Update on pioneering initiative on regulation and evaluation of digital mental health technologies

An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals.

The long-term objective of this three-year project, which began in 2023, is to formulate guidance and other sources of information for developers, healthcare professionals, patients and the public to clarify the regulatory and evaluation requirements for DMHTs.

In this way, DMHTs will be assessed in a risk-proportionate and consistent manner, enabling access to safe and effective products to improve outcomes for people with mental health conditions.

The first work package of the project has now concluded, in which the landscape of available DMHTs and their key characteristics were mapped, and the key challenges for DMHTs across the regulatory and evaluation pathway were explored. A summary of this work has been submitted for publication (Hopkin et al.), and other publications are planned.

The key findings of this work have included the development of a conceptual framework for categorising DMHTs, considerations for regulation and evaluation informed by literature and stakeholder insights and clearer proposals for how DMHTs qualify as Software as a Medical Device (SaMD).

Another key activity was to engage with the public to explore their attitudes and perceptions towards DMHTs, including the potential risks and benefits of these technologies, and their applicability in the current context of mental health care and support.

The MHRA and authors of the summary report, Woodnewton, will be presenting these findings at the Second International Digital Health and Wellbeing Conference in Northern Ireland in June and the report can be accessed here.