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Newsletter 3, March 2025
Welcome to the third newsletter about the MHRA and NICE partnership project, funded by Wellcome, which is addressing the challenges for regulating and evaluating digital mental health technologies (DMHTs).
The purpose of this project is to formulate guidance and other information for developers, healthcare professionals, patients and the public to clarify the regulatory and evaluation requirements for DMHTs.
This will help ensure DMHTs are assessed proportionately and consistently, enabling access to safe and effective products which improve outcomes for people with mental health conditions.
The project continues at pace, and we are pleased to provide a roundup of our latest guidance, articles and other updates.
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We published guidance for manufacturers, on 3 February, setting out how medical device regulations apply to DMHTs, how they are characterised, which products are in scope of the regulations , and how they are classified. The guidance has been widely welcomed, including:
“A new way of thinking from the MHRA to introduce safe and effective technologies to support patient care” Developer of an AI mental health tool
“Fantastic piece of work – sorely needed” GP
Also in February, the project team published a paper in JMIR Mental Health: Toward a new conceptual framework for digital mental health technologies, which outlines eight key domains essential for categorising and understanding DMHTs. Previous papers were published last Autumn in Sage Journal’s Digital Health and The Lancet Digital Health.
We’ve also been spreading the word via specialist and mainstream media. Project manager Holly Coole talked about the challenges of regulating these technologies in a Digital Health podcast in January. On 26 February Holly spoke with Hugo Rifkind on Times radio about the potential for AI to help solve shortages in mental health support.
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Further market research is underway to extend our understanding of user and public perspectives. The research explores how users identify and report adverse events specific to the use of DMHTs. Findings will be published this summer and will inform recommendations to leaders of the MHRA Yellow Card scheme. Our first research report Digital mental health technology: user and public perspectives set out the findings of our initial work.
Future work packages include continuing extensive national and international engagement with subject matter experts, international regulators and Approved Bodies. This will explore the key lifecycle stages for Software as a Medical Device such as clinical evaluation and post-market surveillance.
We anticipate speaking at several high-profile events this year including;
We have decisions pending for several more conference papers, to further broaden awareness and understanding of the project outputs and objectives during the last year of this project.
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We brought together leading experts in AI and mental health to a workshop at the Wellcome Collection in London on 5 February.
Delegates heard from academics and clinicians as well as industry representatives to gain insight into the future of AI technology and consider how its regulation and evaluation may be aligned to enable safe and effective products to reach patients and users.
The project team are drafting a summary of the event which they hope to propose as a paper for publication and updates will be provided in due course. In the meantime, read feedback on LinkedIn from one participant.
The project team anticipates running further online and in person events in the coming months and will publicise these as they arise. The first will be a ‘DMHT Guidance Deep Dive’ webinar for stakeholders who may benefit from a thorough understanding of the recently published guidance. Registration for this event will be open in the next few weeks.
Visit our project web page for our latest press release and other updates.
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If others in your network would like to be added to the mailing list, they can register their interest here.
Best wishes,
Holly Coole and Francesca Edelmann
MHRA Digital Mental Health Technology team
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