What Makes a Quality Health App? Developing a Global Research-based Health App Quality Assessment Framework for CEN-ISO/TS 82304-2: A Delphi Study.

Abstract

The lack of an international standard for assessing and communicating health app quality and even of consensus about what makes a high-quality health app negatively affects uptake of such apps. At the request of the European Commission, international Standard Development Organizations (SDOs) CEN-CENELEC, ISO, and IEC have joined forces to develop a Technical Specification (TS) for assessing the quality and reliability of health and wellness apps. This study aimed to create a useful, globally applicable, trustworthy, and usable framework to assess health app quality. A two-round Delphi technique with 83 experts from 6 continents (predominantly Europe) participating in one (n=42) or both (n=41) rounds was used to achieve consensus on a framework for assessing health app quality. Aims included identifying the at most 100 requirement questions for uptake of health apps that do or do not qualify as medical devices. The draft assessment framework was built on 26 existing frameworks, the principles of stringent legislation, and input from 20 core experts. A follow-up survey with 28 respondents informed a scoring mechanism for the questions. After subsequent alignment with related standards, the quality assessment framework was tested and fine-tuned with manufacturers of 11 COVID-19 symptom apps. National mirror committees from the 52 countries spanning 6 continents who participated in the SDO technical committees, were invited to comment on 4 working drafts and afterwards vote on the TS. The final quality assessment framework includes 81 questions, 67 of which impact the scores of 4 overarching quality aspects. After testing with people with low health literacy, these aspects were phrased as 'Healthy and safe', 'Easy to use', 'Secure data', and 'Robust build'. The scoring mechanism enables communication of the quality assessment results in a health app quality score and label, alongside a detailed report. Unstructured interviews with stakeholders revealed that evidence and third-party assessment are needed for health app uptake. The manufacturers considered the time needed to complete the assessment and gather evidence (2 to 4 days) acceptable. Publication of CEN-ISO/TS 82304-2:2021 Health software - Part 2: Health and wellness apps - Quality and reliability was approved in May 2021 in a nearly unanimous vote by 34 national SDOs from 6 continents. These included 6 of the 10 most populous countries worldwide (China, India, the US, Pakistan, Brazil, and Russian Federation). A useful and usable international standard for health app quality assessment was developed. Its quality, approval rate, and early use provide proof of its potential to become the trusted, commonly used global framework. The framework will help manufacturers to enhance and efficiently demonstrate the quality of health apps, consumers and healthcare professionals to make informed decisions on health apps, and insurers to make reimbursement decisions on health apps.