News & Analysis as of

Food and Drug Administration (FDA) Cybersecurity Whistleblowers

Morgan Lewis - As Prescribed

DOJ Announces First FCA Settlement with Medical Device Company for Cybersecurity Violations

The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The...more

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ Settlement With Medical Technology Company Signals Expanding Cybersecurity FCA Risk for Life Sciences Companies

- What is new: DOJ announced a $9.8 million FCA settlement with Illumina Inc. to resolve claims arising out of alleged cybersecurity deficiencies in DNA sequencing systems Illumina sold to government agencies. - Why it...more

Paul Hastings LLP

At the Crossroads: Illumina Settlement Reflects the Intersection of Cybersecurity and Healthcare Law

Paul Hastings LLP on

On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more

White & Case LLP

DOJ Secures First of Its Kind Cybersecurity False Claims Act Settlement

White & Case LLP on

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 of misrepresenting compliance with federal...more

Morrison & Foerster LLP

2024 Healthcare Fraud Enforcement Year in Review

In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the False Claims Act (FCA) alone resulted in $1.67 billion in settlements and judgments...more

Orrick, Herrington & Sutcliffe LLP

The DOJ’s Focus on Clinical Trial Enforcement: An Ounce of Prevention Is Better Than an Enforcement Action Cure

In early April, the U.S. Department of Justice (DOJ) Civil Division’s Consumer Protection Branch (CPB) published its first-ever “Recent Highlights” report. The report provides background on the CPB, highlights from its recent...more

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