scope:

This report provides information on navigating the existing standards and guidelines that promote interoperability of IVD test results. It also highlights the importance of adopting common terminologies to describe the same IVD test result in the same way across the digital health care ecosystem. AUTO17 documents semantic interoperability and the landscape of applicable standards, identifies existing gaps (because the health care ecosystem is in the early stages of the establishment of semantic interoperability), and provides recommendations on resolving those gaps as of the year 2023. If all actors proposed and requested implementation of the standards highlighted in this report, the health care ecosystem could achieve a significant level of laboratory data interoperability.

Although this report uses the experience and knowledge of health care industry and laboratory experts to provide guidance on achieving semantic interoperability for IVD test results, the authors acknowledge that laboratory testing is not limited to US Food and Drug Administration (FDA)-approved IVD tests that are performed in the intended-use setting. For example, laboratory-developed tests (LDTs) may be developed based on the laboratory's expertise. However, laboratory data information systems are used for reporting all test results, so the same data elements and standards should be used to describe LDTs to achieve interoperability and the other benefits identified in this report.

This report is not intended to guide clinical practice (eg, test ordering, application of IVD test results to patient care), laboratory methodology harmonization efforts, or reimbursement. It does not create additional standards but clarifies the use of existing standards. Additionally, it does not cover legal data ownership and data access.

intended Use: