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Results: 1-10 of 130

Agencies issue regulations regarding 90-day waiting period for group health plans
  • Hodgson Russ LLP
  • USA
  • May 31 2013

The Departments of Health and Human Services, Labor, and the Treasury issued proposed regulations regarding the Patient Protection and Affordable


Guidance on HRAs and other employer payment plans
  • Hodgson Russ LLP
  • USA
  • November 26 2013

Under ACA for 2014. The Treasury and Department of Labor recently published guidance on the application of the Affordable Care Act Market Reforms on


Religious employers and the Women’s Contraceptive Mandate
  • Hodgson Russ LLP
  • USA
  • November 26 2013

This past July, the U.S. Departments of Labor, Health and Human Services, and the Treasury released final regulations regarding health plan coverage


Department of Health and Human Services issues final HIPAA Privacy and Security Regulations
  • Hodgson Russ LLP
  • USA
  • March 29 2013

Under the privacy and security provisions of the Health Insurance Portability and Accountability Act (HIPAA) "covered entities," including employer


FDA and European Medicines Agency to do parallel evaluation of new drug marketing applications
  • Hodgson Russ LLP
  • European Union, USA
  • April 4 2011

FDA is always criticized and questioned about taking longer to approve regulated products than its counterpart agency in Europe, European Medicines Agency (EMA


FDA issues much-anticipated draft guidance on de novo classification process
  • Hodgson Russ LLP
  • USA
  • October 4 2011

The FDA’s draft guidance on the de novo classification process is finally available for comment purposes


No relief in sight for health-care providers
  • Hodgson Russ LLP
  • USA
  • November 22 2010

In recent years, New York health-care providers have seen an explosion of state oversight and enforcement activities


The Physician Payment Sunshine Act final rule: key change from proposed rule affecting foreign entities
  • Hodgson Russ LLP
  • USA
  • June 26 2013

We now have only 36 days to go until August 1, 2013, when the new data collection obligations imposed on "applicable manufacturers" and group


FDA issues draft guidance on medical device reporting for manufacturers
  • Hodgson Russ LLP
  • USA
  • September 3 2013

On July 9, 2013, the FDA issued a draft guidance document titled "Medical Device Reporting for Manufacturers." Written in a question and answer


Medical devices offer fertile ground for future whistleblower activity
  • Hodgson Russ LLP
  • USA
  • May 29 2014

Recent gatherings of False Claims Act attorneys who represent whistleblowers, the government, and the defense revealed a consensus