New advice on using digital tools such as apps and technologies to support mental health has been published by the Medicines and Healthcare products Regulatory Agency (MHRA).
This forms part of a free online resource developed with NHS England and funded by the Wellcome Trust to support the safe and effective use of digital mental health technologies among the public, parents, carers and professionals who use or recommend these tools.
The MHRA said more people were turning to technology for mental health support – from symptom-tracking apps to virtual reality therapies – and that these products are now widely used alongside NHS and community care.
However, it is not always clear what is reliable, safe or right for an individual, so the new advice aims to help people make more informed choices, the MHRA added.
MHRA chair and professor of primary care at the University of Oxford, Professor Anthony Harnden, said: ‘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.’
He said that the guidance will support better conversations between healthcare professionals and patients and help everyone ask the right questions about digital tools.
‘Digital mental health technologies are not a replacement for professional healthcare. Anyone experiencing mental health difficulties should seek support from trained professionals,’ Professor Harnden added.
‘Knowing what good looks like’
The new online resources use short animations and real-world examples to show what safe, well-evidenced mental health digital technologies look like in practice.
The guidance is aimed at anyone using these technologies, as well as parents and carers, and includes professionals who often recommend them, such as pharmacists, teachers, GPs and mental health practitioners.
Liz Ashall-Payne, founding CEO of ORCHA – the Organisation for the Review of Care and Health Apps – welcomed the MHRA’s guidance.
‘Knowing what good looks like is important, but people also need a clear and trusted place to go next,’ she said.
‘App stores are not built to check quality and still host many unregulated tools, which can make choices confusing. Public libraries like Mind UK’s, where tools have already been checked, help people make safer and more confident decisions.’
Understanding digital mental health technologies
The MHRA has suggested five things to check before using a digital mental health tool:
- What is it claiming to do?
- Who is it for?
- Is there evidence that it works?
- What happens to your data?
- Is it 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.
If a regulated digital mental health technology causes harm or distress, patients can report concerns to the MHRA Yellow Card scheme, as is the case with medicines.
Chief scientific officer at the National Institute for Health and Care Excellence, Dr Nick Crabb, 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. Our collaboration with the MHRA and Wellcome is helping to lay the groundwork for this.’
Self-care technologies a routine part of care
Medical director for ORCHA, Dr Tom Micklewright, said that healthcare professionals and the public need clearer support to make self-care technologies a routine part of care, and he added that the new MHRA guidance is an important step in that direction.
‘At the same time, the guidance exposes a persistent gap in digital health infrastructure: clinicians are still expected to individually assess digital products before recommending them. This is unrealistic. Clinicians are not digital specialists, and this additional burden risks further diverting time away from patient care,’ he said.
‘While the MHRA update represents genuine progress, digital tools will only achieve their full potential if NHS staff have access to a centralised, fully assessed and assured repository of digital products that can be used with confidence.’
The MHRA is encouraging anyone using mental health apps or other technologies – or supporting someone who does – to explore the new guidance and report any concerns, helping to improve safety for everyone.
A version of this article was originally published by our sister publication The Pharmacist.
