mhra
MHRA outlines digital mental health working group’s role in regulation and AI priorities
An MHRA summary explains how the DMHT Working Group contributed to classification guidance, clinical evidence work and AI Airlock priorities.
What Changed
MHRA published a research and analysis summary on 9 October 2026 explaining how the Digital Mental Health Technology (DMHT) Working Group supported regulation, evaluation and artificial intelligence priorities. The publication documents contributions to the programme rather than announcing a new binding requirement.
The group was established during phase 1 of a Wellcome-funded project led by MHRA in collaboration with NICE. The project sought to clarify regulation and evaluation of digital mental health technologies that qualify as software as a medical device (SaMD).
Who Is Affected
The publication is relevant to developers and manufacturers of DMHTs within the SaMD scope, alongside clinical research and health technology assessment teams. It does not imply that every mental health application is a medical device.
The group brought together MHRA regulatory experts, NICE assessment experts, NHS England policy expertise, lived experience advisors, psychiatrists, clinical psychologists, mental health nurses, GPs and academic researchers.
Regulatory and Technical Implications
Feedback contributed to MHRA guidance on DMHT qualification and classification. Discussions also supported work on quality-of-life measurement, effectiveness and cost-effectiveness evidence, selection of clinical outcome measures and a BSI standard concerning DMHT clinical studies.
An April 2025 discussion led to additional DMHT examples in MHRA guidance for manufacturers on reporting adverse incidents involving SaMD. Later meetings addressed generative AI risks, possible clinical investigation improvements and potential guidance updates. The summary does not establish these discussions as newly adopted requirements.
Manufacturer Actions
Manufacturers can use the summary to identify related work on device qualification, classification, clinical evidence and incident reporting. Meeting discussions should be distinguished from the content of the relevant guidance when assessing applicable obligations.
For AI-enabled DMHT developers, the publication records the group’s contribution to DMHT AI Airlock and mental health AI sandbox priorities. It does not provide application dates or eligibility conditions, and should not be read as confirmation that applications are open.
Confirmed Dates
The first meeting took place in September 2023. Meetings were initially monthly and later held every other month until April 2026. In August 2025, written feedback replaced a meeting.
The meeting on 23 April 2026 covered phase 2 work packages and Delphi exercise results on AI Airlock priorities. The publication is dated 9 October 2026 and specifies no new compliance deadline.
Official Source
MHRA, “Role of the Digital Mental Health Technology (DMHT) Working Group”, published as research and analysis on GOV.UK. The page lists a six-page PDF summary.
https://www.gov.uk/government/publications/role-of-the-digital-mental-health-technology-dmht-working-group
Source and related services
Research: Role of the Digital Mental Health Technology (DMHT) Working Group ↗Source date: 09/10/2026
This news provides general information and does not replace device-specific legal or conformity assessment advice.