Membership - who do we need input from?
Standard Development Organizations
Regenstrief
SNOMED International
HL7
Federal agencies
FDA
CDC
NLM
NIH
Implementers (Labs, also cross-pollinate with implementation subcommittee)
Health Partners
University of Nebraska
Intermountain Healthcare
Memorial Sloan Kettering Cancer Center
IVD Industry (also cross-pollinate with industry subcommittee)
IICC representatives
Abbott
Biomerieux
Roche
LIS/LIMS vendors
Epic
Cerner (reached out)
Terminology Services (also cross-pollinate with tooling subcommittee)
3M
IMO
Clinical Architecture
Professional associations
Association of Public Health Laboratories (currently maintains the COVID-19 LIVD file)
College of Anatomic Pathology (CAP)
Others?
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
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