2020 Volume 69 Issue 1 Pages 52-62
Japan has adopted the universal health insurance system, in which a detailed, single list of fee points is used to evaluate every claim, regardless of type of insurance. The great success of “Rececom” (i.e., an abbreviation for “receipt computer”) in managing electronic medical claims, which was developed ahead of the world, may also have represented a significant factor in hindering the spread of electronic medical records systems in the personal computer era. Over time, departmental information systems became linked to computerized provider order entry systems, and data exchange over networks became practical. Nevertheless, interoperability between medical information systems became a problem that was impossible to ignore. In the 1980s, a non-profit organization, HL7 International, was established in the United States to create and disseminate international standards for medical information systems. Subsequently, the Japanese Association of Healthcare Information Systems Industry (JAHIS) was established in 1994, and the Association for Medical Informatics and JAHIS founded the HL7 Japan in 1998. JAHIS and HL7 Japan have since led the development of medical information standards in Japan. In 2001, the Healthcare Information System Review Committee announced a “Grand Design for computerization in the medical field,” and MHLW promoted the spread of electronic medical record systems and the development of medical information standards. HELICS, which is an incorporated association of academic societies and industries involved in the provision of health information, was established in 2007. HELICS evaluates proposal to determine whether they should be accepted as proposals for the national standards in Japan. Specific health checkups and specific health guidance are an initiative unique to Japan, drawing worldwide attention as a measure to counter lifestyle-related diseases that are increasing in developed countries. The HL7 CDA document specification is available regarding specific health checkups, and checkup institutions must create and submit checkup reports that conform to the defined specification. The Pharmaceuticals and Medical Devices Agency (PMDA) has three responsibilities: “Relief Service for Adverse Health Effects,” “Review,” and “Post-marketing Safety Measures.” To achieve efficient review and cross-sectional analysis, PMDA requires clinical trial data to be submitted in accordance with the Clinical Data Interchange Standards Consortium (CDISC) standard. Consistent with HELICS proposals, standardization will be promoted principally in accordance with HL7 V2.x and CDA. In addition, the Fast Healthcare Interoperability Resources may be used to develop new medical applications in areas not profiled in these HL7 2.x and CDA related standards in Japan.