SORS: The regulation on the european health data space: an introduction

Abstract

In March 2025, the Regulation on the European Health Data Space was published in the Official Journal of the European Union (OJ). This is a regulatory tool of special relevance for various reasons. The first is that it aims to radically change the way we handle our health data, significantly strengthening concepts like interoperability and data access. Secondly, it represents a first step in the creation of the nine data spaces that European institutions intend to build in the coming years. But above all, the Regulation is important because it marks a significant advancement in a complex issue: the secondary use of health data for research purposes. This presentation will analyze its main features. To this end, I will begin by describing the current regime for handling health data in biomedical research. Next, I'll explain the changes introduced by the Regulation. Finally, I'll provide a critical review of the proposed new scenario, explaining some of its potential vulnerabilities.