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Results: 1-10 of 134

MEWA held to be not fully insured under ERISA
  • Hodgson Russ LLP
  • USA
  • April 15 2011

When unrelated employers join together in an association or other group to purchase or arrange for health insurance, the association is defined as a "multiple employer welfare arrangement" or "MEWA" under the law


New French Sunshine Act guidance
  • Hodgson Russ LLP
  • France, USA
  • July 11 2013

On June 12, 2013, the French Ministry of Health published Circulaire No. DGSPF22013224 relative to Article 2 of the Law No. 2011-2012 of December


Clinical trial financial disclosure: French legislation
  • Hodgson Russ LLP
  • France
  • September 6 2011

The European Parliament and Council’s Directive 200120EC dated April 4, 2001, which has been modified several times, is related to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use


Failure to notify participant that coverage is out of network may be a fiduciary breach
  • Hodgson Russ LLP
  • USA
  • January 31 2014

The U.S. Court of Appeals for the Seventh Circuit, in an en banc decision, held that the husband of a deceased plan participant may continue with his


Departments issue wellness program final regulations
  • Hodgson Russ LLP
  • USA
  • July 31 2013

The Departments of Health and Human Services, Labor, and Treasury issued final wellness program regulations. These final rules are applicable to


Health care reform update government agencies issue grandfather plan regulations
  • Hodgson Russ LLP
  • USA
  • June 29 2010

The U.S. Internal Revenue Service (IRS), Department of Labor (DOL), and Department of Health and Human Services (HHS) have jointly issued long-awaited guidance in the form of interim final regulations detailing the requirements for maintaining grandfather plan status


FDA’s medical device review process: 510(k) premarket notification process scrutinized
  • Hodgson Russ LLP
  • USA
  • November 5 2010

As many know, on August 3, 2010, the Food and Drug Administration (FDA) released proposed reforms to the 510(k) premarket notification program


Decree on advertising medical devices in France
  • Hodgson Russ LLP
  • France
  • August 27 2012

A new French law wants to strengthen the safety of drugs and medical products


How to avoid import detention by the FDA
  • Hodgson Russ LLP
  • USA
  • August 3 2011

An import detention notice from the FDA is received by many importers of foreign goods with mixed feelings of surprise, confusion, and anxiety


Pharma company settles whistleblower suit alleging wrong treatment of drugs as generic
  • Hodgson Russ LLP
  • USA
  • February 17 2012

A qui tam case filed in federal court in Maryland has yielded an $11 million False Claims Act settlement