Mental health apps regulation review requires launch of trade body

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The announcement of a £1.8m project by NICE and MHR to overhaul the regulation of mental health and wellbeing apps has prompted plans for a new trade body for developers of such apps, with an online kick-off meeting expected for January 25, 2023 at 10:00.

Behind the project is Chris Whitehouse, columnist for Med-Tech Innovation News and director of medtech policy at Whitehouse Communications, who says:

It is very early days, but we were already in contact with MHRA and NICE, and DHSCsMedTech management, to discuss how best to facilitate the involvement of responsible app vendors in this major regulatory review, as we have done for other specialist product vendor groups in the past.

We hope to position the new network as a constructive forum for discussion between regulators and the industry.

Dr. Adam Carey, chief executive officer of Corperformance, will chair the meeting and added: Digital innovation in healthcare can bring great benefits at minimal cost and make a real difference to the quality of life of millions of people. It is imperative that regulation is right: protecting patients, while encouraging the development and delivery of exciting, innovative and effective new apps through a proportionate approach.

Funding for the regulatory review is provided by Wellcome, whose director of mental health, Dr. Miranda Wolpert, said at the time of its announcement in October:

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

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

The then Minister for Mental Health Dr Caroline Johnson also said: Digital tools for mental health can be incredibly useful in helping build resilience and prevent problems from getting worse, but it is vital that they are regulated correctly.

This funding will help us better understand these products and give us the tools to ensure everyone who uses them has access to safe and effective support.

App developers wishing to join the meeting should contact Chris Whitehouse [email protected].

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