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Health App Developers Settle with NY AG over Misleading Claims

Posted in Electronic Health Records, FDA, Legislation and Public Policy, Litigation, Medical Devices, Privacy and Data Protection, State Matters

Three health-related mobile application developers, Cardiio, Runtastic and Matis, are required to pay a combined $30,000 in penalties, change misleading ads, and post prominent disclaimers that the apps are not medical devices and are not approved by the Food and Drug Administration under a settlement announced by the New York Attorney General’s Office on March 23.

According to the AG’s press release, the apps developed by Cardiio and Runtastic were marketed as devices for measuring heart rate during vigorous exercise but the apps were not tested for that purpose. The Matis app, “My Baby’s Beat,” claimed to turn any smartphone into a fetal monitor without FDA approval for use as a fetal monitor and without testing the accuracy of the app. In addition to changing their marketing claims and consumer warnings, the apps must now also clearly inform users how personal information will be shared and require affirmative consent to their privacy policies.

The settlements follow a year-long investigation of mobile health apps. In the press release, Attorney General Eric Schneiderman promised to take action against other app developers that disseminate unfounded information that is deceptive and potentially harmful to consumers.

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