Health Discovery Corp. may not make any misleading claims about an app purported to diagnose skin cancer, the U.S. Federal Trade Commission says in a final consent order issued April 13.
The consent order follows a February complaint and subsequent comment period. In the complaint, the FTC said there was no scientific data supporting the company’s claim that its MelApp product can evaluate moles for melanoma symptoms ().
To use the app, customers would photograph the mole on a mobile phone and input other information about it, and the app would categorize the mole as low, medium or high risk for skin cancer. Health Discovery claimed the app’s analysis was accurate and scientifically proven. The FTC, which regulates advertising, says it was not.
The consent order bars the company from claiming its device detects or diagnoses melanoma or its risk factors, unless the statement is supported by scientific evidence. While inspired by MelApp, the wording of the consent order would apply to any device manufactured by Health Discovery. Health Discovery will also pay $17,963 in penalties for violating the FTC Act.
In addition, Health Discovery must maintain all materials related to the consent order for five years and provide them to the FTC upon request. This may include advertising, scientific tests or demonstrations and acknowledgements of the receipt of the order. Health Discovery must report to the commission on its compliance within 60 days.
The commission voted 4-1 to approve the final consent order, with Commissioner Maureen Ohlhausen voting no. Ohlhausen says the regulatory crackdown could have a chilling effect on other medical app makers.
Regulation of mobile apps by the U.S. FDA is still developing, and spokesman Christopher Kelly declined to comment on Health Discovery specifically. However, he notes that unless otherwise ageed to in specific cases the FTC is in charge of regulation of the truth or falsity of advertising, while the FDA has primary jurisdiction over labeling.