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These include fears that secondary use, which is essential in the medical treatment field, will become problematic. Consequently, several problems in the previous law were improved however, a few problems still exist, and some new concerns have emerged. It is now high time for it to be revised. This situation remained for a decade or more. At the time that the previous law was established, both Houses of Councilors recognized that it was insufficient, with the establishment of separate laws being required in multiple fields, including medicine, and it was not actually reviewed. Prior to the revision, the Personal Information Protection Act was established in 2003 and fully enforced in 2005. The Personal Information Protection Act was revised in September 2015 and was fully enforced in May 2017. In this paper, assuming the utilization of the Standardized Structured Medical Record Information Exchange version 2 storage, the following target issues are described: (1) effective utilization of existing standardized storage, (2) secure data collection across medical institutions, (3) privacy risk evaluation in analysis, and (4) traceability while secondary use.Ħ.1.1 Personal Information Protection Act and Next-Generation Medical Infrastructure Act Our JST CREST project, which started in March 2014, has issued the development of technological elements and synthesized the developed methods for real-world system for the secondary use and privacy protection of big data on cloud infrastructure, including safe clinical information management, commercial cloud utilization, and privacy risk evaluation.

On the other hand, under the revised Personal Information Protection Law and the revised ethical guidelines in medical research, privacy protection and patient consent management is a crucial issue for the management of researches. Under the new law for the secondary use of medical information, which was activated in May 2018, the future expected secondary use with information anonymization may contribute to research and development in the medical field of integrated medical research and public health.

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