Access to Health Data, Competition, and Regulatory Alternatives: Three Dimensions of Fairness

The EU legal framework for data access and portability has undergone significant evolution, particularly in the realm odata, with recent initiatives like the European Health Data Space (EHDS) and competition law enforcement expanding data-sharing obligations across various economic actors. This evolution reflects a shift from an initial emphasis on individuals’ fundamental rights to access and port their health data—rooted in privacy protection, personal data rights, and digital sovereignty—towards a more utilitarian perspective. This newer approach extends data-sharing obligations to cover co-generated data involving end-users, business users, and complementors within digital health ecosystems, promoting a concept of data co-use or co-ownership rather than private ownership. Furthermore, the regulatory framework has proactively established ‘data commons’ to foster cumulative innovation and broader industry transformation. The increasing prominence of a fairness rhetoric in EU regulatory and competition law underscores a transformational intent, aiming not only to acknowledge stakeholders’ contributions to data generation but also to ensure equal economic opportunities within the digital health space and facilitate the EU’s digital transition. This study adopts a law and political economy perspective to examine the competition-related bottleneck issues specific to health data, considering the economic structure of its generation, capture, and exploitation. It then analyses the distributive implications of current regulations (including the DMA, Data Act, EHDS, Digital Governance Act, and Competition Law) by exploring relationships between key economic players: digital platforms and end users, platforms and their ecosystem complementors, and external third-party businesses interacting with the digital health ecosystem.