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Dear Colleague,
You have been added to the mailing list for the newsletter related to the Wellcome Trust funded project focusing on effective regulation and evaluation of digital mental health technology because you have been identified as a potential stakeholder.
These newsletters will provide updates on the project and detail any opportunities to be involved.
If others in your network would like to be added to the mailing list, please can they register their interest here.
If you would like to unsubscribe, you can do so here.
The Wellcome Trust funded digital mental health project is led by the MHRA in partnership with NICE. This work was initiated in May 2023 with the full project team onboarded by July 2023.
Since then, significant research and engagement has been undertaken to establish key foundations which will enable the objectives of the project to be achieved.
A working group and project board have been established, including membership of those with clinical, academic, regulatory, policy and evaluation expertise, as well as crucially those with lived experience. The project seeks to incorporate lived experience discussions as an agency-first which are unique when compared to discussions that focus on 'patients' and 'service-users'. Identifying as having lived experiences of mental health challenges may be a viable option to a wider range of people whose help-seeking behaviours and self-identification are not tied to accessing clinical or medical support.
Project meetings commenced in September and successfully met objectives in providing accountability, expertise and experience to the project and will continue on a monthly and quarterly basis respectively.
The project is divided into 5 work packages detailed in the figure below and we are currently in the initial scoping phase.
Project overview
 Areas of consideration in the scoping phase will include:
- Patient and public perceptions, attitudes and beliefs market research project.
- Report on the considerations for regulation and evaluation of DMHTs. This includes extensive health technology appraisal and regulatory review of previous interactions with developers and appraisal of App marketplaces.
- Report describing a conceptualised framework for grouping DMHTs
- Subject matter expert and digital mental health industry workshops
- International regulatory and policy workshops
- Published thought-leadership piece in academic journal.
This work will inform the rest of the project where the main outputs will be guidance documents for developers, healthcare professionals, patients and the public to clarify the regulatory and evaluation requirements. In this way, it is hoped that digital mental health technologies will be regulated in a risk proportionate manner and evaluated consistently to enable access to safe and effective products to improve outcomes for people with mental health conditions
Thank you,
The Medicines and Healthcare products Regulatory Agency
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