日本和韩国对现实世界数据分发监管系统的比较
1Headquarters for Healthcare Policy, Cabinet Office, Japan.
Studies in health technology and informatics
|August 8, 2025
概括
这项研究在法律上比较了日本和韩国的个人信息保护系统,以共享医疗真实世界数据. 日本缺乏数据链接,而韩国限制了大规模数据收集,突出了相互改进的领域.
科学领域:
- 卫生法 法律 卫生法
- 数据 隐私 数据 隐私 数据
- 相对政策的比较研究.
背景情况:
- 来自医疗机构的真实世界数据 (RWD) 的共享对于研究至关重要.
- 现有的个人信息保护法律框架在各国之间存在很大差异.
- 确保数据隐私,同时实现数据共享,带来了复杂的挑战.
研究的目的:
- 在法律上比较日本和韩国的个人信息保护系统.
- 确定处理第三方提供医疗真实世界数据的具体法律和操作差异.
- 根据跨国系统分析提出改进建议.
主要方法:
- 对日本和韩国的数据保护法规进行法律比较分析.
- 对向第三方提供医疗机构获得的真实世界数据的系统进行检查.
- 确定每个国家数据处理基础设施的局限性.
主要成果:
- 日本的系统不支持将假名化医疗数据连接起来.
- 韩国缺乏一个强大的系统,使数据库运营商能够从机构大规模收集医疗数据.
- 两国在数据管理和系统间可操作性方面都面临着不同的挑战.
结论:
- 对日本和韩国数据保护系统的相互理解可以推动监管和运营方面的改进.
- 解决发现的系统缺陷对于促进安全和高效的真实世界数据共享至关重要.
- 对比分析为完善国家数据治理政策提供了基础.
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