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Bridging the gap from medical to psychological safety assessment: Consensus study in a digital mental health context
Hall, Charlotte L. Vallejos, Elvira Perez
Hall, Charlotte L.
Vallejos, Elvira Perez
Abstract
BACKGROUND: Digital Mental Health Interventions (DMHIs) that meet the definition of a medical device are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA uses procedures that were originally developed for pharmaceuticals to assess the safety of DMHIs. There is recognition that this may not be ideal, as is evident by an ongoing consultation for reform led by the MHRA and the National Institute for Health and Care Excellence. AIMS: The aim of this study was to generate an experts' consensus on how the medical regulatory method used for assessing safety could best be adapted for DMHIs. METHOD: An online Delphi study containing three rounds was conducted with an international panel of 20 experts with experience/knowledge in the field of UK digital mental health. RESULTS: Sixty-four items were generated, of which 41 achieved consensus (64%). Consensus emerged around ten recommendations, falling into five main themes: Enhancing the quality of adverse events data in DMHIs; Re-defining serious adverse events for DMHIs; Reassessing short-term symptom deterioration in psychological interventions as a therapeutic risk; Maximising the benefit of the Yellow Card Scheme; and Developing a harmonised approach for assessing the safety of psychological interventions in general. CONCLUSION: The implementation of the recommendations provided by this consensus could improve the assessment of safety of DMHIs, making them more effective in detecting and mitigating risk.
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Date
2024
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Article
Subject
Mental health, Digital technology, Safety
Citation
Taher, R., Bhanushali, P., Allan, S., Alvarez-Jimenez, M., Bolton, H., Dennison, L., Wallace, B. E., Hadjistavropoulos, H. D., Hall, C. L., Hardy, A., et al. (2024). Bridging the gap from medical to psychological safety assessment: Consensus study in a digital mental health context. BJPsych Open, 10 (4), pp.e126.
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© The Author(s), 2024. Published by Cambridge University Press
on behalf of Royal College of Psychiatrists. This is an Open
Access article, distributed under the terms of the Creative
Commons Attribution licence (http://creativecommons.org/
licenses/by/4.0/), which permits unrestricted re-use, distribution
and reproduction, provided the original article is properly cited.
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