Building robust, proportionate, and timely approaches to regulation and evaluation of digital mental health...

Demand for mental health services exceeds available resources globally, and access to diagnosis and evidence-based treatment is affected by long delays. Digital mental health technologies present an opportunity to reimagine the delivery of mental health support by providing innovative, effective, and tailored approaches that meet people's individual preferences and goals. These technologies also present new challenges, however, and efforts must be made to ensure they are safe and effective. The UK Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence have launched a partnership, funded by Wellcome, that explores regulation and evaluation of digital mental health technologies. This Viewpoint describes a series of key challenges across the regulatory and health technology assessment pathways and aims to facilitate discussions to ensure that approaches to regulation and evaluation are informed by patients, the public, and professionals working within mental health. We invite partners from across the mental health community to engage with, collaborate with, and provide scrutiny of this project to ensure it delivers the best possible outcomes.