Developing a Health App Quality Report for CEN-ISO/TS 82304-2 to Satisfy Health Care Professionals' Information Needs on the Quality of Health Apps: Participatory Design Study.

BACKGROUND

Health apps, which comprise medical and wellness apps, hold potential to improve prevention, diagnosis, treatment, and management of disease. Yet, recommendation and prescription rates by health care professionals (HCPs) are low. Trusted standardized health app quality reports providing the information HCPs need to recommend or prescribe a specific app for an individual patient and guidelines from medical societies are considered crucial to enable this digital transformation of medicine. The CEN-ISO 82304-2 (hereinafter "82304-2") Technical Specification, an initiative of the European Commission, includes a research-based health app quality assessment framework comprising 81 quality requirements. Results of 82304-2 app assessments are summarized in an intuitive "health app quality label." The 82304-2 quality label's potential to increase HCP willingness to recommend health apps was recently confirmed. To adequately enable decision-making and thus app recommendations, 82304-2 proposes a more detailed "health app quality report" to complement the 82304-2 quality label.

OBJECTIVE

This study aimed to design the 82304-2 health app quality report that satisfies the information needs of individual HCPs in decision-making on an individual health app for an individual patient.

METHODS

A participatory design approach was applied. In an 18-month process of participatory prototyping with 9 HCPs with digital health expertise, the 82304-2 quality report was iteratively designed. A convenience sample of 31 HCPs indicated the priority 82304-2 quality requirements they considered useful in decision-making on recommending an app, and thus needed detailed quality information. Final feedback meetings with the 9 HCPs and 8 medical societies were used to finalize the 82304-2 quality report design. Web-based questions in these meetings, feedback from the Dutch Patient Federation, and a comparative content analysis and the Health Education Materials Assessment Tool were used to evolve to and evaluate the final 82304-2 quality report design.

RESULTS

In total, 37% (30/81) of the 82304-2 quality requirements were prioritized by >50% of the HCPs. The final 82304-2 quality report design provides detailed information for 90% (27/30) of the prioritized quality requirements. The reporting detail for 2 quality requirements requires more research. The final feedback meetings, the Patient Federation feedback, comparative content analysis, and Health Education Materials Assessment Tool provide indicative proof of the usefulness and usability of the quality report design.

CONCLUSIONS

We succeeded in our aim to design the 82304-2 health app quality report and found promising potential for its distinctive usefulness for HCPs and patients in recommending and considering a health app, respectively, and for medical societies in creating guidance. Further efforts are needed to test its effectiveness, fine-tune multistakeholder and intercontinental usefulness and usability, support medical societies in providing guidance and potentially training on recommending health apps, and advance from the current design to a scalable fully functional version of the quality report and associated open access database.