MHRA Sets Out 44 AI Recommendations for UK Healthcare

The National Commission into the Regulation of AI in Healthcare and the Medicines and Healthcare products Regulatory Agency (MHRA) have published a report outlining how AI should be implemented across UK healthcare settings.

The report sets out a series of recommendations following an extensive public consultation process involving more than 12,000 clinicians and patients.

The National Commission into the Regulation of AI in Healthcare is an advisory body established by the MHRA to review current regulations and provide recommendations for a regulatory framework for AI in healthcare.

One of the report’s authors, Henrietta Hughes, who is Deputy Chair of the Commission and the Patient Safety Commissioner for England, writes on LinkedIn: “Today marks an important step towards ensuring AI is used safely, transparently and in a way people can trust across healthcare.”

She continues: “More than 12,000 people shared their views and their message was clear: people want to know when AI is used in their care, confidence that it supports rather than replaces clinicians and clear accountability if things go wrong.”

Patient-centric, practitioner-enabling

Although there are 44 recommendations in total, the Commission’s core vision for AI regulation across UK healthcare is to create a “patient-centric, practitioner-enabling regulatory system.”

“We have heard clearly about the opportunities of AI to speed up and improve care, and to release more of clinicians’ time for the essentially human aspects of their work with patients,” says Lawrence Tallon, CEO of MHRA.

“We will only realise those opportunities if we have a modern, dynamic regulatory framework that accelerates safe adoption, protects patients and commands public and professional confidence,” he explains.

Continuous monitoring

The Commission argues that the UK needs a more proportionate, lifecycle-based and system-wide approach to regulating AI in healthcare, moving beyond one-off pre-market assessments towards continuous monitoring and assurance. 

The framework should balance patient safety, innovation and timely access, while building trust among patients, healthcare professionals, providers, developers and regulators. 

The report’s recommendations revolve around three core focus areas: 

• Proportionate lifecycle regulation.

• System-wide responsibility and safe management.

• Trust, transparency and predictability.

The report states: “Together, these three areas of change support the Commission’s vision for a regulatory and assurance framework that is safe, proportionate, trusted, flexible and works for everyone.”

“From improving transparency of when AI is used in healthcare to stronger oversight of AI technologies throughout their lifecycle, these recommendations show how we can put people before technology while supporting innovation that improves care and gives clinicians more time to meet patients' needs,” says Henrietta.

NHS AI rollout continues

The report's publication comes amid AI’s growing presence across the NHS and UK healthcare generally.

Recent initiatives that have accelerated NHS AI adoption include its partnership with Microsoft Copilot to provide 500,000 clinicians and support staff access to the software, while NHS England Midlands became the first region to procure an AI-powered ambient voice technology (AVT) provider at scale after agreeing a procurement deal with Heidi. 

Heidi’s AVT technology will soon be used in NHS England Midlands’ 1,239 GP practices and by more than 70,000 clinicians across 15 acute and community trusts.

In addition, the NHS has embarked on an AI-powered initiative with Proximie, AWS and Deloitte to conduct the largest-ever surgical evaluation in the public health service in a bid to unlock additional capacity from existing NHS facilities.  

NHS - key partners

Microsoft
CEO: Satya Nadella | HQ: Redmond, Washington
Microsoft is the global technology company behind the Copilot AI assistant suite, a platform now available to 500,000 NHS clinicians and support staff. Copilot integrates generative AI into everyday productivity tools, aiming to reduce administrative burden. Microsoft's healthcare partnerships have expanded significantly as NHS trusts seek to embed AI into clinical and back-office workflows.

Heidi
CEO: Dr. Thomas Kelly | HQ: Melbourne, Australia
Heidi is an AI-powered clinical documentation company whose AVT transcribes patient consultations into notes. The company has seen its technology rolled out across NHS England Midlands, covering 1,239 GP practices and more than 70,000 clinicians across 15 trusts.

Proximie
CEO: Dr. Nadine Hachach-Haram | HQ: London, UK
Proximie is a health technology platform enabling remote surgical collaboration through video, audio and AI-assisted analytics. Founded in 2016, it lets surgeons virtually observe and guide operations worldwide. Proximie, alongside AWS and Deloitte, is part of an NHS initiative to conduct the largest-ever surgical evaluation across the public health service.

AWS (Amazon Web Services)
CEO: Matt Garman | HQ: Seattle, Washington
AWS is Amazon's cloud computing division, providing infrastructure and AI tools to organisations globally. AWS is a partner in the NHS's surgical capacity initiative alongside Proximie and Deloitte, contributing cloud and data infrastructure to support the evaluation of NHS facilities and unlock additional surgical capacity.

Deloitte
CEO: Joe Ucuzoglu | HQ: London, United Kingdom 
Deloitte is a multinational professional services firm offering consulting, audit, and advisory services. It is a partner in the NHS's AI-powered surgical evaluation initiative, contributing strategic and operational consulting expertise to help the NHS assess and expand surgical capacity across existing facilities.