Life Science Compliance Update

June

2017

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Europe Moves to the Next Level in Protecting Personal Data – The GDPR & Research

Written by , Posted in Privacy

Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA

As cross-border business and technology advances, the European Union’s need to address data privacy protection continually rises. The General Data Protection Regulation will soon be enforceable and undoubtedly will have impact on how pharmaceutical and medical device companies conduct clinical trials and research studies. This article reviews key updates for companies to consider for their clinical trials and research functions as the May 25, 2018 enforcement date approaches.

January

2017

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

Written by , Posted in Abstract, 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.

May

2016

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The Importance of Being Private — OCR Intensifies Enforcement Efforts

Written by , Posted in Abstract, Privacy

Calisha D. Myers, Esq., Staff Writer – Life Science Compliance Update
The Department of Health and Human Services’ Office of Civil Rights is stepping up its enforcement efforts. Phase 2 of its HIPAA compliance audit program has begun, and most covered entities and business associates are potential candidates. Also, first quarter civil penalties for privacy and security violations have reached nearly $5.5 million. This article will provide insight on the audits to be conducted and lessons furnished by the settlements to help companies determine how best to evaluate and adjust their compliance programs.

April

2016

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Through the Worm Hole (Part 1) – Understanding the Parallel Universe of Publically Funded Health Programs

Written by , Posted in Abstract, Privacy

Chris Cobourn, Managing Director, Huron Life Sciences
This is Part 1 of a series of articles designed to help life sciences compliance professionals understand the complex, and sometimes contradictory, universes of publically funded health programs. This article focus on an overview of the publicly funded programs and the populations they serve.

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