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Your mental health app might be a medical device. The MHRA has just said more about what that means

Qurexa Editorial Team10 October 20267 min read 0 0
Your mental health app might be a medical device. The MHRA has just said more about what that means

What happened

On 9 October 2026, the day before World Mental Health Day, the Medicines and Healthcare products Regulatory Agency published two new sets of material about digital mental health technologies. Digital mental health technologies, or DMHTs, are the apps and software people use for their mental health. Some are simple mood diaries. Others deliver therapy, monitor symptoms, or help a clinician make a decision. The first publication explains the role of the DMHT Working Group. This was a group set up as part of a Wellcome-funded project on how these technologies should be regulated and evaluated. The MHRA led it with the National Institute for Health and Care Excellence. The group was not just regulators. Its 27 members included MHRA regulatory experts, NICE health technology assessment experts, NHS England policy experts, psychiatrists, clinical psychologists, mental health nurses, GPs, academic researchers, and advisors with lived experience of mental health conditions. It first met in September 2023, monthly at first and then every other month, until April 2026. The second publication is a set of resources on patient reported outcomes, usually shortened to PROs. A patient reported outcome is simply a questionnaire filled in by the patient rather than the clinician. The resources are aimed at the people building these apps, and explain how to use those questionnaires properly when gathering evidence and monitoring users.

Why this matters

Millions of people in the UK use a mental health app. Very few of them know whether the one on their phone is regulated. The MHRA's position is that it depends on what the app claims to do. An app with a medical purpose, meaning it diagnoses, monitors or treats a condition, and with high functionality, is likely to count as software as a medical device. If it does, it has to comply with medical device regulations, in the same way a blood pressure monitor does. An app that offers general wellbeing content, breathing exercises or mood tracking without medical claims is usually not in that category. That distinction matters a great deal when you are unwell. A regulated device has had to show it works and is safe for its stated purpose. An unregulated wellbeing app has not. The working group's agenda shows which problems the regulators think are hardest. It covered how to categorise these products, what responsibilities app stores have, how to judge whether something works and is worth the money, how to report things that go wrong, and the risks of generative AI in mental health. That last item is the one to watch. Chatbots offering something that looks like therapy have arrived faster than the rules.

What the evidence actually says

The PRO resources are more useful than they sound, because they show what good evidence looks like. They name the standard questionnaires researchers are expected to use rather than inventing their own. These include the PHQ-9 for depression, PANSS for psychosis, EQ-5D for health-related quality of life, the Work and Social Adjustment Scale for how someone is functioning, and the Goal Based Outcome Tool for personal recovery and goals. They also point developers at established standards for running and reporting studies: ISO 14155:2026 on good clinical practice for clinical investigations, the SPIRIT-PRO extension for study protocols, the CONSORT-PRO extension for reporting results, and NICE's Evidence Standards Framework. There is a serious ethics section. It covers balancing how much you ask of someone against survey fatigue, having a clear plan for what happens when a questionnaire answer flags something high-risk such as suicidal thoughts, accessibility and inclusion, involving people with lived experience, and being transparent about who can see the data and why. The MHRA also notes that worsening questionnaire scores may themselves be a sign of an adverse event, and that safety concerns about a marketed device can be reported through the Yellow Card scheme. One honest limit. The MHRA states on the page that these resources are for information and operational support, and are not formal MHRA or NICE regulatory policy, guidance or statutory instruction. They are a steer, not a rulebook.

Qurexa perspective

We think it is worth being clear about our own position here, because the distinction the MHRA is drawing applies to us too. Qurexa offers medication adherence support. That means practical help remembering and taking your medicines: delivery timed to when you actually need it, blister packs or dosette boxes where your pharmacist has arranged them, and reminders. That is a service, not a regulated medical device. We do not diagnose anything, we do not treat anything, and we do not monitor your symptoms. If you are using an app or a service that does claim to do any of those things for a mental health condition, it is reasonable to ask whether it is regulated as a medical device, and who stands behind it if something goes wrong. We would rather you knew the difference than assumed we were something we are not. If you are taking medication for a mental health condition and finding the routine hard, that is common and it is fixable. Talk to your pharmacist about timing, side effects and simpler packaging before you look for an app. The most effective adherence tool is usually a prescription that arrives before you run out.

Practical advice

If you use or are thinking of using a mental health app, a few questions are worth asking. What does it claim to do? Look for the difference between "helps you relax" and "treats depression". The second is a medical claim, and should come with evidence. Is it recommended by anyone you trust? The NHS website lists some digital tools, and some are available on referral through NHS Talking Therapies. A recommendation from your GP or therapist is worth more than a five-star rating. Who can see your data? Mental health information is about as sensitive as data gets. Check the privacy policy for who it is shared with. If you cannot find out, that is an answer. What happens if you tell it something serious? A well-designed tool has a plan for high-risk answers. If an app asks you about suicidal thoughts and then does nothing with your answer, be wary. Be careful with AI chatbots as a substitute for therapy. They are not regulated as treatment, they can be confidently wrong, and they do not know you. If something goes wrong with a product you believe is a medical device, you can report it to the MHRA through the Yellow Card scheme. And if you are in crisis, do not use an app. Call 111 and select the mental health option, call Samaritans free on 116 123, or go to A&E.

What to know

The MHRA published two sets of resources on 9 October 2026 about digital mental health technologies: one explaining the role of its DMHT Working Group, and one on using patient reported outcome questionnaires properly. The key idea for the public is that some mental health apps are regulated as medical devices and some are not. It depends on whether the app has a medical purpose, such as diagnosing, monitoring or treating, and on how much it does. The working group included people with lived experience alongside regulators, clinicians and researchers, and its agenda included the risks of generative AI in mental health. The MHRA stresses these particular resources are operational support, not formal regulatory policy. Before you rely on an app, check what it claims, who recommends it, where your data goes, and what it does if you report something serious. Sources: Medicines and Healthcare products Regulatory Agency, 'Role of the Digital Mental Health Technology (DMHT) Working Group', 9 October 2026, https://www.gov.uk/government/publications/role-of-the-digital-mental-health-technology-dmht-working-group; MHRA, 'Patient reported outcomes (PROs) resources for digital mental health technologies (DMHTs)', 9 October 2026, https://www.gov.uk/government/publications/patient-reported-outcomes-pros-resources-for-digital-mental-health-technologies-dmhts; MHRA, 'MHRA Chair Professor Anthony Harnden: Bringing our strategy to life', 9 October 2026, https://www.gov.uk/government/news/mhra-chair-professor-anthony-harnden-bringing-our-strategy-to-life-listening-learning-and-looking-ahead This article is for general information and does not replace advice from a doctor, pharmacist or other qualified healthcare professional.

#mental health#MHRA#digital health#medical devices#regulation#apps

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