Improving safety claims in digital health interventions using the digital health assessment method.

Objective: Establish a relationship between digital health intervention (DHI) and health system challenges (HSCs), as defined by the World Health Organization; within the context of hazard identification (HazID), leading to safety claims. To improve the justification of safety of DHIs and provide a standardised approach to hazard assessment through common terminology, ontology and simplification of safety claims. Articulation of results, to provide guidance for health strategy and regulatory/standards-based compliance.

Methods: We categorise and analyse hazards using a qualitative HazID study. This method utilises a synergy between simplicity of DHI intended use and the interaction from a multidisciplinary team (technologists and health informaticians) in the hazard analysis of the subject under assessment as an influencing factor. Although there are other methodologies available for hazard assessment. We examine the hazards identified and associated failures to articulate the improvements in the quality of safety claims.

Results: Applying the method provides the hazard assessment and helps generate the assurance case. Justification of safety is made and elicits confidence in safety claim. Controls to hazards contribute to meeting the HSC.

Conclusions: This method of hazard assessment, analysis and the use of ontologies (DHI & HSC) improves the justification of safety claim and evidence articulation.