Mobile Health Apps and the FTC’s Health Breach Notification Rule: New Enforcement Initiative Coming

Mobile health apps are growing in popularity and their number is increasing every year. Many of us find it convenient to use an app to schedule medical appointments, check medical records, track and store health data, and check symptoms. App developers have always needed to be mindful of protecting the privacy of the information that is shared in a mobile health app but recent guidance from the Federal Trade Commission (FTC) signals that the FTC intends to make compliance with its breach notification rule and enforcement a priority.

Last fall the FTC issued a policy statement to clarify that its Health Breach Notification Rule (Rule) “helps to ensure that entities… not covered by the Health Insurance Portability and Accountability Act (HIPAA) nevertheless face accountability when consumers’ sensitive health information is compromised.” The statement acknowledged that the Rule was issued over a decade ago, but that the “explosion” in health apps makes it important now. The Rule requires certain app vendors to notify consumers, the FTC and in some cases, the media if there is a breach of unsecured identifiable health information. Failure to comply with the Rule could result in civil penalties of $43,792 per day. The FTC website contains helpful information that offers tips for app developers, along with a mobile health app interactive tool to assist in determining which federal laws might apply.