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Results: 1-10 of 11

New HHS federal research conflict of interests regulations

  • Reed Smith LLP
  • -
  • USA
  • -
  • April 19 2012

On September 26, 2011, the U.S. Department of Health and Human Services ("HHS") issued new regulations governing the disclosure by faculty members and research staff of significant financial interests related to certain federal grants, and the reporting of "financial conflicts of interest" to certain federal agencies by colleges and universities that receive funding for Public Health Service ("PHS")-sponsored research

OCR announces first enforcement action resulting from a breach self-report

  • Reed Smith LLP
  • -
  • USA
  • -
  • March 15 2012

On March 13, 2012, the HHS Office of Civil Rights (OCR) announced the first enforcement action resulting from a breach self-report required by HITECH’s Breach Notification Rule

510(k) medical device review process reforms

  • Reed Smith LLP
  • -
  • USA
  • -
  • January 19 2011

FDA has issued a press release on its plan to reform the 510(k) medical device review process, outlining changes it intends to implement during 2011

Upcoming hearing on draft DingellWaxman drug safety legislation

  • Reed Smith LLP
  • -
  • USA
  • -
  • September 28 2010

On September 30, the House Energy and Commerce Committee is holding a hearing on draft drug safety legislation (per energycommerce.house.gov, witness list not yet available

FDLI publishes new guide to international prescription product recalls

  • Reed Smith LLP
  • -
  • USA
  • -
  • May 6 2010

Recent events highlight the importance of having a plan for product recalls

White House announces funding for medical tort reform demonstration projects

  • Reed Smith LLP
  • -
  • USA
  • -
  • September 17 2009

On September 17, 2009, the White House released a "Patient Safety and Medical Liability Reform Demonstration" Fact Sheet, which outlines a new $25 million Department of Health and Human Services initiative designed to help states and health care systems identify new models for managing medical liability claims

AHLA Stark reform proposals

  • Reed Smith LLP
  • -
  • USA
  • -
  • August 21 2009

The American Health Lawyers Association released a white paper on August 10, 2009, which analyzes the problems and benefits of the Stark Law and challenges amidst pending health care reform

Congressional hearings on medical device regulation, litigation protective orders

  • Reed Smith LLP
  • -
  • USA
  • -
  • June 5 2009

Congress has been busy and there is no sign it intends to slow down just because it is summer

Will the May 12 hearing on the "Medical Device Safety Act of 2009" recognize the costs of eliminating preemption?

  • Reed Smith LLP
  • -
  • USA
  • -
  • May 8 2009

The House Committee on Energy and Commerce's Subcommittee on Health will hold a hearing on Tuesday, May 12, 2009, at 2:00 p.m. regarding a bill to overturn medical device preemption (H.R. 1346 S. 540), called the "The Medical Device Safety Act of 2009.”

Advertising of medicinal products versus freedom of expression of a journalist - European Court of Justice decision dated 2 April 2009 (C-42107) "Frede Damgaard"

  • Reed Smith LLP
  • -
  • Denmark, European Union
  • -
  • April 28 2009

The European Court of Justice ("ECJ") recently had the opportunity to opine on limits on the scope of advertising for medical products in the European Union, when a journalist who had reprinted factual information about a pain medication sold in Norway but prohibited in Denmark, was made an example under Danish legal provisions prohibiting advertising for medicinal products that are not lawfully marketed in Denmark