The Federal Trade Commission on Monday announced two enforcement actions against the makers of two smartphone apps -- "Mole Detective" and "MelApp" -- that claim to be able to detect the symptoms of melanoma simply by snapping a picture of a mole with a smartphone.
The apps were downloaded by thousands of people and claimed to be able to calculate melanoma risk as high, medium or low by analyzing the pictures. The apps were on the market from 2011 to 2012, and cost as much as $4.99 to purchase. Both apps did suggest that users should see a physician if they had real concerns. But Mary Engle, the FTC's associate director for advertising practices, said that the app advertisements gave an overall impression that they could be used as diagnosis tools.
"You need a trained dermatologist to make that assessment," Engle said.
Marketers for both apps have agreed to settlements with the agency that prevent them from claiming that the apps can accurately detect or diagnose symptoms of melanoma. The company behind MelApp's marketing, Health Discovery Corp., will pay $17,063 as part of its settlement. Mole Detective's developer and original marketer, New Consumer Solutions, will pay $3,930; the agency is pursuing a judgment against a separate, British marketing firm -- L. Health Ltd. -- which did not elect to settle with the FTC.
Mole Detective's original developer, Kristi Zhulke Kimball, and representatives from Health Discover did not immediately respond to a request for comment.
Avi Lasarow, whose company L Health Ltd. bought Mole Detective from Kimball, said in a statement that Kimball guaranteed at the time of the sale that the app hadn't violated any U.S. advertising laws. "This was accepted as part of the legal due diligence exercise that was completed before transfer and in good faith." Lasarow said.
The app became more popular about three weeks after the sale, when it was featured on "The Dr. Oz Show," Lasarow said in the statement. But he said L Health did not launch any new marketing --relying only on marketing that was already in app stores. The application "always stated that it should be used for educational purposes only and must not replace a doctor visit," he said. "Once the FTC started its investigation the application and the website were taken offline."
Smartphones and other mobile technologies do have great potential as tools for consumers and physicians on health matters, but the U.S. government has had trouble grappling with how and when to regulate these devices as medical tools. Health and fitness has been one of the fastest-growing areas of interests for apps, and particularly for wearable devices -- think the Fitbit or any number of dieting and exercise apps. But there have also been an increasing number of apps and devices that purport to diagnose illnesses or help users treat or cope with ongoing conditions. That falls into a much trickier category, one in which consumers who may be hesitant to go to the doctor choose instead to self-diagnose and self-treat.
The Journal of the American Medical Association published a paper in 2013 looking specifically at melanoma detection apps. The study, conducted by several dermatologists at the University of Pittsburgh Medical Center, looked at four popular apps on the Apple and Google applications stores. The results were not great. Researchers found that three of the apps "incorrectly classified 30% or more of melanomas as unconcerning."
The paper did not name the apps, so it's unclear whether MelApp or Mole Detective were included in the study. But the paper's authors did express concern that the apps could lure people into a false sense of security. "This potential is of particular concern in times of economic hardships, when uninsured and even insure patients, deterred by the cost of copayments for medical visits, may turn to these applications as alternatives to physician evaluation," the paper concluded.
The FTC is not the only agency keeping a close eye on the medical technology space. Last month, the Food and Drug Administration began circulating proposed guidelines for what types of health tools should be regulated at a higher level, including products that claim to either diagnose or treat medical conditions.
It's a tricky debate from the regulatory standpoint. There are, after all, some health apps that provide valuable medical information to consumers.
"There are apps that can help you," Engle said. "There are apps that help you track your calories consumed or your heart rate. There are also apps that help you educate yourself on the risk factors for melanoma...there are plenty of free apps that provide a valuable educational function."
But in this case, she said, the advertising for Mole Detective and MelApp appear to have overstepped those bounds -- beyond education and into areas where there could be consumer harm. Engle said that the FTC will continue to look at the mobile marketplace and flag health and safety concerns.