It's time for the FDA to lead mHealth app regulatory strategy

The discussion and increasing debate of how to regulate, review, accredit and assess mHealthcare applications is getting louder, as software tools boast greater and more innovative capabilities than just fitness and health monitoring features.

As FierceMobileHealthcare recently reported, researchers at the University of Cambridge have devised a new smartphone app that promises to enhance the accuracy of colorimetric tests for diabetes, kidney disease and urinary tract infections. That's clearly more than a few steps above tracking heart rates after a daily run.

While the Food and Drug Administration (FDA) has already stated that new mHealth devices (think iPhones being used as endoscopes) will fall under federal medical equipment regulations, it hasn't yet officially issued such a declaration for mobile health software despite increasing lobbying (both pro and con) by lawmakers, industry groups and medical professionals.

Six lawmakers sent a letter last week to FDA Commissioner Margaret Hamburg urging the FDA for greater transparency and clarification and seeking specific answers to questions such as how the federal agency determines which software functions require FDA review. Meanwhile, two lawmakers have proposed a bill called Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 (the PROTECT Act), that would put the National Institute of Standards and Technology in charge of technical standards regarding clinical software. But the mHealth Regulatory Coalition is battling that proposal.

This week, notable physicians published a paper in the Journal of the American Medical Association calling for certification and review mechanisms so clinicians can safely prescribe mobile apps as part of treatment and to ensure patients such tools are safe. 

"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. 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," write the authors.

They're exactly right and on target. Consumers, in this case, patients, should know and be given as much data as possible about an app's capabilities, security level and accuracy. These aren't music apps being downloaded or games. It's a tool that involves personal and confidential data, plays a role in health assessment. potential diagnosis and possibly medical treatment.

Yet in the same vein, no one wants unnecessary or bloated regulations that could hinder tech innovation or delay great healthcare technology getting into the hands of service providers and ultimately, users.

A clear and decisive leadership approach by the FDA for tackling mHealth apps and devices and creating policy and regulatory action that works in the interest of all the parties involved is needed.

Given the fast-growing mobile app landscape, the FDA has to jump into action, and jump soon, as the tidal wave of software innovation isn't going to slow down. - Judy (@FierceHealthIT)

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