[1]潘 姚,敖 琪.健康医疗数据应用中个人信息保护的欧盟实践及启示[J].卫生经济研究,2025,42(08):32-36.
 PAN Yao,AO Qi.EU Practices and Implications of Personal Information Protection in Healthcare Data Application[J].Journal Press of Health Economics Research,2025,42(08):32-36.
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健康医疗数据应用中个人信息保护的欧盟实践及启示

卫生经济研究[ISSN:1004-7778/CN:33-1056/F]

卷:
42
期数:
2025年08期
页码:
32-36
栏目:
他山之石
出版日期:
2025-07-31

文章信息/Info

Title:
EU Practices and Implications of Personal Information Protection in Healthcare Data Application
作者:
潘 姚1敖 琪2
1.四川行政学院,四川 成都 610000
2.浙江大学光华法学院,浙江 杭州 310000
Author(s):
PAN Yao AO Qi
Sichuan Academy of Governance, Chengdu Sichuan 610000, China
关键词:
健康医疗数据个人信息保护一次利用二次利用
Keywords:
healthcare data personal information protection primary utilization secondary utilization
分类号:
R19
文献标志码:
A
摘要:
健康医疗数据的应用,必须以充分保护个人信息为必要前提。欧盟特别关注健康医疗数据应用中个人信息保护问题,针对健康医疗数据的一次利用和二次利用构建了完善的个人信息保护框架及监管机制。我国可借鉴其经验,通过制定专门性法律、明确相关主体权利义务框架、优化外部监管机制等路径,保障健康医疗数据应用中的个人信息安全。
Abstract:
The application of healthcare data must be based on the premise that personal information must be adequately protected. The European Union pays special attention to the protection of personal information in the application of healthcare data, and has constructed a comprehensive personal information protection framework and regulatory mechanism for the primary and secondary utilization of healthcare data. China can learn from its experience, and it is necessary to enact specialized laws, clarify the rights and obligations framework of relevant parties, and optimize external regulatory mechanisms, so as to ensure the protection of personal information in the application of health data.

参考文献/References:

[1] 陈梓铭,吕群蓉.论健康医疗数据的法律概念[J].医学与哲学, 2024,45(11):58-61.
[2] 陈怡.健康医疗数据共享与个人信息保护研究[J]. 情报杂志, 2023,42(05):192-199.
[3] 谢永志.个人数据保护法立法研究[M].北京:人民法院出版社, 2013:69.
[4] European Parliament,Council of the European Union.Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data[EB/OL].(1995-10-24) [2024-10-23].https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A31995L0046.
[5] European Parliament,Council of the European Union.Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC(General Data Protection Regulation) (Text with EEA relevance)[EB/OL].(2016-04-27)[2024-10-23].https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX% 3A32016R0679&qid=1729660947691.
[6] European Parliament,Council of the European Union.Regulation (EU)2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance and amending Regulation (EU) 2018/1724(Data Governance Act) (Text with EEA relevance)[EB/OL].(2022-05-30)[2024-10-23].https://eur-lex.europa.eu/eli/reg/2022/868/oj.
[7] European Parliament,Council of the European Union. Directive (EU)2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union,amending Regulatio(EU) No 910/2014 and Directiv(EU) 2018/1972,and repealing Directive(EU) 2016/1148(NIS 2 Directive) (Text with EEA relevance)[EB/OL].(2022-12-14)[2024-10-23]. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022L2555&qid=1729661120947.
[8] European Parliament,Council of the European Union.Regulation (EU) 2023/2854 of the European Parliament and of the Council of 13 December 2023 on harmonised rules on fair access to and use of data and amending Regulation(EU) 2017/2394 and Directive(EU) 2020/1828 (Data Act) (Text with EEA relevance)[EB/OL].(2023-12-13)[2024-10-23].https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R2854&qid=1729661183102.
[9] European Commission.Communication from the Commission to the European Parliament,the Council, the European Economic and Social Committee and the Committee of the Regions:A European strategy for data [EB/OL].COM/2020/66 final.(2020-02-19)[2024-10-23].https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex% 3A52020DC0066.
[10] European Commission.Proposal for a regulation of the EUROPEAN parliament and of the council on the European Health Data Space[EB/OL].(2022-05-03)[2024-10-23].https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022PC0197.
[11] Quinn P,Ellyne E,Yao C.Will the GDPR restrain health data access bodies under the European Health Data Space(EHDS)[J]. Comput Law Secur Rev,2024(54):1-15.
[12] Council of the European Union.European Health Data Space: Council and Parliament strike provisional deal[EB/OL].(2024-03-15)[2024-10-23].https://www.consilium.europa.eu/en/press/press-releases/2024/03/15/european-health-data-space-council-and-parliament-strike-provisional-deal.
[13] 王雪,夏义堃.健康医疗数据利用中数据权益保障的现实困境与完善对策——以欧盟健康数据空间为例[J].图书与情报, 2024(02):55-68.

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更新日期/Last Update: 2025-07-31