Developing the Sentinel System — A National Resource for Evidence Development

The Food and Drug Administration (FDA) now has the capacity to “query” the electronic health information of more than 60 million people, posing specific questions in order to monitor the safety of approved medical products. This pilot program, called Mini-Sentinel, uses a distributed data network (rather than a centralized database) that allows participating health plans and other organizations to create data files in a standard format and to maintain possession of those files. These organizations perform most analyses of their own data by running computer programs distributed by a coordinating center, and they provide consistent summarized results for the FDA's review.1 The principles and practices involved in this effort to improve the safety of medical products can inform other uses of electronic health information to answer additional important questions about health and health care.