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Results: 1-10 of 640

CFDA requires immediate self-inspection of clinical trial data for pending drug registrations
  • Sidley Austin LLP
  • China
  • July 28 2015

On July 22, 2015, the China Food and Drug Administration (CFDA) issued a far-reaching Circular mandating applicants for a total of 1,622 pending drug


Precision Medicine Initiative: Proposed Privacy & Trust Principles
  • Sidley Austin LLP
  • USA
  • July 15 2015

The White House is soliciting public comments on its Proposed Privacy and Trust Principles (the Proposed Principles) for the Precision Medicine


Court declares no HIPAA violation for relators who retained protected health information
  • Sidley Austin LLP
  • USA
  • July 14 2015

A recent opinion examines the interplay between the Health Insurance Portability and Accountability Act ("HIPAA") and the False Claims Act ("FCA"


District court allows Medicare Advantage upcoding case to proceed
  • Sidley Austin LLP
  • USA
  • July 8 2015

A district court in the Southern District of Florida recently denied motions to dismiss filed by a Medicare Advantage ("MA") plan and MA providers in


In long running Tuomey saga, the Fourth Circuit provides a roadmap for constitutional challenges to excessive FCA awards
  • Sidley Austin LLP
  • USA
  • July 6 2015

On July 2, 2015, the Fourth Circuit affirmed a $237 million verdict against Tuomey Hospital following a retrial in the Government’s long-running


District court refuses to reconsider bifurcation of trial between proof of falsity and other FCA elements
  • Sidley Austin LLP
  • USA
  • July 6 2015

As we have previously discussed on this blog, a court in the Northern District of Alabama last month granted AseraCare's motion to bifurcate its


Connecticut amends breach notification law regarding timing and credit monitoring; imposes new data security requirements on health insurers and state contractors
  • Sidley Austin LLP
  • USA
  • July 2 2015

New legislation out of Hartford means that Connecticut joins Massachusetts in imposing strict state requirements for data protection. S.B. 949


OIG issues Advisory Opinion addressing clinical study patient subsidies
  • Sidley Austin LLP
  • USA
  • July 1 2015

The Department of Health and Human Services Office of Inspector General (OIG) has offered several new points of guidance for medical device


HRSA releases anticipated 340B Proposed Rule on ceiling price calculations and CMPs
  • Sidley Austin LLP
  • USA
  • June 19 2015

A new 340B Proposed Rule, released on June 16 by the Health Resources and Services Administration (HRSA), addresses standards and requirements for


Court dismisses GMP-based FCA claims with prejudice
  • Sidley Austin LLP
  • USA
  • June 16 2015

On Friday, the Northern District of California dismissed with prejudice claims alleging that a failure to obtain supplemental approval for major