New York AG Goes After mHealth App Developers
New York attorney general Eric Schneiderman is using state trade laws to extract concessions and monetary penalties from mHealth app developers, according to attorneys Kristi Kung and Sean Cuddihy (Sheppard Mullin). Writing in an online blog post, Kung and Cuddihy say Schneiderman has taken action against Israel-based Matis for its app marketed as “My Baby’s Beat — Baby Heart Monitor App.” It was designed to register fetal heartbeat sounds using only a smartphone microphone and to isolate and amplify those sounds.
The attorney general said the company claimed that the app transformed a smartphone into a fetal heart monitor and thus could be used to play an unborn baby’s heart rate, even though the app was not an FDA-approved fetal heart monitor.
Matis claimed that its app functioned as a fetal stethoscope without providing sufficient evidence substantiating that it actually plays the sound of the fetal heartbeat (as opposed, for example, to the mother’s heartbeat), Schneiderman said. Kung and Cuddihy write that the attorney general said the developer had used in-app and promotional imagery, text, and categorization to characterize its app as comparable to a medical device without making clear enough whether the developers had adequate evidence to support claims of medical reliability.
Under a settlement, Matis agreed to remove all references to the app’s functionality as a medical device and to display a disclaimer that the app is not a medical device, has not been reviewed by FDA, and is not intended as a replacement for medical advice of any kind.
The attorneys say Matis did not admit to the attorney general’s findings, although it did fully cooperate with the agency’s investigation.
Kung and Cuddihy say the action demonstrates that states are willing to impose their own interpretations, separate and apart from FDA, subjecting those entering the healthcare market to multiple enforcement schemes that may not always align. “An active role for states in this realm raises the question whether states will agree with FDA when it comes to which apps pose less risk and deserve enforcement discretion under the Federal Food, Drug, and Cosmetics Act,” they conclude. They recommend that health app developers review their privacy and security policies as well as their marketing claims to ensure they comply with applicable state and federal laws and regulations.