The Wellcome Trust charity has granted £2m ($2.6m) in funding to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE), advancing efforts to develop clearer and more consistent regulation digital mental health technologies.
The renewed funding will run to Autumn 2028 and give the MHRA and NICE the ability to continue their work on initiatives within a mental health programme that was launched in 2023.
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Work already completed by the agencies will be advanced into its next phase with the fresh funds. The MHRA and NICE said they will now focus on establishing a digital mental health technology AI ‘airlock’ for allowing companies to test new tools with the regulator before wider NHS roll-out.
Other focuses will include undertaking an exploration of international reliance and mutual recognition for the regulation of digital mental health technologies, driving increased quality and evidence for digital mental health technologies in the UK, and considering the challenges in transporting evidence across international settings.
The initiatives 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, according to the two entities. And for developers, the plans will provide a clearer framework that supports both innovation and safety.
Wellcome’s funding comprises part of its commitment to drive transformation in early intervention for anxiety, depression and psychosis, an initiative the charity said aims to create a world where no one is held back by mental health problems.
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By GlobalDataLawrence Tallon, CEO 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.”
NICE CEO Dr Samantha Roberts highlighted that the work resonates with the UK Labour Government’s 10-year plan for the UK National Health Service (NHS).
“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,” Roberts said.
Revealed in July 2025, key plans for Labour’s NHS ‘transformation’ plan includes taking steps to shift the health service from being a ‘sick service’ to one that is preventative. Prime Minister Sir Keir Starmer said this will be achieved with a stronger focus on early diagnosis and screening with the use of technology such as artificial intelligence (AI).
The 10-year plan is also focused on drawing down patient waitlists and the establishment of community health centres to meet this aim.
Rachel Reeves, the Labour Party’s chancellor of the exchequer, delivered her Autumn Budget on 26 November. Resonating with one pillar of the NHS transformation plans, the chancellor told MPs in the House of Commons that the government plans to deliver 100 of 250 new community health centres by 2030. Rollout for the centres will begin in some of the nation’s most deprived areas, including Birmingham and Truro, Cornwall.
