A few years ago, my sister had no interest in getting a smartphone, considering them a giant time waster. She only stooped to buy one when the physician’s drug reference she used every day as a pediatrician was released as an app. When we compare our phones now, where I have Bejewled and Huffington Post, she has Epocrates and the New England Journal of Medicine. (Her phone looks more impressive, mine is much more fun.)
It’s great for a doctor to have reams of medical knowledge available at their fingertips, but for the average Joe, these apps could be misleading and potentially dangerous.
That’s because some healthcare app designers are creating tools that blur the line between information and medical evaluation, and now the FDA is moving toward regulation of any service that might impact patient safety.
That’s not going to affect the calorie counts you look up on My Fitness Pal, but it aims to prevent app creators from trying to virtually diagnose patient health. In March, the FDA hit Biosense Technology with a game changing letter for app makers, wanting to know why its uCheck app hadn’t been cleared through them as a medical device. The easily downloadable app purports to analyze urine dip strips for things like blood sugar and protein levels via iPhone camera.
To be fair, mobile healthcare technology holds great promise, especially in rural areas and disaster situations. To be able to monitor an EKG on a patient over an iPad is a real benefit in humanitarian and emergency medicine. And one study from the Brookings Institution even cites how mobile care could lower healthcare costs as much as $197 billion dollars over 25 years.
“Remote monitoring devices enable patients with serious problems to record their own health measures and send them electronically to physicians or specialists,” the report says. “This keeps them out of doctor’s offices for routine care, and thereby helps to reduce health care costs.” The key component here is well designed, professional software made to be interpreted by medical personnel; not whatever app is free today on Google Play.
Rep. Mike Honda (D-Calif.) just introduced a bill which could be a grand slam - aiding the FDA’s efforts, helping app designers and protecting patients. The Healthcare Innovation and Marketplace Technologies Act seeks to create an office of Wireless Health within the FDA to oversee mobile healthcare; on the surface the bill sounds like big government but Honda’s aim is actually to help his Silicon Valley constituents. In short, he hopes to help creators be able to incorporate necessary regulation into design from the start.
My sister often wonders why she worked so hard to go to medical school when panicked patients come in convinced of something they’ve read on the Internet. Everyone is a doctor these days; hopefully Siri won’t be next.
Edited by
Alisen Downey
