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

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, includ-ing 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 enti-ties 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. © 2023 The Korean Society of Medical Informatics.