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Optimizing the management, exchange of health data and the use of health information between borders is the objective of the European health data space.

The regulation, published on March 5, 2025 and that entered into force on March 26, will involve the practice that In less than four years When a European citizen has to go to the doctor in another Member State, the toilet that he attends will have access to his clinical history, with all the advantages that this entails. «On March 30, 2029 They must be in use of primary data, ”recalled Patxi Amutio, general secretary of the IDIS Foundation.

It is about creating a common hub where each Member State will incorporate the health data of its citizens for this primary use and also as a secondary use option; that is, anonymized or pseudo -impeded data in order to investigate how a pathology evolves, which will allow to continue advancing in more precise and personalized diagnoses and treatments.

In short, a necessary regulation that comes to improve healthcare and biomedical research in the EU, guaranteeing the protection of health data. Which is a challenge. Although, the Covid-19 pandemic promoted the necessary changes towards unique coordination and collaborative work, and this regulation is the lever for the digital transformation of the current health model.

A transformation that will be “very positive for both patients and the health sector”, and that, in the long run, will mean “a savings of 11,000 million euros”, which “will have an impact on the improvement of health of European citizens,” said Eduardo Gómez, economic advisor to the representation of the European Commission in Spain, during the day “European health data space: a future shared, a future.

But this challenging project does not extend to the scope of public health, but will also integrate the «Private health, which has more than 20% of the Spanish health data. This represents 26% of the Spanish population », Marta Villanueva, general director of the IDIS Foundation, said.

In this sense, the IDIS Foundation has presented the Private Health Data Space (EDSP), an initiative that seeks to move towards a system that allows interoperability between entities and facilitates efficient and safe access to medical records.

“It is a key piece within the European health data space, which, with an integrative approach, seeks to grow and consolidate as an essential connection node in our country,” said Amutio.

With a cost of 2.7 million euros (60% comes from the aid given by the European Union through the recovery, transformation and resilience plan, and the rest is executed with the investment effort of the Foundation and its employers), this space of private health data is built on the basis of the shared medical history project miHC“Which came true in June 2023,” Villanueva recalled.

In it, patients can access and manage their medical history in a simple and safe way, to create a data management and management environment, which includes a set of standards, policies and security tools to share data. Thus, patients can consult their medical reports, diagnostic tests and results in a unified way. And the duplicity of evidence is avoided or reduced, “said the general director of the IDIS Foundation.

But while MIHC, which already has more than 1,200,000 accesses and 400,000 users of 16 attached entities, is an initiative oriented to primary data use, the EDSP project focuses on secondary use by enabling an environment where health data can provide social and scientific value ethically and safely.

That is, “Mihc is the germ that validates the IDIS Foundation as an entity capable of agglutinating, orchestrating, normalizing and financing a project that was complex” and now “we started this interoperability project” of the medical history of private health through which the private sector patient may have access to their medical history in any center of Spain, Villanueva said.

“It is a key step on the road to a shared data space, where health data ceases to be fragmented and becomes a tool at the service of the patient, the professional, the researcher and the health policies,” he added.

And, at least for now, they go in times. Thus, it is estimated that by September of this year the deployment of the governance model that will mark the beginning of the active use of the system is ready. Subsequently, it is expected to have the data space use manual, which will facilitate the incorporation of new entities and users.

Both private health initiatives (MIHC and EDSP) are aligned with the European Health Data Regulations, whose implementation will be made progressively between 2026 and 2034.

So, for 2029as Villanueva recalled, the «patient summary (Summary of patient clinical data) in electronic medical records and also for that year the sharing of secondary use data. In addition, the monetization of the data between organizations is authorized ».

For Ruth del Campo, general director of the Ministry of Ministry for Digital Transformation and Public Function, these regulations involve “a unique opportunity for public-private collaboration and place Spain at the forefront of compliance.” Especially when, as she recalled, «according to a study by the Organization for Economic Cooperation and Development (OECD) Only 3% of health data are used for secondary use and that despite more than 75% show interest to that use ».

«In Spain we have funds thanks to the recovery plan. The European regulation and the possibility of financing places us in a very privileged position, ”he said of the field, which took the opportunity to announce a new aid, that of the Data space kit, to finance data connection costs.

«You will have 127 million euros of budget. Es an aid that we will publish in the third quarter and for which we are working with the Ministry of Health as we did with the other aid. The applications will be open for six months, ”he advanced.

Juan Fernando Muñoz, Secretary General of Digital Health, Information and Innovation of the SNS, of the Ministry of Health was also confident: «We have been working for more than 10 years to be reality. The rights of citizens, such as access to their health data, suppose obligations for public administrations, such as doing the entire framework to exchange information with other countries. This also has to be in the hands of the different assistance providers. The private ones will also have to put clinical information not only their own, but also of any other private supplier ».

“Our great challenge,” he continued, “is to integrate the 152,000 private centers, private health suppliers, pharmacies, the 200 software producers that must complete the controls … A challenge for which we are quite well prepared in Spain because we have a part already working and what IDIS has presented today will allow us to integrate those 152,000 private centers.”

Challenges and opportunities

But how do researchers and suppliers see it? For Íñigo de Miguel, from the University of the Basque Country and member of the Board of Directors of the Spanish Association of Health Law, this Regulation «will simplify a lot according to what things. Investigating today with data is a nightmare. This regulation will demand a lot, but then simplify the use of health data ».

José Luis Ruiz Revuelta, Chief Information Office of Sanitas Bupa ELA, who stressed that this regulation “seeks that Patients can move freely at the geographical level and between providers » Health

More critical or realistic was Ángel Blanco, director of Organization, Processes and ICT in Quirónsalud, who said that “this can be used for a lot or nothing. It must be an excuse for us to move forward in doing all the things we can do together. We have almost a unique identification system, but we have no unique catalog or … The starting point is surreal, But if observed with a positive look, we can say that we have many opportunities for improvement ».

«Let’s make a single model within the private health system. Today it is easier to have access to all the information with the Madrid system or the Catalan health than with an insurer. And that makes no sense, ”Blanco concluded.