Tag: Omnibus Rule

HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 27, 2015

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the Federal Register (the “Proposed Rule”).  The 340B Drug Discount Program is the program by which drug and biologic […]

HIPAA FAQ Series: Are Covered Entities Liable for Business Associates’ HIPAA Violations?

This post marks the beginning of a new series on this blog covering various frequently asked questions regarding the Health Insurance Portability and Accountability Act (HIPAA).  There are many questions regarding HIPAA applicability, implementation, and liability that come up repeatedly.  We plan to use this series to discuss and analyze […]

HIPAA Omnibus Rule Deadline for BAAs Approaches

The Final HIPAA Omnibus Rule (the “Omnibus Rule”), published in the Federal Register on January 25, 2013, made various important changes to how entities must comply with privacy and security requirements.  While most deadlines stemming from the Omnibus Rule have passed, one is imminent: the final requirement to update Business […]

HHS Releases Omnibus Rule Guidance on Refill Reminders and Other Topics

Last week, the U.S. Department of Health and Human Services (“HHS”) released guidance that helps to clarify four parts of the Final HIPAA Omnibus Rule (the “Omnibus Rule”) – many provisions of which become effective today.  Specifically, HHS released clarification regarding how the Omnibus Rule governs the following topics: 1) […]

HHS Releases Model Notices of Privacy Practices

The Office for Civil Rights (“OCR”), in collaboration with the Office of the National Coordinator for Health Information Technology (“ONC”), recently developed and released model Notices of Privacy Practices (“Notices”) for health care providers and health plans.  Several different styles and formats are available for customization. 

Constitutional Challenge to HIPAA: HHS Responds

The U.S. Department of Health and Human Services (“HHS”) has responded to a legal challenge filed last week alleging that the Final HIPAA Omnibus Rule (the “Omnibus Rule”) is unconstitutional because it infringes on the First Amendment.  Adheris, Inc. (“Adheris”), a company that sends patients prescription refill reminders and educational […]

Constitutional Challenge to HIPAA

On September 6, 2013, Adheris, Inc. (“Adheris”), an inVentiv company that works with pharmacies and pharmaceutical manufacturers to send medication refill reminders and educational information regarding diseases to patients, filed suit against the U.S. Department of Health and Human Services (“HHS”).  Adheris alleges that certain provisions of the Final HIPAA Omnibus […]