Building a ‘Three-Pronged Governance’ Model for Cross-Border Data Compliance in the Biomedical Industry under the Dual Circulation Pattern

The development of the digital economy has accelerated the global flow of biomedical data, making cross-border governance a critical issue. This study innovatively constructs a ‘regulation-enterprise-technology’ tripartite dynamic balance governance model and proposes a systematic solution combining data classification and categorisation management, standardised compliance frameworks, and federated learning technologies. The study is based on the pilot practice in Shanghai Lingang, verifying the model's application value in reducing compliance costs and enhancing innovation efficiency. The research findings offer new insights into resolving the contradiction between data sovereignty security and global data flow, driving the digital transformation and innovative development of the biopharmaceutical industry.