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New partnership addresses key challenges for regulating 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 categorizing 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.​

The main findings of the report are that whilst DMHTs were perceived as having the potential to make a valuable contribution to the management of health, they should be used as part of a wider treatment package, alongside regular therapy sessions and/or regularly reviewed, prescribed medication.​

Participants expressed a degree of dissatisfaction with the design and effectiveness of DMHTs they had experience with but remained in favor of their continued access, concluding products could be more effective for one person than another. This linked to views on regulation and whilst many participants displayed a lack of knowledge surrounding the role of the MHRA, they were in favor of a risk proportionate approach so as not to unduly restrict access, whilst recognizing the importance of assurance and safety. The project will take forward actions to improve awareness in terms of the responsibilities of the regulator.​

Future work packages will explore qualification and classification of DMHTs as SaMD, clinical evidence and post-market surveillance requirements and will seek to refine the findings and proposals to date into guidance. Activities will also include a continuation of extensive national and international engagement with subject matter experts, collaboration with international regulators to explore current approaches, and conversations with approved bodies to understand collective perspectives.​

A working group and project board have been established to engage, collaborate and provide scrutiny to the project to ensure it delivers the best possible outcomes.​

Insights have been captured from clinical, academic, regulatory, policy and evaluation experts from across the mental health community, as well as those with lived experience of mental health conditions. These stakeholders will continue to have an integral role throughout the project.​

In a joint statement, the Lived Experience Advisors to the project said:

“The scale of the challenge is vast, and it’s been reassuring to see such commitment to lived experience throughout the project whilst enabling flexibility in our involvement.​

“This has effectively facilitated our ability to contribute to key areas of the project that we feel are important.”

The team has skillfully navigated a complex and confusing landscape of software tools to produce robust foundation principles to guide regulation of software as a medical device.”

Dr Lesa Wright, Working group member

David McMullen M.D., Director of the Office of Neurological and Physical Medical Devices in the United States Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health, said:

“As the design, manufacture, distribution and use of medical devices have become increasingly complex and global, the need for harmonized approaches among regulatory authorities has become more vital.​

“The FDA recognizes that successful international harmonization will require the integration of ideas and perspectives from key stakeholders, including other regulatory authorities, to facilitate improved patient access to safe and effective digital mental health technologies. We look forward to working with and learning from others to help further our international harmonization efforts in this area.”



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