Semantic Validation of Standard-based Electronic Health Record Documents with W3C XML Schema

Abstract

The goal of this article is to examine whether W3C XML Schema provides a practicable solution for the semantic validation of standard-based electronic health record (EHR) documents. With semantic validation we mean that the EHR documents are checked for conformance with the underlying archetypes and reference model. We describe an approach that allows XML Schemas to be derived from archetypes based on a specific naming convention. The archetype constraints are augmented with additional components of the reference model within the XML Schema representation. A copy of the EHR document that is transformed according to the before-mentioned naming convention is used for the actual validation against the XML Schema. We tested our approach by semantically validating EHR documents conformant to three different ISO/EN 13606 archetypes respective to three sections of the CDA implementation guide "Continuity of Care Document (CCD)" and an implementation guide for diabetes therapy data. We further developed a tool to automate the different steps of our semantic validation approach. For two particular kinds of archetype prescriptions, individual transformations are required for the corresponding EHR documents. Otherwise, a fully generic validation is possible. In general, we consider W3C XML Schema as a practicable solution for the semantic validation of standard-based EHR documents.