Research: Role of the Digital Mental Health Technology (DMHT) Working Group

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.

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.

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.

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;