HARRISBURG, Pa. — A settlement announced Monday holds a telehealth company accountable for ignoring FDA requirements and misleading patients.
Attorney General Michelle Henry announced a bipartisan national settlement that holds an online telehealth company responsible for misrepresenting the accuracy and fairness of services and for failing to obtain approvals from the U.S. Food and Drug Administration.
The settlement, an Assurance of Voluntary Compliance (AVC), results from an investigation into deceptive business practices by Visibly Inc., formally known as Opternative Inc. The company markets and sells an online vision test, among other products.
The multistate investigation was opened after a letter from the FDA warned Visibly about marketing its online vision tests without the requisite clearance or approval.
In addition, the investigation raised concerns about Visibly's claims regarding the accuracy and safety of its online test, specifically, that the tests were as accurate as in-person exams.
The investigation examined Visibly's misrepresentations about customer satisfaction rates and satisfaction guarantees.
“In recent years, many Pennsylvanians have turned to telehealth care, and those patients deserve to feel comfortable and confident that these services are in their best interest, especially when the care is for something as critical as their vision,” said Attorney General Henry. “Visibly falsely claimed their online eye exams were as accurate as in-person exams when that is simply not true.”
The settlement requires Visibly to adhere to certain standards and pay $500,000 to the participating states. Visibly has agreed, among other things, to:
- Not market or sell any product to consumers unless it can be legally marketed or sold in accordance with the Food, Drug and Cosmetic Act (FDCA) or other FDA authority.
- Not make any representations comparing the safety or effectiveness of any Visibly product to products or services provided in person by medical professionals without possessing competent and reliable scientific evidence substantiating the representation.
- Clearly label that its products have not been endorsed by any provider appearing on its “Find a Doctor” feature.
- Disclose that its online vision test is not a substitute for an in-person comprehensive eye examination, and urge consumers to seek such exams to determine overall eye health.
Visibly sought FDA clearance for its visual acuity test while the investigation was pending, and FDA approval was granted in August 2022.
Any consumers who believe they may be a victim of these or similar practices may file a complaint with the Healthcare Section at www.attorneygeneral.gov, call 1-877-888-4877, or email firstname.lastname@example.org.