The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have been awarded £2m by the Wellcome Trust to strengthen oversight of digital mental health technologies.
“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,” said Lawrence Tallon, Chief Executive of MHRA.
The investment extends a programme launched in 2023, which focuses on the regulation and evaluation of digital tools for mental health.
The programme is aimed at giving clinicians, patients, and developers greater clarity on which digital products are safe, effective, and suitable for use in the UK.
The funding will support work on ensuring that apps, AI-driven systems, and virtual reality interventions meet robust safety and evidence standards.
This work includes:
- Developing a regulatory framework for AI-powered mental health technologies.
- Supporting international alignment and mutual recognition to facilitate faster access to approved tools.
- Raising standards for evidence and quality across the UK’s digital mental health market.
- Ensuring evaluations and research reflect UK-specific populations and clinical contexts.
Digital mental health tools, from apps to AI assessments and VR therapy, are increasingly used across the NHS and by individuals, with evidence showing they can help manage conditions like depression and anxiety.
Clear standards and reliable evidence are essential, yet many users are unaware they can report issues through the Yellow Card scheme, highlighting the need for better guidance.
The funding is expected to support the programme until Autumn 2028, providing developers and healthcare providers with clearer guidance and helping patients navigate the growing digital mental health sector.
In February, MHRA also issued guidance for developers, clarifying when digital mental health technologies are considered medical devices and how they should be assessed for safety and effectiveness.