Role of the Digital Mental Health Technology (DMHT) Working Group
Find out how the Digital Mental Health Technology Working Group supported MHRA and NICE work on regulation, evaluation and AI priorities for DMHTs.
Documents
Details
The DMHT working group was established as part of phase 1 of the Wellcome funded project focusing on effective regulation and evaluation of DMHTs. This was a collaborative project led by the MHRA in collaboration with National Institute for Health and Care Excellence (NICE) to clarify the regulation and evaluation of DMHTs that qualify as software as a medical device (SaMD).
The first meeting of the working group was held in September 2023 and it met monthly initially moving to meetings every other month until April 2026. A wide range of diverse expertise was represented on the working group including: MHRA regulatory experts, NICE health technology assessment (HTA) experts, NHS England policy expertise, lived experience advisors, psychiatrists, clinical psychologists, mental health nurses, General Practitioners (GP’s), and academic researchers. We are very grateful to each of the members who are acknowledged below for their valuable expertise and contributions, without which the success of the project could not have been achieved.
How the working group contributed
The working group played an important role across both phases of the programme. Its discussions ranged from early exploration of key concepts to detailed refinement of project outputs, and it helped shape priorities for phase 2, particularly the Digital Mental Health Technology Artificial Intelligence (AI) Airlock.
How meetings were structured
Meetings provided a structured forum for discussion of regulatory and health technology assessment topics relevant to digital mental health technologies. They also reviewed how feedback from earlier sessions had been reflected in subsequent outputs through a clear “You Said, We Did” approach. Further details of each meeting are set out below.
| Meeting date | Main discussion | You said, we did |
|---|---|---|
| September 2023 | Introduction to the project, group discussion on DMHT insights, and MHRA presentation on the user and public perspectives research plan. | User and public perspectives research plan updated based on discussion. Full report: Digital mental health technology: user and public perspectives. |
| October 2023 | MHRA and NICE presentation and group discussions on core considerations for regulation and evaluation of DMHTs. | Discussion helped shape publication: Considerations for regulation and evaluation of digital mental health technologies. |
| November 2023 | MHRA and NICE presentation and group discussions on categorisation frameworks for DMHTs. | Discussion helped shape publication: Toward a New Conceptual Framework for Digital Mental Health Technologies: Scoping Review. |
| December 2023 | Discussion on app store responsibilities and interim findings from the user and public perspectives research. | Discussion helped shape team thinking on app stores and refined the focus for the next phase of research. |
| February 2024 | Discussion on wider considerations in the DMHT ecosystem and reflections on work package 1. | Discussion impacted the project stakeholder list and shaped following work packages. |
| April 2024 | First in-person meeting. MHRA presented the framework for device characterisation, qualification and classification for DMHTs. | Feedback led to updates to the framework and drafting of the MHRA guidance. |
| May 2024 | Additional meeting to follow up the qualification proposal and reach a more focused consensus. | Feedback led to updates to the framework and drafting of the MHRA guidance. |
| June 2024 | NICE presentation and group discussion on the importance and challenges of measuring quality of life for DMHTs. | Discussion impacted research and team publication: The impact of choice of health-related quality of life measure on outcomes in mental health. |
| August 2024 | Page-by-page review of the draft MHRA guidance for DMHT device characterisation, regulatory qualification and classification. | Feedback led to updates to the draft and publication: Digital mental health technology: qualification and classification. |
| October 2024 | Guest speaker presentation and group discussion on academic papers about DMHT regulation, including a case study on regulatory approval. | Discussion shaped the project team’s thinking around assessing safety for DMHTs and documents required for clinical investigations. |
| December 2024 | MHRA presentation and group discussion on NHS England e-learning. | Discussion helped shape MHRA, NICE and NHS England e-learning for public, patients and carers: MindEd Hub, and for health, social care and education professionals: MindEd Hub. |
| February 2025 | Second in-person meeting. Group discussions on evidence needed to demonstrate effectiveness and cost-effectiveness of DMHTs using 4 case studies. | Discussion helped shape the IMDRF workshop DMHT session on evidence generation and a BSI standard on clinical studies for DMHTs. |
| April 2025 | MHRA presentation and group discussion on DMHT adverse event reporting and potential phase 2 topics. | Discussion led to more DMHT examples in MHRA guidance for manufacturers on reporting adverse incidents involving software as a medical device and helped shape the phase 2 proposal. |
| June 2025 | MHRA and NICE presented project overview and progress. The group reflected on progress and outputs achieved to date. | Discussion helped shape ongoing phase 1 work packages and planned phase 2 work packages. |
| August 2025 | No meeting was held because many members were on leave, but a written feedback exercise was completed. | The project team compiled a feedback summary for members, which informed the focus of the next working group meeting. |
| October 2025 | NICE presentation on selecting outcome measures in DMHT clinical studies and discussion on standardising outcome collection. | Discussion helped shape the BSI standard providing recommendations for clinical studies to generate clinical evidence for DMHTs. |
| December 2025 | Update on Wellcome funding for phase 2, discussion on e-learning dissemination, and discussion on risks of generative AI in mental health. | Members helped disseminate the MHRA, NICE and NHS England e-learning. Discussion also shaped MHRA thinking around risks linked to generative AI in mental health. |
| February 2026 | MHRA discussion on the clinical investigation process and potential improvements, and potential updates to MHRA guidance on DMHT qualification and classification. | Discussion shaped MHRA thinking on clinical investigation improvements and was explored further internally and at a CERSI AI workshop. |
| 23 April 2026 | MHRA and NICE presentation on phase 2 work packages, Delphi exercise results on DMHT AI Airlock priorities, and discussion of phase 1 feedback. | Discussion shaped mental health AI sandbox priorities and the call for applications. Feedback also led to publication of this document acknowledging working group members. |
Acknowledgement of working group members
Representatives from the MHRA and NICE coordinated the working group meetings and contributed to discussions alongside the committee members listed below;
Chris Lynch; Dionne Bowie; Eddie Alder; Ellie Thomas; Farhan Ismail; Gareth Hopkin; Grace Gatera; James Woollard; Jemma Kehoe; Joanna Gavins; John Powell; Judith Harrison; Kate Cavanagh; Laura Cox; Laura Van Staaden; Lesa Wright; Mark Salmon; Maria Loades; Matthew Moore; Melanie Calvert; Michelle Rigozzi; Phillip Stimpson; Sarah Bonney; Sarah Fothergill; Sophie Cooper; Sophie Hughes; Tom Pelly.