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Data and Privacy Protection
Session Chair(s)
Peter S. Alterman, PhD
Chief Operating Officer
SAFE-BioPharma Association, United States
In 2018, EU General Data Privacy Requirements (GDPR) will extend scope of EU data protection law to all foreign companies processing data of EU residents. For pharma companies, CROs, and others involved in the clinical development process, violations of the new regulation can result in fines up to $10 million Euros or 2% of the organization's worldwide revenue. The US and the EU have entered into a vexed relationship regarding data protection and privacy, Privacy Shield. The panel will discuss current privacy regulations in the US and how the GDPR relates to US privacy initiatives, including HIPAA and ONC regulations and proposed legislation in the US Congress.
Learning Objective : Discuss EU GDPR; Describe the US government privacy and data protection requirements; Discuss issues related to these two frameworks for protecting PII.
Speaker(s)
The €10 Million Penalty: Are You Ready for EU's New PII Regulation?
Peter S. Alterman, PhD
SAFE-BioPharma Association, United States
Chief Operating Officer
Data Protections, Data Directives, and Clinical Trial Data: How Can I Collect and Use My Global Clinical Trial Data?
Jonathan Andrus, MS
CRIO, United States
President and Chief Operating Officer
Emerging Technologies Coupled With the Ever Increasing Globalization of Data and Information Demand New Ways to Discuss and Protect Personal Information
Debra N. Diener, JD, MA
Privacy and Identity Management, United States
Consultant
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