The FDA has not issued details on which mobile medical applications require its approval and which don’t, Katz and several other physicians say. “The FDA is learning, or trying to figure this out. They’re trying to think of medical apps as either prescriptive or informative.”
A medical app that determines a patient’s blood sugar is too high and sends the patient an immediate signal with an alert to the case manager and a warning to the patient to take an extra dose of insulin would be prescriptive, he says. That would contrast with a pill reminder software system that simply reminds the patient to take medication on time.
Those applications that should get FDA approval “would be those that provide physicians with information that they use to make a diagnosis or treatment decision,” explains Joseph Smith, MD, PhD, chief medical and science officer with the West Wireless Health Institute in La Jolla, CA.
“The developer needs to make sure that the transmission and the display of that information can’t corrupt the underlying data in a way that would mislead or misguide a physician to make the wrong decision. It’s not just a snapshot or a photograph of the data,” he says.
Unlike a surgical technique or a new drug, there have been few clinical trials or testing in academic medical centers of the hundreds of apps being launched, and there are many questions about how they should be tested.
If the app conveys information from a database of drug side effects, how often is that updated? How are providers alerted to problems with a drug they don’t use that often? In what populations or settings are they used appropriately? Do physicians have the time and inclination to check?