Industry Explainer
Published 6 October 2026
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The MHRA established the independent National Commission into the Regulation of AI in Healthcare in September 2025, bringing together global AI leaders, clinicians and regulators to advise on how the regulatory framework should evolve to be Safe, Fast and Trusted.
Industry has been central to this work. Through the Commission’s Technology Working Group, sector roundtables, the Call for Evidence and wider research and engagement, developers and manufacturers were clear about the changes needed to support the safe and effective use of AI in healthcare.
The Commission’s report Recommendations for a future regulatory framework, published in September 2026, responds directly to these priorities. The Government has now accepted the recommendations and will take a coordinated, cross-government approach to implementation.
What this means for you: supporting responsible innovation, greater clarity to innovate, invest and grow
Five points
**1. A clearer and more proportionate route to market ** Greater certainty about classification, evidence requirements and the regulatory pathway your product will follow.
2. Regulation that supports safe updates and faster improvement
Clearer approaches to product changes and updates, helping beneficial improvements reach patients while maintaining appropriate safeguards.
3. Real-world evidence that supports adoption and growth
Stronger evidence of how products perform in practice to support improvement, procurement, investment and growth.
4. A stronger route from regulation to adoption
Better alignment between regulatory and healthcare assurance requirements, reducing unnecessary duplication and supporting adoption.
5. Clearer responsibilities across the product lifecycle Greater clarity about the safeguards required for safe deployment and who is responsible for putting them in place.