The Government has accepted all 44 recommendations from an independent commission examining how artificial intelligence should be regulated in healthcare, setting out a new approach to overseeing AI used by the NHS and in medical devices.
The recommendations from the National Commission into the Regulation of AI in Healthcare include moving towards continuous monitoring of AI medical devices throughout their working lives, clearer information for patients and possible staged authorisation allowing promising systems to enter supervised NHS use while further evidence is gathered.
The Government says it has accepted all 44 recommendations in full and will publish a comprehensive implementation roadmap by spring 2027.
Acceptance of the recommendations does not mean that all 44 measures have already become law or regulation. Some require further guidance, consultation, regulatory development or implementation.
AI regulation to move beyond one-off approval
A central recommendation is that regulation should take account of the way some AI systems continue to change after they enter clinical use.
Traditional medical-device regulation has generally focused heavily on assessment before a product enters the market. The commission argues that AI requires greater emphasis on monitoring performance and safety throughout a product's lifecycle.
The Government says the new approach will strengthen post-market monitoring so regulators can identify changes in performance and emerging risks after an AI system has been deployed.
Staged authorisation could allow earlier NHS use
Ministers will also explore staged authorisation for some AI technologies.
Under the proposed approach, an AI system showing sufficient promise could potentially be used in tightly controlled NHS settings while additional real-world evidence about its performance is collected.
That would not amount to unrestricted approval. The commission recommends safeguards, monitoring and evidence requirements intended to allow innovation while maintaining patient protection.
MHRA guidance due by December
The Medicines and Healthcare products Regulatory Agency is expected to publish draft guidance by December 2026 explaining how AI medical devices that can change or adapt over time should be regulated.
Further consultation is expected during 2027 as the Government and regulators work through implementation of the commission's recommendations.
The Government has committed to publishing a full roadmap by spring 2027 setting out how all 44 recommendations will be taken forward.
Patients should know when AI is involved
The commission also calls for greater transparency around the use of artificial intelligence in healthcare.
The Government says patients should receive meaningful information when AI is being used as part of their care and should be able to understand the role the technology is playing in clinical decisions.
The recommendations also address accountability, evidence standards, monitoring and how regulators should respond when AI systems are updated after deployment.
New AI Airlock phase opens
The policy is already moving into an implementation and testing phase through the MHRA's AI Airlock regulatory sandbox.
A new phase of the programme is being used to test approaches to post-market monitoring and lifecycle regulation of AI medical devices.
The sandbox allows developers, regulators and healthcare experts to examine regulatory questions in controlled conditions before wider rules and guidance are finalised.
Government backs commission in full
Ministers say accepting all 44 recommendations will provide a clearer framework for developers while maintaining safeguards for patients.
The commission was established to consider how Britain's regulatory system should respond to rapidly developing AI technologies in healthcare, particularly systems whose behaviour or performance can change after initial approval.
The reforms are intended to create a regulatory model capable of assessing not only whether an AI product is safe when it enters service, but whether it remains safe and effective as it is used and updated.
The Government's announcement represents acceptance of the commission's recommendations and the beginning of implementation. It does not mean every recommendation has already been enacted or that every proposed regulatory mechanism is currently in force.