Triple-S Management Corp. (“Triple-S”), a Puerto Rico-based health insurer, has been fined $6.8 million by the Puerto Rico Health Insurance Administration (“PRHIA”) following a Health Insurance Portability and Accountability...more
Since 2009, the HHS Office for Civil Rights (“OCR”) has posted all large data breaches – those that involve 500 or more individuals – online on its so-called “Wall of Shame.” In 2013, 160 large data breaches were reported to...more
On December 18, 2013, New York State Governor Andrew Cuomo signed the Nonprofit Revitalization Act of 2013 (the Act) into law, triggering the first overhaul of the New York Not-for-Profit Corporation Law (N-PCL) in more than...more
GlaxoSmithKline (“GSK” or the “Company”) announced yesterday that it will stop paying health care professionals to promote its drug products and will no longer tie the compensation of its worldwide sales force to individual...more
Welcome to our series, “The 12 Days of Privacy” as we look to “gifts” that may be received this season and some of the big issues ahead ….
Day One – - HIPAA 2014 – Where will the Audit Trail Lead?
The year 2013...more
Those powerful words were spoken by New York Governor Andrew M. Cuomo just over two years ago in his announcement of the formation of a task force to combat excessive executive compensation at not-for-profit corporations that...more
The HHS Office of Civil Rights (OCR) announced that the Health Information Technology (HIT) Policy Committee’s Privacy and Security Tiger Team will hold a virtual, public hearing on Monday, September 30 from 11:45 a.m. to...more
The U.S. Food and Drug Administration (FDA) has issued long-awaited final guidance for developers of mobile medical apps. The final guidance comes more than two years after the FDA published its draft guidance in July 2011. ...more
With the September 23, 2013 compliance date for the HIPAA Omnibus Rule only one week away, the Office for Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC) have developed...more
Last week, the Massachusetts’ Secretary of Health and Human Services, John Polanowicz, announced the launch of a new $5 million program designed to detect and prevent provider fraud, waste, and abuse in MassHealth, the...more
Texas Governor Rick Perry signed a series of bills into law last week modifying some of the state’s Medicaid statutes and programs. The laws will take effect on September 1, 2013....more
As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information...more
The Food and Drug Administration has taken its first action against a mobile app maker for failure to obtain pre-marketing clearance. ...more
Understanding the complexities of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules is often a challenge for health care providers and consumers. Recognizing the widespread...more
Gun violence is a hot topic in the wake of the Newtown shootings and the aftermath of last week’s Boston Marathon bombings, and now health privacy has joined the debate....more
Originally published in the Health Care Fraud Report, 17 HFRA 219, on 03/06/2013.
The final rule (the ‘‘Final Rule’’) implementing the Physician Payments Sunshine Act (‘‘Sunshine Act’’), published in the Federal...more
As we have reported in this blog, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently released final regulations containing modifications to the HIPAA Privacy, Security, Enforcement, and...more
The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more
The Department of Health and Human Services, Office for Civil Rights (OCR) has posted on its website sample business associate agreement provisions to help covered entities and business associates comply with the new business...more
Mintz Levin is pleased to provide this section-by-section analysis of the HIPAA Omnibus Rule.
The chart lists provisions of the proposed privacy, security and enforcement rules mandated by the Health Information...more
In OIG Advisory Opinion 12-20, the OIG determined that a proposed arrangement (the “Proposed Arrangement”) by a hospital (the “Requestor”) would not constitute grounds for the imposition of sanctions under the Anti-Kickback...more
Originally published in Compliance Today on December 1, 2012.
..Covered entities are now subject to privacy and security audits by OCR.
..OCR published audit protocols regarding its standards for such...more