Collaboration Details

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Title of Collaborative Activity:

SHIELD – Standardization of Lab Data to Enhance Outcomes Research and Value Based Care

Description of Collaborative Activity:

This project will expand the collaborative efforts of FDA and other stakeholders involved in the SHIELD initiative to ensure laboratory information interoperability, such that the same type of device is described the same way in electronic health records (EHR) systems. To realize this goal, this project will develop code mapping manuals to consistently map the same LOINC (Logical Observations Identifiers Names and Codes) to the same type of IVD. This is important because without the specific guidance, manufacturers of IVD devices and laboratories often assign different (and frequently incorrect) LOINC codes for the same type of device. This project will also pilot implementation of SHIELD standard digital formats to update infrastructure in active healthcare provider laboratories, which will include the seamless distribution of LOINC and SNOMED-CT (Systematized Nomenclature of Medicine--Clinical Terms) coding to those provider institutions and registries.

Type of Collaborative Activity:

Committee, Advisory Group, or Work Group

Year the Collaborative Activity Originated:

NIH Participating Institutes/Centers/Office of the Director:

NLM

HHS Agency Collaborators on this Activity:

FDA