Why Fix the Roof when it's Not Raining?                                                            June 2011

As you know, recent media reports that medical device companies may still be only vaguely aware of their enormous legal risks inherent to their healthcare businesses and markets.  This sleepy concern may be a case of deferred maintenance.  Why do today what you haven't started yet - such as, set up protections from baseless accusations and misguided investigation?  Much industry denial may relate to the very ambiguity of regulators and compliance professionals. YourDocs was designed to confine nebulous interpretations such as ill-defined rules, permissive exclusions, and unlimited powers over private concerns to easily manageable and concrete processes within your organization.

 

Companies may find themselves spending significant time and resources evaluating and implementing new compliance programs.  Such programs may present considerable unnecessary expense about communicating sensitive information related to products, research, and services. 

 

The unique YourDocs web-based subscription and service includes and exceeds compliance.  It may actually help protect you from assaults inflicted by vague interpretations of people receiving your information for their own agendas. YourDocs can be easily implemented to hold you harmless from the interpretations of others.  It can also manage and monitor your disclosures, tracking and reporting requirements across your entire organization. No matter the size of your group, all activity by your customers, prospects, internal and external teams may be confirmed, managed, tracked and reported easily from this single subscription.

 

YourDocs may also be made transparent to regulators and auditors, as you choose, by simply providing a unique login for them too.

 

We are available to conduct an introductory demonstration of this proprietary web-based subscription. Please submit your request here.

 

If you are interested in a complimentary trial and are open to participating in one of our roundtable focus groups, please contact Keri directly at the number below. 

 

- YourDocs Team

 
In Shift, Feds Target Top Execs For Health Fraud

WASHINGTON (May 31, 2011 ) - It's getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations. The new tactic is raising the anxiety level - and risks - for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid. Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a check for a number followed by lots of zeroes and promise not to break the rules again.  (Read Full Story)

 

FDA can slap device executives with felony counts

 

(April 28th, 2011) - If you're working on a medical device that's new and unprecedented, you might be a prime target for government litigation, according to Harvey Silverglate, a Cambridge attorney who specializes in civil liberties litigation, criminal defense and student rights.

Federal laws in regard to medical device safety, he argues, are sometimes so vague and complicated that it's impossible to defend against an accusation of wrongdoing. Technologies and techniques that stray from the status quo are especially vulnerable because they are not well understood by the government officials and judges who ultimately decide how to treat them.  (Read Full Story)

 

 

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