Announcing Inclusion of Unique Device Identifiers in EHR Certification Criteria and the Common Clinical Data Set

Dear UDI Email Subscribers,

This week marked an important milestone for the adoption of unique device identifiers (UDIs) in healthcare settings. On October 6, the Office of the National Coordinator for Health IT (ONC) published the final rule
for the 2015 Edition Health IT Certification Criteria intended to increase interoperability – a secure but seamless flow of electronic health information – and improve transparency and competition in the health IT marketplace. On the same date, the Centers for Medicare and Medicaid Services (CMS) published a final rule
that specifies the requirements that eligible providers and hospitals must meet to qualify for Electronic Health Record (EHR) incentive payments and solicits feedback about the Electronic Health Record (EHR) Incentive Programs going forward.

Incorporation of UDIs into electronic health information is a critical cornerstone of the FDA’s plan to strengthen our National Medical Device Postmarket Surveillance system.Althoughfull implementation of the unique device identification system will take several years, the inclusion of UDIs for implantable devices as part of EHR certification criteria and the CCDS are pivotal to developing the infrastructure needed to incorporate standard, structured device information into Health IT.

For more information on the CMS final rule, please visit the CMS Newsroom
. For more information on ONC’s editions of certification criteria, please see the ONC Factsheet
.

For more information about the Unique Device Identification (UDI) System, please visit the FDA’s UDI webpage
.

To access UDI data through the FDA’s free public portal, visit AccessGUDID
.

Sincerely,
FDA UDI Team
Food and Drug Administration
Center for Devices and Radiological Health

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