Evaluating the Global Business Impact of U.S. Restrictions on Cross-Border Data Access

In 2025, the United States implemented 28 CFR Part 202, a landmark regulation restricting cross-border access to sensitive personal and government-related data by foreign entities, particularly those associated with China, Russia, Iran, North Korea, Cuba, and Venezuela. This rule profoundly impacts global clinical research, biotechnology, and digital health companies operating or collaborating internationally.

This whitepaper analyzes the regulation’s scope, implications, and exemptions—especially for FDA-regulated studies—and provides actionable strategies for compliance. It highlights potential disruptions to international clinical trials, cloud-based data storage, outsourcing to restricted geographies, and collaborative research across borders. With enforcement already affecting major U.S. biomedical datasets, companies must take a proactive, risk-based approach to data governance, regulatory intelligence, and operational planning.

Whether you’re a pharmaceutical innovator, medical device developer, or digital health provider, this guide offers critical insights to maintain compliance, protect sensitive data, and mitigate global operational risks.