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Life Sciences Enforcement Actions Clinical Laboratory Testing

Alston & Bird

DOJ Settles Cyber Qui Tam Action Against Illumina for Allegedly Unsecured Genomic Sequencing Products

Alston & Bird on

On July 31, 2025, the United States Department of Justice (DOJ) announced a $9.8 million settlement with Illumina, Inc. (Illumina) to resolve alleged False Claims Act (FCA) violations related to cybersecurity vulnerabilities...more

Epstein Becker & Green

Beyond HIPAA: FTC’s Data Protection Authority Results in Settlement with Genetic Testing Company

Epstein Becker & Green on

A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more

McDermott Will & Schulte

[Webinar] 2021 +Dx Diagnostics Forum - April 6th, 12:00 pm - 3:30 pm EST

Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement Spotlight: US Prosecutors Continue To Target Medical Technology Companies

Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more

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