Get ready for new scrutiny of cell phone-, tablet-based medical apps

At long last, FDA issues draft guidance on what to expect

The Food and Drug Administration (FDA) has made it clear that cell phone applications that aid in clinical decision-making or act as medical devices will soon be subject to the strictest Class II and Class III regulations. The news comes in the form of long-awaited draft guidance issued by the agency in July, and it puts clinicians and ED managers on notice that they need to insure that any relevant phone or computer tablet applications that are used in their care settings are properly FDA-approved.

"It is incredibly significant, and a very big step that was needed from the FDA," observes Zachary Bujnoch, senior health care industry analyst in the San Antonio, TX, office of Frost & Sullivan, a global consulting firm. He explains that up until now, applications that essentially transform cell phones into functioning electrocardiograms, for example, have been largely unregulated. "Now there is guidance out there that says that this type of application is a medical device," adds Bujnoch.

The draft guidance may leave some clinicians still wondering whether their cell phone- or tablet-based applications are subject to more rigorous FDA regulations, but it provides a long list of specific applications that would fall under the more rigorous regulatory oversight, including:

  • Apps that attach EKG/ECG leads to a mobile platform to collect/analyze/monitor EKG/ECG signals;
  • Apps that connect wirelessly to a blood glucose tester to display, calculate, trend, convert, or download results to a PDA;
  • Apps that act as a blood glucose meter by using an attachment to a mobile platform;
  • Apps that use the mobile platform with or without a microphone to act as an electronic stethoscope to amplify heart, lung, blood vessel, enteral, and other body sounds;
  • Apps that use a mobile platform to upload electroencephalograph (EEG) recordings and automatically detect seizures;
  • Apps that use pictures and sound to diagnose conditions by comparing to previously determined diagnoses of images, symptoms, sounds, or other physiological measurements;
  • Apps that use a mobile platform in determining blood donor eligibility prior to collection of blood or blood components.

(To see the full list of examples, review the FDA's draft guidance here: http://www.fda.gov/downloads/MedicalDevices)

In brief, if a tablet or cell phone application assists you in making a clinical decision, then you need to make sure the software you are using is FDA approved, explains Bujnoch, but he acknowledges that there are still many applications that are not specifically mentioned in the document. What is clear, however, is that regulators are trying to draw a line between mobile applications that pertain to wellness and are not subject to stricter regulation, and applications that are used for clinical decision-making and, therefore, must be subject to the higher regulatory standards, adds Bujnoch.

The FDA is accepting input on the draft guidance, and may not formalize these standards until next year, but Bujnoch believes the document already has some teeth. "It is really going to put the squeeze on a lot of [mobile application] companies that don't have their regulatory act together," he says.

Further, he advises ED providers to familiarize themselves with the draft guidance, as well as what types of mobile applications are used in their care settings. "This is an area where things are going to change, and you need to be aware of it," he says.

Source

  • Zachary Bujnoch, Senior Industry Analyst, Telehealth-Healthcare, Frost & Sullivan, San Antonio, TX. Phone: 210-247-3832. E-mail: Zachary.bujnoch@frost.com.