News & Analysis as of

Enforcement Actions Medical Devices Cybersecurity

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

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

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 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

Butler Snow LLP

Cybersecurity: What Businesses Need to Know

Butler Snow LLP on

Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Mintz - Health Care Viewpoints

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - September 2019 #3

Robinson & Cole LLP on

Many cities in the United States utilize a self-pay portal for residents to pay bills online, known as Click2Gov. Click2Gov was compromised in 2017 and 2018, when hackers were able to access over 300,000 payment cards and...more

McDermott Will & Schulte

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Spanish

ANTICORRUPTION DEVELOPMENTS - DOJ Files Superseding Indictment in Haitian Port Corruption Plot - On October 30, 2018, the U.S. Department of Justice (DOJ) filed a superseding indictment in the District of Massachusetts...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Russian

ANTICORRUPTION DEVELOPMENTS - DOJ Files Superseding Indictment in Haitian Port Corruption Plot - On October 30, 2018, the U.S. Department of Justice (DOJ) filed a superseding indictment in the District of Massachusetts...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Chinese

ANTICORRUPTION DEVELOPMENTS - DOJ Files Superseding Indictment in Haitian Port Corruption Plot - On October 30, 2018, the U.S. Department of Justice (DOJ) filed a superseding indictment in the District of Massachusetts...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - October 2018

ANTICORRUPTION DEVELOPMENTS - DOJ Files Superseding Indictment in Haitian Port Corruption Plot - On October 30, 2018, the U.S. Department of Justice (DOJ) filed a superseding indictment in the District of Massachusetts...more

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