JMIR Publications

ABSTRACT

Background:

In recent years, the considerable increase in the number of mobile health apps has made healthcare 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 is to provide a set of standards for mobile health-related apps on the basis of what is available from guidelines, frameworks, and standards in the field of health app development.

Methods:

To identify the most important criteria, we used three strategies. First, we conducted a systematic review of all the studies published on health-related apps. Second, we searched for health-app recommendations on the websites of professional organizations. Finally, we looked for standards governing the development of software for medical devices on the specialized webs of regulatory organizations. Then, we compiled the criteria we had identified and determined which of them could be regarded as essential, recommendable or desirable.

Results:

We identified a total of 168 criteria from the systematic review, 282 criteria from published guidelines, and 53 criteria from the standards of medical devices. These criteria were then grouped and subsumed under 8 categories, which included 36 important criteria for health apps. Of these 7 were considered to be essential, 18 recommendable, and 11 desirable. The more essential criteria an mHealth application has, the greater its quality.

Conclusions:

This set of standards can be easily used by health care providers, developers, patients and other stakeholders, both to guide the development of mHealth related apps and to measure the quality of an mHealth app.