The Federal Trade Commission is cracking down on marketers of mobile apps for making unsubstantiated claims about their ability to accurately analyze moles for symptoms of melanoma.
According to FTC, marketers of MelApp and Mole Detective deceptively claimed the apps accurately analyzed melanoma risk and could assess such risk in early stages and also lacked adequate evidence to support such claims. While the marketers agreed to settlements that bar them from continuing to make such scientifically unsupported claims, the regulatory agency said it is pursuing charges against two additional marketers of Mole Detective who did not agree to settle.
Truth in advertising laws apply in the mobile marketplace, said Jessica Rich, director of the FTCs Bureau of Consumer Protection, in a written statement. App developers and marketers must have scientific evidence to support any health or disease claims that they make for their apps.
Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, observes that as of late the U.S. Food and Drug Administration appears to be deferring to the FTC when it comes to medical claims about mobile apps.
In this particular case, to me it seems relatively clear that the app is a medical device, and yet FTC still took the lead, Thompson told Health Data Management. Indeed, these can be very high risk apps. I agree that FTC has the right to enforcement, but the silence from FDA is somewhat deafening.
Last month, the FTC told a Texas company it must stop making unsubstantiated claims that their computer game permanently improves childrens focus, memory, attention, behavior, and school performance, including for children with attention deficit hyperactivity disorder.
A 2013 study published in JAMA Dermatology found that several popular smartphone apps designed to evaluate photographs of skin lesions and provide feedback to non-clinician users about the likelihood of malignancy were not accurate. The performance of smartphone applications in assessing melanoma risk is highly variable, and 3 of 4 smartphone applications incorrectly classified 30 percent or more of melanomas as unconcerning, concluded the study. Reliance on these applications, which are not subject to regulatory oversight, in lieu of medical consultation can delay the diagnosis of melanoma and harm users.
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