The U.S. Department of Health and Human Services, Food and Drug Administration (FDA) recently issued draft guidance entitled “Guidance for Industry-Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media For Prescription Human and Animal Drugs and Biologics.”

The draft guidance is intended to describe the FDA’s current thinking about how manufacturers, packers, and distributors

The Department of Health and Human Services announced on February 24 that it is seeking information about conducting a pre-audit survey. That is, it plans to conduct a “survey of up to 1200 [HIPAA] covered entities (health plans, health care clearinghouses, and certain health care providers) and business associates (entities that provider certain services to

DPD

In honor of National Data Privacy Day, we provide the following “Top 14 for 2014.”  While the list is by no means exhaustive, it does provide critical areas businesses will need to consider in 2014.

  1. Location Based Tracking.  As the utilization of GPS enable devices becomes more and more prevalent, employers are often faced

Today, the Office for Civil Rights formally announced its HIPAA audit plan, with audits commencing in November 2011. A new page on OCR’s website answers some helpful questions for covered entities and business associates, which are summarized in this report.
Continue Reading OCR Announces HIPAA Audit Program

CDPH’s data privacy enforcement activity continues, this time affecting 6 hospitals and a nursing home with total penalties approaching $800,000.
Continue Reading California Department of Public Health Continues to Fine Hospitals and Nursing Homes for Data Breaches

On February 22, 2010, the Office of Civil Rights (OCR) posted on its website its first list of covered entities that have reported breaches of unsecured protected health information affecting more than 500 individuals. OCR acknowledged the HITECH Act requires HHS to make this information public by posting it on an HHS website.

The breach notification rule became effective on

In a key step toward developing a proposed U.S. health information technology (HIT) infrastructure, the Centers for Medicare & Medicaid Services has announced that Iowa’s Medicaid program is the first to receive federal matching funds for planning activities necessary to implement the electronic health record (EHR) incentive program established by the American Recovery and Reinvestment

The Department of Health and Human Services (HHS) published interim final regulations on October 30, 2009, to update existing enforcement regulations under HIPAA for statutory revisions made by the Health Information Technology for Economic and Clinical Health (HITECH) Act. These regulations become effective November 30, 2009, and only address the provisions of the HITECH Act