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Industry Impact

Incentives

Providing review of mappings

Requirements in regulations (for example support for keeping mappings updated to the latest version of the mapped to standards)

Issues

Vendors thought that the FDA would hold them accountable for encouraging “off-label use” based on the interpretation of the LOINC code(s) published

Vendors may want to limit access to their mappings to paying customers only (or at least know who is downloading LIVD files)

Vendors operate internationally, so need to ensure mappings are not just US regulation focused

Standards Development Issues

Ensure the LOINC - SNOMED CT collaborative agreement and how to deal with differences in approaches

Format Considerations

current format is spreadsheet for manual review and use

Ideally we