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Introducing the Innovation in Medical Evidence Development and Surveillance System (IMEDS)

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For some time, the FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities to conduct large scale evaluations of safety issues in an environment that is secure and protects patient privacy. The type of information and evaluations desired to be in the database include epidemiologic studies of medical products supplied in collaboration with multiple healthcare data partners and the analytic center utilized by the FDA.

So on January 1, 2017, the FDA announced the unveiling of a new resource called the Innovation in Medical Evidence Development and Surveillance System, or IMEDS. The FDA states that the IMEDS framework provides governance that allows private-sector entities (even in regulated industries) to gain access to the system with appropriate oversight.  As a result, the FDA distributed data as well as scientific methods and tools which will now be available for entities outside of FDA who want to conduct important research to advance patient safety (through their Sentinel System).  Through the Sentinel System, FDA routinely utilizes information from large amounts of electronic healthcare data to better inform regulatory decisions.

The Sentinel System is the FDA’s national electronic system whose goal is to transform the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices. In response to the FDA Amendments Act (FDAAA) of 2007, in May 2008 the FDA launched the Sentinel Initiative. The Sentinel system proactively monitors the safety of medical products after they have reached the market and complements the Agency’s existing Adverse Event Reporting System.

The Sentinel System Website can be accessed here. It should be noted that currently, the Sentinel Distributed Database is comprised largely of administrative and claims data from health insurers. Efforts are underway to augment this data with:

  • Clinical data, including vital signs and laboratory test results
  • Electronic health records
  • Hospital data
  • Medicare data
  • Disease registry data

References:

Introducing IMEDS, a Public-Private Resource for Evidence Generation  

The post Introducing the Innovation in Medical Evidence Development and Surveillance System (IMEDS) appeared first on UL EduNeering.


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