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Sunday, August 17, 2025

Latest Cybersecurity False Claims Act Settlement with Diagnostics Provider Focuses on Sensitive Health Systems - Inside Privacy

In a recently announced settlement agreement with the U.S. Department of Justice (“DOJ”), Illumina, Inc. (“Illumina”) agreed to pay $9.8 million to resolve claims arising from alleged cybersecurity vulnerabilities in genomic sequencing systems that the company sold to federal agencies. The case is the latest in a series of False Claims Act (“FCA”) settlements under the current administration that evidence DOJ’s continued focus on cybersecurity obligations for government contractors, particularly those that maintain sensitive data and personal information on behalf of federal customers.

Case Summary[1]

The case, which was filed by a former employee under the qui tam provisions of the FCA (31 U.S.C. § 3730(b)), alleged that Illumina submitted, or caused to be submitted, false claims under its government contracts for genomic sequencing systems which were allegedly susceptible to certain cybersecurity vulnerabilities and lacked an “adequate product security program and sufficient quality systems” to identify and address vulnerabilities. Specifically, DOJ claimed that the company knowingly failed to:

  • Incorporate product cybersecurity into software design, development, installation, and on-market monitoring;
  • Properly support and resource personnel, systems, and processes tasked with product security; and
  • Adequately correct design features that introduced cybersecurity vulnerabilities into its genomic sequencing systems.

Furthermore, DOJ alleged that the company falsely...



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