Reducing Uncertainty about the Adoption of CEN ISO/TS 82304-2: A Qualitative Interview Study on the Compatibility of a Health App
Assessment Framework with Catalan and Italian Health Authorities’ Needs (Preprint)
Authors: Hoogendoorn Petra , Shokralla Mariam , Wilemsen Romy , Guldemond Nick , Villalobos-Quesada Maria 
Published: October 2024

BACKGROUND

Health authorities of European Union (EU) Member States (MS) increasingly pursue integration of quality health apps in their healthcare systems. Several of these authorities have developed their own assessment framework (AF) to evaluate the quality of individual health apps, but struggle with its efficient implementation. The European Commission initiated Technical Specification (TS) CEN ISO 82304-2:2021 Health software - Part 2: Health and wellness apps - Quality and reliability (hereinafter the “TS” or “innovation”) to address the scattered EU landscape of AFs for health apps. Decision-making on adoption of the TS is MS competence and considered an uncertainty-reduction process. “Compatibility” of the TS with MS health authorities' needs and evaluations by peers are effective in reducing this uncertainty and mediate harmonisation.

OBJECTIVE

To examine the “compatibility” of the TS with the needs of health authorities of two EU MS, to enhance the compatibility of the TS, and potentially reduce the uncertainty of peer health authorities in their considerations on adopting the TS.

METHODS

Semi-structured interviews were conducted with a regional (Catalonia, Spain) and a national health authority (Italy). Compatibility was visualised using the Value Proposition Canvas, where we mapped out (a) authorities’ needs: “gains”, “pains” and “jobs”, (b) the TS “products and services” and their distinct characteristics: “gain creators” and “pain relievers”, and (c) the compatibility or “fit” between (a) the authorities’ needs and (b) the TS.

RESULTS

Despite their diversity, the needs of the two authorities were similar. Both acknowledged the value and need of integrating quality health apps and using an AF. Both experienced that without enabling EU legislation and standardisation, and with the many authorities involved, achieving (consensus on) an AF is challenging. Nine TS-related products and services and 17 distinct characteristics (e.g., its multi-stakeholder evidence base), were found to be compatible with 3/9 gains perceived by authorities (e.g., stimulating prescriptions and use of apps), 7/9 pains (e.g., legislation and harmonisation issues), and 6/11 jobs (e.g., assessing apps). Indirect effects, three anticipated future services and one anticipated gain creator/pain reliever increase this compatibility.

CONCLUSIONS

Our results suggest that the TS is compatible with the needs of the two authorities concerned. The similarity in their needs suggests that health authorities share common fundamental needs. Both profiling the needs of the Catalonian and Italian authorities and mapping their compatibility with the TS potentially reduce peer authorities’ uncertainties in adopting an AF in general and the TS in particular. More research is recommended to confirm our results in other settings and further finetune compatibility to achieve wide adoption. To our knowledge, this is the first effort to systematically analyse the compatibility of an AF, with the potential to harmonise AFs and accelerate the uptake of health apps.