Current Status and the Future of Protection and Utilization of Personal Information at Medical Facilities Based on the Understanding of Related Regulations

In September 2015, “the Act on the Protection of Personal Information” was amended. Accordingly, “the Ethical Guidelines for Medical Research Involving Human Subjects” were also amended. “The Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field...

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Published inYAKUGAKU ZASSHI Vol. 141; no. 2; pp. 187 - 191
Main Authors Uchikura, Takeshi, Momo, Kenji, Sasaki, Tadanori
Format Journal Article
LanguageJapanese
Published Japan The Pharmaceutical Society of Japan 01.02.2021
Subjects
Computer Security - ethics
Computer Security - legislation & jurisprudence
Computer Security - trends
Confidentiality - ethics
Confidentiality - legislation & jurisprudence
Confidentiality - trends
development
ethical
guideline
Health Facilities
Humans
personal-information
development
ethical
personal-information
research
guideline
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Abstract In September 2015, “the Act on the Protection of Personal Information” was amended. Accordingly, “the Ethical Guidelines for Medical Research Involving Human Subjects” were also amended. “The Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field,” which came into effect in May 2018, aims to collect and utilize medical information of each patient from medical institutions for the purpose of research and development in the medical field. Thus, the rules of personal information that need to be followed are changing considerably in the balance between importance of protection and utilization for medical development. Therefore, health care professionals and researchers are required to fully understand the current situation and the future.
AbstractList In September 2015, "the Act on the Protection of Personal Information" was amended. Accordingly, "the Ethical Guidelines for Medical Research Involving Human Subjects" were also amended. "The Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field," which came into effect in May 2018, aims to collect and utilize medical information of each patient from medical institutions for the purpose of research and development in the medical field. Thus, the rules of personal information that need to be followed are changing considerably in the balance between importance of protection and utilization for medical development. Therefore, health care professionals and researchers are required to fully understand the current situation and the future.
In September 2015, "the Act on the Protection of Personal Information" was amended. Accordingly, "the Ethical Guidelines for Medical Research Involving Human Subjects" were also amended. "The Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field," which came into effect in May 2018, aims to collect and utilize medical information of each patient from medical institutions for the purpose of research and development in the medical field. Thus, the rules of personal information that need to be followed are changing considerably in the balance between importance of protection and utilization for medical development. Therefore, health care professionals and researchers are required to fully understand the current situation and the future.In September 2015, "the Act on the Protection of Personal Information" was amended. Accordingly, "the Ethical Guidelines for Medical Research Involving Human Subjects" were also amended. "The Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field," which came into effect in May 2018, aims to collect and utilize medical information of each patient from medical institutions for the purpose of research and development in the medical field. Thus, the rules of personal information that need to be followed are changing considerably in the balance between importance of protection and utilization for medical development. Therefore, health care professionals and researchers are required to fully understand the current situation and the future.
Author Uchikura, Takeshi
Momo, Kenji
Sasaki, Tadanori
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References 1) Act on the Protection of Personal Information: 〈https://elaws.e-gov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=415AC0000000057〉, cited 13 July, 2020.
3) 3rd Joint Conference on the Handling of Personal Information in Medical Research: 〈https://www.mhlw.go.jp/file/05-Shingikai-10601000-Daijinkanboukouseikagakuka-Kouseikagakuka/0000129071.pdf〉, cited 13 July, 2020.
6) Personal Information Protection Board, “Handbook on the use and protection of personal information.”:〈http://www.ppc.go.jp/files/pdf/personal_280229sympo_pamph.pdf〉, cited 13 July, 2020.
4) Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field: 〈https://elaws.e-gov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=429AC0000000028〉, cited 13 July, 2020.
2) Ethical Guidelines for Medical and Health Research Involving Human Subjects: 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10600000-Daijinkanboukouseikagakuka/0000153339.pdf〉, cited 13 July, 2020.
16) Cabinet Office. “What is Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field?”: 〈https://www8.cao.go.jp/iryou/gaiyou/pdf/seidonogaiyou.pdf〉, cited 6 October, 2020.
13) Ethical Guidelines for Clinical Studies: 〈https://www.mhlw.go.jp/general/seido/kousei/i-kenkyu/rinsyo/dl/shishin.pdf〉, cited 13 July, 2020.
18) Nikkei Business Publications, Inc.: 〈https://project.nikkeibp.co.jp/behealth/atcl/feature/00003/020500071/?P=1〉, cited 13 July, 2020.
14) Araki K., Masuzawa Y., Takahashi Y., Nakayama T., Jpn. J. Public Health, 65, 730-743 (2018).
10) Ethical Guidelines for Human Genome and Gene Analysis Research: 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10600000-Daijinkanboukouseikagakuka/0000153405.pdf〉, cited 13 July, 2020.
9) 105th the Personal Information Protection Commission: 〈https://www.ppc.go.jp/files/pdf/0517_shiryou5.pdf〉, cited 13 July, 2020.
11) Ethical Guidelines for Epidemiology Research: 〈https://www.mhlw.go.jp/seisakunitsuite/bunya/hokabunya/kenkyujigyou/i-kenkyu/dl/02-02.pdf〉, cited 13 July, 2020.
20) Public Commentary on the Draft Ethical Guidelines for Life Science and Medical Research:〈https://search.e-gov.go.jp/servlet/PcmFileDownload?seqNo=0000203655〉, cited 13 July, 2020.
5) Basic Policy on the Protection of Personal Information: 〈https://www.ppc.go.jp/files/pdf/300612_personal_basicpolicy.pdf〉, cited 13 July, 2020.
17) Cabinet Office, Certification of Business Operators under the Next Generation Medical Infrastructure Act:〈https://www8.cao.go.jp/iryou/nintei/nintei/jigyousha/jigyoushanintei.html〉, cited 13 July, 2020.
15) Inoue Y., Hospitals, 78, 831-836 (2019).
8) Guidance for the proper handling of personal information by medical and nursing care providers: 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-12600000-Seisakutoukatsukan/0000194232.pdf〉, cited 13 July, 2020.
12) Guidelines for Gene Therapy Clinical Research: 〈https://www.mhlw.go.jp/content/000561788.pdf〉, cited 13 July, 2020.
7) Ministry of Culture, Science and Technology. “Revision of Ethical Guidelines for Medical and Health Research Involving Human Subjects in accordance with the amendment of the Act on the Protection of Personal Information.”:〈http://pathology.or.jp/news/pdf/rinri_170710.pdf〉, cited 6 October, 2020.
19) Promulgation of the Amendment Act of the Act on the Protection of Personal Information etc.: 〈https://www.ppc.go.jp/news/press/2020/200612/〉, cited 13 July, 2020.
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References_xml – reference: 14) Araki K., Masuzawa Y., Takahashi Y., Nakayama T., Jpn. J. Public Health, 65, 730-743 (2018).
– reference: 18) Nikkei Business Publications, Inc.: 〈https://project.nikkeibp.co.jp/behealth/atcl/feature/00003/020500071/?P=1〉, cited 13 July, 2020.
– reference: 4) Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field: 〈https://elaws.e-gov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=429AC0000000028〉, cited 13 July, 2020.
– reference: 6) Personal Information Protection Board, “Handbook on the use and protection of personal information.”:〈http://www.ppc.go.jp/files/pdf/personal_280229sympo_pamph.pdf〉, cited 13 July, 2020.
– reference: 20) Public Commentary on the Draft Ethical Guidelines for Life Science and Medical Research:〈https://search.e-gov.go.jp/servlet/PcmFileDownload?seqNo=0000203655〉, cited 13 July, 2020.
– reference: 15) Inoue Y., Hospitals, 78, 831-836 (2019).
– reference: 2) Ethical Guidelines for Medical and Health Research Involving Human Subjects: 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10600000-Daijinkanboukouseikagakuka/0000153339.pdf〉, cited 13 July, 2020.
– reference: 17) Cabinet Office, Certification of Business Operators under the Next Generation Medical Infrastructure Act:〈https://www8.cao.go.jp/iryou/nintei/nintei/jigyousha/jigyoushanintei.html〉, cited 13 July, 2020.
– reference: 3) 3rd Joint Conference on the Handling of Personal Information in Medical Research: 〈https://www.mhlw.go.jp/file/05-Shingikai-10601000-Daijinkanboukouseikagakuka-Kouseikagakuka/0000129071.pdf〉, cited 13 July, 2020.
– reference: 5) Basic Policy on the Protection of Personal Information: 〈https://www.ppc.go.jp/files/pdf/300612_personal_basicpolicy.pdf〉, cited 13 July, 2020.
– reference: 13) Ethical Guidelines for Clinical Studies: 〈https://www.mhlw.go.jp/general/seido/kousei/i-kenkyu/rinsyo/dl/shishin.pdf〉, cited 13 July, 2020.
– reference: 16) Cabinet Office. “What is Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field?”: 〈https://www8.cao.go.jp/iryou/gaiyou/pdf/seidonogaiyou.pdf〉, cited 6 October, 2020.
– reference: 8) Guidance for the proper handling of personal information by medical and nursing care providers: 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-12600000-Seisakutoukatsukan/0000194232.pdf〉, cited 13 July, 2020.
– reference: 7) Ministry of Culture, Science and Technology. “Revision of Ethical Guidelines for Medical and Health Research Involving Human Subjects in accordance with the amendment of the Act on the Protection of Personal Information.”:〈http://pathology.or.jp/news/pdf/rinri_170710.pdf〉, cited 6 October, 2020.
– reference: 12) Guidelines for Gene Therapy Clinical Research: 〈https://www.mhlw.go.jp/content/000561788.pdf〉, cited 13 July, 2020.
– reference: 1) Act on the Protection of Personal Information: 〈https://elaws.e-gov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=415AC0000000057〉, cited 13 July, 2020.
– reference: 9) 105th the Personal Information Protection Commission: 〈https://www.ppc.go.jp/files/pdf/0517_shiryou5.pdf〉, cited 13 July, 2020.
– reference: 11) Ethical Guidelines for Epidemiology Research: 〈https://www.mhlw.go.jp/seisakunitsuite/bunya/hokabunya/kenkyujigyou/i-kenkyu/dl/02-02.pdf〉, cited 13 July, 2020.
– reference: 10) Ethical Guidelines for Human Genome and Gene Analysis Research: 〈https://www.mhlw.go.jp/file/06-Seisakujouhou-10600000-Daijinkanboukouseikagakuka/0000153405.pdf〉, cited 13 July, 2020.
– reference: 19) Promulgation of the Amendment Act of the Act on the Protection of Personal Information etc.: 〈https://www.ppc.go.jp/news/press/2020/200612/〉, cited 13 July, 2020.
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Snippet In September 2015, “the Act on the Protection of Personal Information” was amended. Accordingly, “the Ethical Guidelines for Medical Research Involving Human...
In September 2015, "the Act on the Protection of Personal Information" was amended. Accordingly, "the Ethical Guidelines for Medical Research Involving Human...
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SubjectTerms Computer Security - ethics
Computer Security - legislation & jurisprudence
Computer Security - trends
Confidentiality - ethics
Confidentiality - legislation & jurisprudence
Confidentiality - trends
development
ethical
guideline
Health Facilities
Humans
personal-information
Title Current Status and the Future of Protection and Utilization of Personal Information at Medical Facilities Based on the Understanding of Related Regulations
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