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This article is part of the “2014 Top Tech to Watch” series, IEEE Spectrum’s annual prediction of technologies that will make headlines in the coming year.
This year, when patients throughout the United States begin downloading the world’s first doctor-prescribed smartphone app, mobile health care will finally get what big-time medicine most requires: a way to get insurance companies to pay for it.
The app, called BlueStar, helps people with Type 2 diabetes (the most common kind) by suggesting, in real time, when to test their blood sugar and how to control it by varying medication, food, and exercise. That it requires a physician’s prescription is actually an advantage, because it means insurance companies will reimburse BlueStar’s fee.
“This is a piece of software getting the same treatment as a medical device,” says Sonny Vu, cofounder of Misfit Wearables in San Francisco, a maker of wearable computing devices. “It’s pretty world-changing.”
The U.S. Food and Drug Administration cleared BlueStar for market in 2010, in line with its recent determination to regulate devices that provide a diagnosis or recommend a treatment, not those that simply track activity, like calories consumed or steps taken. The success that WellDoc, the app’s manufacturer, has had with the FDA may inspire other mobile health companies to go the regulatory route. “It gives us hope that you can pull something like this off,” says Vu. The European Commission has also issued guidance on regulations for mobile health apps, but countries such as China and India have not.
WellDoc, based in Baltimore, began a regional launch last fall and plans to do a national push in 2014. The success of the app hinges on how many physicians prescribe it. “[WellDoc] will have to convince providers that it’s valuable,” says Athena Philis-Tsimikas, corporate vice president at the Scripps Whittier Diabetes Institute in San Diego.
Read more: http://spectrum.ieee.org/biomedical/devices/bluestar-the-first-prescriptiononly-app
Via Parag Vora
