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Paul Hastings LLP

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

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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 and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Foley Hoag LLP - Security, Privacy and the...

DOJ’s “Bulk Sensitive Data Rule” is in Effect, and May Require Significant Compliance Obligations as Enforcement is Set to Begin

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Pursuant to a newly effective U.S. Department of Justice (DOJ) regulation, the transfer and storage of certain sensitive U.S. government and personal data may be prohibited or restricted, depending on the intended recipient,...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: False Claims Act

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Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

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The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Hogan Lovells

State Licensing Spotlight – Medical Device Manufacturers & Distributors: Compliance Strategies for Avoiding or Reducing Penalties

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Medical device manufacturers and distributors have come under increasing scrutiny from state licensing agencies and operating without a required license may lead to severe consequences. These can include financial penalties;...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: Securities Enforcement

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Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the eighth episode of When Your Life Sciences Are on the...more

Jones Day

China Finalizes Its First Anti-Corruption Guidelines for the Health Care and Life Sciences Industry

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On January 14, 2025, China's State Administration for Market Regulation ("SAMR"), the primary regulatory agency in China for overseeing market supervision, issued its Compliance Guidelines for Health Care Companies to Prevent...more

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

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ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

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Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

McDermott Will & Schulte

Special Report - Decoding Genomic Data Security: Lessons from FTC’s Vitagene Enforcement and the NIST CSF Profile for Genomic Data

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Remarkable progress in DNA and RNA sequencing have democratized the generation and analysis of genomic data across diverse industry sectors, including biopharmaceutical research, healthcare, consumer ancestry, law...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

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ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Butler Snow LLP

Cybersecurity: What Businesses Need to Know

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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

American Conference Institute (ACI)

[Event] 18th Annual FCPA & Anti-Corruption for the Life Sciences Industry - May 10th - 11th, New York, NY

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Hosted by American Conference Institute, the 18th Annual Conference on the FCPA & Anti-Corruption for the Life Sciences Industry returns for another exciting year with curated programming that shines a global spotlight on...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

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On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

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