Government of Catalonia: new governance of the Health Data Space

The Government of the Generalitat has approved Agreement GOV/214/2026, of August 25, which establishes the governance model for the deployment of the Health Data Space of Catalonia (EDSC) and determines the bases for the organization and development of the Health Data Access Body (ODAS), operational as of March 26, 2027. The agreement is published in the Official Gazette of the Generalitat de Catalunya (DOGC) number 9739, of August 27, 2026, with the official reference CVE-DOGC-A-26237053-2026, within the section of other provisions of the Department of Health.

A framework to deploy the European Regulation

The regulation responds to the need to anticipate institutional adaptation to Regulation (EU) 2025/327 of the European Parliament and of the Council, of February 11, 2025, regarding the European Health Data Space (EHDS), which amends Directive 2011/24/EU and Regulation (EU) 2024/2847. Although the European regulation is already in force, its effective application begins on March 26, 2027, with a progressive deployment until the year 2035.

The agreement aligns with the Catalonia Leads Plan and with measure 6.6 of the Department of Health’s Action Plan, and is based on the trajectory of the Program for the management of data analysis for health research and innovation in Catalonia (PADRIS), created on April 24, 2019, to make health data available to the scientific community.

Three bodies, three responsibilities

The institutional governance model distributes competencies among three bodies, which must exercise their functions as of March 26, 2027:

• The Department of Health assumes the functions of the digital health authority in Catalonia, with strategic direction, institutional coordination, and supervision of regulatory compliance, as well as relations with state and European authorities.
• The Catalan Health Service (CatSalut) holds ownership and integral management of the EDSC, including technological infrastructure, data governance, quality, custody, security, and interoperability, consistent with the European infrastructure MyHealth@EU.
• The Agency for Health Quality and Evaluation of Catalonia (AQuAS) assumes the status of Health Data Access Body (ODAS) in Catalonia.

The model is deployed in coordination with the Secretariat of Telecommunications and Digital Transformation and with the state structure and the European infrastructure for the secondary use of data, HealthData@EU.

The ODAS, single point of access for secondary use

The ODAS is established as the competent body of the Generalitat to manage requests for access to electronic health data for secondary use, in accordance with articles 51, 57, 58, and 59 of Regulation (EU) 2025/327, and acts as the single point of access in Catalonia. Care, diagnostic, or therapeutic purposes linked to healthcare are excluded.

To guarantee impartiality, AQuAS must adopt several organizational safeguards:

• Provide the ODAS with its own structure relative to the other units of the entity.
• Establish its own and unique collegiate body of functional governance, with representation from various disciplines, including ethics experts.
• Assign personnel with specialized knowledge who act in favor of the public interest.
• Adopt technical and organizational measures to guarantee the security of the processing environment.
• Protocolize the procedure for evaluating requests and granting data permits, conditional upon favorable reports from research ethics committees.
• Establish systems for monitoring, supervision, and complaints.

The ODAS will be financed by the funds that the Department of Health assigns annually for the activity of PADRIS, with additional resources and the income it may receive for providing data for secondary use, in accordance with article 62 of Regulation (EU) 2025/327. The agreement is signed by the Secretary of the Government, Javier Villamayor Caamaño, and the Minister of the Presidency, Albert Dalmau Miranda, by assignment of functions.

A step for research and innovation

The agreement consolidates Catalonia as a pioneering territory in the secure reuse of health data, at a time when research, innovation, and health planning increasingly depend on access to this data. For patients, professionals, and researchers, the new governance guarantees secure, equitable, and transparent access, while protecting citizens’ rights and trust in the system, within the framework of the progressive deployment of the European Health Data Space.

Fuente: Diari Oficial de la Generalitat de Catalunya, núm. 9739, 27 d’agost de 2026, altres disposicions, Departament de Salut (referència oficial: CVE-DOGC-A-26237053-2026).