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MindEd Medicines and Healthcare Products Regulatory Agency (MHRA): Digital Mental Health Technologies (DMHT)

Programme information

Title:: MindEd Medicines and Healthcare Products Regulatory Agency (MHRA): Digital Mental Health Technologies (DMHT)
Description:: Digital Mental Health Technologies (DMHTs) are becoming well established within mental health services and through direct-to-consumer models. Apps and websites targeting common mental health problems, such as anxiety and depression, have expanded most rapidly, with some experts suggesting that up to 20,000 apps are now available.

In addition, there is growing use of DMHTs in other mental health conditions and functions (e.g. triage, diagnosis, treatment, monitoring), some using more complex technology (e.g. artificial intelligence (AI) based chatbots and virtual reality (VR)).

There are concerns over lack of clarity around who the technologies are aimed at, whether claims of safety and effectiveness are properly supported by evidence and high early discontinuation rates impacting future help-seeking behaviour and other indirect harms. Due to the distinct nature of DMHTs, stakeholders have called for more clarity on how regulatory requirements apply and their route to use in the NHS.

The aim of this project is for a consensus and to spread clarity of a proportionate regulatory system and joined up route to use in the NHS for DMHTs. The tip sheets in this project were developed as part of a Wellcome funded project to clarify the medical device regulations applicable to these technologies and approaches to their clinical evaluation. The project was led by the MHRA in collaboration with NICE and main outputs will be published guidance documents for developers, healthcare professionals, patients and public. The impact will be access to safe and effective DMHTs to improve outcomes for people with mental health conditions.
Created:: 5 Jan 2026
Last Major Update:: 5 Jan 2026
Keywords:: Medicines and Healthcare products Regulatory Agency, MHRA, Digital Mental Health Technologies, DMHT, SaMD, Software as a medical device, Medical Device, intended purpose, safety, regulation, regulatory status, risk, Class of medical devices, UKCA marks, CE marks, registration, medical purpose, NICE, yellow card scheme, yellow card, MHRA medical vigilance system, adverse events, serious incidents

Programme Information

Title:: MindEd Medicines and Healthcare Products Regulatory Agency (MHRA): Digital Mental Health Technologies (DMHT)
Description:: Digital Mental Health Technologies (DMHTs) are becoming well established within mental health services and through direct-to-consumer models. Apps and websites targeting common mental health problems, such as anxiety and depression, have expanded most rapidly, with some experts suggesting that up to 20,000 apps are now available.

In addition, there is growing use of DMHTs in other mental health conditions and functions (e.g. triage, diagnosis, treatment, monitoring), some using more complex technology (e.g. artificial intelligence (AI) based chatbots and virtual reality (VR)).

There are concerns over lack of clarity around who the technologies are aimed at, whether claims of safety and effectiveness are properly supported by evidence and high early discontinuation rates impacting future help-seeking behaviour and other indirect harms. Due to the distinct nature of DMHTs, stakeholders have called for more clarity on how regulatory requirements apply and their route to use in the NHS.

The aim of this project is for a consensus and to spread clarity of a proportionate regulatory system and joined up route to use in the NHS for DMHTs. The tip sheets in this project were developed as part of a Wellcome funded project to clarify the medical device regulations applicable to these technologies and approaches to their clinical evaluation. The project was led by the MHRA in collaboration with NICE and main outputs will be published guidance documents for developers, healthcare professionals, patients and public. The impact will be access to safe and effective DMHTs to improve outcomes for people with mental health conditions.
Created:: 5 Jan 2026
Last Major Update:: 5 Jan 2026
Keywords:: Medicines and Healthcare products Regulatory Agency, MHRA, Digital Mental Health Technologies, DMHT, SaMD, Software as a medical device, Medical Device, intended purpose, safety, regulation, regulatory status, risk, Class of medical devices, UKCA marks, CE marks, registration, medical purpose, NICE, yellow card scheme, yellow card, MHRA medical vigilance system, adverse events, serious incidents