MHRA and NICE secure £2m for digital mental health tech project

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have secured £2 million from Wellcome to continue work on the regulation of digital mental health technologies (DMHTs).

The programme aims to improve outcomes for people with mental health conditions by ensuring that both medical professionals and the public have safe and effective access to DMHTs.

Since launching in 2023, it has focused on introducing clearer, risk-proportionate regulation and evaluation, working closely with people with lived experience, mental health specialists, developers and international partners.

Lawrence Tallon, chief executive at the MHRA, said: “Digital mental health support is becoming part of daily life for many people.

“When someone turns to a tool to help with their mental health, they need to know it is safe, effective and built on reliable evidence. This funding helps us continue that work.

“By creating clear, practical guidance for both users and developers, we can give people confidence in the tools they use and help responsible innovation reach the public more quickly.”

The next phase of the programme will build on current work already completed by the project team across the MHRA and NICE, including establishing a DMHT AI airlock – a regulatory sandbox for AI medical devices – which allows companies to test new tools with the regulator before wider NHS roll-out.

MHRA and NICE will also use the funding, which runs until 2028, to explore international reliance and mutual recognition for the regulation of DMHTs, drive increased quality and evidence for them on the UK market, and consider the challenges in transporting evidence across international settings.

For the public and clinicians, this will mean better access to safe and effective mental health tech and clearer information about what they do, how they have been assessed, and the evidence behind them.

Dr Samantha Roberts, chief executive at NICE, said: “DMHTs are playing an increasingly important role in people’s lives and NHS care, so it’s vital that we have robust frameworks in place to evaluate their effectiveness and safety.

“NICE is working to deliver faster, and fairer access to the best innovations. As part of the 10 year health plan, we are committed to giving patients fairer access to the best digital tools, diagnostics and medical devices, and providing a more coordinated path to the NHS for developers ending the postcode lottery in access.

“To achieve this, we’re going faster to recommend the safe introduction of promising HealthTech with evidence generation by allowing early use so that the NHS and patients can benefit from these promising technologies sooner.”

To find out more about the project, listen to this episode of Digital Health Unplugged featuring Holly Coole, senior manager for digital mental health at MHRA, talking about the challenges of regulating DMHTs and why it is so important to protect patient safety.