MHRA and Manchester NHS launch sandbox to test AI and health tech

The Medicines and Healthcare products Regulatory Agency (MHRA) has partnered with Manchester University NHS Foundation Trust (MFT) to test new healthcare technologies in real NHS environments, with the aim of speeding up the safe adoption of innovations that prove effective.

The first major programme under the partnership will be a new Manchester Sandbox, where technologies can be deployed and evaluated with patients and clinicians as part of day-to-day healthcare.

The programme will generate evidence on their safety, effectiveness and impact, helping the NHS assess which technologies could improve patient care and be suitable for wider adoption.

The first technologies are expected to include AI-enabled medical devices, such as tools designed to identify patients at higher risk of complications from long-term conditions, potentially allowing earlier support and treatment.

Testing AI in real NHS settings

The partnership builds on the MHRA’s use of regulatory sandboxes, which allow emerging technologies and regulatory approaches to be explored in controlled environments with appropriate oversight.

Working with MFT, the regulator wants to evaluate healthcare technologies that could improve patient care and safety and reduce pressure on NHS services, while exploring proportionate, lifecycle-based approaches to regulation.

A key focus will be addressing the gap between technologies showing promise during development and demonstrating that they can work safely and effectively in real healthcare environments.

Evidence generated through the Manchester programme will be shared across the NHS and could inform how successful technologies are introduced elsewhere in the country. It is also intended to give developers a clearer understanding of the evidence required for wider NHS use.

Lawrence Tallon, chief executive of the MHRA, said: “AI and other emerging technologies have enormous potential to improve patient care. The challenge is understanding how they work in practice and where they can make the biggest difference.

“Manchester brings together the NHS, innovators, researchers and regulators to do exactly that. The learning from this programme could help shape how safe and effective technologies are introduced across the country, helping more patients benefit from innovation.”

From innovation to adoption

Manchester University NHS Foundation Trust is one of the UK’s largest NHS trusts, and the partnership is intended to draw on the region’s existing healthcare research, digital and AI capabilities.

The initiative was launched at MFT’s Oxford Road Campus, with demonstrations including wearable products and AI-powered Ambient Voice Technology products.

MFT chief executive Mark Cubbon said bringing the different parties together earlier should help create a clearer path between the development of healthcare technologies and their safe adoption.

“Patients should benefit from innovation as quickly as possible, but they should never have to choose between access and safety,” he said. “This partnership brings together key partners earlier in the process so we can understand what works and how new technologies perform in real healthcare settings.”

Health Innovation Minister James Frith said the programme would allow technologies to be tested under “strict oversight and guardrails”, while helping identify those that could make a difference to patients.

“Manchester is leading the way in getting the best new technologies into the hands of local patients faster – from AI models that can identify people at risk sooner to innovative treatments that could transform NHS care,” he said.

“But innovation must never come at the expense of safety.”

Next phase planned

MFT and the MHRA plan to hold a roundtable later this year involving healthcare providers, technology developers, researchers and patient and public representatives to identify future opportunities and help shape subsequent projects.

The MHRA will also invite expressions of interest from medical device developers interested in participating in the next phase.