InfoBytes Blog
FTC finalizes new rule on health data breach notification requirements
On April 26, the FTC released a final rule that will amend its Health Breach Notification Rule to require vendors of health apps and related entities not covered by the Health Insurance Portability and Accountability Act (HIPAA) to notify affected individuals, the FTC, and in some cases, the media of a health data breach. The NPRM was published in May 2023 (covered by InfoBytes here). The final rule will apply to breaches of unsecured personally identifiable health data and, among other things, clarify that a “breach of security” to include “an authorized acquisition of unsecured [personal health record] identifiable health information that occurs as a result of a data security breach or unauthorized disclosure.” Further, the final rule will define a “[personal health record’s] identifiable health information” to cover health diagnoses, medications, health information tracked on applications or websites, or emergent health data to adopt health apps and privacy and data security risks collected by these technologies.
Under the rule, the FTC will require each vendor who discovered it was the target of a security breach of personal health record identifiable health information to notify each U.S. resident whose information was compromised during the security breach, notify the FTC, and, in cases where 500 or more residents are confirmed or reasonably believed to have been affected by the breach, to notify “prominent media outlets” no later than 60 days after the discovery of the breach (with an exception for law enforcement concerns). The rule will go into effect 60 days after the date of publication in the Federal Register.