欧洲卫生数据空间提案和韩国政策建议中的二次使用规定。

IF 2.3 Q3 MEDICAL INFORMATICS
Won Bok Lee, Sam Jungyun Choi
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引用次数: 0

摘要

目的:本文探讨了欧盟委员会于2022年5月提出的欧洲健康数据空间(EHDS)的二次使用规定,并为韩国提供了政策建议。方法:对欧盟公布的EHDS提案文本及其他相关文件进行分析,并对相关文献进行梳理。结果:EHDS提案旨在为收集和用于初级保健的电子健康数据创造新的患者权利;建立数据共享系统,将电子医疗数据用于二级目的,包括研究、提供个性化医疗和开发医疗人工智能应用。这些规定设想要求私人和公共数据持有者在强制性的基础上与第三方共享某些类型的电子健康数据。新的政府机构,称为健康数据访问机构,将审查数据访问申请并颁发数据许可。结论:EHDS提案的总体目标是使目前掌握在少数组织手中的电子健康数据可供第三方重新使用,以刺激创新和研究。虽然韩国采取类似的计划并要求私营实体与第三方共享其专有数据将非常具有挑战性,但韩国政府应考虑至少使通过公共资助的研究收集的健康数据更容易用于二次使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Secondary Use Provisions in the European Health Data Space Proposal and Policy Recommendations for Korea.

Secondary Use Provisions in the European Health Data Space Proposal and Policy Recommendations for Korea.

Objectives: This article explores the secondary use provisions of the European Health Data Space (EHDS), proposed by the European Commission in May 2022, and offers policy recommendations for South Korea.

Methods: The authors analyzed the texts of the EHDS proposal and other documents published by the European Union, as well as surveyed the relevant literature.

Results: The EHDS proposal seeks to create new patient rights over electronic health data collected and used for primary care; and establish a data sharing system for the re-use of electronic health data for secondary purposes, including research, the provision of personalized healthcare, and developing healthcare artificial intelligence (AI) applications. These provisions envisage requiring both private and public data holders to share certain types of electronic health data on a mandatory basis with third parties. New government bodies, called health data access bodies, would review data access applications and issue data permits.

Conclusions: The overarching aim of the EHDS proposal is to make electronic health data, which are currently held in the hands of a small number of organizations, available for re-use by third parties to stimulate innovation and research. While it will be very challenging for South Korea to adopt a similar scheme and require private entities to share their proprietary data with third parties, the South Korean government should consider making at least health data collected through publicly funded research more readily available for secondary use.

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来源期刊
Healthcare Informatics Research
Healthcare Informatics Research MEDICAL INFORMATICS-
CiteScore
4.90
自引率
6.90%
发文量
44
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