Citing misleading claims and irresponsible privacy practices, the NY Attorney General’s Health Care Bureau entered into settlements with three mobile health application developers this past week. Two of the app developers claimed that their apps accurately measured heart rates during strenuous exercise, and a third claimed that its app could be used with a smartphone as a fetal heart monitor, even though the app was not an FDA-approved fetal heart monitor. The Attorney General stated, “We won’t tolerate non-evidence based apps that threaten the well-being of New Yorkers.”
In addition to paying a penalty, the app developers will now post clear and prominent disclaimers informing consumers that their apps are not medical devices and are not approved by the FDA. The developers also agreed to make changes to their privacy practices to require affirmative consent from consumers to accept their privacy policies for the apps. The developers will also disclose to consumers the types of personally identifying information that are collected by the apps and how such information will be used and shared with third parties.
More information about the app developers and the settlements can be found at here.
Last year, the Federal Trade Commission issued Best Practices for mobile health app developers which can be found here, as well as an interactive tool to assist mobile health app developers to determine whether the FTC Act, the FTC’s Health Breach Notification Rule, HHS’s Health Insurance Portability and Accountability Act (HIPAA), or the FDA’s Federal Food, Drug & Cosmetic Act applies to their product. The tool can be found here.