The HHS OIG released its Work Plan for FY 2014 three months ago and is hard at work investigating the issues highlighted in its annual publication. The OIG’s annual Work Plan lists current and new projects it will address during 2014, and is an excellent source for healthcare facilities to use in identifying potential compliance risk areas. The Work Plan has a number of items that impact children’s hospitals. Whether you immediately added these issues to your organization’s list of potential risk areas or still haven’t had the opportunity to review this year’s Work Plan, we recommend that you do not lose sight of these issues.

When inter partes review actions first became available in 2012, no generic pharma companies availed themselves to this litigation tool. Not until 2013 did a generic pharma company first seek inter partes review (“IPR”) of a brand drug patent in Apotex Inc. v. Alcon Pharmaceuticals, Ltd., IPR2013-00012 and -00015. In response to Apotex’s petition for inter partes review, the Patent Trial and Appeal Board (“PTAB”) ruled there was a reasonable likelihood that the two challenged patents were invalid for obviousness. Interestingly, a U.S. District Court previously determined that one of the patents was not invalid based upon the same prior art references.  Id. at Paper 43; March 19, 2013.

“End-users, sysadmins, and developers lead the pack when it comes to mucking things up, though pretty much all of us are guilty.” These are simple, yet telling, words from the 2014 Data Breach Investigations Report released this week by Verizon.

The report statistics indicate:

  •  46 percent of all data security incidents in healthcare come from theft or simply losing a laptop or other device containing confidential information—triple that of almost all other industry sectors

A deluge of patent applications were filed at the United Stated Patent and Trademark Office on the day before central provisions of the new America Invents Act (AIA) went into effect on March 16, 2013.  This rush to file indicates many inventors wish to preserve their patent status under the pre-AIA provisions.

The first-to-file provisions apply to any patent application that contains OR CONTAINED AT ANY TIME a claim having an effective filing date on or after March 16, 2013, and also apply to any patent application claiming priority of another application/patent that contains OR CONTAINED AT ANY TIME such a claim. America Invents Act § 3(n)(1) (emphasis added).

Because the healthcare community relies upon encryption to safeguard e-Protected Health Information (ePHI), vulnerability to the underlying security of any encryption code is potentially devastating.

The Heartbleed computer bug is gaining substantial media coverage recently, and for good reason. Organizations, especially those in healthcare, should pay special attention to risks from the bug. Heartbleed is not a computer virus, but is actually a software defect. The defect went unnoticed for a long period of time, and was unfortunately adopted by many websites.

Discovered by Neel Mehta of Google Security, the Heartbleed bug is based on a fault in functionality in the widely used OpenSSL library. This library is used by security vendors’ products to secure web browsing and even mobile banking applications. For example, if you go to a site like Amazon, you may notice a little lock in the browser section of the bar with the letters “https”– that is a sign that the website uses, and is a part of, the OpenSSL library. When the Heartbleed bug is exploited, the attacker can retrieve memory, up to 64KB from the remote system.  Such information may contain usernames, passwords, keys or other useful information that enables bigger attacks.

On April 1, 2014, the Department of Labor’s Office of Federal Contract Compliance Programs agreed to the dismissal of its December 2008 complaint against Florida Hospital of Orlando. This action follows DOL’s March 11, 2014 agreement to a five-year moratorium on compliance and enforcement actions against Tricare service providers. These developments reflect a significant rollback of OFCCP’s prior position as to the scope of its jurisdiction. In his March 11, 2014 letter to Congress, Secretary of Labor Thomas Perez recognizes that Congress had intended to limit OFCCP’s jurisdictional authority over Tricare healthcare providers.

Are you wondering how much to pay your pediatric cardiologist?  Or perhaps whether the compensation another pediatric subspecialty is demanding is justifiable?  A recent article in the In-House Counselor, a publication of the American Health Lawyers Association, may provide guidance.

The article, which was written by Tom Schnack of Seim Johnson and was edited by…

In an unprecedented move, on April 8, 2014, the Office of the Inspector General (“OIG”) posted a notice of termination of one of its previously issued advisory opinions.  Specifically, the OIG issued a Final Notice of Termination of Advisory Opinion No. 11-18 (“Notice of Termination”).  The OIG issued Advisory Opinion 11-18 on November 30, 2011 (“Advisory Opinion”).  Under the proposed arrangement, the Requestor, a publicly traded company that provides web-based business services to physician practices, would provide a new service to its existing customers, called “Coordination Service,” to facilitate the exchange of information between the ordering (or referring) healthcare practitioners and providers (“Ordering Health Professionals”) and  receiving healthcare practitioners and providers.   Ordering Health Professionals could refer patients to other healthcare professionals who were existing subscribers of Requestor’s services (“Trade Partners”) or to healthcare professionals not currently receiving Requestor’s services (“Non-Trading Partner”).

This article was originally published by the American Health Lawyers Association. Copyright 2014, American Health Lawyers Association, Washington, DC.  Reprint permission granted.

Recently, the Obama Administration released its fiscal year 2015 budget proposal, which includes several proposals of special interest to children’s hospitals. The Budget proposes several new and strategic investments in the nation’s health care…

If you are forming a new venture or starting a new research project, consider these important IP issues before taking the plunge…

1)  Evaluate the “Patent Landscape” before you invest significant resources. A patent attorney can help you with a “Freedom to Operate” opinion. This FTO opinion will contain a “prior art” search, which provides information regarding comparable patents, their inventors/assignees, whether the patents are in good standing, and the remaining patent term. This information will give you a greater understanding of the patentability of your new idea, will help you avoid infringing someone else’s patents, and will help you identify potential licensing issues. The FTO opinion can also help to avoid “willful” infringement should you later be sued.