Illumina Inc. to Pay $9.8M to Resolve False Claims Act Allegations Arising from Cybersecurity Vulnerabilities in Genomic Sequencing Systems

Source: United States Department of Justice Criminal Division

Illumina Inc. has agreed to pay $9.8 million to resolve allegations that it violated the False Claims Act when it sold to federal agencies certain genomic sequencing systems with cybersecurity vulnerabilities. Illumina is a Delaware corporation, headquartered in California, that manufactured and sold genomic sequencing systems throughout the United States.

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,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “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.”

“This settlement demonstrates our continuing commitment to combat cybersecurity risks by ensuring that federal contractors protect private and sensitive government information.” said Acting U.S. Attorney Sara Bloom for the District of Rhode Island.

“This settlement demonstrates our continued commitment to work with our law enforcement partners and the Department of Justice to ensure companies fulfill their contractual obligations,” said Acting Special Agent in Charge Christopher M. Silvestro of the Defense Criminal Investigative Service (DCIS) Northeast Field Office, the law enforcement arm of the Department of Defense’s Office of Inspector General. “Safeguarding the validity of Department of Defense research and data is vital to supporting the warfighter.” 

“Significant damage can result from a failure to adhere to required cybersecurity standards, especially when the systems involved include sensitive genomic data,” said Special Agent in Charge Roberto Coviello of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). “HHS-OIG and our law enforcement partners remain dedicated to ensuring that entities who do business with the government uphold their cybersecurity obligations.”

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, On-Market Portfolio at Illumina, to receive $1,900,000 as her share of the settlement. The qui tam case is captioned United States ex. rel. Lenore v. Illumina Inc., No. 1:23-cv-00372 (D.R.I.).

The resolution obtained in this matter 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 U.S. 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. 

Department of Justice, CIA Transmit Declassified Durham Documents to Senator Chuck Grassley

Source: United States Department of Justice Criminal Division

WASHINGTON – Today, the Department of Justice transmitted the declassified Appendix of the Durham Report to the Senate Judiciary Committee following collaboration with the Central Intelligence Agency (CIA). This transmission advances President Donald J. Trump’s directive for maximum transparency and underscores the Attorney General’s commitment to that objective. It also fulfills a request for disclosure by Senate Judiciary Chairman Senator Chuck Grassley (R-IA), whose leadership on this issue has been instrumental.

This latest transmission to Senate Republicans follows the Department’s recent disclosure of information related to the FBI’s handling of the investigation into Hillary Clinton’s use of a private email server and mishandling of classified information.

Following the transmission of new Durham documents, Attorney General Pamela Bondi, CIA Director John Ratcliffe, and FBI Director Kash Patel released the following statements:

“Today, the Department of Justice provided Chairman Grassley with previously classified information relating to Special Counsel Durham’s investigation into possible coordination between the Clinton campaign and the Obama administration to interfere with the 2016 presidential election. This Department of Justice, alongside the CIA, is committed to truth and transparency and will continue to support good-faith efforts by Congress to hold our government accountable.” – Attorney General Pamela Bondi

“Today, CIA and the Department of Justice under Attorney General Pam Bondi are taking a bold step forward in declassifying the underlying intelligence in the Durham appendix showing the false Trump-Russia collusion narrative for what it was – a coordinated plan to prevent and destroy Donald Trump’s presidency. CIA stands with the Department and is committed to transparency and rebuilding trust in the IC. The American people deserve the opportunity to see the evidence for themselves.” – CIA Director John Ratcliffe

“The American people deserve the full, unfiltered truth about the Russia collusion hoax and the political abuse of our justice system it exposed. Today’s declassification and release of documents tied to the Durham report is another step toward that accountability. The FBI will continue working tirelessly with our federal partners at DOJ, CIA, and more to uncover the facts that should have been brought to light years ago. I’m grateful to Chairman Grassley for his steadfast leadership on this issue, and I look forward to our continued partnership in exposing one of the most shameful frauds ever perpetrated on the American public.” – FBI Director Kash Patel

Defense News in Brief: 101 Critical Days of Summer Mid-Term Update

Source: United States Navy

The weekend of July 12-13 marked the midpoint of the 101 Critical Days of Summer. There were seven motorcycle fatalities, two vehicle fatalities and one pedestrian fatality during the first half of the summer and we still have a significant portion of the second half left. These losses are tragic and sobering and remind us that we must double down on our efforts to apply the principles of risk management in all our efforts and mitigate the risks we identify.

Defense News in Brief: U.S. Marines Mobilize Without Delay: Shift from Exercise to Crisis Response

Source: United States Marines

U.S. Marines postured around the globe serve as America’s rapid crisis response force, ready to meet the Nation’s needs at a moment’s notice. On July 26 Marine Corps readiness was on display, when U.S. Marine Medium Tiltrotor Squadron 363, operating under Marine Rotational Force–Darwin, deployed four MV-22B Ospreys more than 1,950 nautical miles from Darwin, Australia, to Clark Air Base, Philippines.

Justice Department Releases Guidance for Recipients of Federal Funding Regarding Unlawful Discrimination

Source: United States Department of Justice Criminal Division

WASHINGTON – Today, the Department of Justice released Guidance to ensure that recipients of federal funding do not engage in unlawful discrimination.  In particular, it clarifies that federal antidiscrimination laws apply to programs or initiatives that involve discriminatory practices, including those labeled as Diversity, Equity, and Inclusion (“DEI”) programs.  Entities that receive federal funds, like all other entities subject to federal antidiscrimination laws, must ensure that their programs and activities comply with federal law and do not discriminate on the basis of race, color, national origin, sex, religion, or other protected characteristics—no matter the program’s labels, objectives, or intentions.

“This Department of Justice will not stand by while recipients of federal funds engage in illegal discrimination,” said Attorney General Pamela Bondi. “This guidance will ensure we are serving the American people and not ideological agendas.”

“The federal government must ensure that taxpayer money is used lawfully and for the public good,” said Assistant Attorney General Harmeet K. Dhillon. “The very foundation of our anti-discrimination laws rests on the principle that every American deserves equal opportunity, regardless of race, color, national origin, sex, religion, or other protected characteristics.”

This new Guidance emphasizes the significant legal risks of initiatives that involve discrimination based on protected characteristics and offers non-binding best practices to help entities that receive federal funds avoid the risk of violations and the revocation of federal grant funding.

Read the Guidance HERE.