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Results: 1-10 of 134

Vermont cannot require ERISA plans to report claims data
  • Hodgson Russ LLP
  • USA
  • April 30 2014

In October 2011, the State of Vermont enacted a statute requiring the establishment and maintenance of a unified health care database designed to


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


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


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


The application of the medical device excise tax to foreign manufacturers selling to end-users in the United States
  • Hodgson Russ LLP
  • USA
  • May 6 2013

As of January 1, 2013, the first sale of a taxable medical device in the United States by a manufacturer, producer, or importer has been subject to a


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


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


Employer not penalized for failing to provide timely COBRA notice
  • Hodgson Russ LLP
  • USA
  • March 31 2014

The U.S. District Court for the Northern District of Iowa held that a family, mistakenly receiving almost a year's worth of free employer coverage


Final rules: essential health benefits, cost-sharing, and actuarial value
  • Hodgson Russ LLP
  • USA
  • May 31 2013

Beginning in 2014, non-grandfathered individual health insurance policies and policies issued to small employers must provide "essential health


Establishment registration: FDA's new importer disclosure policy burdens foreign establishments
  • Hodgson Russ LLP
  • USA
  • October 24 2012

A foreign establishment cannot register with the FDA for the fiscal year 2013 without disclosing the names, addresses, and phone numbers of “all known importers” of its device in the United States