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.
The app addresses one of the toughest tasks a physician has: changing patient behavior.
Doctors ask diabetic patients to keep a daily record of glucose readings, food, exercise, and medications. If managed well, these factors keep patients’ blood sugar in a safe range, reducing their risk of complications from the disease. But only 15 to 20 percent of patients actually keep a log, says Philis-Tsimikas.
Diabetes apps that make activity tracking easier are available, but their effectiveness is limited. “No one does it, because you have to wait 90 days before you get feedback [at your next doctor visit],”