Development and operation of an electronic health record system using CDISC Standards

Abstract

Many discussions on secondary use of data are being conducted according to the computerization of medical information. Particularly in the R&D field, real world data is expected to reduce development costs and improve quality. Some countries require the provision of clinical data during the reimbursement procedure. What is important when using data secondarily is data standardization. HL7 is the standards that is often mentioned when using electronic health record, but CDISC standardization is more necessary when conducting R&D. Here we report an approach about the CDISC standardization of electronic health records to use in R&D. Furthermore, we introduce other efforts in Japan and other countries. CDISC standardization of electronic health records makes efficiency and reliability improvement in the process from generation points of data to analysis, whereas there are some restrictions and issues in applying the CDISC Standards to electronic health records. In this paper, we report these pros and cons and discuss the prospects in the standardization of them.