On June 20, 2024, the United States District Court for the Northern District of Texas ordered the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) to vacate its guidance that had restricted HIPAA-covered entities’ use of third party online tracking technologies, such as common website advertising and analytics tools. In vacating the guidance, the court held that the agency exceeded its authority by redefining what is considered protected health information (PHI) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). While this order is a defeat for OCR’s guidance on online tracking technologies, regulated companies should react cautiously. The order could be appealed and potentially reversed, OCR could still bring enforcement actions in other circuits advancing their interpretation of PHI, and the Federal Trade Commission’s (FTC’s) laws and state privacy laws could still apply.Continue Reading Texas District Court Vacates OCR’s HIPAA Bulletin on Online Tracking Technologies, But Issues Mixed Decision

On April 26, 2024, the Federal Trade Commission (FTC) announced a Final Rule that amends the Health Breach Notification Rule (HBNR or Rule) to significantly broaden the FTC’s enforcement power in the area of digital health. Under the Final Rule, many developers of everyday health and wellness apps (Developers) will now constitute “health care providers” subject to the HBNR. The consequences of failing to comply with the HBNR could be steep—failure to comply with the Rule could subject a company to civil penalties of $51,744 per violation. Below, we provide a summary of the Final Rule and highlight some of the key challenges it presents.Continue Reading FTC Final Rule Officially Broadens Health Breach Notification Rule, Targets Health and Wellness Apps

The Federal Trade Commission (FTC) recently announced two proposed settlement agreements (in the form of a stipulated order)1 (the “consent orders”) with Monument, Inc., an alcohol addiction treatment service, and Cerebral, Inc., a subscription-based online health care treatment service, signaling the FTC’s continued commitment to pursue digital health companies that the FTC believes have improperly used or disclosed consumers’ health information. The complaints focus on the companies’ disclosure of consumers’ health information to advertising platforms without the consumers’ consent, as well as Cerebral’s alleged failure to honor its “easy” subscription cancellation promises. Of note, the FTC complaint against Cerebral named its CEO personally liable for his alleged involvement with the counts raised in the complaint. The CEO has not agreed to a settlement and the case will proceed in the district court.Continue Reading FTC Announces Proposed Settlement Agreements with Two Digital Health Companies for Disclosing Consumers’ Health Information to Third-Party Advertisers, Among Other Violations

On March 18, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) updated its guidance on the use of online tracking technology by covered entities regulated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and their business associates (together, “regulated entities”). While the updated guidance from OCR seems intended to clarify, and even narrow, the circumstances under which regulated entities’ use of websites and mobile app tracking technologies constitutes a disclosure of Protected Health Information (PHI), it fails to provide clarity on the exact scope, rendering compliance challenging. We summarize the updates to the guidance below and analyze briefly how these updates may impact the use of tracking technologies on unauthenticated and authenticated webpages, and what companies may explore in terms of compliance.Continue Reading OCR at HHS Updates Guidance on Use of Online Tracking Technology by HIPAA-Regulated Entities

On July 20, 2023, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) sent a joint letter to approximately 130 hospitals, telehealth providers, health app developers, and other healthcare industry companies warning of the “serious privacy and security risks” related to the use of online tracking technologies integrated into their websites and mobile apps. The FTC released a press release about the joint letter here and OCR released a press release about the joint letter here.Continue Reading OCR and FTC Issue Joint Letter to Healthcare Companies Warning About Online Tracking Technologies

On June 16, 2023, the Federal Trade Commission (FTC) announced a proposed settlement agreement (in the form of a stipulated order) with genetic testing company Vitagene, Inc., now known as 1Health.io (1Health.io), for allegedly misrepresenting its security and privacy practices regarding its data storage, deletion, and usage. The FTC also alleged that the company unfairly changed material privacy policy disclosures without obtaining affirmative consumer consent.Continue Reading FTC Announces Proposed Settlement with 1Health.io Genetic Testing Firm for Privacy and Security Violations

On May 17, 2023, the Federal Trade Commission (FTC) announced a proposed settlement agreement (in the form of a stipulated order)1 with Easy Healthcare Corporation, which operates the Premom fertility tracking app (Premom). The

Continue Reading FTC Announces Proposed Settlement with Premom Fertility Tracking App for Privacy Practices