Healthc Inform Res.  2023 Jul;29(3):199-208. 10.4258/hir.2023.29.3.199.

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

• Lee WB
• Choi SJ

• KMID: 2544871
• DOI: http://doi.org/10.4258/hir.2023.29.3.199

Abstract

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.

Keyword

European Health Data Space, Health Data, Electronic Health Records, Secondary Use, Privacy

Figure

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  Figure 1 Flowcharts for secondary use in the EHDS Proposal. (A) For data access applications and data requests to multiple data holders in more than one member state. (B) For data access applications and data requests to a single data holder in one member state. HDAB: health data access body, EHDS: European Health Data Space, EHD: electronic health data.

Reference

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