Digital mental health technology
The Wellcome Trust has funded a 3-year project focusing on effective regulation and evaluation of digital mental health technology.
The project will improve outcomes for people with mental health conditions by enabling access to safe and effective digital mental health technologies. This will be achieved by ensuring that digital mental health technologies are regulated through continuous evaluation to minimise risk.
MHRA is leading this project in partnership with NICE, and working with many different industry, medical and public experts such as:
- lived experience advisors
- patients and the public
- clinical experts
- academia
- industry experts
- UK and international policymakers
- regulatory bodies
- evaluation agencies
- charities
The results of this project will include various published guidance documents to make clear the regulation and evaluation of these technologies for patients, the public, healthcare professionals and developers.
Project newsletters
- Newsletter 4: November 2025
- Newsletter 3: March 2025
- Newsletter 2: November 2024
- Newsletter 1: November 2023
Guidance
Digital mental health technology: qualification and classification
BSI standard
The public consultation on a new standard for digital mental health technologies (DMHTs) is now open, which can be accessed via the British Standards Institute (BSI) website.
The MHRA has sponsored the BSI to develop this standard, which provides recommendations for designing and conducting clinical studies to generate evidence for DMHTs. The standard aims to apply to the pre-market phase and real-world data collection in the early implementation, post-market phase. It covers factors such as: controls, sample characteristics, safety, effectiveness and engagement end points, follow up periods.
We are inviting feedback from stakeholders across digital health, healthcare, academia and patient communities to help ensure the standard is robust, practical and reflects a wide range of perspectives.
The consultation is open until Monday 29 June 2026.
Online learning resources
The MHRA and NHS England’s MindEd Technology Enhanced Learning programme have published online resources to help the public and professionals understand what safe and effective digital mental health technologies look like in practice, and how to report concerns using the MHRA Yellow Card scheme.
The resources are tailored for public, patients and carers and health, social care the education professionals, including teachers, nurses, GPs and mental health practitioners. They are hosted on the MindEd website, and use tip sheets and animations to explain what technologies regulated as medical devices look like and how to select or recommend a product appropriate for use.
With DMHTs becoming well established within mental health services and also widely available to consumers directly, these MindEd resources provide clear information about the regulation of DMHTs for professionals and the public.
Published articles
Sage Journals Digital Health, 4 November 2024
Considerations for regulation and evaluation of digital mental health technologies
The Lancet Digital Health, 15 November 2024
Building robust, proportionate and timely approaches to the regulation and evaluation of digital mental health technologies
Toward a New Conceptual Framework for Digital Mental Health Technologies: Scoping Review, 19 February 2025
Advancing Digital Health and Open Science JMIR Publications, 7 April 2026 Strength of Evidence to Support Decision-Making on the Use of Digital Mental Health Technologies in NICE Evaluations: Cross-Sectional Analysis of Studies
Webinar recordings
Review the recording of the Digital mental health technology project: Progress update and E-Learning webinar – 28 January 2026
Progress update and E-Learning webinar – 28 January 2026
Review the recording of our webinar from Thursday 15 May 2025:
Research reports
Press releases
Updates to this page
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Added link to the BSI consultation now open
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Advancing Digital Health and Open Science JMIR Publications link added to published article section.
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Updated to add new section to page under BSI standard
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Added link to Review the recording of the Digital mental health technology project: Progress update and E-Learning webinar – 28 January 2026.
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Added new section 'online learning resources', and link to press release 'MHRA Issues New Guidance for People Using Mental Health Apps and Technologies'
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Added link to news story: MHRA and NICE receive £2 million from Wellcome to improve safety and effectiveness of digital mental health technologies
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Added the November 2025 Newsletter
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Added research report 'Digital mental health technology: user and public perspectives on identifying and reporting harms'
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Added link in 'Guidance' section to 'Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance'
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Added link to webinar from Thursday 15 May 2025
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March 2025 project newsletter added
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Added link to article 'Toward a New Conceptual Framework for Digital Mental Health Technologies: Scoping Review'.
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Added guidance document: Digital mental health technology: qualification and classification and associated press release.
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Published link to Newsletter 2: November 2024
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Added link to 'Subject Matter Expert project update webinar' video.
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First published.