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By Brian Dunphy, Laurence Freedman
The United States Department of Justice (DOJ) filed an amicus curiae brief with the Supreme Court on November 30, 2018 in a closely watched FCA lawsuit, after the Supreme Court asked for the Solicitor General's views.
By Eli Greenspan, Katie Weider, Rodney Whitlock
This week, Congress is expected to pass a two-week extension to avoid a partial government shutdown. This will give both sides time work out the remaining spending bills,
By Rodney Whitlock, Katie Weider
First, while the 2015 guidance focused on the number of individuals actually estimated to receive coverage, the new guidance focuses on the availability of coverage.
By Adam Samansky, Alexander G. Roan
A federal district court judge recently applied the recent U.S. Supreme Court decision in WesternGeco LLC v. ION Geophysical Corporation,
By Todd Rosenbaum
In a previous post, we addressed what may happen when a defendant in federal litigation seeks to compel arbitration under Ch. 1 of the Federal Arbitration Act, 9 U.S.C. § 4, but the applicable arbitration agreement ...
By Susan Foster
Companies based outside of the European Union sometimes find it challenging to determine whether the General Data Protection Regulation (GDPR) applies to them.
By Aaron L. Josephson
On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety.
By Christina Sperry, Elissa M. Kingsland
As explained below, the petition must be accompanied with additional material.
By Rodney Whitlock, Eli Greenspan, Katie Weider
Welcome back. This week, Congress returns to Washington with 10 working days to prevent a partial government shutdown by December 7th.
By Julie Korostoff
As noted in previous posts in this series, AI tools hold great promise for applications in healthcare.
By Gilbert Samberg
The Hong Kong International Arbitration Centre ("HKIAC") has promulgated a new set of Administered Arbitration Rules ("AAR"), effective November 1, 2018.
By Rodney Whitlock, Constance M. Garner, Alexander Hecht, Katie Weider, Eli Greenspan
On Friday, the news came out that Sen. Chuck Grassley (R-IA) would move back to chair the Finance Committee ...
By Kenneth E. Jenkins, Jeffery C. Giering
Under the Mayo/Alice test for patent eligibility, answering the questions of whether any particular claim is "directed to" a "judicial exception" without "significantly more" ...
By Bridgette Keller
In its favorable Advisory Opinion 18-11, the OIG explains how a managed care organization's proposed incentive program to pay network providers ...
By Laura A. Stefani
Emerging medical imaging technologies being developed for the terahertz spectrum may face regulatory hurdles from an unexpected Federal agency: the Federal Communications Commission (FCC).
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