Implementation Status of the Proposal for a Regulation of the European Health Data Space in Portugal: Are We Ready for It? Margarida MATEUS* a & Maria LOUREIRO* a,1 , A. Raquel FERNANDES a , Miguel OLIVEIRA a and Ricardo CRUZ-CORREIA a a Faculty of Medicine, University of Porto, Porto, Portugal *These authors contributed equally to this work. Abstract. The European Health Data Space (EHDS) proposal aims to establish a set of rules and governance frameworks to promote the use of electronic health data for both primary and secondary purposes. This study aims at analysing the implementation status of the EHDS proposal in Portugal, particularly the points concerning the primary use of health data. The proposal was scanned for the points that gave member states a direct responsibility to implement actions, and a literature review and interviews were conducted to assess the implementation status of these policies in Portugal This study found that Portugal is well advanced in the implementation of policies concerning the rights of natural persons in relation to the primary use of their personal health data, but also identified challenges, which include the lack of a common interoperability framework for the exchange of electronic health data. Keywords. Data Protection, Electronic Health Data, European Health Data Space, Primary Use of Data, Portugal 1. Introduction In May 2022, the European Commission (EC) launched the proposal for a Regulation on the European Health Data Space (EHDS) establishing a set of rules, infrastructures, and governance instruments, under a common governance framework, to promote both primary and secondary uses of electronic health data (EHD) [1]. This represents a crucial step in achieving seamless cross-border healthcare in the European Union (EU) and an important opportunity for using the extensive health data which is currently neglected by granting access to researchers and public health authorities to large international electronic health datasets [2]. The adoption of this ambitious project will accelerate the availability and quality of EHD, improve the diagnosis and treatment of patients and contribute to the continuity of care across borders. The EC aims at enforcing the Regulation by 2025 but this deadline depends on its approval and correct implementation, which relies on the engagement of a highly complex multi-stakeholder environment (e.g., member states, health providers, citizens, academia, regulators, as well as industry). 1 Corresponding Author: Maria Loureiro, E-mail: up201405046@med.up.pt Caring is Sharing – Exploiting the Value in Data for Health and Innovation M. Hägglund et al. (Eds.) © 2023 European Federation for Medical Informatics (EFMI) and IOS Press. This article is published online with Open Access by IOS Press and distributed under the terms of the Creative Commons Attribution Non-Commercial License 4.0 (CC BY-NC 4.0). doi:10.3233/SHTI230062 48