The European Health Data Space (EHDS) Regulation marks a decisive step toward a more connected, advanced, and public-oriented healthcare model. This regulation paves the way for a more digital, integrated, and patient-centered healthcare system by allowing health data—under appropriate protection guarantees—to be used for secondary purposes such as advancing research, improving healthcare planning, and accelerating the development of more effective treatments. While this framework promises clear benefits, such as personalized therapies and more efficient and equitable healthcare systems, precise regulatory development in Spain will be essential to ensure the protection of citizens’ rights and strengthen social trust, as highlighted by Top Doctors Group®, a technological leader in digital health transformation.
However, the Regulation does not provide all answers. It delegates crucial aspects—such as what constitutes “significant public interest” or how to guarantee every person’s right to exclude their data from secondary use—to each member country. In this context, Spain faces a critical challenge: the upcoming Digital Health Law must clearly specify in which situations health information can be used without explicit consent, how citizens will be able to easily withdraw consent, and which uses must be entirely prohibited to maintain public trust.
EHDS offers an unprecedented opportunity to strengthen public health across Europe, but a rigorous and transparent legislative process will be necessary to ensure the protection of individual rights and turn this data space into a true driver of improvement for European healthcare systems.
“We are convinced that rigorous and transparent implementation is key for this initiative not to remain on paper and to produce a real, positive impact on patients and professionals,” affirms Jordi Cusidó, Chief Innovation Officer of Top Doctors Group®. “In short, properly executed mandatory interoperability is not a threat, but a double opportunity: for citizens, who gain security, continuity of care, and control over their data; and for healthcare providers, large and small, who can valorize the clinical and economic value of the information they already generate, integrating into data spaces like GlobalHDS instead of remaining isolated in incompatible systems. The difference between “meaningless paperwork” and real change in the upcoming Digital Health Law will depend on two factors: the technical quality of the requirements and the level of financial support we can deploy.”
Interoperability of the digital health record: a necessary structural change
The mandatory shift to an interoperable digital health record, based on European standards and extended to the private sector, goes beyond mere technical compliance. It is a structural transformation that will directly impact how clinical data is documented, shared, and exploited. In this context, Top Doctors Group® foresees two fundamental impacts on hospitals and clinics:
1. The care-related impact: reducing duplicate tests, improving continuity across primary, hospital, and rehabilitation care levels, enhancing medication safety, and potentially facilitating second opinions for complex or chronic patients.
2. The scientific and economic impact: securely and anonymously contributing data opens new avenues for participating in research projects, monetizing data contributions within regulated frameworks, especially benefiting smaller centers that can integrate into shared data spaces without substantial R&D infrastructure.
Nevertheless, this evolution requires significant investment in modernizing information systems, improving data quality, and training multidisciplinary teams. Top Doctors Group® emphasizes the risk of a ‘digital healthcare gap’ if not all centers—including regional and private facilities—are supported financially and technically. “It’s clear that this doesn’t come free: combining interoperability obligations with financial and technical support, along with EHDS’s standardization goals, is vital to prevent any center, whether public or private, from falling behind due to lack of resources. Demanding interoperability without support will create a digital healthcare divide. If we ask a regional hospital to do the same as a large group but without funding or technical resources, some will be left out of research, European projects, or even future agreements,” warn experts at the Group.
The positive aspect is that national and European funds are already being mobilized to support this transition. The Ministry of Digital Transformation and Public Function has announced specific funding lines—including tens of millions of euros for 2025/26—to promote hospital and clinic participation in data spaces.
GlobalHDS: a successful use case for leading EHDs implementation in Spain
In this context, GlobalHDS was created precisely as one of these national health data spaces—where centers can integrate once and participate repeatedly in research and innovation projects without reinventing the wheel each time, as well as leverage their data’s value.
This intelligent hospital system encompasses the entire clinical process: outpatient consultations, inpatient progress, clinical history, schedules, operating rooms, medication, consents, PACS imaging tests, anesthesia, and ICU. It also includes a listener (automatic clinical history transcription tool) with configurable templates, ICD-10 coding, test and clinical question proposals, and automated summaries of the clinical history via Artificial Intelligence. Additionally, it features a chatbot for patients and advanced modules for invoice reconciliation with insurers. All these tools optimize internal and clinical processes, reducing management times by up to 30%.
Furthermore, it guarantees data governance so that European patient clinical data moves as needed for care and scientific purposes, always under EU-defined rules and standards. The patient has full control over their health data across the entire EU.
“Within Top Doctors Group, we have our THT (Top Health Tech) division dedicated to developing and supplying B2B solutions for clinics, laboratories, and hospitals, aimed at digitizing and optimizing key healthcare provider processes. This way, hospitals and clinics are not only ensuring compliance with the European Health Data Space’s data sovereignty requirements but also creating an interoperable, integrated, and protected digital health ecosystem that makes the care process experience excellent. This daily management tool provides the healthcare centers with a suite of applications that simplify and automate routine tasks. It can now be considered a significant successful use case for EHDS, with over 45 reference hospitals and hospital groups, 15 in implementation, across 8 countries,” states Teo Sardà, CEO of Top Health Tech, a subsidiary of Top Doctors Group.
The ideal model for Spain: federated with a single national access point
Experience with coordinating health data spaces suggests that the best model for Spain involves not creating new macrostructures but establishing clear governance supported by appropriate technology. Top Doctors Group advocates for a federated model with a “one-stop shop” at the national level, serving as the entry point for researchers. The project would be presented once via a single channel.
Behind this portal, a federated network of nodes (regional health authorities, AEMPS, large hospitals, public and private spaces) connected through standards like GAIA-X and connectors such as Eclipse, enabling coordinated application of access rules, permissions, and consents. The national authority sets common criteria (evaluation standards, contract templates, anonymization levels, maximum deadlines, etc.), while regional nodes act as data custodians, applying these rules locally.
In this framework, researchers don’t face institutional complexity: they see a single catalog of available data, submit a unified request, and receive an integrated response with secure access—even though multiple regions and agencies are working behind the scenes. If each region has different forms, APIs, and formats, however, researchers end up dealing with 17 mini-portals. From there, the bottleneck is no longer just legal but also technical.
This model makes sense because, when multiple regions and agencies like AEMPS apply different criteria, in practice the results are:
– Unpredictable timelines: a study might take weeks in one region and months in another.
– Duplications: researchers answering the same questions multiple times, with different formats.
– Inequality risk: some projects focus on “easier” territories, leaving others unable to participate.
To prevent this architecture from replicating these problems, three essentials are needed:
– A mandatory minimum common standard: harmonized risk criteria and levels across the country (for example, what constitutes low risk when data is fully anonymized). Regions can be more strict but not create parallel procedures.
– Mutual recognition: if a project is already evaluated and approved by a competent authority (such as a national node or a leading regional authority), other nodes should acknowledge that assessment without starting over.
– Clear rules and deadlines in law: maximum response times, “positive silence” provisions for very low-risk uses, and requirements to justify denials or additional restrictions.
“If the Law remains only a formal structure (‘a national authority and X regional bodies’) without clear rules on deadlines, criteria, and coordination, the outcome will be foreseeable: more logos, more organizational charts… and the same uncertainty for researchers,” Cusidó emphasizes.
Therefore, Top Doctors Group recommends that to prevent the new architecture from increasing bureaucracy, the law primarily define the flow and then the organizational structure: outline in the Law the standard request process and maximum timelines before assigning responsibilities. Second, promote a digital single entry point connecting to the future National Health Data Space and regional spaces like OHSIRIS or private solutions like GlobalHDS. It is also essential to establish a requirement for access rules and contract models to be published in standard, machine-readable formats so connectors can turn them into “smart contracts” managing permissions automatically. Lastly, create a single national metadata catalog to ensure uniform criteria for searches and interactions.
“By doing this, the new architecture doesn’t necessarily add bureaucracy; in fact, it can reduce it because the researcher interacts with a single system, while institutional complexity is managed ‘below’ through the federated data spaces,” concludes.
The real transformation will occur when the Law clearly defines the workflow, deadlines, and criteria, and technology enables much of the ‘bureaucracy’ to be codified in electronic contracts and machine-readable policies. Only then can duplication and uncertainty be eliminated, providing the agility the system needs. “The key lies in how the Law is written and implemented because vague declarations (‘interoperability will be achieved,’ ‘European standards will be used’) without detailed technical requirements, timelines, maturity levels, and financial mechanisms risk rendering it largely ineffective,” Cusidó explains. “If instead, the Law and its regulatory framework specify detailed standards (which standards are required, what clinical history profiles, data quality indicators, common services), and link them to funding programs and operational data spaces like GlobalHDS, tangible improvements will be seen daily: better-structured histories, nearly real-time data reuse, and more agile, predictable access for research.”
Integrating comprehensive management platforms like Ofimedic, a complete clinic and medical center management software, exemplifies the technological foundation needed for effective data collection and standardization, fueling these interoperable spaces.
Spain: an ‘accumulated advantage’ for leading EHDS implementation
Spain benefits from a valuable ‘accumulated advantage’ by not starting from scratch. Projects like GlobalHDS, OHSIRIS, and IDERHA have demonstrated the ability of hospitals and health services to work with federated and secure data. This prior experience, with technical nodes, governance models, and trained teams, positions Spain favorably to lead EHDS implementation.
Top Doctors Group experts emphasize that the key is for the Digital Health Law to leverage this progress: “The legal risk is not to slow down the momentum but to miss the opportunity. If the law ignores these spaces and designs structures from zero, we will duplicate ministries and processes. Recognizing these nodes as part of the National Health Data Space and testing grounds for EHDS will make Spain one of the most attractive environments in Europe for real-world data trials and AI algorithm validation,””
Additionally, they highlight that what will truly make a difference now is not just technology— which is already mature and robust— but how the Law is crafted to align with and enhance that reality. “If we get this right, Spain can attract more investment, generate qualified employment, and, most importantly, offer citizens new opportunities to participate in research and benefit earlier from medical innovation,”
conclude.