We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 134

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


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


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


Medical plan preauthorization language violates SPD standards
  • Hodgson Russ LLP
  • USA
  • August 29 2012

In Koehler v. AETNA Health Inc., the U.S. Court of Appeals for the Fifth Circuit held that Aetna’s benefits decision was not, as a matter of law, entitled to deference where the same document, Aetna’s certificate of coverage, served as both the plan document and summary plan description (SPD


Under Park Doctrine, FDA can prosecute individuals for company violations of FDCA
  • Hodgson Russ LLP
  • USA
  • March 18 2011

Since at least 1975, the FDA has had the authority to prosecute responsible corporate officers under the so-called Park Doctrine


Delegation and project management in the clinical trial process
  • Hodgson Russ LLP
  • USA
  • March 11 2011

Adaptive clinical trials in the US are complex exercises in management tasks, social collaboration, and clinical patient care


American Sleep Medicine to pay more than $15.3m to resolve allegations of Medicare fraud
  • Hodgson Russ LLP
  • USA
  • February 7 2013

The federal government recently settled a $15 million False Claims Act (FCA) case against American Sleep Medicine LLC, according to a recent Justice


Research grant fraud
  • Hodgson Russ LLP
  • USA
  • June 3 2014

False Claims Act practitioners at recent gatherings seem to agree that research grant fraud will be a growing area of whistleblower activity. As the


Sunshine Act data collection checklist
  • Hodgson Russ LLP
  • USA
  • August 13 2013

As we discussed in an earlier post, the data collection obligations under the Physician Payment Sunshine Act commenced on August 1, 2013, and all


HHS proposes substantial reinsurance fee
  • Hodgson Russ LLP
  • USA
  • February 28 2013

The Patient Protection and Affordable Care Act (PPACA) establishes, among other things, a transitional reinsurance program to provide payments to