Table 3.
List of recommendations on how to adapt the medical regulatory safety assessment model to meet the needs of the digital mental health field
| Recommendation 1 | Publish guidelines for professionals on how to assess and report adverse events data in digital mental health research. |
| Recommendation 2 | Standardise the optimum way to assess the relatedness of an adverse event to the intervention, procedure or device, by using a variety of independent evidence sources. |
| Recommendation 3 | When evaluating safety, differentiate between self-guided and clinician-guided interventions. |
| Recommendation 4 | Broaden the scope of potential serious adverse events in digital studies to consider impact on mental health. |
| Recommendation 5 | Monitor psychological deterioration to prevent potential harm, using post-treatment follow-ups. |
| Recommendation 6 | Utilise the suggestions outlined (Supplementary Appendix C) to support people experiencing deterioration in any treatment context. |
| Recommendation 7 | Improve the visibility of the Yellow Card Scheme as the primary means of reporting adverse reactions in the digital mental health field. |
| Recommendation 8 | Change the Yellow Card ‘psychiatric conditions’ category label to ‘mental health adverse reactions’. |
| Recommendation 9 (a & b) | Expand the Yellow Card category that captures mental health data to incorporate informative subcategories and additional contextual information. |
| Recommendation 10 | Develop an overarching, harmonised framework for assessing the safety of any psychological intervention (digital or otherwise). |