The announcement of a £1.8m project by NICE and MHRA to review the regulation of mental health and well-being apps has prompted plans for a new trade body for developers of such apps, with an online launch meeting planned for 25th January 2023 at 10 am.
Behind the project is Chris Whitehouse, director of MedTech Policy at sector specialist Whitehouse Communications, who says: “It’s very early days, but already we’re in touch with MHRA and NICE, and the DHSC’s MedTech directorate to discuss how best we can facilitate the engagement of responsible app providers in this important regulatory review, as we have done for other groups of specialist product suppliers in the past.”
“We hope to position the new network as a constructive forum for discussion between regulators and the sector.”
Dr Adam Carey BSc, MA, MB, BChir, MRCOG, NTCC, chief executive of Corperformance, will chair the meeting and adds: “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. We must get regulation right: protecting patients while encouraging developing and delivering exciting, innovative and effective new apps through a proportionate approach.”
The funding for the regulatory review is being 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 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 the regulation is at the right level, relevant and robust.”
Minister for mental health at the time, Dr Caroline Johnson, also said: “Digital mental health tools can be incredibly useful to help build resilience and prevent problems worsening, but these must be regulated properly. This funding will help us better understand these products and give us the tools to ensure everyone using them can access safe, effective support.”