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Principles & Policies

The FDA, Sentinel Operations Center, and Collaborating Institutions have developed Principles and Policies to govern participation in the activities of the Sentinel Initiative. Click on the links below for key elements of the Sentinel System Principles and Policies.

A white paper addressing compliance under the Health Insurance Portability and Accountability Act (HIPAA) and the Common Rule for data sources participating in the Sentinel Initiative can be found​ here.