Section 905 of FDAAA calls for the
Health and Human Services Secretary to develop methods to obtain
access to disparate data sources and to establish a postmarket risk
identification and analysis system to link and analyze healthcare
data from multiple sources. The law sets a goal of access to data
from 25 million patients by July 1, 2010, and 100 million patients
by July 1, 2012. The law also requires FDA to work closely with
partners from public, academic, and private entities.
This is a one time collection
of information as a result of FDAAA, which mandates FDA to
establish an active surveillance system for monitoring drugs, using
electronic data from healthcare information holders. The Sentinel
Initiative is the FDA's response to that mandate. Its goal is to
build and implement a new active surveillance system that will
eventually be used to monitor all FDA-regulated products.