AI recommendations ‘can help Britain carve own path on medical device regulation’

Alasdhair McDonald and Sarah Taylor of Pinsent Masons were commenting after the National Commission into the Regulation of AI in Healthcare made a series of recommendations designed to strengthen the regulation of AI in healthcare.

The independent Commission was established by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in September last year and has undertaken the largest ever UK evidence-gathering initiative relating to the regulation of healthcare technology. It engaged with patients, the public, clinicians, healthcare leaders, industry and technology developers.

The Commission’s recommendations include that a review be undertaken of existing regulation and guidance concerning medical devices, with a view to making it clearer when software and AI-enabled products fall within the scope of regulation. It also said a more flexible approach to regulation is required, proposing a system of “staged authorisations” and one in which safety requirements could be added or removed over time depending on the risk assessed to patient safety. It also identified a role for real-world data to be used to enable post-market monitoring. This oversight model would operate in addition to pre-market regulatory requirements to offer balanced oversight “across the product lifecycle”.

Measures to address the risk of bias were also proposed by the Commission, which called on the MHRA to lead on the development of guidance for medical device manufacturers on “health equity expectations for software and AI-enabled medical devices across the product lifecycle”. That guidance should factor in “consideration of the diversity of the intended population, with particular regard to underserved population groups”, it said.

Further guidance should also be produced to help developers provide “clear, transparent information to users and the public”, the Commission said. That guidance could explore how developers can do so through “use of model cards, careful user-centred interface design and dynamic labelling”, it said by way of example.

Taylor said: “There is a lot to be said for promoting patient confidence by providing transparent information for users of such devices. There is a lot of concern in some medical communities – diabetes being one – about the continuity of care and mistrust generated by what is perceived to be a lack of communication from device manufacturers about safeguards, so new transparency guidance would be a real positive.”

McDonald said the Commission’s report can be tied into the MHRA’s roadmap for reform of medical device regulation in Britain.

“The MHRA and UK government’s roadmap is aimed at creating a distinct post-Brexit framework for regulation of medical devices, while maintaining substantial alignment with international standards,” McDonald said. “As part of that update, the UK will remain substantially aligned with EU and other international regulatory approaches, while diverging in selected areas such as market access pathways and reliance mechanisms.”

“Medical device regulation in the EU, specifically where AI is concerned, is regarded as difficult to navigate, as devices have to comply not only with the specific medical device regulations in force but also the separate requirements of the AI Act. For Britain, therefore, divergence, rather than strict alignment may be good. However, where there has been divergence through the implementation of the UK roadmap to date, it has largely been linguistic rather than structural, as updated legislation often performs the same or similar function to differently worded regulations in the EU. This is confusing,” he said.

“However, the MHRA and UK government are behind schedule in implementing the roadmap. This means it still has time to build the recommendations of the Commission into its policy approach for AI, and the recommendations can also be implemented in secondary guidance,” McDonald said.

“Ultimately, the UK and its patients will benefit if the new regulatory framework provides a clear, proportionate and agile risk-based path for AI-enabled and other innovative medical devices, encouraging investment and development and facilitating patient access. It would be good to avoid the perceived complexity of the EU regime,” he added.