FTC probe shuts down HeHealth’s AI-powered STI detection apps

AI digital health startup HeHealth has shut down two apps it claimed could diagnose sexually transmitted infections (STIs) from photos of penises submitted by users, after the Federal Trade Commission (FTC) launched an investigation into the company.

In a letter to HeHealth on July 11, the FTC said it issued a civil investigation request to the company in June because of concerns about advertising claims and privacy practices.

The letter specifically highlighted concerns about the company’s Calmara app, which was launched in March 2024 and was aimed at users who wanted “clarity” about the status of their ITS partners.

“FTC staff were concerned that the company’s marketing materials exaggerated the extent to which Calmara could detect STIs,” the letter said.

HeHealth, a startup based in Singapore, was founded in 2022 by Mei-Ling Lu and Yudara Kularathne. They claimed that their AI model could detect more than 10 STIs.

But the FTC disputed that claim.

The regulator said HeHealth’s main study supporting its claims admitted it used data to train its AI model with images from people who had never had diagnostic tests to confirm they had an STI. The FTC also said the model was tested on a small number of images and that four of the study’s five authors worked for HeHealth or were paid consultants. Ultimately, the study said the model was trained and evaluated to detect four STIs, despite the company claiming it could detect more than 10.

In addition, the FTC sought information about the company’s privacy practices “given the sensitivity of the images” and its advertising claims about “maintaining the anonymity” of people whose photos were uploaded to the app.

The FTC also notified HeHealth that it is illegal to make claims about health benefits without reliable scientific evidence.

In response to the survey, HeHealth shut down both apps in July, issued refunds to US customers and deleted all user information.

While the applications were closed, company website and YouTube channel are still online.

STAT reported that Lu said in a LinkedIn post this month that the company’s challenges were due to a “decrease in curiosity.”