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FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as labeling
  • Hogan Lovells
  • USA
  • December 26 2018

On November 20, the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital

Court provides insight into when funds may be held responsible for portfolio company conduct
  • Sidley Austin LLP
  • USA
  • December 19 2018

The government has intervened in a qui tam suit against a compounding pharmacy and its private equity fund owner in which it is alleged that the

Regulatory authority publishes announcement regarding medical device sales centres
  • Fırat Izgi Attorney Partnership
  • Turkey
  • December 19 2018

The Medicines and Medical Devices Agency, the regulatory authority for pharmaceuticals and medical devices in Turkey, recently announced that its

Supreme Court opines on limitations of GPs' freedom of conscience
  • Homble Olsby Advokatfirma AS
  • Norway
  • December 19 2018

The Supreme Court recently deemed that a municipality's termination of its agreement with a general practitioner (GP) after she refused to insert an

OCR Requests Comments on Ways to Modify HIPAA
  • Epstein Becker Green
  • USA
  • December 18 2018

On December 14, 2018 the Department of Health and Human Services, Office for Civil Rights (“OCR”) formally issued a Request For Information (“RFI”)

NICE Publishes Evidence Standards for Digital Health Technologies
  • CMS Cameron McKenna Nabarro Olswang LLP
  • United Kingdom
  • December 18 2018

As digital health innovations develop at an increasing rate, it is important that they are clinically effective and offer economic value. NICE has

Recovery of Damages on a Bond in Connection with a TRO Barring a Pharmaceutical Product Launch
  • Cozen O'Connor
  • USA
  • December 18 2018

Hikma and related companies have been awarded more than $31 million in damages on a $46 million bond because they were wrongfully restrained from

Reforming America’s Healthcare System Through Choice and Competition: The Trump Administration Recommends Healthcare De-Regulation
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • December 18 2018

On December 3, 2018, the U.S. Department of Health and Human Services (“HHS”), in collaboration with the Departments of the Treasury and Labor, the

The Court has jurisdiction to order an inquest even when the Chief Coroner decides not to do so
  • Harper Grey LLP
  • Canada
  • December 18 2018

The Court of Appeal dismissed an appeal brought by the Chief Coroner of the Yukon. On an application for judicial review, a Chambers Judge had ordered

Retaliation: What Is Temporal Proximity?
  • FisherBroyles LLP
  • USA
  • December 18 2018

It’s pretty important: in 2016, then-EEOC Chair Jenny R. Yang said that “Retaliation is asserted in nearly 45 percent of all charges we receive and