The U.S. Food and Drug Administration has awarded a contract to Harvard Pilgrim Health Care to develop a pilot of the FDA's Sentinel System, which will use automated healthcare data to evaluate medical product safety, according to an FDA news release.
The Sentinel System will bolster the FDA's efforts in monitoring product safety. Sentinel will provide FDA with the ability to analyze information collected during the course of routine healthcare, such as data from electronic health record systems, administrative and insurance claims databases and medical registries.
Read the news release about the FDA's Sentinel System.
Read other coverage about medical devices:
- AAMI Urges Federal Agencies to be More Engaged in Developing Medical Device Standards
- FDA Proposes Medical Device Innovation Initiative
- Study: No Safety Benefit Recognized From Slower, Burdensome FDA Approval Process for Devices
The Sentinel System will bolster the FDA's efforts in monitoring product safety. Sentinel will provide FDA with the ability to analyze information collected during the course of routine healthcare, such as data from electronic health record systems, administrative and insurance claims databases and medical registries.
Read the news release about the FDA's Sentinel System.
Read other coverage about medical devices:
- AAMI Urges Federal Agencies to be More Engaged in Developing Medical Device Standards
- FDA Proposes Medical Device Innovation Initiative
- Study: No Safety Benefit Recognized From Slower, Burdensome FDA Approval Process for Devices