The resulting ‘Sentinel System’ is said to strengthen FDA’s ability to track how drugs and medical products perform once they go on the market. Ultimately, this system is expected to help monitor medical products throughout their entire life cycle and thus better ensure the protection and promotion of public health.
The Sentinel System will enable FDA to have access to a variety of electronic data sources to identify possible adverse events once a drug or medical product has been approved for use, while protecting patient privacy use tools and processes that ensure the protection of personal and proprietary information support research and epidemiology studies, as well as FDA’s existing risk identification and analysis processes.
The Sentinel System will be created through public or private partnerships. These partnerships will make it possible for the agency to access large, existing electronic databases without compromising patient privacy.
In addition to creating the new system, the Sentinel Initiative will also explore joining the emerging Nationwide Health Information Network (NHIN). The NHIN will connect clinicians across the health care system and enable the sharing of data as necessary with public health agencies. It will help ensure that treatment decisions are supported by the most current and complete data.