Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina sold genomic sequencing systems with cybersecurity vulnerabilities to federal agencies and falsely represented that the software on the genomic sequencing systems adhered to cybersecurity standards.
This settlement is the first of its kind, highlighting the expansion of cybersecurity enforcement to the healthcare industry. It follows the announcement of DOJ’s re-launch of the joint DOJ and Department of Health and Human Services (HHS) False Claims Act work group and builds on the Civil Cyberfraud Initiative. In announcing the resolution, DOJ highlighted the “importance of cybersecurity in handling genetic information.”[1]
The DOJ’s investigation and settlement arose from the filing of a qui tam complaint by Illumina’s former Director for Platform Management. The DOJ intervened in the whistleblower suit to effectuate a settlement. The relator, a former Illumina employee, will receive $1.9 million as their portion from the settlement.
In its settlement with the company, the DOJ contends that Illumina submitted, or caused to be submitted, false claims to U.S government agencies (collectively, the “Agencies”). The basis for liability was the company’s representations of its cybersecurity posture.
Specifically, the DOJ found that from...
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