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Results: 1-10 of 413

OIG report and Special Advisory Bulletin identify vulnerabilities in copay coupon processing

  • Hogan Lovells
  • -
  • USA
  • -
  • September 25 2014

Completing a project identified in its last two work plans, on 19 September 2014 the Office of Inspector General for the U.S. Department of Health

As business associate agreements amendment deadline approaches, OCR discusses upcoming HIPAA audits

  • Hogan Lovells
  • -
  • USA
  • -
  • September 18 2014

The 2009 HITECH Act mandated that the U.S. Department of Health and Human Services Office for Civil Rights ("OCR") conduct periodic audits of covered

National Health IT week at the FCC

  • Hogan Lovells
  • -
  • USA
  • -
  • September 16 2014

This week the Federal Communications Commission's (FCC's) CONNECT2HEALTHFCC Task Force, a group formed in March 2014 that is focused on using

NIH issues rules on Genomic Data Sharing

  • Hogan Lovells
  • -
  • USA
  • -
  • September 16 2014

On August 27, 2014, the National Institutes of Health (NIH) issued a new Genomic Data Sharing (GDS) Policy, which replaces the current genome-wide

Medicaid drug rebate program: HHS OIG issues report on dispute resolution between manufacturers and states

  • Hogan Lovells
  • -
  • USA
  • -
  • August 28 2014

On Wednesday, August 20, 2014, the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services (HHS) released areport

Federal Circuit revives certain sham petitioning antitrust counterclaims in Tyco-mutual ANDA litigation

  • Hogan Lovells
  • -
  • USA
  • -
  • August 26 2014

In a split decision, the U.S. Court of Appeals for the Federal Circuit affirmed summary judgment on two antitrust counterclaims brought by Mutual

FDA issues two proposed guidance documents for Laboratory Developed Tests

  • Hogan Lovells
  • -
  • USA
  • -
  • August 25 2014

On July 31, 2014, FDA provided Congress advance copies of two proposed guidance documents regarding Laboratory Developed Tests (LDTs), which the

FDA releases revised de novo pathway guidance

  • Hogan Lovells
  • -
  • USA
  • -
  • August 19 2014

On August 14, 2014, the U.S. Food and Drug Administration (FDA or the Agency) released an updated draft guidance document regarding de novo premarket

California appeals court rules that mere possession of medical information by unauthorized person is insufficient to support breach claims under the CMIA

  • Hogan Lovells
  • -
  • USA
  • -
  • August 6 2014

In a ruling that was welcome news to health care providers, insurers, and others that maintain medical information of California residents, the

Finalized and draft 510(k) guidance documents formalize and clarify FDA’s evaluation of substantial equivalence

  • Hogan Lovells
  • -
  • USA
  • -
  • August 5 2014

On July 28, 2014, the U.S. Food and Drug Administration (FDA) finalized its guidance, The 510(k) Program: Evaluating Substantial Equivalence in