ABSTRACT
This chapter explores the transformative potential of the European Health Data Space (EHDS) in enhancing patient control over electronic health records across the European Union. It assesses the extent to which Chapter II of the EHDS innovates patients’ rights beyond the data subject rights framework found in the General Data Protection Regulation (GDPR). Chapter II of the EHDS builds on the rights under the GDPR, while delineating new rights and obligations. The author compares the rights enshrined in the EHDS with those under the GDPR, highlighting enhancements that could significantly empower patients. The chapter draws attention to the new requirements of mandatory digital record-keeping, and enhanced data portability and participation rights, which could fundamentally shift patient interactions with their healthcare data. This analysis also draws on Denmark, recognised for its advanced digital health infrastructure, in considering the implications of the EHDS for less-digitised member states. The Danish example illuminates potential best practices and challenges, noting political pushback against extensive documentation requirements. This illustrates that national contexts will affect the implementation of the EHDS provisions. The chapter concludes that the EHDS holds the potential to revolutionise patient data control while acknowledging the inherent challenges in harmonising healthcare data practices across diverse healthcare systems.
