The right standard for the job? On the limits of standard setting as a tool for governing commercial actors

Abstract

ABSTRACT Data standards play a key role in the governance of commercial actors on the market for health data. This commentary explores expectations for standard-setting in the European Health Data Space (EHDS), a pivotal legal initiative for facilitation of cross-border health data exchange. While EHDS aims to establish shared standards for interoperability and innovation in the European Union (EU) and affiliated countries, the analysis reveals some of the inherent complexities. We draw on insights from policy analysis and Science and Technology Studies (STS) that underscore how standards are performative and have unpredictable and uneven implications. To exemplify this, the commentary delves into the intricate issues surrounding the harmonization of diagnostic codes and pharmaceutical prescriptions. In conclusion, it asserts that while standard setting has unpredictable effects, it still involves prioritizing some purposes and benefits over others. We raise questions about the distribution of costs and benefits among stakeholders in the evolving landscape of health data governance and call for further empirical investigation.