MHRA issues new guidance for people using mental health apps and technologies
New advice on using apps and other digital tools to support mental health was published by the Medicines and Healthcare products Regulatory Agency (MHRA) on the 27th of January, as part of free online resources developed with NHS England for the public, parents, carers and professionals who use or recommend these tools.
More people in the UK, particularly young people, are turning to digital tools for mental health support. From symptom-tracking apps to virtual reality therapies, these products are now widely available and often used alongside NHS and community care, but it is not always clear which are reliable, safe or right for an individual. The new guidance aims to help people make more informed choices and know what to do if something doesn’t feel right.
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.
“As a GP, I’ve seen how patients can benefit from accessing digital tools alongside traditional forms of care. This guidance supports better conversations between clinicians and patients and helps everyone ask the right questions about whether a tool is right for them.
“Digital mental health technologies are not a replacement for professional healthcare. Anyone experiencing mental health difficulties should seek support from trained professionals.”
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.
What the new resources offer
The new online resources use short animations and real-world examples to show what safe, well-evidenced digital mental health technologies look like in practice, and explain how to report concerns through the MHRA Yellow Card scheme so action can be taken to protect others.
The guidance is aimed at anyone using these technologies, as well as parents and carers, and includes professionals who often recommend them, including teachers, nurses, GPs and mental health practitioners.
The resources have been developed by the MHRA in partnership with NHS England’s MindEd Technology Enhanced Learning programme as part of a Wellcome-funded project to support the safe and effective use of digital mental health technologies.
Since its start in 2023, the MHRA, in collaboration with the National Institute for Health and Care Excellence (NICE) has focused on proportionate regulation and evaluation in the fast-moving area of digital mental health technologies, working closely with people with lived experience, mental health specialists, developers and international partners.
Chief Scientific Officer at NICE, Dr Nick Crabb, said:
“Our role at NICE is to help practitioners and commissioners get the best care to people, fast, while ensuring value for the taxpayer. As digital mental health technologies become more widely used, it’s vital that people can access tools that are safe, effective and built on robust evidence.
“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 – ensuring that innovation in mental health is matched by rigorous, proportionate evaluation so that the best digital tools can reach those who need them.”
Head of Digital Technology, Discovery Research and Mental Health at Wellcome, Matthew Brown, said:
“As more people turn to digital mental health technologies for support, we need practical ways for regulators, developers, and healthcare providers to work together so that safe, effective interventions reach those who need them.
“These technologies offer transformative opportunities and we need better evidence to understand what works, for whom, and in which contexts. Our partnership with MHRA and NICE over the coming years reflects this commitment, bringing research, policy, and innovation together to create earlier and more effective support for anxiety, depression, and psychosis.”
The Health Minister in Northern Ireland, Mike Nesbitt said:
“Digital tools give people information at their fingertips, helping them understand their conditions better, which can help them take greater control of their mental health and take steps to find tailored solutions. I welcome this new resource, which will allow people to make more informed choices around which apps are safe and effective, based on evidence.
“For me, health literacy is both about understanding your own health and also how to navigate a complex Health and Social Care system. Apps will prove to be highly accessible tools in improving health literacy. It is important people have confidence in the Apps they may rely upon.”
Head of Information at Mind, Stephen Buckley, said:
“It’s really important that people can understand what good support looks like. Digital tools such as these are a useful way for people to access information and help alongside more traditional mental health support.”
President of the British Psychological Society, Dr Roman Raczka, said:
“As more people turn to mental health therapy apps for support, it is timely that the MHRA has introduced this new guidance to help users make an informed choice in an ever-growing market.
“However, we must remember that while AI can deliver significant benefits, it must never replace the human support which is fundamental to effective mental health care. Instead, it must be integrated thoughtfully to support human-led care, not replace it entirely. AI cannot replicate genuine human empathy and can create an illusion of connection rather than meaningful interaction.”
Head of Public Affairs & Advocacy at the National Counselling & Psychotherapy Society, Meg Moss, said:
"It's encouraging to see the MHRA publishing guidance on digital mental health tools; it is clearly much needed. As more people, particularly young people, turn to apps and online platforms for support, they will need more practical advice around safety, efficacy, and protecting their data. At the same time, we must be clear about what digital tools can and cannot offer. Digital tools cannot replace the healing power of a genuine human relationship. Decades of research consistently show that the quality of the therapeutic relationship – the trust, empathy, and collaboration between client and practitioner – is one of the strongest predictors of positive outcomes. Even as we embrace innovation, we must ensure it enhances, rather than erodes, opportunities for people to be in meaningful relationship with another human being."
The MHRA are 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.
