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Results: 1-10 of 1,013

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation
  • Hogan Lovells
  • USA
  • May 17 2017

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA


Combatting the Massive Wave of WannaCry Ransomware
  • Hogan Lovells
  • Spain, United Kingdom, USA
  • May 13 2017

Major companies, health care organizations and government agencies are facing a wave of cyberattacks involving ransomware that takes control of


“Double Dip” Effectively Approved by Center for Medicare and Medicaid Services
  • Hogan Lovells
  • USA
  • May 11 2017

Last week the Centers for Medicare and Medicaid Services (CMS) issued Release No. 104 to Manufacturers and Release No. 180, which invalidated earlier


Why Healthcare and Life Sciences Companies Need to Step Up Their Compliance Efforts in Advance of a U.S. Government Investigation
  • Hogan Lovells
  • USA
  • May 8 2017

In this hoganlovells.com interview, Hogan Lovells partner Gejaa Gobena discusses how the perception of compliance, remediation, and self-disclosure


Health Care Reform Bill Clears the House, but Could Hit a Wall in the Senate
  • Hogan Lovells
  • USA
  • May 5 2017

The American Health Care Act (AHCA), a bill that would repeal and replace key portions of the Affordable Care Act (ACA), narrowly passed the House of


New York Regulators Lead the Charge to Fill Health Data Protection Gaps Left by Federal Law
  • Hogan Lovells
  • USA
  • April 27 2017

After a year-long investigation into mobile health apps claiming to be able to measure vital signs or health indicators through smartphone sensors


CMS Request for Information Presents Rare Opportunity for Medicare Stakeholder Engagement
  • Hogan Lovells
  • USA
  • April 24 2017

On 14 April 2017, the Centers for Medicare & Medicaid Services (CMS) published the fiscal year (FY) 2018 Medicare Hospital Inpatient Prospective


Just One More Day: Compliance Deadline for New ClinicalTrials.gov Regulations is Tuesday, 18 April 2017
  • Hogan Lovells
  • USA
  • April 17 2017

On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for


FDA Cleared First DTC Genetic Tests for Health Risks
  • Hogan Lovells
  • USA
  • April 17 2017

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe's Personal Genome Service (PGS) Test for 10


Court Upholds DOJ Antitrust Lawsuit Challenging Carolinas Healthcare System’s Anti-Steering Provisions
  • Hogan Lovells
  • USA
  • April 6 2017

Despite a recent decision by the Second Circuit suggesting that anti-steering contractual provisions in other industries may not be anticompetitive