Standards for Mobile Health–Related Apps: Systematic Review and Development of a Guide

BACKGROUND: In recent years, the considerable increase in the number of mobile health (mHealth) apps has made health care more accessible and affordable for all. However, the exponential growth in mHealth solutions has occurred with almost no control or regulation of any kind. Despite some recent initiatives, there is still no specific regulation procedure, accreditation system, or standards to help the development of the apps, mitigate risks, or guarantee quality. OBJECTIVE: The main aim of this study was to propose a set of criteria for mHealth-related apps on the basis of what is available from published studies, guidelines, and standards in the various areas that are related to health app development. METHODS: We used three sources of information to identify the most important criteria. First, we conducted a systematic review of all the studies published on pain-related apps. Second, we searched for health app recommendations on the websites of professional organizations. Third, we looked for standards governing the development of software for medical devices on the specialized websites of regulatory organizations. Then, we grouped and subsumed the criteria we had identified on the basis of their shared characteristics. Finally, the comprehensibility and perceived importance of the resulting criteria were evaluated for face validity with a group of 18 stakeholders. RESULTS: We identified a total of 503 criteria from all sources, which, after close analysis, were grouped into eight different categories, including 36 important criteria for health apps. The resulting categories were usability, privacy, security, appropriateness and suitability, transparency and content, safety, technical support and updates, and technology. The results of the preliminary analysis showed that the criteria were mostly understood by the group of stakeholders. In addition, they perceived all of them as important. CONCLUSIONS: This set of criteria can help health care providers, developers, patients, and other stakeholders to guide the development of mHealth-related apps and, potentially, to measure the quality of an mHealth app.