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The Federal Trade Commission (FTC) continues to enforce and update its Health Breach Notification Rule (HBNR) amidst a fast-changing regulatory environment. A new rule, which took effect this week, expands the scope of the HBNR, as the FTC ramps up enforcement activity related to disclosures of identifiable health data, and other agencies implement changes to the…

Over the course of the past few months, the Office of Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC), both of which are divisions of the U.S. Department of Health and Human Services (HHS), have issued a series of new regulations and guidance related to the Health Insurance…

Newly effective regulations governing confidentiality of Substance Use Disorder (SUD) records now more closely mirror regulations implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and other federal law. The new measures ease the administrative burden on programs by aligning regulations governing the privacy of Part 2 SUD records with the regulatory framework…

The State of Washington appears close to enacting a new law that regulates the privacy of consumer health information.   If passed, the new law – the My Health My Data Act (MHMDA) –would take effect March 31, 2024 and apply to non-governmental entities that collect, process, share, or sell health information that can be linked…

Many privacy professional may have missed it, but In the run-up to the New Year — while many U.S. companies were focused on complying with the California Privacy Rights Act (CPRA) — Congress passed an appropriations bill that contains significant new cybersecurity requirements for medical device companies.  The  Omnibus Appropriations Bill, which was signed…

The U.S. Department of Health and Human Services (HHS) released guidance to address how the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule applies to various entities’ requests for information related to an individual’s COVID-19 vaccination status.

HHS emphasized that the Privacy Rule applies only to covered entities, including health plans and most…

On September 15, 2021, the Federal Trade Commission (“FTC”) issued a policy statement affirming the applicability of its Health Breach Notification Rule (the “Rule”), 16 CFR Part 318, to health apps and connected devices that are not subject to the Health Insurance Portability and Accountability Act (“HIPAA”) but are capable of drawing information from multiple sources.
Continue Reading  FTC Guidance Affirms Breach Notification Obligations for Health Apps and Connected Devices

The Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) has continued its enforcement of HIPAA’s privacy and security rules in the new administration, announcing a number of settlements of alleged violations in the first seven months of 2021.  This settlement activity followed a few other significant HIPAA developments…

The new year began with an unusual amount of activity related to the Health Insurance Portability and Accountability Act (HIPAA). Health care providers, health plans, health care clearinghouses, and business associates subject to HIPAA will need to consider three significant developments—one regulatory, one legislative, and one judicial—relating to the Privacy and Security Rules under HIPAA and the related Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH).
Continue Reading  A Fast Start: 2021 Begins With Major HIPAA Developments

The Cybersecurity Infrastructure Security Agency, Federal Bureau of Investigation, and Department of Health and Human Services have jointly posted an advisory to warn hospitals and other health care providers about the threat of malicious attacks on their information systems.  At least six hospitals across the United States were recently victimized by attacks using Trickbot malware…