Laboratory Data and Interoperability to be Focus of FDA Workshop

Recognizing that laboratory tests "influence between 70 to 80 percent of clinical decisions," the Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the National Library of Medicine (of the National Institutes of Health) are holding a public workshop Sept. 28, 2015, to improve ease of sharing laboratory data. The agencies seek public input on "promoting semantic interoperability of laboratory data between in vitro diagnostic devices and database systems." Also at issue are the standards for reporting laboratory data and models for interoperability.

The full-day workshop will include discussion regarding use of Logical Observation Identifiers Names and Codes (LOINC), uniform Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT), Unified Code for Units of Measure (UCUM), Unique Device Identifier (UDI) codes, Structured Product Labeling (SPL) and Electronically Exchanging Directory of Services (eDOS). The FDA indicated a discussion paper with more detailed discussion of the workshop's subject matter will be released online before the workshop.

Brief presentations to establish parameters for the discussion will be followed by interactive panel discussions and opportunity for public comment. A streaming webcast of the workshop will also be available. Space for live and web attendance are limited. Attendance is free and first-come, first-serve but attendees must register by Sept. 18 and requests to make a presentation during the public comment session must be submitted by Sept. 2, 2015. Written and electronic public comments on the issues are also welcomed and are due by October 26, 2015. More information can be found at the FDA website or the Notice published in the Aug. 3, 2015 Federal Register.