More than a decade ago, the Federal Trade Commission (FTC) promulgated a Health Breach Notification Rule (the Rule). The Rule requires certain businesses that access or collect consumers’ identifying health information to notify affected consumers, the FTC and, in some cases, the media, in the event that there is a data security breach leading to the unauthorized access or sharing of consumer health information. Although the Rule has long been available to the FTC, the FTC has not actively enforced it.

The FTC, however, appears to be poised to changing its approach. It has signaled renewed interest in the Rule, largely in recognition of the evolution of technology and health care since the Rule’s passage—most particularly regarding health care portals and wearable health devices—that has caused an explosive expansion of the amount of health data collected by organizations and entities that are not otherwise governed by the heightened privacy and security protections set forth in the Health Information Portability and Accountability Act (HIPAA) and its progeny.

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