Using electronic health information for pharmacovigilance: the promise and the pitfalls

The Food and Drug Administration (FDA) is embarking on the "Sentinel Initiative" to create an electronic network operating across provider electronic health records, health plan claims databases, Medicare databases, and other data sources to monitor FDA-approved medical products. Many private research collaborations also are working to improve our "early warning" system for drugs, such as the eHealth Initiative Foundation (eHI) Connecting Communities for Drug Safety Collaboration, a public-private sector effort. In this article, the author examines a variety of legal issues from the compliance perspective of the private data sources participating in these drug safety programs. These legal issues include: the Food and Drug Act Administration Amendments Act of 2007; privacy laws, including the Health Insurance Portability and Accountability Act, federal alcohol and drug abuse treatment regulations, and state health information confidentiality laws; human subject research compliance; and tort liability.