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NICE & MHRA to review the regulation of digital mental health tools

The National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been given £1.8m of funding to improve the regulation of digital mental health tools.

The funding, which has been provided by the Wellcome Trust, will help tackle the various regulatory challenges that have arisen since the recent influx of mental health tools available on the market over the last few years.

This new project will review the medical device regulation process, including a focus on determining what specifically qualifies as a medical device, the risk classification certain devices fall under, and a review of the current evidence base for medical devices.

In order to do this, NICE say they and the MHRA will engage with people with lived experience, industry experts, actual patients as well as the international community to help encourage shared learning in digital mental health.

As a result of these deliberations, it is hoped that the various mental health software available will be appropriately regulated as medical devices, ultimately helping the public access effective and safe products that allow them to protect their mental health accordingly.

Johan Ordish, Head of Software and AI at the MHRA said: "Digital mental health tools offer millions of people vital support and guidance to explore and help manage their mental health issues every day.

"However, there are a number of regulatory complexities in establishing when these products should be regulated and what evidence they must have to demonstrate safety and effectiveness. We need to make sure that we are able to answer these questions, to ensure that patients can be confident in the choices they make to support their mental health."

Dr Miranda Wolpert, director of Mental Health at Wellcome, said: "As an increasing number of people turn to digital tools for support with mental health problems, we believe that getting the right level of regulation is vital.

"At Wellcome, we support the development of new and improved interventions for mental health, which includes digital interventions. One of the ways that we can encourage the development of tools that genuinely help and support as many people as possible will be through risk-appropriate guidance and regulation.

"The MHRA will be engaging with and learning from people with lived experience of mental health conditions, helping to ensure that that the regulation is at the right level, relevant and robust."

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