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FDA Hits “Pause” on Regulation of LDTs
  • Foley & Lardner LLP
  • USA
  • February 12 2017

On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion

With Short-Term Government Funding Bill in Place, Congress Adjourns until after Elections
  • Reed Smith LLP
  • USA
  • September 30 2016

On September 29, 2016, President Obama signed into law HR 5325, which averts a government shutdown by continuing funding for the federal government

Billing Companies Beware - OIG Signals a Crack Down on Fraud and Abuse at All Levels
  • Mintz
  • USA
  • September 28 2016

In an unprecedented administrative action, the U.S. Department of Health & Human Services Office of the Inspector General (“HHS-OIG”) penalized a

FDA Issues Draft Guidance To Streamline Regulatory Oversight Of NGS-Based Tests For Diagnosing Germline Diseases
  • Foley & Lardner LLP
  • USA
  • July 31 2016

Personalized or Precision Medicine needs reliable and accurate diagnostic tests to guide clinical intervention and treatment decisions. Traditional

The future of medicine
  • Maddocks
  • Australia
  • July 29 2016

On Wednesday, Garvan Institute of Medical Research launched their new genomic pathology service Genome.One. Genome.One is accredited by NATA to the

Sweeping Changes in Store for Laboratory Payments: Medicare Sets Rule for Market Rates Starting in 2018
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • July 6 2016

On June 17, 2016, the Centers for Medicare and Medicaid Services (CMS) released a final regulation implementing 216 of the Protecting Access to

Will New Medicare Law Get Lab Technicians Heated Up?
  • FTI Consulting Inc
  • USA
  • April 1 2016

The government's demand for reams of data from clinical labs is meant to help curb the cost of Medicare reimbursement for diagnostic testing. But it

Consultation sur le signalement obligatoire des atteintes à la protection des données au Canada
  • Blake Cassels & Graydon LLP
  • Canada
  • March 18 2016

Le 4 mars 2016, Innovation, Sciences et Développement économique Canada (le ministère ) a publié un document de consultation où il sollicite les

OIG Approves Hospital-provided Transcription Services Arrangement in Advisory Opinion 15-15
  • Ober Kaler
  • USA
  • February 12 2016

The Office of Inspector General (OIG) recently issued Advisory Opinion 15-15 and concluded that an arrangement under which a hospital proposed

Spain - Private hospital fined 40,001 Euros for unlawfully subcontracting a diagnostic test
  • Baker McKenzie
  • Spain
  • January 18 2016

This case stems from an alleged patient data breach brought about by an ex officio inspection request from the Director of the Spanish DPA and a