Life Science Compliance Update

January

2017

Sailing with a New Safe Harbor in Sight: The EU-U.S. Privacy Shield

Written by , Posted in Privacy

Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

Beginning August 1, 2016, the United States Department of Commerce began accepting self-certifications to the EU-U.S. Privacy Shield from organizations looking to transfer personal data collected within the European Union to the United States. This article provides an overview of the Privacy Shield, its interplay with privacy issues companies face with compliance with the EFPIA Disclosure Code, provisions related to pharmaceutical and medical products (i.e., clinical data, adverse event reporting), and whether the Privacy Shield can survive.


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