Telehealth Company Faces Charges for Neglecting FDA Requirements
A national settlement is holding a telehealth company responsible for falsely proclaiming the accuracy and fairness of its services and for failing to obtain FDA approvals.
Previously known as Opternative Inc, a telehealth company named Visibly, Inc. is facing charges after describing its services as accurate and fair without receiving approvals from the US Food and Drug Administration (FDA), resulting in an Assurance of Voluntary Compliance (AVC).
Based in Chicago, Visibly, Inc. is a healthcare technology company that aims to provide digital vision care solutions to assist both patients and providers.
Earlier this month, Attorney General Michelle Henry of Pennsylvania announced a bipartisan national settlement that is holding Visibly responsible for claiming the credibility of services and not obtaining the necessary FDA approvals.
Leading to an AVC, the investigation into the company began after an FDA letter provided Visibly with a warning about the description of its online vision tests prior to receiving approval. This investigation also explored the company’s claims of the safety and accuracy of its online test, specifically the claim that its test was as accurate as in-person exams. The investigation further examined Visibly's inaccurate descriptions of customer satisfaction rates, as well as 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 Henry in a press release. “Visibly falsely claimed their online eye exams were as accurate as in-person exams when that is simply not true.”
Due to these false claims, Visibly faced an AVC that forced the company to abide by certain standards while paying $500,000 to the states involved.
Visibly also agreed to not sell products that cannot be marketed under the standards of the Food, Drug, and Cosmetic Act (FDCA) and other FDA authority, not compare its products to in-person services unless there is scientific research proving the thesis, clearly indicate that providers from its “Find a Doctor” feature have not endorsed its products, and establish that online vision test services cannot fully replace in-person review.
Amid the investigation, Visibly requested approval from the FDA and received it in August 2022.
The FDA is increasingly approving virtual care and mHealth solutions that aim to enhance care access and patient outcomes.
In June 2022, the StrivePD Ecosystem gained FDA approval for using the Apple Watch to monitor Parkinson’s Disease.
The StrivePD software ecosystem collects patient-reported symptom data through Apple Watch measurements. Developed by San Francisco-based Rune Labs, the StrivePD tool gathers data on tremors and dyskinetic symptoms from the Apple Movement Disorder API. This can help clinicians and researchers track symptoms of Parkinson’s and treatment progress.
In November 2021, a solution known as Ease VRx from AppliedVR became the first virtual reality-based digital therapeutic for pain relief to obtain FDA approval.
Containing preloaded software content, EaseVRx is a virtual reality headset that guides lower back pain patients through an eight-week program based on cognitive behavioral skills. It includes various features, including biopsychosocial pain education, diaphragmatic breathing training, mindfulness exercises, and more.