The FTC recently released its Closing letter to HeHealthInc., which provides an AI-powered app, Calmara, for detecting sexually transmitted infections (“STIs”). HeHealth marketed the app as having an accuracy rate of over 94% in detecting over ten STIs, including HPV, syphilis, and herpes.
In June, FTC staff issued a civil investigative demand to HeHealth, identifying concerns with HeHealth’s advertising claims and seeking, among other things, to substantiate those claims in accordance with the standard required for health claims, namely, competent and reliable scientific evidence. FTC staff also requested information about the company’s privacy practices, given the sensitivity of the images and information HeHealth collects from users and the company’s statements about maintaining user anonymity. Significantly, FTC staff also sent a civil investigative demand to HeHealth, identifying concerns with HeHealth’s advertising claims and seeking, among other things, to substantiate those claims in accordance with the standard required for health claims, namely, competent and reliable scientific evidence. FTC staff also requested information about the company’s privacy practices, given the sensitivity of the images and information HeHealth collects from users and the company’s statements about maintaining user anonymity. Notice of criminal offences regarding the substantiation of product claims to HeHealth, warning the company that making unsubstantiated health claims constitutes an illegal act or practice.
In response, HeHealth provided information and engaged in discussions with FTC staff. As a result of those discussions, the company agreed to terminate the STI detection app and remove all associated advertising claims; refund all U.S. customers whose app purchases were not completed; delete all customer personal information obtained through the app; and delete customer personal information obtained or accessed through its payment provider. And it agreed to do all of this by the July 15 deadline.thThe company’s officers are also prohibited from making false statements about any similar medical detection product in the future.
So what was wrong with the information provided by HeHealth, information so sketchy that it had to shut down within a month? According to the closure letter, the data used by HeHealth to test and train the AI detection model included images uploaded by individuals who had never undergone diagnostic testing to confirm whether the individual associated with the image actually had an STI. Additionally, the AI model’s performance was evaluated on a small number of images and was only trained to detect visual symptoms like marks or lesions, limiting its reliability, particularly for asymptomatic individuals. Finally, the reliability of HeHealth’s study was also undermined by the fact that four of the study’s five authors worked for HeHealth or were paid consultants.
The takeaway? Methods for conducting studies and collecting data may evolve, especially as AI-based tools improve and become more ubiquitous and accepted, but the standard for substantiating a health or safety claim will likely remain the same: An advertiser must have competent and reliable scientific evidence at the time it makes its claims that has been objectively conducted and evaluated by qualified individuals and that is generally accepted in the industry to produce accurate and reliable results. And the FTC is watching closely.