On 27 January 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) published new free online guidance to help the public, parents, carers, and health, social care, and education professionals understand what safe and effective digital mental health technologies look like in practice. Developed in partnership with NHS England, the resources respond to the growing use of digital tools such as symptom-tracking apps, online therapies, and virtual reality, particularly among young people, and aim to support more informed choices and clearer pathways for raising concerns.
The guidance emphasises that while digital mental health tools can complement NHS and community care, it is not always clear which products are reliable, appropriate, or evidence-based. It offers practical advice for everyday use, supports better conversations between clinicians and patients, and reinforces that digital tools are not a replacement for professional healthcare.
A central feature of the guidance is a “five things to check” framework for anyone considering a digital mental health tool:
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What it claims to do – distinguishing general wellbeing support from claims to diagnose, treat, or manage a mental health condition, which should be clearly explained and evidence-based.
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Who it is for – ensuring the intended age group and users are clearly stated.
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Evidence of effectiveness – looking for transparent information on testing or evaluation, such as clinical studies.
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Data use and protection – understanding how sensitive personal data are stored and used.
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Regulatory status – checking whether the product is regulated as a medical device and displays a CE or UKCA mark, and whether it is listed on the MHRA public register.
The MHRA clarifies that not all digital mental health technologies are regulated as medical devices; some are classed as wellbeing or lifestyle products. While this does not automatically mean they are unsafe, such products may not have undergone the same level of regulatory scrutiny. Concerns or adverse incidents involving regulated products can be reported through the MHRA Yellow Card scheme.
The new resources use short animations and real-world examples to illustrate what good practice looks like and explain how to report concerns. They are designed for a wide audience, including the general public, parents and carers, and professionals such as teachers, nurses, GPs, and mental health practitioners.
The work forms part of a Wellcome-funded collaboration between the MHRA and NHS England’s MindEd Technology Enhanced Learning programme, and builds on ongoing efforts since 2023 by the MHRA and National Institute for Health and Care Excellence (NICE) to support proportionate regulation and evaluation of digital mental health technologies. Partners including Wellcome, Mind, and the British Psychological Society highlighted the importance of robust evidence, health literacy, and ensuring that digital and AI-enabled tools support—rather than replace—human-led mental health care.
The MHRA encourages anyone using or recommending digital mental health technologies to explore the guidance and report concerns, helping to improve safety and confidence across this rapidly evolving area.
Read the original press release from the Medicines and Healthcare products Regulatory Agency.
