The MDEpiNet informatics team provides leadership and expertise in the areas of data element standardization, harmonization, and interoperability as well as the adoption of unique device identification (UDI) data requirements.
The informatics group collaborates with relevant stakeholders to identify, define, and standardize pertinent data elements. This ensures the development of high quality registries that capture all clinically relevant elements. The team leverages published international and national standards for data definitions to allow for the seamless harmonization between developed registries and other data sources. These processes allow for the generation of high quality data that can be utilized for research and regulatory processes.
In terms of UDI expertise, the informatics group offers support in the following ways: (1) educates CRN vendors, clinicians, and regulators (U.S Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), Office of National Coordinator (ONC), National Library of Medicine (NLM)) on the lessons learned and best practices for scanning, integrating the FDA’s AccessGUDID data and capturing structured device data at the point of care; (2) participates as subject matter experts in workshops or forums that are dedicated to adoption of UDI in health data including electronic health records and the systems that feed and use electronic health record data including medical device registries that would be part of the CRN; (3) works with other CRN collaborators to provide feedback to manufacturers and resolve data quality issues identified with the use of UDI on manufacturer labels and links to that UDI to quality issues in AccessGUDID.
In the Women's Health Technology (WHT) CRN, experts from FDA, ONC, and NLM led the process to standardize and harmonize common data elements among the each of the clinical areas, the inclusion of the core minimum data set in the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR®) Implementation Guide and pilots to test the WHT-CRN’s ability to address priority questions from stakeholders. Read more about the WHT-CRN informatics efforts here.
The SMART (Specific, Measurable, Achievable, Results-oriented, Time-bound) working group is also focused on supporting pilot projects that will result in improved capture and exchange of UDIs and other structured device data across the medical device ecosystem: