The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance to support the users of mental health apps and other digital technologies.
It is part of the free online resources developed by the agency in partnership with NHS England’s MindEd Technology Enhanced Learning programme to serve the public, parents, carers, and professionals who suggest the tools.
The MHRA said it has focused, in collaboration with the National Institute for Health and Care Excellence (NICE), on a proportionate approach to regulate and evaluate the "fast-moving area" of digital mental health technologies as part of the Wellcome-funded project, launched in 2023.
With an increasing number of the population, particularly the youth, utilising digital tools, spanning from symptom-tracking apps to virtual therapies, to improve their mental health, the regulator said its new guidance will help users to identify the reliable, safe, and appropriate tools.
The guidance explains five factors to consider while choosing the right digital mental health tool.
It urges the people to understand the tools’ claims and know who it is for. People must also make sure there is evidence supporting the tool’s claims to ensure its credibility.
The guidance stresses on the importance of learning how the users’ data is stored and used as well.
Lastly, it also advises people to make sure their digital tool is regulated as a medical device using the MHRA’s online public register.
The new online resource uses short animations and real-world examples to help people take informed decisions regarding their mental health tools. It also explains how to report concerns through the MHRA Yellow Card scheme so action can be taken to protect others.
“Our aim is to give people clear, practical advice they can use in everyday life, so they understand what good looks like and when to speak up if something doesn’t feel right,” said Professor Anthony Harnden, MHRA chair and professor of primary care at the University of Oxford.
“This guidance supports better conversations between clinicians and patients and helps everyone ask the right questions about whether a tool is right for them,” he added.
However, he also reminded that these digital tools cannot replace professional healthcare and urged people suffering from mental health issues to seek professional help in time.
Dr Nick Crabb, chief scientific officer at NICE said, “These new resources will help people ask the right questions and make informed choices. This matters now more than ever, as the government’s 10 Year Health Plan expands NICE’s technology appraisal process to cover devices, diagnostics and digital products for the first time.”
