiable patient information into public AI tools. Mentions of models, tools or vendors are for identification, not endorsement.