The FDA has a link to where they are releasing information about the Sentinel Initiative which appears to be one big aggregator of sorts, but there’s not enough stated to really be 100% how it will function. It could become a big Cloud too. The project is large enough though that is has to be done in increments. Insurers and others have offered to include information that will offer the FDA a larger source of business intelligence needed for their decision making processes. BD
A national electronic system that will transform FDA’s ability to track the safety of drugs, biologics, medical devices--and ultimately all FDA-regulated products once they reach the market--is now on the horizon. Launched in May 2008 by FDA, the Sentinel Initiative aims to develop and implement a proactive system that will complement existing systems that the Agency has in place to track reports of adverse events linked to the use of its regulated products.
Monitoring the safety of its regulated products is a major part of FDA’s mission to protect public health. But, currently, the Agency’s efforts are limited to its largely passive safety monitoring systems, which depend on healthcare professionals, patients, consumers and pharmaceutical companies to report any adverse effects of FDA-regulated products. The Sentinel System would enable FDA to actively query diverse automated healthcare data holders—like electronic health record systems, administrative and insurance claims databases, and registries—to evaluate possible medical product safety issues quickly and securely.
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