Illumina has agreed to pay $9.8 million after allegations that its genomic sequencing systems sold to federal agencies contained cybersecurity vulnerabilities.
Illumina Inc has agreed to pay $9.8 million to resolve allegations that it violated the False Claims Act when it sold certain genomic sequencing systems with cybersecurity vulnerabilities to federal agencies, according to a release from the US Department of Justice.
The settlement resolves allegations that, between February 2016 and September 2023, Illumina sold government agencies genomic sequencing systems with software that had cybersecurity vulnerabilities without having an adequate security program and sufficient quality systems to identify and address those vulnerabilities.
Specifically, the United States contended that Illumina knowingly failed to incorporate product cybersecurity in its software design, development, installation, and on-market monitoring; failed to properly support and resource personnel, systems, and processes tasked with product security; failed to adequately correct design features that introduced cybersecurity vulnerabilities in the genomic sequencing systems; and falsely represented that the software on the genomic sequencing systems adhered to cybersecurity standards, including standards of the International Organization for Standardization and National Institute of Standards and Technology.
“Companies that sell products to the federal government will be held accountable for failing to adhere to cybersecurity standards and protecting against cybersecurity risks,” says assistant attorney general Brett A. Shumate of the Justice Department’s Civil Division, in a release. “This settlement underscores the importance of cybersecurity in handling genetic information and the department’s commitment to ensuring that federal contractors adhere to requirements to protect sensitive information from cyber threats.”
Settlement Resolves Allegations Under False Claims Act
The settlement resolves a lawsuit filed under the whistleblower provisions of the False Claims Act, which permit private parties to sue on behalf of the government when a defendant has submitted false claims for government funds and receive a share of any recovery. The settlement in this case provides for the whistleblower, Erica Lenore, a former director for platform management of on-market portfolio at Illumina, to receive $1,900,000 as her share of the settlement.
The resolution was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the United States Attorney’s Office for the District of Rhode Island, with assistance from DCIS, the Army Criminal Investigation Division, the HHS Office of the Inspector General, and the Department of Commerce Office of the Inspector General.
The matter was investigated by trial attorney Erin Colleran of the Justice Department’s Civil Division and acting US attorney Sara Bloom of the District of Rhode Island. The claims resolved by the settlement are allegations only and there has been no determination of liability.
ID 156684071 © Photovs | Dreamstime.com
