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Results: 1-10 of 857

HHS Issues New Guidance on Ransomware and HIPAA
  • Hogan Lovells
  • USA
  • July 29 2016

The Department of Health and Human Services (HHS) released guidance on July 11, 2016, intended to help the healthcare industry prepare for and


Medical Device Alert - The European Commission published a revised MEDDEV on the classification of stand alone software as medical device
  • Hogan Lovells
  • USA
  • July 18 2016

On 15 July 2016, the European Commission issued a revised version of MEDDEV 2.16 entitled “Guidelines on the qualification and classification of


FDA Releases Two Draft Guidances on Next Generation Sequencing
  • Hogan Lovells
  • USA
  • July 15 2016

On July 6, 2016, the FDA announced two new draft guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests


FDA Denies Three Petitions on Biosimilar Labeling: Refers Petitioners to Guidance Process
  • Hogan Lovells
  • USA
  • July 15 2016

The U.S. Food and Drug Administration denied three pending petitions regarding biosimilar labeling without substantively addressing most of the


Antitrust lawsuit shows DOJ support of steering transparency initiatives
  • Hogan Lovells
  • USA
  • July 14 2016

Antitrust agencies have made it clear that hospital mergers are a high enforcement priority. United States v Carolinas Healthcare System signals that


When is a Hospital Not Paid as a Hospital?
  • Hogan Lovells
  • USA
  • July 13 2016

CMS Proposes to Reform Reimbursement for Off-Campus Provider Based Departments On July 6, 2016, the Centers for Medicare & Medicaid Services (CMS


Privacy Shield and the Future of Europe
  • Hogan Lovells
  • European Union, Ireland, USA
  • July 12 2016

For the second time in less than a month, Europe stands on the threshold of history. As many Europeans are still trying to wrap their heads around


Do Digital Health Apps Risk Being Defeated by a Lack of Patient Engagement?
  • Hogan Lovells
  • United Kingdom, USA
  • July 5 2016

On 16th June, industry representatives met at the FT Digital Health Summit in London to discuss innovation and disruption in digital health. Digital


FCA Penalties Double, Increasing Financial Exposure
  • Hogan Lovells
  • USA
  • July 1 2016

FCA Penalties Double, Increasing Financial Exposure The U.S. Department of Justice (“DOJ”) will nearly double the statutory penalties under the False


Understanding Escobar: The Supreme Court Endorses FCA Implied Certification, with Limits
  • Hogan Lovells
  • USA
  • June 28 2016

A unanimous Supreme Court held in Universal Health Services, Inc. v. United States ex rel. Escobar (“Escobar”) that under the civil False Claims Act