FCA Cases Look at Cybersecurity: Attorneys

Seven Gibson Dunn attorneys say cybersecurity is a major focus for government False Claims Act (FCA) investigations. Writing in an online post, the attorneys say that in light of recent new medical device cybersecurity requirements, content in premarket submissions to FDA on cybersecurity procedures and disclosures “constitute another area of increasing risk for companies.”

The attorneys say it is critical for companies with products or services that may receive government reimbursement to ensure that their cybersecurity systems are up to date and any statements made regarding those systems are accurate.

The post discusses new FDA cybersecurity requirements and notes that more extensive cybersecurity disclosures to the agency “expand the potential for cybersecurity-related false statements and subsequent FCA risk.” It also analyzes the rise of FCA cases for claims relating to cybersecurity in the healthcare industry more generally.