JAMA paper: mHealth apps need more review, assessment

The proliferation and increasing use of mobile healthcare apps requires an unbiased review and certification process, argues a paper published Monday in the Journal of the American Medical Association.

"If we can develop mechanisms to assure clinicians of the quality and safety of mHealth apps, we foresee a potential future in which physicians regularly prescribe apps to their patients, much in the way that they prescribe drugs today," says Adam C. Powell, PhD., president of Payer+Provider Syndicate who wrote the paper with Adam B. Landman and David W. Bates, both of Harvard Medical School, Brigham and Women's Hospital and Partners Information Systems. Bates also serves as chair of the Food and Drug Administration Safety Innovation Act Workgroup.

"We hope that our article serves as a call to action, and promotes the development of the certification and review mechanisms that clinicians need to feel confident when prescribing apps," Powell told FierceMobileHealthcare in an email.

The call for review and assessment comes as mobile apps expand beyond health and fitness monitoring. As FierceMobileHealthcare previously reported, University of Cambridge researchers have developed a new smartphone app that promises to enhance the accuracy of colorimetric tests for diabetes, kidney disease and urinary tract infections.

The call for review also comes at a time when lawmakers and industry groups are debating FDA oversight of mobile healthcare apps. The mHealth Regulatory Coalition says a proposed law to eliminate FDA oversight on mobile healthcare software would pose serious risks to patients. Other lawmakers support the law, called the Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 (PROTECT Act), which aims to curb FDA regulatory power.

Today's mHealth app market, says Powell, boasts an "overwhelming diversity of tools," which present a barrier to both patients and clinicians. "We hope that credible reviews will enable patients to more confidently make choices while navigating the vast number of apps available," he said.

The paper suggests the Office of the National Coordinator could facilitate such a review process by supporting the development of guidelines for mHealth apps and by commissioning app certification entities.

"App certification and review could potentially be done by both for-profit and non-profit entities, in a similar manner to which review occurs in many other industries," note the authors. "The short reviews found in app stores are currently inadequate, as they do not contain any sort of comprehensive clinical or security review. When patients use an app, they need to feel confident that the medical information provided is accurate and that their personal data is being handled securely."

For more information:
- read the paper in JAMA

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