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Newsletter 2, November 2024
We’re excited to share an update about progress of the MHRA and NICE partnership, funded by Wellcome, which is addressing the challenges of regulating and evaluating digital mental health technologies (DMHTs).
Above all else, we aim to ensure that the approaches we develop are informed by patients, the public and professionals working in mental health as well as those developing these technologies. Further information about how we are doing this is included in this update.
The long-term objective of this 3-year project, which began in 2023, is to formulate guidance documents and other sources of information for developers, healthcare professionals, patients and the public to clarify the regulatory and evaluation requirements applicable to DMHTs. In this way, it is hoped that DMHTs will be assessed proportionately and consistently, enabling access to safe and effective products to improve outcomes for people with mental health conditions.
Since our last newsletter, the project’s first work package has concluded, which mapped the landscape of available DMHTs and their key characteristics. The key challenges for DMHTs across the regulatory and evaluation pathway were also explored.
We are delighted that summaries of some aspects of this work have been published in The Lancet Digital Health and Sage Journals Digital Health. Further publications are in the pipeline, and we are grateful to current and former colleagues at NICE and MHRA for their collaboration.
The project team attended eMHIC’s Digital Mental Health International Congress in Ottawa in September, to share learnings about our findings to date. Our presentation can be viewed online.
We have engaged at length with the public to understand attitudes and perceptions towards DMHTs, including the potential risks and benefits of these technologies, and their applicability in the context of current mental health care and support. Our research report, Digital mental health technology: user and public perspectives, sets out the findings of this work.
And earlier this year, we contributed to this article in The Observer that highlights some of the challenges of digital mental health apps.
We are now well underway with our second work package to improve information and understanding about what qualifies as a medical device. Earlier this year, we held a webinar for subject matter experts to give an update on the approach to qualification of DMHTs as Software as a Medical Device (SaMD). For those who missed it, here’s the webinar recording.
We anticipate being able to publish the full guidance in Spring 2025.
Future work packages include continuing extensive national and international engagement with subject matter experts, international regulators and Approved Bodies. We will explore the key lifecycle stages for SaMD such as device classification, clinical evaluation and post-market surveillance.
In February 2025, the project team will be hosting an event to explore the regulation and evaluation of artificial intelligence (AI) in digital mental health technologies. This event will be held in person and further details will be provided for those who wish to attend. Places will be limited so early registration is encouraged.
Visit our project web page for our latest press release and other updates.
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Best wishes,
Holly Coole and Francesca Edelmann
MHRA Digital Mental Health Technology team
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