NICE and MHRA will review 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 received £1.8m funding from the Wellcome Trust to improve the regulation of digital mental health tools.

Over the next three years, the two agencies will use the money to tackle the challenges involved in regulating the vast marketplace of apps and digital tools designed to support mental health and wellbeing.

The joint project will review the medical device regulation process, focusing on establishing what qualifies as a medical device as well as the risk classification certain devices fall under. It will also review the current evidence base for medical devices, with the aim of creating a set of guidelines for appropriate, risk-proportionate regulation of these products. At the moment, regulation of digital mental health tools can be tricky, because it is not clear whether they can be treated as medical devices for regulatory purposes.

The two organisations will engage with patients and industry experts to help encourage shared learning in digital mental health.

Regulatory complexities

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.”

The eventual aim is to make sure that people who turn to digital tools for support with mental health problems can be confident that the product they are using is safe and effective. “We believe that getting the right level of regulation is vital,” said Dr Miranda Wolpert, director of Mental Health at Wellcome. “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.”

Mark Salmon, programme director for information services at NICE, said: “This work is one way both organisations can simplify and streamline the process of getting wide-scale adoption of safe, clinical and cost-effective digital mental health products into the hands of the people who need them and help ease the pressure on the NHS.”