The Ministry of Health has taken a significant step toward modernizing the health system by launching a public consultation for the upcoming Digital Health Bill. This initiative, open until October 20, 2025, seeks to collect ideas and proposals from citizens, organizations, and interested entities, with the aim of aligning Spanish regulations with Regulation (EU) 2025/327 of the European Parliament, which governs the European Health Data Space (EHDS).
The bill has several ambitious goals, highlighting the need to guarantee citizens' rights to their electronic health data. Given the complexity of the Spanish healthcare system, with powers distributed across different autonomous communities, it is vital to clearly define the obligations of the regional administrations so that citizens can enjoy these rights no matter where they are.
Another key element of the project is to establish a new governance model for the primary and secondary use of health data. The primary use focuses on direct patient care and seeks to ensure full interoperability with European initiatives. Regarding secondary use, it aims to enhance the value of data in biomedical research, technological innovation, and health policies. The establishment of regional and national bodies that facilitate ethical and secure handling of data, integrating them at the European level, is anticipated.
The law will also address the interoperability of the digital health record, currently limited to the public sector. The integration of private providers is essential to ensure that all patients have unified access to their health information, thereby improving the quality of care.
The use of digital technologies in healthcare will be another focus of the law. With the rapid advancement of tools such as artificial intelligence and biometrics, it is crucial to establish a regulatory framework that guarantees the safety and rights of patients.
Finally, the bill will establish conditions for the incorporation and financing of digital health products, ensuring that new devices and applications are integrated in a way that provides value and safety to the national health system.
With this initiative, Spain seeks not only to meet European requirements, but also to improve its own processes and systems, ensuring a modern, efficient health service that respects the rights of citizens.
Fuente: Ministerio de Sanidad
