Incorporation of (UDIs) in Healthcare settings

09 Oct

Incorporation of (UDIs) in Healthcare settings

Clients are being made aware of a recent development which is considered as 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.

Goal of this Activity:
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 about the Unique Device Identification (UDI) System, please visit the FDA’s UDI webpage.

? Email us at info@mdiconsultants.com for more information regarding UDI requirements and Ref: UDI Info.

Incorporation of (UDIs) in Healthcare settings