The Regulation of AI in Healthcare - the Government accepts National Commission recommendations

What action will the Government take?

In line with the 10-Year Health Plan for England and the Life Sciences Sector Plan, the Government will focus on a number of priority areas as it adopts a coordinated, UK-wide approach to implementation of the recommendations:

• The MHRA will take steps to modernise the regulatory framework for software and AI-enabled medical devices to ensure it remains fit for rapidly evolving technologies through legislative reform and clear guidance. This includes providing clearer guidelines on when a product qualifies as a medical device, an improved classification approach and clarity on how intended purpose includes design and functionality considerations.
• Equity throughout the lifecycle of AI-enabled technologies will be promoted.
• The MHRA will work to develop and implement a more proportionate, lifecycle-based approach to regulation that better balances pre-market evidence requirements with robust post-market assurance.
• The MHRA will explore practical, forward-looking implementation of Predetermined Change Control Plans ('PCCPs'), novel staged authorisation pathways that enable earlier access while generating real world evidence, and expanded use of regulatory sandboxes to test novel technologies and regulatory approaches.
• Guidance will be developed setting out how manufacturers should identify, describe and communicate the operational conditions necessary for the safe deployment and use of AI-enabled devices.
• An AI Readiness Toolbox will be developed to support healthcare organisations in assessing and preparing for the safe adoption of AI-enabled technologies.
• A working group will be set up to ensure that responsibilities are clear across manufacturers, healthcare providers, professionals, and regulators. The DHSC will work with the Patient Safety Commissioner to ensure patients have access to redress.
• The MHRA and partners will increase patient and public engagement in regulatory decision-making and explore new approaches to communicating information about AI-enabled technologies and emerging safety concerns.
• There will be clearer guidance, resources, and opportunities for early engagement for developers and manufacturers, by improving predictability and confidence in the regulatory system.

What next?

While the response does not bring in any immediate legal change, the MHRA intends to issue draft guidance on PCCPs by December 2026 for public comment. A consultation on a new, proportionate approach to classification and qualification for software and AI-enabled devices will be launched by Spring 2027. An implementation plan and roadmap will also be published in Spring 2027, providing further detail on roles, responsibilities, timelines, and key deliverables, with annual progress updates thereafter. 

Much of the immediate work falls to the MHRA and the practical detail to implement these recommendations will become clearer over the coming months. However, healthtech developers and suppliers now have a good idea of what their obligations will be. They should use this time to ensure that the intended purpose of their AI product is well-defined, that they have systems in place for the continuous, real-world monitoring of their devices and that roles and responsibilities are clearly allocated.