EHDS: A revolution in health data management

The European Health Data Space (EHDS) has established itself as one of the European Union’s most ambitious projects in the field of digital health. It is conceived as a federated, interoperable, secure and privacy-focused infrastructure integrating health data generated in all Member States. The EHDS was approved by Regulation (EU) 2025/327 and entered into force in March of the same year and aims to turn health data into a strategic asset to improve healthcare, accelerate innovation in health technologies and empower European patients. The implementation of this infrastructure represents a structural change that will affect hospitals, researchers, technology companies, authorities and, above all, citizens. Its recent progress presents a series of milestones among which we can highlight:

March 2027: the primary use of cross-border data (MyHealth@EU) becomes operational. Primary use corresponds to the direct use of data by the patient himself or by health professionals for the healthcare purposes for which they were originally collected. Uses could include: data from clinical consultations, electronic prescriptions, medical history, diagnosis and continuity of care in any member country, etc. In this case the citizen retains control over his data.
March 2029: activation of the platform for secondary use (HealthData@EU). Secondary use corresponds to the reuse of health data for purposes other than healthcare, always in secure environments and under the supervision of the national Health Data Access Bodies (HDABs). Uses could include: biomedical research, medical artificial intelligence, epidemiological studies, public policy development, health technology assessment, etc. In the case of secondary use, the EHDS clearly defines the legal framework with which the data must comply, such as that they must be anonymised or, failing that, pseudonymised, operated in secure processing environments, and without the possibility of downloading or re-identification. Possible and non-permitted uses are also defined. Possible uses could include: scientific research (both public and private), training of AI algorithms in health, evaluation of quality and efficiency of health systems, elaboration of health statistics, academic training in health sciences, public policies, planning and prevention. On the other hand, uses that are expressly prohibited include those used for commercial purposes or that may cause harm to individuals. These include use for personalised marketing, negotiation of financial loans, development of products that put public health/individual safety at risk, and any situation that could unfairly disadvantage or discriminate against individuals.

In addition to these key dates identified for the operation of these primary and secondary use data networks (MyHealth@EU; HealthData@EU), others have been set for full compliance with technical standards, certification of medical record systems and secure processing environments.

Although the EHDS does not seek direct economic benefits, it does enable a new sustainable business ecosystem, namely around secondary use, which will allow for a source of economic provision. These models would operate on the principle of cost recovery, i.e. fees can be charged in proportion to the technical effort, but not for profit. Some of the models that could be applied are:

Data-as-a-Service (DaaS): would provide data sets on demand, respecting regulatory conditions.
AI and medical analytics: They would provide real data that would enable the development of personalised diagnostic tools, thus contributing to precision medicine.
Decentralised clinical trial preparation: The use of EHDS data would serve to accelerate cohort selection.

The implementation of the EHDS thus promises significant health and economic benefits. For example, the economic magazine Cinco Días (2024) estimates that the digital health industry could grow by up to 30% annually with full implementation of the EHDS. Moreover, the economic impact would be both for healthcare systems through reduced healthcare costs, increased efficiency in resource planning, improved clinical interoperability, and for the economy of companies in the healthcare sector (digital health, startups, biotechs, pharmaceuticals). But in addition to the economic impact, the patient would clearly benefit from various aspects such as: improved continuity of care, the implementation of personalised treatments, progress in prevention and research into diseases.

The EHDS therefore marks a turning point in the way Europe manages and exploits health data. Its federated, secure and ethical approach will drive research, medical innovation and more personalised, efficient and connected care. It also opens up new opportunities for sustainable business models focused on the public interest. Its success will depend on interoperability, citizen trust, data quality and transparent governance. The EHDS is a strategic infrastructure that will contribute to building smarter, preventive and equitable healthcare across the European Union.