The FDA released the following statement about final rules released by the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare & Medicaid Services (CMS), related to the adoption of unique device identifiers (UDIs):
This week marked an important milestone for the adoption of UDIs in healthcare settings. On Oct. 6, the 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 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 EHR Incentive Programs going forward.
Providers and hospitals use certified EHR technologies to deliver care and share information. Now, for the first time, UDIs and an implantable device list will have to be included as a standard part of this information, known as the Common Clinical Data Set (CCDS). The CCDS is required to be included in a patient’s summary of care documents and is expected to result in improved exchange, recording, and access to patient’s information including the identification of their implantable devices using UDIs. These regulations are expected to go into effect during the spring of 2016 and will create a new source of information to improve patient and clinician decision-making because it will give providers access to information about their patients’ implantable devices.
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. Although full 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.
