In the medical device industry, recent healthcare reforms such as the Federal Sunshine Act and the medical device tax present new and challenging regulatory risks.
In the absence of enforcement precedent, or even regulatory guidance, assessment and management of these risks have yet to yield a set of best practices. Of course, even within longstanding areas of regulatory compliance, and where there is ample precedent and guidance, there are still plenty of lessons to be learned, especially as regulators increasingly turn their eye to new areas of enforcement for the industry.
For example, the onslaught of Foreign Corrupt Practices Act enforcement actions in the medical device industry is evidence of the compliance challenges for the industry and the risks that face this increasingly global medical marketplace.
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