MHRA issues guidance to help users assess digital mental health technologies
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance to help people safely choose and use mental health apps and digital technologies, amid the growing use of digital tools to support wellbeing and mental health care. The guidance is intended for anyone who uses digital mental health technologies (DMHTs), as well as parents and carers, and professionals who may recommend or support their use, including teachers, nurses, GPs and mental health practitioners. The guidance was developed in partnership with NHS England’s MindEd Technology Enhanced Learning (TEL) programme and forms part of an ongoing project supported by the Wellcome Trust, aimed at promoting the safe and effective use of DMHTs and strengthening the regulatory framework governing them. The MHRA highlights that some DMHTs are classified as medical devices, including those that claim to diagnose, treat or manage a mental‑health condition. In such cases, products must meet relevant safety standards and display a Conformité Européene (CE) or UK Conformity Assessed (UKCA) mark and users can verify whether a product is registered via the MHRA’s online public register, which provides additional reassurance that the product meets UK safety standards and is monitored once in use. However, MHRA notes that not all DMHTs fall within medical device regulation. Some are instead categorised as wellbeing or lifestyle products, which does not mean they are unsafe, but that they may not have undergone the same regulatory checks as medical devices. It adds that if a regulated DMHT causes harm or distress, concerns can be reported through the Yellow Card scheme.