Naoki Nakashima MD PhD is the Director/Professor (2014- ) of the Medical Information Center of Kyushu University Hospital, and also Vice CIO of Kyushu University, Japan. He has been a specialist of diabetes mellitus for more than 30 years and simultaneously worked as a specialist of medical informatics for 20 years. He is the president of Japan Association for Medical Informatics (JAMI) from June 2019 for three years. He is also the president of Asia Pacific Association for Medical Informatics (APAMI) from January 2021. He focuses on the methodologies of disease management and patient-engagement in chronic diseases from primary to tertiary prevention, including personal health record (PHR), telemedicine, IoT sensor network, cyber physical system, data driven medical study, learning health system, and artificial intelligence.
Electronic Clinical Pathway to be used in Learning Health System
Real-world evidence is defined as clinical evidence about the usage and potential benefits or risks of a medical product derived from analyses of real-world data (RWD). Standardization and structuring of data are necessary for analysis of RWD collected from different institutions to use medical purpose level. However, electronic medical record is not a good data source of RWD for achievement high quality data analysis, because of difficulty of standardization and filled by unstructured data
About 2,000 of Japanese hospitals are using clinical pathway system (scheduled procedures are planned by diagnosis basis) in electronic medical record system, but not standardized. We have lead the ePath project which determined the outcome-oriented standard structure of data, electronic message and repository for analysis of high quality medical RWD collected from multiple medical institutes, and conducted a verification study with 4 top vendors of electronic medical record with 4 hospitals.
In the data structure, we have three layers with an outcome (layer 1), assessments (layer 2, multiple), and tasks (layer 3, same number to layer 2, linked as 1: N: N), and named as “OAT unit” as a basic unit in medical process. Now, we can describe all processes of inpatient clinical course by series of OAT unit on clinical pathway system in main diseases. We are analyzing medical process RWD like a Toyota automobile factory, improving by medical PDCA cycle ‘Kaizen’ to form a multi-institutional Learning Health System.