HBNR

On September 15, the Federal Trade Commission (“FTC”) and U.S. Department of Health and Human Services (“HHS”) announced an updated joint publication describing the privacy and security laws and rules that impact consumer health data.  Specifically, the “Collecting, Using, or Sharing Consumer Health Information? Look to HIPAA, the FTC Act, and the Health Breach Notification Rule” guidance provides an overview of the Health Insurance Portability and Accountability Act, as amended, and the implementing regulations issued by HHS (collectively “HIPAA”); the FTC Act; and the FTC’s Health Breach Notification Rule (“HBNR”) and how they may apply to businesses.  This joint guidance follows a recent surge of FTC enforcement in the health privacy space.  We offer below a high-level summary of the requirements flagged by the guidance.Continue Reading FTC and HHS Announce Updated Health Privacy Publication

On May 18, 2023, the Federal Trade Commission (“FTC”) announced a notice of proposed rulemaking (the “proposed rule”) to “strengthen and modernize” the Health Breach Notification Rule (“HBNR”).  The proposed rule builds on the FTC’s September 2021 “Statement of the Commission on Breaches by Health Apps and Other Connected Devices” (“Policy Statement”), which took a broad approach to when health apps and connected devices are covered by the HBNR and when there is a “breach” for purposes of the HBNR.  The proposed rule primarily would (i) amend many definitions that are central to the scope of the HBNR (e.g., “breach of security,” “health care provider,” and “personal health record”), and (ii) authorize expanded means for providing notice to consumers of a breach and require additional notice content.  According to the FTC, these changes to the HBNR would ensure the HBNR “remains relevant in the face of changing business practices and technological developments.”  Below, we provide a brief summary of the history of the HBNR leading up to this proposed rule, a brief summary of the proposed rule, and a timeline for commenting.Continue Reading FTC Announces a Notice of Proposed Rulemaking to Expand Scope of the Health Breach Notification Rule

On May 17, the Federal Trade Commission (“FTC”) announced an enforcement action against Easy Healthcare Corporation (“Easy Healthcare”) alleging that it shared users’ sensitive personal information and health information with third parties contrary to its representations and without users’ affirmative express consent, in violation of Section 5 of the FTC Act.  It also alleges that Easy Healthcare failed to notify consumers of these unauthorized disclosures, in violation of the Health Breach Notification Rule (“HBNR”).  According to the proposed order, Easy Healthcare will pay a $100,000 civil penalty for violating the HBNR and, among other requirements, will be permanently prohibited from sharing users’ personal health data with third parties for advertising purposes.  The FTC also noted that Easy Healthcare will pay a total of $100,000 to Connecticut, the District of Columbia, and Oregon for violating their laws.Continue Reading FTC Announces Second Enforcement Action Under Health Breach Notification Rule Against Fertility App Developer Easy Healthcare

On February 1, the Federal Trade Commission (“FTC”) announced its first-ever enforcement action under its Health Breach Notification Rule (“HBNR”) against digital health platform GoodRx Holdings Inc. (“GoodRx”) for failing to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to third-party advertisers.  According to the proposed order, GoodRx will pay a $1.5 million civil penalty and be prohibited from sharing users’ sensitive health data with third-party advertisers in order to resolve the FTC’s complaint. 

This announcement marks the first instance in which the FTC has sought enforcement under the HBNR, which was promulgated in 2009 under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, and comes just sixteen months after the FTC published a policy statement expanding its interpretation of who is subject to the HBNR and what triggers the HBNR’s notification requirement.  Below is a discussion of the complaint and proposed order, as well as key takeaways from the case.Continue Reading FTC Announces First Enforcement Action Under Health Breach Notification Rule