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Human Genome Project Food and Drug Administration (FDA) Department of Health and Human Services (HHS)

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

Holland & Knight LLP

Sequence of Events: Genetic Testing Offers Significant Promise, But Coverage and Access Limited

Holland & Knight LLP on

In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...more

King & Spalding

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

King & Spalding on

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

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