FDA mobile app guidance opens the door to benefits for doctors

Like many, doctors see the appeal of mobile applications, but they have been cautious about using them in their practices. But now that the FDA has issued its final guidance on medical mobile applications, the path is clearer on how these tools can be used in offices.

“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 the treatment,” said Melissa McCormack, managing editor for Software Advice. “Having an FDA seal of approval will give doctors peace of mind to use some apps in their practice the way they might a FDA-approved medical device.”

[See also: Big growth potential seen in mHealth app market]

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 a heart arrhythmia with an iPhone EKG that has no FDA approval, for example, the plaintiff’s attorney can argue that the doctor should never have used the tool because it’s experimental and unproven. However, an attorney can’t make that claim if the doctor is 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.