Testing and Iterative Improvement of the CEN ISO/TS 82304-2 Health App Quality Assessment: Pilot Interrater Reliability Study.

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 experience difficulties scaling, and there is currently no comprehensive, consistent, internationally recognized assessment framework. Therefore, health apps often need to undergo several quality evaluations to enter different markets, leading to duplication of work.