Balancing Scientific and Commercial Interests: The European Health Data Space Response to Commercial Scientific Research

Commercial interests have increasingly engaged in scientific research, particularly as the European Health Data Space (EHDS) allows access to electronic health records for such studies. Normative legal research was conducted to examine EU Member States' effective medical research legislation and landmark cases. Eleven EU Member States' legislation do not reference commercial medical research. Regarding the others, some adopt stricter rules for commercial research. Others prioritize incentives for non-commercial research. Related legislation primarily regulates research based on funding sources, diverging from the multi-actor and multi-interest nature of health data research. Both the GDPR and ethical guidelines generally exempt anonymized data from oversight, creating a governance gap. Low marginal costs and the black-box nature of data-driven approaches further intensify funding biases, potentially undermining public trust. Member States also differ in data subjects' right to opt out of scientific research. Such regulatory fragmentation undermines EHDS implementation and creates opportunities for regulatory arbitrage. Commercial scientific research should be understood as a type of research conducted by profit-driven actors through ongoing business operations. Special measures should be applied to commercial scientific research within the EHDS, including mandatory consideration reflecting data market pricing, tiered data dividends, compulsory health data access body ethical review, conflicts of interest declaration, and opt-out rights for data subjects. Rules for providing data access are tailored to the stage of research and require a balancing test between research interests and trade secrets. Raw data should be made accessible. Processed data should be made available when classified as essential. Research results should always be provided. A centralized EU platform is recommended to reduce administrative burdens.