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Medical Devices › Digital Health › False Claims Act (FCA)

Morgan Lewis - As Prescribed

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

Morgan Lewis - As Prescribed on

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

Goodwin

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

Goodwin on

The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

White & Case LLP

Fraud and abuse risks in digital health: What tech companies need to know about healthcare enforcement – Part II

White & Case LLP on

For companies looking to monetize their hard-earned innovations in digital health, there is a minefield of potential healthcare enforcement to avoid. As discussed in Part I of this alert, such healthcare enforcement can lead...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

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