Jisedaiiryokibanho no Tikujyokaisetsu (Commentary on Next Generation Medical Infrastructure Law)

Although there is widespread awareness of the importance of Evidence-Based Medicine (EBM), medical information needs to be obtained from medical institutions, a universal database constructed, and a system established that enables multiple medical institutions to use that information for their own research purposes. While Japan has medical information databases that can be used nationwide, they mainly consist of input data related to medical practice. Although outcome data resulting from implementing medical practice is collected by some institutions, available data are still far from sufficient. Furthermore, the medical insurance system in Japan is divided into regional health insurance and employees’ insurance, and there is inadequate linking of databases based on each type, which further hinders the development of Evidence-Based Medicine. This is further exacerbated by individual research institutions in Japan often establishing medical information databases to suit their own research objectives, which results in fewer cases and regional bias, and creates problems such as difficulty tracing medical treatment history for patients treated in multiple medical institutions. The above issues have led to the demand for legislation to enable EBM using big data related to medical care. The Act for Authorized Providers of De-identified Health Data, which was intended to contribute to research and development in the medical field (Next Generation Medical Infrastructure Act), was decreed to achieve this end.
 
The author was a member of the Medical Information Handling System Coordination Working Group of the Next Generation Medical Care ICT Infrastructure Council, which deliberated on the drafting of this law. However, for this law to achieve the desired results, it was considered crucial that not only businesses that handle medical information understand the significance and content of the law but also the general public. Therefore, this book was published to provide a step-by-step commentary on the law. It explains the background of the legislation and the necessity to establish special provisions for the previous legal system, before moving onto the commentary. The law, the order for enforcement, and the regulation for its enforcement have been appended at the end of the book as reference materials to enable readers to refer to this information as needed.
 
This law is extremely important not only for legal study majors but also for those majoring in medicine or pharmacy studies. Thus, specific examples have been provided as far as possible, and the book endeavors to explain the law to ensure that the concepts are easy to understand for students who are not majoring in legal studies, as well as including sufficient content from a legal science perspective. In particular, as it is positioned as a special law of a general law related to the protection of personal information, special care is taken to clarify this position within the legislation on said protection.
 

(Written by UGA Katsuya, Professor Emeritus, Graduate Schools for Law and Politics / 2021)