Though the Food and Drug Administration has released final guidelines for the regulation of mobile health applications, an internationally renowned expert in patient safety has called for the creation of mHealth app review and certification organizations to evaluate the vast majority of apps that remain unregulated.

In a viewpoint article published online today in the Journal of the American Medical Association, David Bates, M.D., senior vice president for quality and safety and chief quality officer for both Brigham and Women’s Hospital and Brigham and Women’s Physicians Organization, argues that the FDA has largely left the review and certification of apps to the marketplace.

The problem, Bates and his co-authors assert, is that currently available reviews of mHealth apps have “largely focused on personal impressions, rather than evidence-based, unbiased assessments of clinical performance and data security” which are “available for other categories of health information technology software.”

Bates chaired the Food and Drug Administration Safety and Innovation Act Workgroup that made recommendations to the government about the regulation of health IT and mobile apps. In September 2013, the FDA published its final guidance on mobile medical apps that outlined a risk-based approach and stated its intention to focus on high-risk apps.

However, the JAMA article finds that in general "apps that provide precise treatment recommendations and diagnostic information will receive more regulatory attention," while "apps that provide users with the ability to log life events, retrieve medical content, or communicate with clinicians or health centers will not be regulated under its jurisdiction."

An October 2013 study by the IMS Institute for Healthcare Informatics analyzed more than 43,000 healthcare apps available on the Apple iTunes store and found a lack of evidence of the clinical benefits of the apps, without which app use will not be able to move from "a novelty into the mainstream of healthcare" nor realize its full potential. In order to achieve the potential of mHealth apps, the JAMA article calls for the establishment of an unbiased review and certification process.

"As a start, an organization could feasibly review the quality of the most widely used and clinically useful mHealth apps," states the article. "Furthermore, guidelines could be established to help developers build high-quality apps and to serve as a basis for app review. The guidelines might include a broad range of categories, such as safety, accuracy, and security. 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."

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