NEJM: the Sentinel System

http://www.ncbi.nlm.nih.gov/pubmed/21226658

N Engl J Med. 2011 Jan 12. [Epub ahead of print]
Developing the Sentinel System - A National Resource for Evidence Development.
Behrman RE, Benner JS, Brown JS, McClellan M, Woodcock J, Platt R.

From the Food and Drug Administration, Silver Spring, MD (R.E.B., J.W.); the Engelberg Center for Health Care Reform, Brookings Institution, Washington, DC (J.S. Benner, M.M.); and the Department of Population Medicine, Harvard Pilgrim Health Care Institute, and Harvard Medical School - both in Boston (J.S. Brown, R.P.).
Abstract
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 . . . .