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RAPID - Phase II Informatics/GUDID


  • Joe Drozda, MD, Sisters of Mercy Health System

  • Ted Heise, PhD, MedInstitute

  • Behnaz Minaei & Terrie Reed, US Food and Drug Administration

  • James Tcheng, MD, Duke Clinical Research Institute


Members of the RAPID Informatics and GUDID Integration Working Group advanced the interoperable collection and exchange of health information, promoting adoption of GUDID in health information systems, and demonstrating the utility of the GUDID as a means of standardizing device data and improving the ability to link records across registries and other data sources.


Key Responsibilities

  • Describe the core set of common domain variables (general patient identifiers & common clinical data elements) needed to aggregate data sets from multiple sources

  • Provide subject matter expertise needed to support the representation of RAPID core data elements (CDEs) in interoperable, standards-based models (i.e., LOINC, SNOMED CT).

  • Develop sets of supplemental clinically relevant device attributes for PAD devices (by device category).

  • Provide input to FDA regarding enhancements for GUDID tools and functionality available to industry partners who need to revise their GUDID entries when quality concerns are identified.

  • Review and update core GUDID data elements & value sets from Phase I to ensure the quality of data in GUIDID is acceptable to health systems, registries and supports the statistical analysis plan for the SPEED OPC, and is aligned with Learning UDI Community recommendations and initiatives.

  • Use existing device data in VQI to identify and review the GMDN and SNOMED Hierarchies to develop a device categorization approach to be evaluated in Phase III for aggregation and reporting.

  • Develop mechanisms for hospitals to incorporate UDI into EHI systems (supply chain, procedure documentation, EHR, billing) via bar code scanning.

  • Interface with the AHRMM Learning UDI Community.

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