Abstract: Objective To analyze the law and policy framework for use of electronic health data in FDA's Sentinel Initiative to give some suggestions and help for post-marketing drug safety surveillance, especially active safety surveillance, in China. Methods This article studies the sentinel data model, and summarizes how the initial pilot phase of the FDA's Sentinel Initiative, Mini-Sentinel, is being conducted in compliance with applicable federal and state laws. Results FDA is successful in building a good operation model: based on privacy and public trust, FDA established a distributed data system and asked all the participants to obey the mandatory policies and procedures to assure the fairness. Conclusion The privacy and public trust is the premise of drug safety surveillance. The mandatory policies and procedures are the base of implementing surveillance practices. The efficient data model is the tool and way of surveillance operation.

Key words: privacy, health insurance portability and accountability act (HIPAA), distributed system, mini-sentinel common data model(MSCDM), policies