Life Science Compliance Update

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March 20, 2017

Accountability: The shifting landscape of compliance responsibilities


The meaning of effectiveness of healthcare compliance programs has shifted in recent years. This article examines that shift and what it means for the role of the Compliance Officer including the need to evaluate and oversee a portfolio of risks.

Now that we are two months into the new year, this is a good time to reflect and examine the effectiveness of healthcare compliance programs. The measure of what “effective” means has changed dramatically in recent years. When the PhRMA Code on Interactions With Health Care Professionals (“Code”) was published in 2002, and for many years after, effectiveness was essentially defined by a company’s compliance department as adhering to the OIG’s Seven Elements of an Effective Compliance Program, as well as providing review and approval of individual activities or transactions. It was essentially the compliance department’s responsibility to “police” the organization and prevent them from making poor decisions. Today’s measure of effectiveness still hinges on decision-making, but the accountability is more squarely placed on the shoulders of the decision makers.

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