Experts argue mobile health apps should be reviewed, certified

A viewpoint article recently published in JAMA argued that mobile health (mHealth) apps should be reviewed and certified by experts to “ensure the apps do not post potential harm to their users or have significant security or privacy vulnerabilities.”

According to the article, there are more than 40,000 medical, health, and fitness apps on the market, and while the U.S. Food and Drug Administration (FDA) has stated that apps acting as medical devices or accessories would require its approval, other health apps-such as ones that retrieve medical content, communicate with practitioners, or log health and fitness activity-would not fall under the agency’s jurisdiction.

Authors Adam C. Powell, PhD; Adam B. Landman, MD; and David W. Bates, MD, state, “Although the FDA has focused on safety, it has largely left the review and certification of apps to the marketplace.” Current reviews of apps are generally personal impressions given by users, “rather than evidence-based, unbiased assessments of clinical performance and data security.” 

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While the authors state that it would be unlikely any organization could review all 40,000 health apps, the top-selling and most clinically-useful apps should be reviewed for safety, accuracy, security, effectiveness, and quality.

“By telegraphing these guidelines, as well as standardized approaches to achieving them, the organization will be able to influence mHealth app developers early in their planning process, enabling them to build their apps with these principles and a review process in mind,” stated the authors.

The article suggested the Office of the National Coordinator for Health Information Technology could help in the development of guidelines and certification of the apps, as it is now doing for electronic health records.