News & Analysis as of

Healthcare Biotechnology Enforcement Actions

Orrick, Herrington & Sutcliffe LLP

Medical Devices, Cybersecurity & The False Claims Act: What are the Key Takeaways from the Illumina - DOJ Settlement?

Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more

Arnall Golden Gregory LLP

DOJ Sharpens Focus on Cybersecurity Compliance in Healthcare: Illumina FCA Settlement Signals Broader Trend

On July 31, 2025, the U.S. Department of Justice announced that Illumina Inc. agreed to pay $9.8 million to resolve False Claims Act (“FCA”) allegations concerning cybersecurity deficiencies in its genomic sequencing systems...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 5, May 2023

Cyber Resilience Programs Falling Short on Preparing Workers for a Crisis- “At two-thirds of organizations, there is a fear that almost all employees, 95%, will not understand how to recover following a cyberattack.” ...more

Hogan Lovells

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

Hogan Lovells on

On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn Jarald Henderson, based...more

Polsinelli

FDA Targets Medical Device Companies

Polsinelli on

FDA Developing New Risk and Benefit Perception Scale - Since 2008, the U.S. Food and Drug Administration has increased its presence and tightened its control over medical device companies, and this trend is expected to...more

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