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Results: 1-10 of 16

Will Consent Be Disfavored as Basis for Processing Personal Data in Clinical Research Under EU Data Protection Law?
  • Ropes & Gray LLP
  • USA, United Kingdom, European Union
  • June 18 2018

The European General Data Protection Regulation ("GDPR"), which took effect on May 25, 2018, requires that all processing of personal data subject


Proposed Rule would Delay Common Rule General Compliance Date Until January 21, 2019 While Permitting Earlier Implementation of Three “Burden-Reducing” Provisions
  • Ropes & Gray LLP
  • USA
  • April 23 2018

In January 2017, the federal departments and agencies that follow the Federal Policy for the Protection of Human Subjects, which is typically referred


Life Sciences Quarterly: The Use of Social Media and Mobile Applications in Clinical Trials & Recent Developments in Research Fraud
  • Ropes & Gray LLP
  • USA
  • December 14 2017

What are the legal implications of using social media and mobile applications in clinical trials and the recent developments impacting research fraud


What To Know About New FDA Informed Consent Guidance
  • Ropes & Gray LLP
  • USA
  • August 14 2017

On July 25, 2017, the U.S. Food and Drug Administration issued a guidance document announcing its intention not to object to an institutional review


A Modern Approach To Digital Health Product Regulation
  • Ropes & Gray LLP
  • USA
  • August 7 2017

As part of an overarching initiative to update its regulatory oversight of digital health technologies, the U.S. Food and Drug Administration has


FDA Indefinitely Delays Action on Regulating Laboratory Developed Tests
  • Ropes & Gray LLP
  • USA
  • November 23 2016

On November 18, 2016, the Food and Drug Administration (FDA) notified industry groups that it no longer plans to finalize its draft guidance on


China FDA Clarifies Legal Consequences of Clinical Trial Data Inspections
  • Ropes & Gray LLP
  • China
  • August 31 2016

China’s recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable. However, the legal consequences for


European Commission Releases Text of Proposed Privacy Shield Agreement for Transfer of European Union Citizen Data to the United States
  • Ropes & Gray LLP
  • USA, European Union
  • March 8 2016

On February 29, 2016, the European Commission released the full text of the proposed EU-U.S. Privacy Shield agreement, a data protection


The U.S.-EU Safe Harbor Framework is invalid: now what?
  • Ropes & Gray LLP
  • USA, European Union
  • October 9 2015

A confluence of events has tested the strength of the Safe Harbor Framework and for now, it is no longer a port in the storm. Most recently, on


EU - US personal data transfers - Safe Harbor under threat
  • Ropes & Gray LLP
  • USA, European Union, Ireland
  • September 25 2015

Following a private challenge by an Austrian law student to the storage by Facebook of his personal data on servers located in the United States, the