Once again, a mobile medical app manufacturer has been caught in the Federal Trade Commission's enforcement web as a result of allegedly deceptive ad practices. Earlier this week, the FTC announced that Aura Labs, Inc. (doing business as AuraLife and AuraWare) agreed to settle charges that Aura violated the FTC Act by deceiving consumers with claims that its “Instant Blood Pressure (IBP)” app was as accurate as a traditional blood pressure arm cuff. The FTC also alleged that Aura’s owner had provided a positive review and “five star” rating for the app without disclosing his connection to the company. A link to the FTC’s Press Release announcing the settlement can be found here.
According to the FTC, consumers use the IBP app by putting their right index finger over the phone’s rear camera lens while holding the base of the phone over their heart. Aura and its founder and co-owner, Ryan Archdeacon, claimed that the app was just as accurate as, and could be used to replace, a traditional blood pressure arm cuff, although, according to the FTC, clinical data indicated that this was untrue.
Under the terms of the FTC settlement, Aura and Archdeacon are barred from making unsupported blood pressure performance claims in the future and must disclose any material connections between Aura and people who endorse its products. The stipulated federal court Order in the matter also prohibits the defendants from making any claims about the health benefits of any product or device without the scientific evidence to support the claims. In addition, the Order imposes a judgment of $595,945.27, which is suspended based on the defendants’ inability to pay. The full amount will become due, however, it they are later found to have misrepresented their financial condition.
The FTC expects marketers of health apps to have “reliable scientific evidence” to substantiate app performance claims, and the Aura settlement illustrates the Commission’s ongoing concerns regarding the accuracy and reliability of various health apps in the marketplace relative to the performance claims for which such apps are promoted. Commenting on the settlement, Jessica Rich, Director of the FTC’s Bureau of Consumer Protection, pointed out that “while the Commission encourages the development of new technologies, health-related claims should not go beyond the scientific evidence available to support them.”
The proceeding against Aura may be part of an emerging focus at the Commission on health-related mobile apps. Last year, the Commission brought cases against several companies that claimed their mobile apps could detect symptoms of melanoma. In those proceedings, the marketers of MelApp and Mole Detective agreed to settlements that barred them from continuing to make such unsupported claims.
Arent Fox will continue to follow and report on developments involving enforcement trends in the advertising of pharmaceuticals and medical devices. Please contact Georgia C. Ravitz, Naomi J. L. Halpern or James R. Ravitz for further assistance.