WHO/Europe and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) are launching a Knowledge Community dedicated to the regulation of digital mental health technologies. The Community is open to all interested parties, including representatives of Member States; intergovernmental, governmental and nongovernmental organizations; the private sector; and academic institutions. Software engineers and service users are also welcome.
About the Community
Knowledge Communities are informal, time-bound forums that bring together multidisciplinary expertise to support the analysis of complex issues related to data and digital health in the WHO European Region. Designed as problem-focused platforms, they enable members to collectively identify potential solutions through shared experience, dialogue and reflection.
This Knowledge Community will support the development of clear, evidence-informed and proportionate regulatory approaches for digital mental health technologies. It will address regulatory considerations across the lifecycle of these tools, from development and validation to ongoing evolution and post-market changes.
Topics will include user-centred design in mental health contexts; defining sufficient evidence for safety and effectiveness; when and how regulatory oversight should apply; and accountability and trust. The discussions will inform a joint WHO–MHRA report, building on current regulatory frameworks and recent studies highlighting gaps in oversight of artificial intelligence-driven mental health solutions.
The discussion will span 6 weeks starting on 6 November 2025, with a kick-off webinar at 10:30 CET and a specific subtheme introduced each week. WHO moderators will guide the dialogue to maintain focus and depth, posing follow-up questions as needed to encourage meaningful exchange.
Harnessing collaboration
This initiative directly supports the Regional Digital Health Action Plan for the WHO European Region 2023–2030, the WHO Global Strategy on Digital Health 2020–2025, and the WHO European Framework for Action on Mental Health 2021–2025, all of which identify collaboration and knowledge exchange as strategic priorities.
In addition, the insights generated by the Knowledge Community will support a project led by MHRA, funded by Wellcome and delivered in partnership with the United Kingdom’s National Institute for Health and Care Excellence (NICE), which aims to address how regulatory requirements apply to digital mental health technologies.
To become part of the Knowledge Community, complete the online application form by 23 October 2025. If you have any questions, write to EUDigitalHealth@who.int before the application deadline.