An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges in the regulation and evaluation of digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals.
The long-term goal of this three-year project, which began in 2023, is to develop guidance and other sources of information for developers, healthcare professionals, patients and the public to clarify 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 is now complete, mapping the landscape of available DMHTs and their key characteristics and exploring key challenges for DMHTs across the regulatory pathway and evaluation. An abstract of this work has been submitted for publication (Hopkin et al.) and further publications are planned.
Key findings of this paper include the development of a conceptual framework for categorizing DMHTs, considerations for regulation and evaluation based on literature and stakeholder knowledge, and clearer proposals for how DMHTs qualify as Software as a Medical Device (SaMD).
Another key activity was working 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 the authors of the summary report, Woodnewton, will present these findings at the Second International Conference on Digital Health and Wellbeing in Northern Ireland in June, and the report is accessible here.
The main findings of the report are that, while DMHTs were considered to have the potential to make a valuable contribution to health management, they should be used as part of a wider treatment package, alongside regular treatment sessions and/or regularly reviewed, prescribed Medication.
Participants expressed a degree of dissatisfaction with the design and effectiveness of the DMHTs they had experienced, but remained in favor of their continued access, as the products could be more effective for one person than another. This was linked to views about regulation and, while many participants showed a lack of knowledge about the MHRA’s role, they were in favor of a risk-based approach to not unduly restrict access, while recognizing the importance of safeguarding and safety. The project will take action to improve awareness of the regulator’s responsibilities.
Future work packages will explore the certification and classification of DMHTs as SaMD, clinical evidence and post-market surveillance requirements and will seek to refine the findings and recommendations to date into guidance. Activities will also include continued extensive national and international engagement with subject matter experts, collaboration with international regulators to explore current approaches, and conversations with authorized bodies to understand collective perspectives.
A task force and a project board have been established to participate, collaborate and review the project to ensure it delivers the best possible results.
Input has been captured from clinicians, academics, regulators, policy makers and evaluators 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 project’s Lived Experience consultants said:
“The scale of the challenge is huge and it is reassuring to see such a commitment to lived experience across the project, while also allowing flexibility in our involvement.
“This effectively facilitated our ability to contribute to key areas of the project that we believe are important.”
The team deftly navigated a complex and confusing landscape of software tools to create strong fundamentals that will guide the regulation of software as a medical device.”
Dr. Lesa Wright, member of the task force
David McMullen MD, Director of the Office of Neurological and Physical Medical Devices at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, said:
“As the design, manufacture, distribution and use of medical devices become increasingly complex and global, the need for harmonized approaches between regulators 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 together and learning from others to help advance our efforts for international harmonization in this area.’
