Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide
The example shared in this paper serves as a guide for academics and professionals working in the field of digital mental health. It provides insights into the safety assessment requirements of regulatory bodies when a clinical investigation of a digital mental health intervention is proposed. Methods, scales and tools that could easily be adapted for use in other similar research are presented, with the expectation that these will assist other researchers in the field seeking regulatory approval for digital mental health products.
Authors
- Pamela Charlotte Jacobsen (ORCID: https://orcid.org/0000-0001-8847-7775)
- Neha Gupta (ORCID: https://orcid.org/0000-0001-5412-9721)
- Jeroen Keppens (ORCID: https://orcid.org/0000-0003-3858-7858)
- Emmanuelle Peters (ORCID: https://orcid.org/0000-0003-3327-9223)
- Jenny Yiend (ORCID: https://orcid.org/0000-0002-1967-6292)
- Che-Wei Hsu (ORCID: https://orcid.org/0000-0002-3297-3961)
- Rayan Taher (ORCID: https://orcid.org/0000-0001-8592-527X)
- Sukhwinder S. Shergill (ORCID: https://orcid.org/0000-0003-4928-9100)
- Clare Heaysman (ORCID: https://orcid.org/0009-0003-7024-2830)
- Charlotte L Hall (ORCID: https://orcid.org/0000-0002-5412-6165)
- Thomas Kabir (ORCID: https://orcid.org/0000-0001-8908-0964)
- Aislinn Bergin (ORCID: https://orcid.org/0000-0002-4276-3466)
- Daniel Ståhl (ORCID: https://orcid.org/0000-0001-7987-6619)
- Philip K. McGuire (ORCID: https://orcid.org/0000-0003-4381-0532)
- Ben Wensley Stock
- Nayan Kalnad
Institutions
- Department of Health and Social Care (GB)
- University of Nottingham (GB)
- Medway School of Pharmacy (GB)
- King's College London (GB)
- Wiltshire College (GB)
- University of Oxford (GB)
- King's College School (GB)
- NIHR MindTech MedTech Co-operative (GB)
- McPin Foundation (GB)
- Kent and Medway Medical School
- University of Bath (GB)
- University of Otago (NZ)
Publication Details
- Journal
- Trials
- Published
- 2024-09-09
- DOI
- https://doi.org/10.1186/s13063-024-08421-1
- Citations
- 10
- Primary Topic
- Digital Mental Health Interventions
- Type
- article
- Field-Weighted Citation Impact
- 4.10
Funders
- National Institute for Health and Care Research
- Department of Health and Social Care
- King's College London
- Medical Research Council
- Engineering and Physical Sciences Research Council
- Economic and Social Research Council