Regulations for Medical Apps

November 9th, 2011 by Andrea Bennett

The FDA has set guidelines for medical apps, but is it being strict enough?

Brought to you by Liberty Mutual's
The Responsibility Project

Want to know if your prescription drugs interact? There’s an app for that. Or whether a medication could change the way you feed your baby? There’s one for that, too. But what about an app that lets your doctor use his/her smartphone as an electrocardiogram machine to tell if you’re having a heart attack? Or one that lets him/her view your ultrasound results remotely in real-time?

Doctors are now using mobile phones to calculate prescription dosages, review treatment guidelines and even view MRI and CT scan results. But beyond doctors, the U.S. Food and Drug Administration has expressed concern about patient interactions with medical apps. In response, the FDA is issuing guidelines for a number of mobile medical apps that affect both doctors and patients.

Specifically, the FDA is regulating mobile apps that:

  • Are used as an accessory to an FDA-regulated medical device (such as an app that allows a doctor to view medical images on an iPad and make a diagnosis);
  • Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography (or ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

The FDA has already approved two apps within these guidelines.

The first approved app, Mobile MIM, allows physicians to examine scans and make diagnoses on the go. The free app is available in two versions: Mobile MIM for physicians and VueMe for patients. AirStrip OB, the second app already approved by the FDA, allows physicians to view data in real time from sensors strapped to a patient’s abdomen.

Still, some medical professionals are expressing concern about the way the FDA is approving medical apps. According to an Information Weekarticle, The American Medical Informatics Association has issued statements questioning the wisdom of lumping all medical apps together. Meryl Bloomrosen, the AMIA's VP for public policy and government relations, argues that, when evaluating the risk posed by clinical decision-support software, the FDA guidelines should consider such details as whether the program is, "mediated by a human being or not.”

The FDA estimates that there are already more than 17,000 medical applications available, and they expect that by 2015, 500 million smartphone users will rely on healthcare apps for medical information.

What’s your take? Do interactions with medical professionals belong in a doctor’s office or a hospital? Or are medical apps a modern way to increase efficiency in healthcare?

You can track the coming apps and FDA approvals at iMedicalApps.com, a site that reviews medical applications.