JMIR Publications

ABSTRACT

Background:

The need for national-level medical data management is recognized in areas such as healthcare management, drug development, epidemiology, and policy making. Conventional integrated care electronic health record (EHR) projects in Japan, which rely on subsidies, are not sustainable and will be restricted within the next 5 years, as per the general subsidy period. Therefore, the sustainability of EHR needs to be discussed not only from the perspective of system implementation but also from the legal background arrangement. As a result of the demand for the secondary use of medical data, a national-level project called the Sennen Karte Project was initiated in 2015 in Japan.

Objective:

The objective of this project is to establish an integrated care EHR that generates revenue through secondary use, enabling a sustainable service that does not require subsidies. System implementation, sustaining a nationwide network, and legislation of a new Act are necessary.

Methods:

The development of the data extraction function on major hospital electronic medical record products employs a Japanese local standard format medical markup language. Then, store the data in the integrated care EHR using an XML database and an ISO 13606/OpenEHR-based database. Additionally, EHR services, including mobile apps, web user interfaces, data backup services, and statistical report services, are implemented. Policy engagement was undertaken to facilitate the introduction of new legislation enabling the monetization of secondary use. A government-authorized company was established for the collection and secondary use of medical data.

Results:

As a result, the project was initiated to promote legislation for a new act that endorses a framework for generating profit from secondary use. The new Act passed parliamentary scrutiny in 2018 and came into effect in 2019. Since 2015, an EHR has been implemented, and data retrieval from partner hospitals has been started. The project has partnered with over 100 hospitals in the first four years. Almost 60 connected hospitals provide medical records for secondary use. Both system development and regulatory design achieved a sustainable framework for the proposed project, which has been ongoing since 2015 and continues.

Conclusions:

This project aims to provide a sustainable, integrated care EHR. Legislation and system implementation have created an environment that supports the secondary use of medical data from hospitals. It can be concluded that the linkage between the profit and non-profit sectors has realized the first step of the proposed medical information circulation model, which aims to provide sustainable EHR services in Japan.