MHRA and NICE receive £2 million from Wellcome to improve safety and effectiveness of digital mental health technologies
Source: gov.uk (2025-11-27)

Additional funding will allow the MHRA and NICE to continue developing clear, proportionate guidance for digital mental health technologies, supporting safer, more effective tools for people across the UK.

People across the UK will have better access to high quality, safe and effective digital mental health support, thanks to extended funding for clearer regulation and evaluation of these technologies.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have secured a £2 million funding boost from Wellcome to continue its joint work on clearer, more consistent regulation and evaluation of digital mental health technologies. Running to Autumn 2028, the renewed support builds on activities already underway to help people across the UK access safe and effective digital mental health technologies.

From symptom-tracking apps to AI-powered assessments and virtual reality therapy, digital mental health technologies are increasingly used by individuals and across the NHS to support mental health. Research from the UK suggests they can provide real benefits for some people (https://pubmed.ncbi.nlm.nih.gov/40112295/), in managing depression, anxiety and stress, alongside other forms of care. As these technologies become more embedded in everyday care, clear standards and reliable evidence are essential so users, clinicians and services can trust how they work and what they offer.

Although certain digital mental health technologies fall under medical device regulations and must meet the same strict safety standards as other medical devices, new research from Woodnewton (https://www.gov.uk/government/publications/digital-mental-health-technology-user-and-public-perspectives-on-identifying-and-reporting-harms) suggests that many people do not realise they can report problems with digital mental health tools in the same way, via the Yellow Card scheme (https://yellowcard.mhra.gov.uk/), reinforcing the need for clearer guidance and communication.

Since launching in 2023 (https://www.gov.uk/government/news/mental-health-funding-of-18m-welcomed-by-mhra-and-nice-to-explore-regulation-of-digital-mental-health-tools), the programme has focused on introducing clearer, risk-proportionate regulation and evaluation to a fast-moving area, working closely with people with lived experience (https://www.gov.uk/government/news/meet-the-women-helping-ensure-that-digital-mental-health-technologies-are-safe-effective-and-developed-considering-the-needs-of-the-people-who-use-th), mental health specialists, developers and international partners.

The next phase will build on current work already completed by the project team across the MHRA and NICE, including:
- Establish a digital mental health technology AI airlock – a regulatory sandbox for AI medical devices – which lets companies test new tools with the regulator before wider NHS roll-out
- Explore international reliance and mutual recognition for the regulation of digital mental health technologies
- Drive increased quality and evidence for digital mental health technologies on the UK market
- Consider the challenges in transporting evidence across international settings
For the public and clinicians, this will mean better access to high quality, safe and effective digital mental health technologies and clearer information about what they do, how they have been assessed, and the evidence behind them. For developers, this will provide a clearer framework that supports both innovation and safety.

This funding is part of Wellcome’s commitment (https://wellcome.org/our-priorities/mental-health) to drive transformation in early intervention for anxiety, depression and psychosis, to create a world where no one is held back by mental health problems.

Lawrence Tallon, Chief Executive of 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.”

Dr Samantha Roberts, Chief Executive of NICE, said:

“Digital mental health technologies 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.”

Professor Miranda Wolpert, Director of Mental Health at Wellcome:

“Our partnership with the MHRA and NICE over the next few years is a great example of how our research funding and policy work is fostering collaboration to bring more pathways to earlier interventions for anxiety, depression and psychosis.

“They will be creating practical tools that help regulators and developers work together on safe and effective solutions, supporting regulators to build a clearer global picture of frameworks and evidence. This will help get the best digital interventions into the hands of people with mental health problems.”

Notes to editors
- More information about the project can be accessed through the Digital mental health technology hub (https://www.gov.uk/government/collections/digital-mental-health-technology).
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
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