Digital mental health technology
Wellcome have funded the MHRA and NICE to focus on clarifying effective regulation and evaluation of digital mental health technology (DMHT).
Background
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 they are engaging with a wide range of stakeholders, including:
- clinicians
- researchers
- industry
- lived / living experience advisors
- patients and the public
- international regulators
- health technology appraisal organisations
- UK and international policy makers
- charities.
The project’s phase 1 commenced in May 2023 and phase 2 commenced in May 2026 and will continue until Autumn 2028.
A broad range of outputs across the project have been produced and these are shown for phase 1 to date.
Together, they support MHRA plans on implementing the medical devices future regime and the National Commission into the Regulation of AI in Healthcare work.
Phase 1
MHRA Guidance
Digital mental health technology: qualification and classification
BSI standard
The MHRA has sponsored the BSI to develop this standard, which provides recommendations for designing and conducting pivotal clinical studies to generate evidence for DMHTs. It covers aspects such as: controls; sample characteristics; safety, effectiveness and engagement end points; and follow up periods. A technical author and steering group with a wide range of global expertise has supported the drafting and editing, There was a public consultation in June 2026 and the standard will be published early 2027.
Resources
Patient reported outcomes (PROs) resources for digital mental health technologies (DMHTs)
Interpreting small differences in health utilities and incremental QALYs (March 2026)
Yellow card reporting
Based on feedback, the yellow card reporting website has been edited to make it clearer that DMHT issues can be reported via this route, supporting MHRA’s ongoing safety monitoring of medical devices and digital technologies - Yellow Card, Making medicines and medical devices safer
Online learning
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 and 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.
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:
Subject Matter Expert project update webinar
Research Reports
Digital mental health technology: user and public perspectives
(3 May 2024)
Digital mental health technology: user and public perspectives
(20 November 2025)
Working group summaries
Role of the Digital Mental Health Technology (DMHT) Working group
Published articles
Considerations for regulation and evaluation of digital mental health technologies Sage Journals Digital Health, 4 November 2024
Building robust, proportionate and timely approaches to the regulation and evaluation of digital mental health technologies The Lancet Digital Health, 15 November 2024
Toward a New Conceptual Framework for Digital Mental Health Technologies: Scoping Review JMIR Mental Health, 19 February 2025
Strength of Evidence to Support Decision-Making on the Use of Digital Mental Health Technologies in NICE Evaluations: Cross-Sectional Analysis of Studies JMIR Mental Health, 7 April 2026
The impact of choice of health-related quality of life measure on outcomes in mental health: A systematic review and meta-analysis of head-to-head comparisons Value in Health, 16 June 2026
A Lived Experience Perspective on Digital Regulatory Practices Journal of Psychiatric and Mental Health Nursing, 3 October 2026