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Regulatory Violations Department of Health and Human Services (HHS) 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

Womble Bond Dickinson

Synthetic Data May Be The Solution to AI Privacy Concerns

Womble Bond Dickinson on

AI is hungry for data. Training and testing the machine-learning tools to perform desired tasks consumes huge lakes of data. More data often means better AI....more

Robinson+Cole Health Law Diagnosis

Fifth Circuit Overturns “Arbitrary and Capricious” $4.3 Million HIPAA Penalty Against Hospital

On January 14, 2021, the U.S. Court of Appeals for the Fifth Circuit overturned a $4.348 million penalty for alleged HIPAA violations assessed by the U.S. Department of Health & Human Services (HHS) against the University of...more

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