1. Food and Drug Administration Amendments Act of 2007
2. FDA The Sentinel Initiative: Access to Electronic Healthcare Data for More Than 25 Million Lives http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM233360.pdf
3. Rosati , K Evans , BJ McGraw , D HIPAA and Common Rule Compliance in the Mini-Sentinel Pilot White Paper of the Mini-Sentinel Privacy Panel 2011 at 5 http://www.minisentinel.org/work_products/About_Us/HIPAA and Common Rule Compliance in the Mini-Sentinel Pilot.pdf