Guidance has been drawn up for GPs and nurses to help them make safe recommendations on apps and other digital tools created to support mental health.
Free, online resources have been developed by the Medicines and Healthcare products Regulatory Agency (MHRA), NICE and NHS England that also includes steps on how to report any concerns.
The guidance published this week has been taken as ‘more people in the UK, particularly young people, are turning to digital tools for mental health support’ while it not always being ‘clear which are reliable, safe or right for an individual’, the MHRA said.
Meanwhile, as products – some of which are classed as medical devices – are now widely available and often used alongside NHS and community care, the new guidance aims to ‘help people make more informed choices and know what to do if something doesn’t feel right’.
Digital tools for mental health support can range from symptom-tracking apps to virtual reality therapies.
The advice comprises short animations and real-world examples to show what safe, well-evidenced digital mental health technologies look like in practice. Tip sheets also explain how to report concerns through the MHRA Yellow Card scheme so action can be taken to protect others.
Five tips on factors to consider before using a digital mental health tool have been published too (see box below).
The resources are relevant not only to GPs, nurses or mental health practitioners but also to other professionals recommending mental health apps and digital tools, such as teachers, as well as parents parents and carers, and anyone using these technologies.
MHRA Chair, professor of primary care at the University of Oxford and GP Professor Anthony Harnden said the guidance supports ‘better conversations between clinicians and patients and helps everyone ask the right questions about whether a tool is right for them’.
‘As a GP, I’ve seen how patients can benefit from accessing digital tools alongside traditional forms of care.
‘When someone turns to a tool to help with their mental health, they need to know it is safe, effective, and built on reliable evidence. 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.’
Professor Harnden further warned that digital mental health technologies are not a replacement for professional healthcare. ‘Anyone experiencing mental health difficulties should seek support from trained professionals,’ he said.
Two sets of ‘tip sheets’ are available one for health, social care, and education professionals and one for the general public.
They have been developed by the MHRA and NICE in partnership with NHS England’s MindEd Technology Enhanced Learning programme under a Wellcome-funded project to support the safe and effective use of digital mental health technologies.
Five things to check before using a digital mental health tool
1. What is it claiming to do?
Does the product offer general wellbeing support, or does it claim to diagnose, treat or manage a mental health condition? Claims about medical benefit should be clearly explained and supported by evidence.
2. Who is it for?
A tool built for adults may not be suitable for teenagers or children. Age and intended users should be clearly stated.
3. Is there evidence it works?
Trustworthy products will explain how they have been tested or evaluated, for example in a clinical study. Be cautious of products making big promises without clear supporting information.
4. What happens to your data?
These tools often collect very sensitive personal information. You should be able to easily find out how your data is stored and used.
5. Is it is regulated as a medical device?
Some digital mental health technologies are classed as medical devices, for example those claiming to diagnose, treat or manage a mental health condition. These must meet safety standards and display a CE or UKCA mark. People can look for the marking and check whether the product is registered using the MHRA’s online public register. This gives you extra reassurance, as it means it meets UK safety standards, is registered with the MHRA and is monitored once in use.
Not all digital mental health technologies are regulated as medical devices – some are instead classed as wellbeing or lifestyle products. This does not necessarily mean they are unsafe, but they may not have been through the same checks.
If a regulated digital mental health technology causes harm or distress, you can report concerns to the MHRA Yellow Card scheme.
Source: MHRA
