A summary of the findings from the UK National Commission into the Regulation of Artificial Intelligence in Healthcare’s Call for Evidence has been published, which highlights the need for a significant overhaul of the current framework.
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 to support the delivery of the government’s ten-year Health Plan for England and its Life Sciences Sector Plan. While the recommendations to the MHRA are expected later this summer, this initial report, published on 11 June, showcases the findings from a Call for Evidence that ran from December 2025 to February 2026.
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, many of which emphasised 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% calling for a ‘significant overhaul’.
The findings also suggest the increased need to shift to continuous post-market surveillance, with many 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 the need for a national AI incident reporting system.
Another finding emphasised the need for human oversight and responsibility, similarly echoed in the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guiding principles released earlier this year, with one principle focusing on human-centric design.
The ten key findings from the Call for Evidence are summarised below:
1. There is a clear call for a proportionate, lifecycle-based approach to regulation
2. There is strong consensus for significant regulatory reform
3. There is broad consensus that AI systems will increasingly require continuous post-market surveillance and monitoring
4. Responsibility should be shared across the system, with each individual and institution understanding their role and responsibilities
5. Human oversight and responsibility for clinical judgment should be retained
6. Transparency and explainability is key for the ongoing deployment of AI systems
7. Data access and use is central to the role of AI in healthcare moving forward
8. There is a need for robust training and improved AI literacy
9. There is a need to improve incident reporting and learning mechanisms
10. Patient and public engagement, trust and communication will continue to be key for the deployment of AI systems
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.
