Background: Health information exchange (HIE) allows healthcare providers to access a patient's medical information to improve patient care continuity. The standardized data realize the HIE values. Since the Health Level 7 Clinical Document Architecture (CDA) is flexible, implementation guides (IG) are needed for use cases. Although many CDA IGs have been developed, they did not describe how these CDA IGs were developed. A national CDA IG that meets the local requirements is demanded since the data differs according to the digital divide and social-cultural background of the country that wants to establish HIE. Due to their localized contents, other countries cannot directly adopt the published CDA IGs.
Objectives: We developed the national CDA IG, namely, Korean (K)-CDA IG that meets the local requirement, including reusable structured templates, value sets, and object identifiers (OIDs). We present a detailed description of the development process and the technical methods of the national CDA IG in the Korean context.
Methods: The K-CDA IG was developed in the following stages: analysis, development, and evaluation. First, we investigated the health information environment and electronic health record (EHR) systems and conducted a gap analysis with published CDA IGs. Second, a templated CDA approach was taken for designing modular. Lastly, we consulted a technical advisory group for comments on the validity of the K-CDA IG.
Results: A total of 35 CDA templates were developed. We improved 28 value sets of which 13 were Korea specific and 15 were based on the ones used in other IGs, and made a set of rules to establish the OID structure.
Conclusion: We presented the development process and the technical specifications of K-CDA IG. We explored how the results can be used as interoperability criteria in the national EHR systems certification program. Finally, we provided recommendations that could guide other entities planning their HIE programs.
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