About
Background
Across the European Union, healthcare professionals, pharmacists, researchers, and regulators generate and rely on vast amounts of essential health data daily. The COVID-19 pandemic highlighted the importance of health data in guiding effective public health decisions and managing crises. While the pandemic accelerated the adoption of digital tools, significant challenges remain that prevent the full realization of digital health’s potential. To drive the digital transformation and expand the use of health data, the European Commission established the development of a European Health Data Space (EHDS) a key priority for 2019-2025. The EHDS aims to promote digital transformation in the European Union by regulating the use of electronic health data and facilitating secure cross-border access through clear rules, common standards and practices, supported by digital infrastructures and a governance system. This will allow citizens to have better control over their health data and benefit from improved care both in their own country and across the EU. The EHDS also encompasses the secondary use of health data for research, medical innovation, and policymaking, enabling better healthcare, more targeted treatments, and improved health decisions. In April 2024, the European Parliament and the Council reached a political agreement on the EHDS proposal by the Commission. The EHDS Regulation is expected to be published in early 2025 and will take effect in 2027.
Useful Links
European Health Data Space (EHDS):
European Health Data Space – European Commission (europa.eu)
The proposal for a regulation on the European Health Data Space:
https://health.ec.europa.eu/publications/proposal-regulation-european-health-data-space_en
About HealthData@PT
The HealthData@PT − Setting up a Health Data Access Body in Portugal − action aims to establish the national infrastructure, network and the foundational elements necessary to ensure secure access and use of health data for the purposes of research, medical innovation and health policymaking (secondary use of health data). Additionally, HealthData@PT seeks to provide tools to improve the overall quality of health data for secondary use. The HealthData@PT action aims to prepare the national ecosystem for the intra- and cross-border secondary use of health data, with the main goal of improving therapeutic outcomes and strengthening the healthcare system. The establishment of these national foundations is crucial for ensuring the successful integration of Portugal into the future cross-border infrastructure HealthData@EU. This action will advance the technical implementation of the Health Data Access Body in Portugal, crucial for the future national integration into the HealthData@EU infrastructure for the cross-border sharing of electronic health data.
This four-year initiative was approved by the European Commission in the scope of the EU4Health programme 2021–2027, and started officially in November of 2023.
Goals
To establish a dedicated infrastructure that supports the discovery, access, and processing of health data for secondary use, in compliance with the EHDS, the HealthData@PT action will develop five digital business capabilities.
The HealthData@PT action is co-funded by the European Union, EU4Health Program 2021-2027 under Grant Agreement Nr 101128332. The views and opinions expressed are those of the author(s) and do not necessarily reflect the position of the European Union or HaDEA. Neither the European Union nor the grant-awarding authority can be held responsible for these opinions.
