WASHINGTON, July 16, 2019 /PRNewswire/ -- Responsible Telemedicine is a 501(c)(4) registered non-profit that works to safeguard the health and well-being of patients that choose to utilize telemedicine services. The group is the de facto consumer-driven telehealth industry watchdog.
The non-profit has filed a lawsuit against WebMD in the Superior Court of the District of Columbia in hopes of rectifying WebMD's alleged disregard for patient well-being through the mislabeling of STD tests, overcharging based on false pretenses, and the withholding of material information relevant to patients who are interested in purchasing diagnostic testing for sexually transmitted infections.
WebMD claims that all of their diagnostic tests are approved by the United States Food and Drug Administration (FDA). These nine tests include tests for chlamydia, gonorrhea, hepatitis B, hepatitis C, syphilis, herpes 1, herpes 2 , HIV and trichomoniasis. However, only three of the listed tests have actually been FDA approved: those for HIV, hepatitis B, and hepatitis C. Five of the tests that were not approved have utilized the 510(k) exemption from the FDA that clears the tests for distribution. This FDA 510(k) clearance only indicates that the device is similar to another already-marketed device. 510(k) Clearance does not ordinarily require human trials. Per federal law, it is illegal to market a 510(k) cleared product as FDA-Approved. One of the tests that WebMD sells, Trichomoniasis, is neither FDA-approval nor 510(k) clearance for testing in male urine, yet is still falsely marketed to consumers as FDA-approved.
"To misrepresent the level of approval process that a clinical diagnostic assay has gone through with the FDA is a gross misrepresentation and breach of patient trust, and it goes entirely against the best interest of the consumer. It is our responsibility to improve the quality of telemedicine practiced in this digital age, and what WebMD is doing feels counterintuitive to that effort," said Responsible Telemedicine Executive Director, Aadel Sarfani.
The allegations filed against WebMD also state that the type of review of patient information that WebMD suggests is made to determine whether testing is appropriate for a consumer is not actually undertaken. WebMD is billing patients for an "independent physician review" to determine if testing is appropriate yet the patient is not asked about their past medical history or present medical conditions making a meaningful review impossible to conduct.
"Trust is an important foundation of telemedicine. When a well-respected source in the medical field, like WebMD, breaks patients' trust, quick and swift action must be taken. Responsible Telemedicine is going to look for answers when big-name companies make false claims and mislead patients in the pursuit of profit," said Sarfani.
The complaint filed against WebMD further alludes to decisions that were made to withhold vital information from the consumer regarding whom the tests were initially intended for. For example, WebMD offers the public an antibody serologic test for herpes testing, which is not clinically recommended for those who are showcasing herpes symptoms. WebMD does not ask patients if they are symptomatic or inform patients that this Herpes test is not recommended for symptomatic patients.
In addition to the misrepresentation of FDA-approval, misrepresentation of services performed and the withholding of material information, the complaint filed by Responsible Telemedicine also outlines concerns that WebMD has not taken steps to ensure that it is in compliance with a number of state medical rules that govern telemedicine.
"It is Responsible Telemedicine's hope that we can create a future of transparency and trust in digital healthcare. Highlighting where WebMD has failed feels like a step in the right direction," said Sarfani.
SOURCE Responsible Telemedicine