Whose health data, whose profits? Shaping the infrastructure for secondary use of data in the European Health Data Space

The European Health Data Space (EHDS) is set to revolutionize health data sharing across the EU by enabling the reuse of data for purposes of research and innovation, which include applications like AI training and public health research. To reach its objectives, it introduces mechanisms for data sharing, a new governance system and a technical infrastructure. While the EHDS purports to significantly enhance EU competitiveness and build upon the strict foundations of the GDPR, this contribution argues that traditional data protection rules fail to encompass the full range of systemic risks embedded within the proposed technological and governance infrastructure. The mechanism's deep reliance on private actors for its construction, coupled with the potential accumulation of infrastructural power, poses critical, overlooked risks.

Drawing upon legal doctrinal methodology and informed by literature of Science and Technology Studies and Law and Political Economy, this contribution analyzes the framework for secondary use of data. Specifically, we apply our findings concerning intellectual monopolies and infrastructural power (e.g., drawing on Star and Rikap) to reveal risks unforeseen in the legislation and absent in the literature. This analysis suggests that the EHDS framework, despite its compelling stated goal of creating an "equal playing field" for access, ultimately fortifies existing technology monopolies. By giving access to patient's health data, the EHDS structurally enables powerful actors with significant resources use the infrastructure to their advantage. This process risks transferring potential societal benefits into concentrated private hands, thereby creating a systemic power imbalance that jeopardizes public interest and trust in healthcare systems. 

Part of panel: Digitalization as sphere transgression - part 2.