Digital Mental Health Technology: Research on identifying and reporting harms associated with the use of DMHT and awareness of the MHRA Yellow Card Scheme

Key Findings

• — Most users did not think DMHT posed any risk and few recognised the term; specific concerns raised included AI replacing human treatment making problems worse, self-treatment in isolation exacerbating misdiagnosis or unmanaged suicidal ideation, false or misleading diagnoses, addiction and isolation, and excessive screen time.
• — Participants expected DMHT-related harms would be hard for users to recognise themselves, and argued for supervised use within a care plan, including apps that let clinicians see usage data or that check in with users displaying concerning behaviour.
• — Most users said that even if they recognised harm they would not report it because they would not know how, expected it to make no difference, or could not manage it while unwell; the exception was reporting back to the professional who recommended the app.
• — Few users, and none of the healthcare professionals interviewed, had heard of the Yellow Card scheme in relation to DMHT; participants favoured a simple feedback route, with some wanting an independent body such as an ombudsman or regulator rather than developers.
• — The report recommends integrating reporting into apps and app stores and lists of approved products, and records that participants' perceptions may not match objective reality.

Methodology Notes

Grounded-theory qualitative study by Woodnewton for the MHRA: 24 focus groups with adults identified as current or potential DMHT users (including people with diagnosed mental health conditions), six focus groups with children and young people (up to 17), and 30 one-to-one interviews with health, care and education intermediaries; 200 participants; mostly online with some in-person sessions. Findings are perceptions and are not extrapolable to prevalence. 81-page PDF dated November 2025, published on GOV.UK 20 November 2025 as part of the MHRA and NICE Wellcome-funded DMHT regulation project. Adult participant table: 76 female, 43 aged 18 to 29.

Sources