The Wellcome Trust has awarded £2m ($2.6m) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) to advance their work on strengthening the regulation of digital mental health technologies.

The renewed funding, which runs until Autumn 2028, will allow both agencies to progress the next phase of a mental health programme launched in 2023. The initiative aims to create clearer, more consistent regulatory pathways to ensure digital mental health tools are safe, effective and evidence-based.

Building on work already completed, the MHRA and NICE will now focus on establishing a digital mental health technology AI “airlock,” enabling companies to test new tools with the regulator ahead of wider NHS deployment. The agencies will also explore international reliance and mutual recognition pathways for digital mental health regulation, support improvements in the quality of evidence generated in the UK, and evaluate how evidence can be applied across different global settings.

The agencies said these efforts will help ensure that the public has better access to high-quality digital mental health technologies and clearer information about how they work and how they have been assessed. Developers will also benefit from a more robust and transparent regulatory framework that supports safe innovation.

The investment forms part of Wellcome’s wider commitment to improving early intervention for anxiety, depression and psychosis, with the charity aiming to create a world in which no one is held back by mental health challenges.

Lawrence 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 noted that the programme aligns closely with the UK Labour Government’s 10-year transformation plan for the 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,” she said.

Unveiled in July 2025, Labour’s plan seeks to shift the NHS from a “sick service” to a preventative health system, with a strong focus on early diagnosis, screening and the use of technologies such as artificial intelligence. The strategy also prioritises reducing patient waiting lists and expanding access to care through a network of new community health centres.

Chancellor Rachel Reeves reinforced this vision in her Autumn Budget on 26 November, confirming that the government will deliver 100 of the planned 250 community health centres by 2030, beginning with some of the UK’s most deprived areas, including Birmingham and Truro, Cornwall