JAPAN Law and Practice Contributed by: Yoshifumi Onodera, Hiroyuki Tanaka, Naoto Shimamura and Rio Ichii, Mori Hamada & Matsumoto
• when it provides anonymously processed informa - tion to third parties, discloses information that will be included in the anonymously processed infor - mation and the medium to be used to deliver the information in compliance with the PPC Ordinance, and explicitly informs the third-party recipients that the disclosed information is anonymously pro - cessed information (Article 43.4); • does not do anything to identify the individual (Arti - cle 43.5); and • takes measures to secure the safe control of, and address complaints regarding, the handling of anonymously processed information and to pub - licly announce such measures (Article 43.6). According to the PPC Guidelines, statistical informa - tion, meaning information that can be obtained by extracting data concerning a common element from information taken from several people and tallying them up by category, is not anonymously processed information because statistical information is not information regarding an individual and, thus, is not covered by any regulations under the APPI. The 2020 amendment of the APPI introduced the con - cept of pseudonymously processed information. This is information that is processed so that it cannot be used to identify a specific individual without collation with other information (Article 2.5). Pseudonymously processed information is exempted from certain regu - lations under the APPI, such as restrictions on chang - ing the purpose of use and the obligation to comply with the data subject’s rights, and report/notification obligations in the case of a data breach (Article 43). Next-Generation Medical Infrastructure Act In May 2023, the Next-Generation Medical Infra - structure Act was promulgated as a special act under the APPI, with the aim of promoting the use of anonymised individual medical information – such as health check-up results and medical records – for research and development in the medical field. The law establishes a new system for creating and using “pseudonymously processed medical information”. “Pseudonymously processed medical information” refers to information that has been processed so that an individual cannot be identified unless it is collated
with other information. While it requires the removal of identifiers such as names and IDs from personal information, it does not require the removal of distinc - tive values or names of rare diseases. The Next-Generation Medical Infrastructure Act is broadly composed of the following three elements. Certification of businesses creating pseudonymously processed medical information The government certifies businesses that receive medical information from medical institutions based on notification to the individuals concerned, and that create and provide pseudonymously processed medi - cal information (“certified pseudonymously processed medical information creation businesses”). Certification of users of pseudonymously processed medical information Certified pseudonymously processed medical infor - mation creation businesses may provide pseudony - mously processed medical information only to users certified by the government in accordance with stand - ards such as security management (“certified pseu - donymously processed medical information user busi - nesses”). Certified pseudonymously processed medical infor - mation user businesses are prohibited from re-iden - tifying the information and from providing it to third parties. However, exceptions are permitted, such as submission to the Pharmaceuticals and Medical Devices Agency (PMDA), an incorporated administra - tive agency that conducts pharmaceutical approval reviews, and joint use among certified pseudony - mously processed medical information user busi - nesses. Use of pseudonymously processed medical information to support pharmaceutical approval For the purpose of applying for pharmaceutical approval, certified pseudonymously processed medi - cal information user businesses are permitted to pro - vide pseudonymously processed medical information to the PMDA and other relevant bodies.
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