Tag: Health and Human Services

Advocate Data Breaches Result in Largest HIPAA Settlement To Date

On August 8th, 2016, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued the largest Health Insurance Portability and Accountability Act (HIPAA) settlement to date with Advocate Health Care System (Advocate).  Advocate agreed to pay $5.55 million to settle a variety of HIPAA violations.  Advocate […]

HHS Releases Crosswalk Between HIPAA Security Rule and NIST Framework

The U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR)  recently released a “crosswalk” developed with the National Institute of Standards and Technology (NIST) mapping  the Health Insurance Portability and Accountability Act (HIPAA) Security Rule and the NIST Framework for Improving Critical infrastructure Cybersecurity (the Framework). […]

“Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”.  The Common Rule is a uniform federal policy for the Protection of Human Subjects, originally issued in 1991. The U.S. agencies […]

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 […]

21st Century Cures Passes House of Representatives; Ups the Ante for HHS Grant and Contracting Fraud

Earlier today H.R. 6, “21st Century Cures”, passed the House of Representatives by an overwhelming vote of 344-77.  Among the myriad provisions, the bill contains language creating civil money penalties (CMPs) for fraudulent grants and contracting with the Department of Health of Human Services (HHS). According to a summary of the bill […]

Lawmakers Call to Clarify HHS’ Mobile Medical App Regulation

The mobile medical application marketplace has developed into a $68 billion industry; however, the U.S. Department of Health and Human Services (HHS) has not yet updated guidance regarding the Health Insurance Portability and Accountability Act’s (HIPAA) application to app developers that collect and use sensitive personal data. In response to […]

HHS Delays ICD-10 Implementation Requirements

On August 4, 2014, the United States Department of Health and Human Services (HHS) issued a final rule delaying the compliance date for health care providers, health plans, and health care clearinghouses to transition to the International Classification of Diseases, 10th Revision (ICD-10) until October 1, 2015.