European Data Protection Board Issues Guidance on Interplay Between GDPR and Rules Governing Data in Clinical Trials

On January 23, 2019, the European Data Protection Board (EDPB), released an opinion on the relationship between the European Clinical Trials Regulation (CTR) and the EU General Data Protection Regulation (GDPR) (the “Opinion”). The CTR, scheduled to take effect in 2020, is designed to harmonize how clinical trials are assessed and supervised across the EU. It introduces a Clinical Trials Information System and establishes rules that protect individuals and enhance transparency requirements. In its Opinion, the EDPB provides guidance on (1) the legal bases for primary uses of clinical data, i.e., processing personal data in the course of a clinical trial protocol, and (2) secondary uses of clinical trial data…

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New Guidance about Transparency: Notices Must Be Accurate, Clear and Easy To Locate

Important guidance about the General Data Protection Regulation’s (GDPR) transparency requirements has been released from Europe. The Article 29 Working Party, an advisory body that oversees data protection in the EU, issued a paper that provides practical guidance and clarity about the obligations of data controllers with respect to informing individuals about the collection, use and protection of their data. The GDPR requires that notices must: be concise, transparent, intelligible and easily accessible (Article 12.1); use clear and plain language (Article 12.1); the requirement for clear and plain language is of particular importance when providing information to children (Article 12.1); be provided in writing “or by other means, including where…

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Achieved Compliance Approved for Participation in Privacy Shield: Program Essential to Any Company Moving Data from the EU to the U.S.

Achieved Compliance is pleased to announce that it has been approved to participate in the EU-U.S. “Privacy Shield” program. The Privacy Shield provides companies on both sides of the Atlantic with a mechanism to comply with data protection requirements when transferring personal data from the European Union and Switzerland to the United States. The Privacy Shield updates the Safe Harbor regime that had supported data flows between the jurisdictions since 2000. As a participant in the Privacy Shield, Achieved Compliance meets all EU legal requirements for protection of data about EU citizens. Companies that use Achieved Compliance software and services can rest assured that we are committed to protecting data…

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