Mobile medical applications increasingly are being used by patients and consumers. Now healthcare providers are evaluating whether and how to work with their patients in tapping these apps. But they're proceeding cautiously because of the dearth of clinical evidence for many consumer apps, and because some developers may be misleading consumers by overstating their products' capabilities.
In September, developers of a consumer-marketed mobile app, UltimEyes, agreed to pay $150,000 to settle an enforcement action by the Federal Trade Commission based on the claim that the app was “scientifically shown to improve vision.” The promoters “did not have the scientific evidence to support their claims,” the FTC said.
Earlier this year, the federal agency went after marketers of two mobile apps, Mole Detective and MelApp, “for deceptively claiming their mobile apps could detect symptoms of melanoma even in its early stages.” The apps' marketers reached settlements that bar them from continuing to make such unsupported claims, the FTC said.
The FTC action on the melanoma apps followed research led by Dr. Laura Ferris, an assistant professor at the University of Pittsburgh, that was published in JAMA Dermatology in 2013. Her team looked at four such apps. “We saw that they didn't work all that well,” Ferris said in an interview. “You can't just put these out there with no validation or no data to back them up, because the stakes are too high.”
That's a particular issue for the poor, the uninsured, and the underinsured who might buy an app for a few dollars and diagnose themselves, rather than pay for a doctor's visit, she said.
Given the growing use of mobile medical apps, “I think we will be seeing an increase in scrutiny and enforcement by the FDA and the FTC,” said Monica Chmielewski, a partner at Foley & Lardner. She doubted that more “innocuous” apps like weight trackers would be subject to scrutiny. “But when you have these mobile medical devices treading in the areas of diagnosis and treatment, for those I think we'll see increased enforcement.”
Only 16% of healthcare professionals currently use mobile applications with their patients, but 46% plan to do so in the next five years, according to a 2015 survey of 500 professionals by Research Now, a Plano, Texas-based market research firm. Even so, 86% of the professionals surveyed said they believe mobile apps will increase their knowledge of their patients' conditions, while 46% said the apps will improve their relationships with patients.
Research Now also surveyed consumers who use medical apps and found that 96% said they believe the devices help them improve the quality of their lives. Sixty percent use them to monitor their activity and their workouts, 49% to count their calories and 42% to monitor weight loss.
“I have patients asking me all the time about health-related apps,” said Dr. Mike Sevilla, a family physician who belongs to a six-physician group practice in Salem, Ohio. “It's really a great way for me to talk to my patients and make them accountable” for managing their own health.
He recommends apps from the Mayo Clinic and WebMD to patients. “We're coming into the holidays and people are already thinking about weight loss and lowering their cholesterol and counting their steps.” Sevilla said. He believes home blood-pressure readings via apps often are more accurate because patients' blood pressure can rise when they come to the doctor's office.