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REMS Integration Into Electronic Health Records To Be Tested By US FDA In Software Pilot

 
• By Derrick Gingery

The prototype pulls information from the electronic record to fill out enrollment and other forms, but stakeholders say it must work for most, if not all, REMS drugs in order to be widely used.

REMS-EHS prototype
MITRE engineers demonstrated the REMS integration tool for the audience at a Duke-Margolis Center for Health Policy workshop. • Source: Screenshot of Duke-Margolis Workshop

A new software package that could integrate risk evaluation and mitigation strategy activities into electronic medical record systems is ready for testing, but uptake may prove to be the ultimate challenge.

The US Food and Drug Administration is working with The MITRE Corp. to design the prototype, which could streamline patient...

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