In the UK, a summary of the findings from the National Commission into the Regulation of Artificial Intelligence in Healthcare’s Call for Evidence was published on 11 June. The National Commission was launched in September 2025, bringing together a wide variety of stakeholders to provide advice to the Medicines and Healthcare products Regulatory Agency (MHRA) on a new framework for regulating AI in healthcare and support the delivery of the government’s ten-year Health Plan for England and Life Sciences Sector Plan. Whilst the recommendations to the MHRA are expected later this summer, this initial report showcases the findings from a Call for Evidence that ran from December 2025 to February this year.
Over 700 individuals (68% of responses) and organisations (32% of responses) took part in the survey. The questions posed aimed to support the Commission in gaining feedback on key areas with regards to how regulation can be future-proofed to deliver both innovation and safety to patients. The questionnaire was a mix of both qualitative and quantitative questions, ranging from the topic of liability in the case of adverse events to the management of post-market surveillance with AI technologies.
From the responses, the report details ten key findings, with many of the findings emphasising the need for reform of the current regulatory environment. Of all respondents, 21% indicated a need for a ‘complete overhaul’ of the framework for regulating AI in healthcare, with 50% answering ‘significant overhaul’.
The findings also suggested the increased need to shift to continuous post-market surveillance, with many of the AI technologies being not appropriate for one-off approvals. This was supplemented by calls for improved incident reporting and learning mechanisms, with some respondents suggesting a national AI incident reporting system.
Another one of the findings also emphasised the need for human oversight and responsibility, in which we saw something similar echoed in the FDA and EMA’s guiding principles released earlier this year, with one of the principles focussing on human-centric design. The full ten key findings can be found at the bottom of the article.
In a similar trend, the European Commission has opened a survey on AI in Healthcare and Pharmaceuticals, which will seek feedback from stakeholders on AI adoption in the two sectors. The survey is open until the 26 June 2026 and will influence future policy decisions.
