Life Sciences Legal Forecast: 2014 Compliance Issues Keeping Executives Up at Night
January 20, 2015
Written by ALM Legal Intelligence and sponsored by Foley Hoag LLP
As expected, compliance risk weighs heavily on the minds of general counsel (“GC”) in the life science industry. This report’s findings fall into two broad categories:
- What keeps life science general counsel up at night?
- What protections they are implementing to reduce their exposure to damages?
In the first category, the False Claims Act (FCA) outpaced all other concerns by an almost 10 percent margin. The FCA was a concern for 56% of respondents. HITECH-HIPAA rules and changes to federal rules were cited by 46% and 45%, and off-label marketing of drugs and/or medical devices concerns were cited by 25%.
What are the three most significant risks that are top of mind for your business? Please rank the risks below from 1 to 3, where 1 is the biggest risk. Only rank three of the following.