Towards a Single Data Exchange Standard for Use in Healthcare and in Clinical Research

Background: The development processes of data exchange standards for use in healthcare are very different from those used in clinical research. Healthcare data standards are traditionally developed by the Health Level 7 (HL7) organization, whereas those for use in clinical research are mostly developed by the Clinical Data Interchange Standards Consortium. No alignment of these standards has so far taken place. Objectives: Due to the increasing use of electronic health records as primary source in clinical research, it becomes necessary to align these standards, not only the semantic standards, but also the data exchange standards (formats) themselves. Methods: Mutual feature gaps between ODM and FHIR are investigated. Results: A transition path how the HL7-FHIR standard and the CDISC-ODM transport standard can grow into a single standard for use both in healthcare and in clinical research is presented.