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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)
Like to see that data instances of test data is being collected for regulatory use – so FDA would need to share the requirements
Industry is being asked by customers to provide LOINC mapping (not so much SNOMED codes yet) because there is a requirement for reporting to PH as well as for MU to have the tests be represented using LOINC
ONC should clearly state that LOINC mapping is still required and needs to be maintained
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
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Current format is spreadsheet for manual review and use
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Future formats should
support automatic mapping, if possible
support mapping assistance for manual selection
be more easily searchable