Health Data Governance: Comparative Perspectives between the European Union and the Brazilian National Congress

Abstract

The study compares the European Health Data Space (EHDS) and the substitute to Bill 5.875/2013, analyzing institutional structure, governance, data subject rights, and data interoperability. A qualitative and documental approach was adopted, with a systematic analysis of regulatory frameworks and specialized literature. The results indicate greater robustness, detailed provisions, and phased implementation in the European model, while the Brazilian model still presents normative and operational gaps. It is concluded that the European experience provides important references to enhance health digitalization and data protection in Brazil.