In a first sign of government regulation on healthcare-related mobile apps in the U.S., it was announced today that the FTC has taken action against the makers of two so-called “acne cure” apps on the basis of providing false claims and misrepresenting medical research.
The two apps — “AcneApp” and “Acne Pwner” — claimed they could cure acne by using colored lights emitted from smartphone screens. Consumers were advised to hold the display screen next to the area of skin to be treated for few minutes daily while the app was activated. According to the FTC complaint, there were approximately 3,300 downloads of AcnePwner, which was offered for 99 cents in the Android Marketplace. Ads for Acne Pwner stated, “Kill ACNE with this simple, yet powerful tool!”
The marketers of AcneApp claimed, “this app was developed by a dermatologist. A study published by the British Journal of Dermatology showed blue and red light treatments eliminated p-acne bacteria (a major cause of acne) and reduces skin blemishes by 76%.” There were approximately 11,600 downloads of AcneApp from the iTunes store, where it was sold for $1.99. The FTC charged the acne treatment claims made for both apps were unsubstantiated. It also charged that the marketers of AcneApp falsely claimed that the study in the British Journal of Dermatology proves that blue and red light therapy, such as the type provided by AcneApp, is an effective acne treatment.
Under the terms of the FTC settlement order, Koby Brown and Gregory W. Pearson — doing business as DermApps — is ordered to pay $14,294, while Andrew N. Finkle — doing business as Acne Pwner — has to pay $1,700. In addition, the settlements would bar the marketers from making acne-treatment claims about their mobile apps and other medical devices, as well as the safety, performance, benefits, or efficacy claims about any device, without competent and reliable scientific evidence. The two marketers of AcneApp would also be barred from misrepresenting research, tests, or studies.
This is a big deal in the world of mHealth and signals the future of government intervention, regulation and on-going scrutiny of healthcare apps on smartphones and tablets going forward. It’s also worth mentioning that the FTC only just settled its first case against any kind of mobile app — one that charged an app company with collecting and storing children’s personal data without parental permission — on Aug. 15. Just three weeks later, regulators already have turned their attention to healthcare.