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UDI Ruled a Requirement for EHRs

A final rule issued by the Office of the National Coordinator for Health IT of the U.S. Department of Health and Human Services will require providers, i.e. hospitals, to incorporate unique device identifiers (UDIs) into electronic health records (EHR), allowing providers to track devices used by their patients at any point of care.

This means that future providers, who did not implant the device originally, can diagnose and coordinate follow-up care by pulling up the UDI information in the patient’s EHR through the Global Unique Device Identification Database (GUDID).

Regulations for UDI inclusion are expected to go into effect during spring 2016. To be successful, according to the ruling, health IT modules have to be able to “record, change, and access a list of UDIs corresponding to a patient’s implantable devices, parse certain data from a UDI, retrieve the ‘Device Description’ attribute associated with a UDI in the GUDID, and make accessible to a user both the parsed and retrieved data.”

UDI integration at the provider level is meant in part to incentivize providers to adopt EHR systems. This step in UDI implementation is also critical to FDA’s plan to strengthen postmarket surveillance.


More on UDI:

New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices

 Unique Device Identification (UDI): Many Questions Remain