Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and advisor to MedTech suppliers, looks at the impact of a major grant from the Wellcome Trust to fund development of new standards for digital mental health apps.
UK medical device regulators have said that people across the UK are set to benefit from safer, more effective digital mental health support following a significant funding boost for the development of new standards. The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have secured 2 million from The Wellcome Trust to continue their joint work on clearer regulation and evaluation of digital mental health technologies.
This renewed support, running until autumn 2028, builds on progress already made since the programme’s launch in 2023. The funding will enable MHRA and NICE to strengthen guidance, improve evidence standards, and ensure that digital tools designed to support mental health are safe and effective.
From symptom-tracking apps to AI-powered assessments and virtual reality therapy, digital mental health technologies are increasingly woven into daily life and NHS services. Research in the UK suggests these tools can help people manage depression, anxiety, and stress, often alongside traditional forms of care.
The concern is that as their use expands, the need for clear standards and reliable evidence becomes more urgent. Clinicians, patients, and services must be able to trust how these technologies work and what they offer. Without consistent regulation, there is, regulators fear, a risk that innovation could outpace safety, leaving users uncertain about the quality of the support they receive.
Although some digital mental health technologies already fall under medical device regulations, requiring them to meet the same strict safety standards as other medical devices, public awareness remains limited. Research from Woodnewton highlights that many people do not realise they can report problems with digital mental health tools through the Yellow Card scheme, the same mechanism used for medicines and medical devices.
This gap underscores the importance of clearer communication and guidance. By improving awareness, regulators can empower users to report issues, helping to build a more transparent and responsive system of oversight.
Since its inception, the MHRA-NICE programme has focused on introducing risk-proportionate regulation and evaluation tailored to the fast-moving digital health sector. Collaboration has been central to this work, with input from people with lived experience, mental health specialists, developers, and international partners.
The next phase of the programme will expand on this foundation, with priorities including:
Establishing a digital mental health technology AI airlock – a controlled environment to test and evaluate AI-driven tools before they reach the public.
Exploring international reliance and mutual recognition – working with global regulators to harmonise standards and reduce duplication.
Driving increased quality and evidence – ensuring that technologies on the UK market meet robust standards of effectiveness and safety.
Considering challenges in transporting evidence internationally – addressing how data and evaluations can be applied across different healthcare systems.
For the public and clinicians, this, say the regulators, will mean better access to high-quality digital mental health technologies, along with clearer information about how they have been assessed and the evidence behind them. For developers, it will provide a more transparent framework that balances innovation with safety.
More information about the project can be accessed through the Digital mental health technology hub.
The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.
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