FDA guidance brings clarity to mobile app selection

Doctors are just as keen on the appeal of mobile applications as anyone else, but that doesn’t mean they’re ready to implement such technology into their practices. They need more guidance to make that leap, and now — thanks to the FDA and its final rules on medical mobile applications — they finally have it.

“The rule will be a boon for doctors who want to use apps to help manage conditions, especially in younger patients who are open to or even prefer mobile health engagement in treatment,” said Melissa McCormack, managing editor forSoftware Advice. “Having an FDA seal of approval will give doctors peace of mind to use some apps in their practice the way they might an FDA-approved medical device.”

And since surveys indicate patients now expect their doctors to be more tech savvy – 90 percent of those with a chronic disease would accept a mobile app prescription from their doctor according to a survey by health communications firm Digitas Health – those who incorporate mobile apps into their practice are likely to see a bump in their patient satisfaction scores. That should translate into a growing patient panel, which in turn will grow their bottom line. 

Physicians have been hesitant about using many medical apps because of fear that, without FDA approval, if something goes wrong and they get sued for misdiagnosis, the odds of losing the case and paying out a large financial settlement is much greater if the app in question didn’t have FDA approval.

If the clinician fails to diagnose heart arrhythmia with an iPhone EKG that has no FDA approval, for example, the plaintiff’s attorney could argue that the doctor should never have used the tool because it’s experimental and unproven. However, an attorney couldn't make that claim if the doctor were using an FDA-approved app.   

With the new FDA guidance, the parameters are much clearer.

“One of the issues that the [mobile health] industry and providers have been struggling with is the lack of clarity in terms of what’s regulated and what’s not regulated,” said Kim Tyrrell-Knott, JD, an attorney with EpsteinBeckerGreen. The new guidelines provide that clarity, Tyrrell-Knott said, by explaining which apps will be scrutinized by the FDA and which won’t.

Tyrrell-Knott also believes the new rules will encourage innovation by mobile app entrepreneurs because they now have a more clearly defined roadmap. And a more clearly defined roadmap means, ultimately, better apps, which in turn could result in greater productivity for doctors.

This article is based on reporting from Healthcare Finance News.