Recommendations for developing a lifecycle, multidimensional assessment framework for mobile medical apps

Digital health (DH) and mobile medical apps (MMAs) have shown great promise in transforming healthcare, but their adoption in clinical care has been unsatisfactory, and regulatory guidance and coverage decisions have been lacking or incomplete. A multidimensional assessment framework for regulatory, policymaking, Health Technology Assessment (HTA) and coverage purposes based on the MMA lifecycle is needed. A targeted review of relevant policy documents from international sources was conducted to map current MMA assessment frameworks to formulate 10 recommendations, subsequently shared amongst an expert panel of key stakeholders. Recommendations go beyond economic dimensions such as cost and economic evaluation and include also: MMA development and update, classification and evidentiary requirements, performance and maintenance monitoring, usability testing, clinical evidence requirements, safety and security, equity considerations, organizational assessment, and additional outcome domains (patient empowerment and environmental impact). The Covid-19 pandemic greatly expanded the use of MMAs, but temporary policies governing their use and oversight need consolidation through well-developed frameworks to support decisionmakers, producers and introduction into clinical care processes, especially in light of the strong international, cross-border character of MMAs and the new EU Medical Device and HTA Regulations and Next Generation EU funding earmarked for health digitalization