Tag: Health and Human Services

“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.  

Health System Agrees to Pay $800,000 following Improper Disclosure of Medical Records

This week, Parkview Health System, Inc. (“Parkview”) agreed to pay $800,000 and enter into a Corrective Action Plan to settle allegations that Parkview violated the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  In 2008, Parkview took custody of between 5,000 and 8,000 medical records of patients for a retiring physician in order […]

HHS Issues Reports on HIPAA Breaches and HIPAA Compliance

Last week, the U.S. Department of Health and Human Services (“HHS”) released two reports to Congress, pursuant to its obligations under the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”): a report on Breaches of Unsecured Protected Health Information for 2011 – 2012 (the “Breach Report”) and a […]