A Method of Justifying Confidence in the Safety of Digital Health Interventions.

Digital health interventions (DHIs) enable improvements in health strategy and address health system challenges. The World Health Organization provides a formal classification for DHIs. However, safety claims, about such interventions, vary in quality and are often vague as to how they are communicated between technical, clinical experts and stakeholders. By combining the classifications with a method of safety analysis and justification, we postulate confidence in the safety of digital technology. Confidence is resulting from the application of the framework to the DHI, using defined health system challenges. The framework and derived safety justifications can be applied to any DHI. It can serve as guideline for health strategy, regulatory and standards based compliance.