The MHRA has launched two reports describing the findings of an
extensive engagement and evidence gathering programme undertaken
to inform future rules on how AI can be used safely in
healthcare, published today (11 June 2026).
Undertaken to support the independent National Commission into
the Regulation of AI in Healthcare, the research draws on
wide-ranging input from patients, the public, healthcare
professionals, industry and system partners. The
Research and Engagement
report sets out one of the most comprehensive evidence bases
to date on how AI is currently perceived, used and governed
across the UK health system.
Also published today are the findings of the recent Call for Evidence
which 760 people and institutions added their voice to earlier
this year.
The over-arching view of these contributions is a recognition of
the potential benefits of the AI in healthcare, provided
that rules appropriately set standards for safely and
effectively. There is a broad consensus that existing regulatory
approaches need to be adapted to meet the rapid pace of change
and development of AI technology.
These reports will inform the AI Commission's recommendations,
due to be published later this summer, which will help the MHRA
and wider health system shape the rules to protect patients,
support innovation and ensure that new
technologies deliver real-world benefit for
people.
These reports bring together the views of patients and public,
alongside frontline health staff, and experts from healthcare,
science, technology and policy. The Commission
worked with partner organisations, including with the health and
social care charities coalition National Voices to engage often
underrepresented groups, and with the Health Foundation who
delivered a series of public deliberative sessions. Additionally,
the MHRA hosted a public Ask Me Anything session, providing
an opportunity for patients and the public to engage
directly with Commission leadership.
Key themes included strong support for a regulatory approach
which included ongoing monitoring of technologies for
performance, safety and efficacy once they are put into practice;
the importance of striking a balance between tight regulation and
being able to move at pace so patients can benefit more quickly
and public expectation that any technology is subject to rigorous
safety checks, transparency, accountability and human
oversight.
Chair of the National Commission into the Regulation of
AI in Healthcare, Professor Alastair Denniston,
said:
This programme of research and evidence gathering from people
across the UK has been an absolutely critical part of the
National Commission, and will directly influence the
final recommendations we make. I would like to personally thank
everyone for their contributions, taking the time to contribute
their experience, insights and views.
The increasing AI in healthcare will affect all of us. These
views consistently highlight the potential to bring many
benefits, enhancing quality, speed, convenience and increasing
safety, but also highlights that this is a change that the
regulators and wider health system need to actively engage with,
including ensuring that our regulations and governance systems
match the risks and benefits of these new technologies.
Lawrence Tallon, Chief Executive of the MHRA,
said:
Our role is to ensure patients can benefit from
innovation while remaining appropriately protected. The
evidence published today provides an essential foundation for
getting that balance right, supporting a regulatory approach that
is proportionate, adaptive and grounded in real-world
use.
We will continue to work closely across the system to ensure the
UK remains a leader in the safe and effective use of AI
in healthcare.
Deputy Chair of the National Commission into the
Regulation of AI in Healthcare and Patient Safety Commissioner,
Professor Henrietta Hughes, said:
The AI Commission puts patients' voices at the centre,
bringing too often unheard perspectives from the margins into the
heart of decision-making. This means patient experience directly
shapes how these technologies are developed, regulated and used
in practice. This valuable research and engagement work shows how
trust, transparency and safety can be built into the principles
and recommendations guiding the future of AI in healthcare.
Louis Horsley, Research and Insight Manager at National
Voices, said:
National Voices is very grateful for the opportunity to
inform the work of the National Commission on the Regulation of
Artificial Intelligence in Healthcare. The equitable and
effective roll-out of AI in our healthcare system is essential to
ensuring that the NHS works for everyone, and our upcoming report
provides some insights into how this could be achieved from the
perspective of patient groups and community members who are more
at risk of experiencing health inequalities or have more complex
needs.
