Framework for GDPR Fines Published by the Dutch Authorities

The Dutch Data Protection Authority (AP) has announced a new policy for determining the fines to be imposed for violations of the General Data Protection Regulation (GDPR) and its national implementing act. The AP’s assessment will first take into account the maximum amounts specified by the European Regulation: either 10 million euros or 2% of the annual worldwide turnover, or 20 million euros or 4% of the annual worldwide turnover, depending on the violation incurred. Violations that are subject to fines are divided into three or four categories designed by the data protection authority to take into account the weight of the breached requirements, with each assigned a…

READ MORE

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…

READ MORE

U.S. Senate Commerce Committee To Hold Hearings on Privacy February 27, 2019

On February 27, 2019, the U.S. Senate Committee on Commerce, Science and Transportation will convene a hearing titled “Privacy Principles for a Federal Data Privacy Framework in the United States.” Committee members will focus on potential Congressional action to “address risks to consumers and implement data privacy protections for all Americans.” Committee Chairman Sen. Roger Wicker of Mississippi described the hearing as an opportunity to “help set the stage for meaningful bipartisan legislation.” The hearing comes in the midst of calls from policymakers, advocates and industry for law that would protect individuals, foster trust, and promote innovation. Several lawmakers introduced legislation in the last Congress, and bills are expected…

READ MORE