Geopolitical Data Barriers in Biomedicine: Resolving Sino–U.S. Regulatory Conflicts and Compliance Challenges Under Executive Order 14117

Abstract

The globalization of the biomedical industry is closely linked to the cross-border flow of data, but the U.S.–China data regulatory conflict has exacerbated the compliance dilemma for multinational enterprises. The U.S. Executive Order 14117 builds a data blockade system against Chinese biomedical enterprises by expanding the scope of regulation, refining data standards, and restricting transaction scenarios on the grounds of national security, forming a sovereignty rivalry and technical standard conflict with China’s Data Security Law and other regulations. This study reveals the core conflict points between the two countries in data classification, encryption requirements, and jurisdictional overlap through institutional comparison and case analysis and proposes to resolve the compliance conflicts through internal governance and external adjustment. The study builds a dynamic risk assessment model and a cross-border collaboration framework to provide strategic support for enterprises to balance R&D efficiency and compliance security. The results provide new ideas for cracking the cross-border compliance barriers under the data sovereignty game, which is of practical significance for maintaining the stability of the global biomedical industry chain.