On July 30, 2025, the U.S. Department of Justice ("DOJ") announced that biotechnology company Illumina Inc. agreed to pay $9.8 million plus interest to resolve allegations that it misrepresented compliance with federal cybersecurity requirements for medical device software. The settlement resolves a whistleblower suit brought under the False Claims Act ("FCA") by a former Illumina employee, in which the government later intervened.
The complaint alleged that, from January 2016 to April 2023, Illumina failed to incorporate adequate cybersecurity into the design, development, installation, and marketing of certain products used for research and clinical purposes. According to the relator, Illumina also failed to maintain adequate product security programs, correct known cybersecurity vulnerabilities that created vulnerabilities, or provide sufficient support for personnel and systems tasked with product security. During this period, the company allegedly certified to the U.S. Food and Drug Administration ("FDA") that its products complied with applicable cybersecurity requirements despite these deficiencies.
Under the terms of the settlement, Illumina will pay $4.3 million in restitution as part of the total $9.8 million resolution. The relator will receive $1.9 million of the settlement proceeds. Illumina has denied the allegations but stated that it agreed to resolve the matter to avoid the uncertainty, expense, and distraction of litigation. The company emphasized that...
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