Testing and iterative improvement of the CEN ISO/TS 82304-2 health app quality assessment: a pilot study (Preprint)

BACKGROUND With the increasing use of health apps and ongoing concerns regarding their safety, effectiveness, and data privacy, numerous health app quality assessment frameworks have emerged. However, assessment initiatives are struggling to scale, and a comprehensive, consistent, internationally recognised framework is lacking. Therefore, health apps often need to undergo several quality evaluations to enter different markets, leading to duplication of work. The CEN ISO/TS 82304-2 health app assessment seeks to address this issue, aiming to provide an internationally accepted quality evaluation through a network of assessment organisations located in different countries. OBJECTIVE The aim of this study was to develop and evolve the draft CEN ISO/TS 82304-2 assessment handbook and developer guidance by testing them across organisations in several countries. METHODS Assessment organisations from 5 countries were engaged to evaluate 24 health apps with the evolving CEN ISO/TS 82304-2 assessment across 3 evaluation rounds. The information submitted by a given health app developer was evaluated by 2 assessment organisations and inter-rater reliability was examined. In addition, app developers and assessors were asked to report how much time they spent on information collation or evaluation, and to rate the clarity of the developer guidance or assessor handbook, respectively. The collected data were used to iteratively improve the handbook and guidance between rounds. RESULTS The inter-rater reliability between assessment organisations improved from round 1 to round 2 and stayed relatively stable between rounds 2 and 3, with 80% (55/69) of assessment questions demonstrating moderate or better (Gwet AC1 >0.41) agreement in round 3. The median time required by developers to prepare the assessment information was 8 hours and 59 minutes (IQR 5.7-27.1 hours) in round 3, while assessors reported a median evaluation time of 8 hours and 46 minutes (IQR 7.1-11.0 hours). The guidance and handbook were generally perceived as clear, with a median round 3 clarity rating of 1.73 (IQR 1.64-1.90) for developers and of 1.78 (IQR 1.71-1.89) for assessors, where 0 = ‘very unclear’, 1 = ‘somewhat unclear’, and 2 = ‘completely clear’. CONCLUSIONS To our knowledge, this is the first study to examine the consistency of health app evaluations across organisations located in different countries. Given that the CEN ISO/TS 82304-2 guidance and handbook are still under development, the inter-rater reliability findings observed at this early stage are promising, and the study provided valuable information for future refinement of the assessment. This study marks an important first step towards establishing the CEN ISO/TS 82304-2 assessment as a consistent, cross-national health app evaluation. It is envisioned that the assessment will ultimately help to avoid duplication of work, prevent inequities by facilitating access to smaller markets for developers, and build trust among users, thereby increasing the adoption of high-quality health apps.