This document provides a thorough analysis of the European Union’s General Data Protection Regulation (GDPR) and its implications for U.S. universities and academic medical centers (AMCs). With the GDPR’s enforcement from May 25, 2018, data privacy requirements have become more stringent and possess a notably broader extraterritorial reach compared to the previous Data Protection Directive. The regulation applies to U.S. institutions not only when they maintain an establishment in the European Economic Area (EEA), but also when they offer goods or services—such as online courses, study abroad programs, telemedicine, or research collaboration—to individuals in the EEA, or when they monitor the behavior of EEA residents through online tracking, research studies, or other activities.
The document outlines the GDPR’s key requirements, including expanded definitions of personal and special categories of data, enhanced rights for data subjects (such as rights of access, erasure, and objection), and stricter controls over consent and data processing. Significantly, the GDPR imposes direct compliance obligations on U.S. entities regarding data transfers to and from the EEA, necessitating legal mechanisms such as explicit consent, model contracts, or—for eligible for-profit entities—Privacy Shield certification. U.S. universities and AMCs are advised to assess their exposure to GDPR jurisdiction through detailed review of their educational, research, patient care, and data transfer activities. Where subject to the GDPR, institutions must implement robust governance, documentation, security measures, procedures for data subject requests, and breach reporting, or face substantial penalties. The document concludes with a set of fact-finding and implementation recommendations to support compliance and risk mitigation under the GDPR framework.
