Compliment Your Risk Management Program

February 2011

You Must Control The Who, What, When, Where,

& How People View and Use Your Information,

Or Others Will

Knowledge sharing in the healthcare industry is a critical deliverable. As noted by these abstracts, the risks to you of giving everyone unmanaged and unmonitored access to your sensitive information are all too real. Fortunately, there may be a few certainties that exist to protect you that warrant attention; control the exchange of your knowledge and information, control who sees it and most importantly, hold those seeking your knowledge responsible for how they interpret and use it. The future of such knowledge control has arrived to compliment your efforts.

--YourDocs Team

January 14, 2011 Vol. IX Issue 2

Health Lawyers Weekly

Court Upholds Medicare Exclusion Of Drug Company Lawyer And Executives

According to a summary of remarks made at a Food and Drug Law Institute panel in late October, the FDA outlined several steps that companies should implement to prevent off-label marketing including formally monitoring of: sales and marketing operations, detailing at speaker events, promotions, and publications. The FDA and OIG have clearly defined the tremendous risk to all distributor and manufacturer personnel of uncontrolled sales promotions that "knowingly or unknowingly" qualify as misconduct" [emphasis added]. Read Full Story

January 23, 2011

The New York Times

Heart Doctor Group Cooperating in Federal Investigation

A leading professional group for doctors is cooperating in a Department of Justice investigation into proper use of the ICD devices. The announcement comes two weeks after a medical journal article suggested one in five heart defibrillators may be implanted for questionable reasons. The authors of the study examined national registry data from nearly 112,000 patients who received the devices from 2006 to 2009. According to the article published in the Journal of the American Medical Association, patients and others who fall outside prescribing guidelines make up a fifth of the defibrillator population. Read Full Story

January 25, 2011

Bloomberg

AngioDynamics Warned by FDA on NanoKnife Promotion

AngioDynamics Inc. said it received a letter from U.S. regulators alleging the company of promoting its NanoKnife surgical device for unapproved uses. The Food and Drug Administration notified Latham, New York- based AngioDynamics in a warning letter that some of the company's statements, including those on its website, "promote the use of the NanoKnife System beyond its currently cleared indications," AngioDynamics said today in a statement. Read Full Story

November 12, 2010 Vol. VIII Issue 44

HealthLawyers Weekly

RiskyBusiness:

The Pursuit Of Healthcare Industry Executives And Managers

New guidance claims OIG has the authority to exclude all "officers" as well as any "managing employees"- defined as individuals with operational or managerial control over the entity or who directly or indirectly conduct day-to-day operations. Under its newly articulated standard, they will operate with a presumption in favor of exclusion if there is evidence that the officer or managing employee knew "or should have known" of misconduct. However, the OIG can, will and has excluded individuals whether they were knowing or unknowing of wrongdoing. Read Full Story

Hold Individuals Accountable For

Their Use and Interpretation of Your Knowledge.

YourDocs^©helps you manage your risk and secure your field force interactions with your customers. Your subscription to YourDocs© web-based service helps protect your knowledge repository from unauthorized access, as well as from inaccurate or unintended representations of your documents and expertise.

YourDocs^©is your tool to hold individuals accountable for their use and interpretation of your knowledge repository.

YourDocs^©helps you implement proof-of-compliance and control over potentially undisciplined sales, marketing, and customer communications of any type.

YourDocs^© is a unique subscription for streamlining your training certification program with advanced capabilities for managing, auditing, and distribution with proof of compliance.

YourDocs^©seamlessly integrates into existing knowledge-sharing processes maintaining easy, yet controlled access around-the-clock control and the peace of mind that comes with a knowledge-sharing network that is working to protect your interests.

Now is the Time to Evaluate Solutions for Robust Compliance

or Request a Demo

sales@yourdocs.net or Call 800.883.8705

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