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Tuesday, June 20 • 2:00pm - 3:00pm
#243: Data and Privacy Protection

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Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

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 Objectives

Discuss EU GDPR; Describe the US government privacy and data protection requirements; Discuss issues related to these two frameworks for protecting PII.

Chair

Peter S. Alterman, PhD

Speaker

The €10 Million Penalty: Are You Ready for EU's New PII Regulation?
Peter S. Alterman, PhD

Data Protections, Data Directives, and Clinical Trial Data: How Can I Collect and Use My Global Clinical Trial Data?
Jonathan Andrus, MS

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


Speakers
avatar for Peter Alterman

Peter Alterman

Chief Operating Officer, SAFE-BioPharma Association
Dr. Alterman serves on numerous government and industry electronic identity management committees and workgroups. Peter has received numerous government and private sector awards for leadership in federated identity management.
avatar for Jonathan Andrus

Jonathan Andrus

Chief Business Officer, Clinical Ink, Inc.
As Chief Business Officer, Jonathan Andrus brings over 20 years of eClinical experience and leads Clinical Ink’s solution management & compliance teams to help sponsors and CROs better leverage eSource, eCOA and ePRO data. At Clinical Ink, Mr. Andrus is responsible for P&L across... Read More →
avatar for Debra Diener

Debra Diener

Consultant, Privacy and Identity Management
Over 30 years in senior managerial, legal, policy and legislative positions in all three branches of the Federal Government. Served as the Senior Advisor and Director of Privacy Policy for the Dept of Homeland Security; served on US delegations to international bodies including the... Read More →

Tuesday June 20, 2017 2:00pm - 3:00pm
N426a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  01: Data-BigData-eHealth, Session