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Welcome to the fourth update about our digital mental health technologies project delivered by the MHRA in partnership with the National Institute for Health and Care Excellence (NICE) and funded by Wellcome.
The project continues at pace and in this issue we cover recent updates to guidance, new research and standards development, and our work with the public and health professionals to improve understanding and regulation of DMHTs.
Following the publication of our first report on public perceptions of the risks and benefits of DMHTs, we’ve published a second market research study focused on adverse event reporting.The report is now available and explores:
- Barriers to identifying and reporting harm associated with the use of DMHTs
- How manufacturers, healthcare professionals, and regulators can better support reporting.
Following updates to Post-market surveillance regulations, we've updated the MHRA guidance for manufacturers on reporting adverse incidents involving software as a medical device.
New additions include:
- More examples of DMHT-related incidents such as AI therapy chatbots, technical failures in virtual reality therapy and incorrect AI assessments
- Clarification on vigilance requirements
An additional MHRA project report, published in August, provides more information about the regulatory change and the guidance updates.
In May, we hosted a webinar about our MHRA guidance covering the characterisation, regulatory qualification, and classification of DMHTs.
A recording of the webinar presentation is available.
In July, we published an updated version of this guidance. The changes reflect:
To see what’s been updated see the ‘Revision History’ on the last page of the MHRA guidance.
To receive automatic alerts about future updates, click “Get emails about this page”.
Our analysis of DMHTs evaluated by NICE shows that:
- Some products are backed by strong clinical evidence
- Key evidence gaps remain, which can hinder adoption.
Developers should identify and address these gaps early in the product lifecycle.
A paper on this work has been submitted to JMIR Mental Health and is available as a pre-print until 5 December 2025.
We’re working with the British Standards Institute (BSI) to develop a standard for best practice in designing clinical studies for DMHTs — both pre- and post-market.
This will support:
- developers of DMHTs
- stakeholders who design clinical studies and assess clinical evidence.
A technical author and diverse steering group are in place and a one-month public consultation is planned for Spring 2026.
To take part, contact Nisha Sawon at nishadevi.sawon@bsigroup.com, quoting PAS 709 Review Panel. Your input will help ensure the standard reflects national and international best practice.
Working with the World Health Organization (WHO), we have set up a global knowledge community focused on discussing risk-proportionate approaches to regulating significant changes to DMHTs, including the use of pre-determined change control plans.
The kick-off webinar took place in early November and it runs for six weeks with weekly subthemes to guide discussion.
Thanks to all those who are participating and we look forward to sharing learnings from the knowledge community in 2026
The project team has been actively presenting at national and international conferences to share our work and raise awareness of DMHT regulation:
On World Mental Health Day in October, Holly Coole and lived experience expert Grace Gatera featured on a Digital Health Unplugged podcast where they explored how AI and digital mental health technologies are being developed and regulated to keep people safe. |
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We’re collaborating with the NHS to develop tip sheets for:
- Healthcare professionals
- Patients, carers and the public
These will help users identify acceptably safe, effective DMHTs that suit their needs.
These are coming in early 2026 — stay tuned!
Stay connected
All outputs and resources are available on our DMHT project webpage.
Sign up for email updates and follow MHRA on LinkedIn to stay informed
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