European digital identification for health data: what hospitals and clinics must do

Key data

Spanish health centers—both public and private—face mandatory technological adaptation. The Commission Implementing Regulation (EU) 2026/2099, published on 22 September 2026, establishes the technical mechanism that will allow citizens, professionals and health centers to authenticate digitally to exchange medical records between EU countries.

This is not a recommendation: it is the technical standard that national systems must comply with to connect to the European Health Data Space (EHDS). Regional governments and the Ministry of Health are the first obligated parties, but private centers that want to operate in this environment will also need to adapt.

What does this regulation establish?

The regulation defines the interoperable technical mechanism that enables cross-border exchange of electronic health data in the EU. In practical terms, it establishes three pillars:

The regulation affects three types of system users: natural persons (patients), healthcare professionals and healthcare providers (hospitals, clinics, health centers). Each will need an identification and authentication mechanism recognized at European level to access or share health data in another Member State.

The regulation is based on the eIDAS Regulation framework and the GDPR, strengthening authentication as a guarantee of data protection in cross-border environments.

Economic and operational impact

The regulation does not set specific investment amounts or penalties in the published text. However, the operational and economic consequences are clear:

• Investment in technological adaptation: Health information systems in regional governments and the Ministry of Health will need to update their infrastructures to comply with new technical standards and authentication protocols.
• European credentials for professionals: Healthcare professionals will need to obtain credentials recognized at European level, which involves registration processes, verification and possibly specific training.
• Cost of non-compliance: Centers that do not meet technical requirements will be excluded from cross-border data exchange, which limits care for European patients and may represent a competitive disadvantage for private clinics with international ambitions.
• Impact on private clinics: Although the direct obligation falls on public administrations, private centers that want to integrate into the EHDS will need to adopt the same technical standards.

Who does it affect?

• Regional governments: Must adapt their health information systems to the new EHDS technical standards and interoperability.
• Ministry of Health: Coordination and implementation at national level of the identification and authentication mechanism.
• Public and private hospitals: Will need to update their digital infrastructures to connect to the European system.
• Clinics and health centers: Any healthcare provider that wants to exchange data with other EU countries must comply with technical requirements.
• Healthcare professionals (doctors, nurses, pharmacists...): Must obtain authentication credentials recognized at European level.
• Patients: Benefit from access to their health data in any Member State, but must also have recognized digital identification mechanisms.
• Technology providers in the health sector: Healthcare software companies (HIS, EHR) that will need to update their solutions to comply with new protocols.

Practical example

A private hospital in Barcelona treats a German patient in the emergency department. To access his medical record stored in Germany, the responsible doctor needs to authenticate with credentials recognized at European level in accordance with the eIDAS Regulation. If the hospital has not adapted its information system to the new interoperable authentication mechanism of the EHDS, access is impossible: the doctor cannot consult allergies, previous medication or relevant medical history.

This same scenario applies in reverse: a Spanish doctor working in another EU country needs his European credentials to access the system. Without technical adaptation, the professional is excluded from information exchange, with the resulting clinical risk and loss of competitiveness for the center.

What should companies do now?

1. Audit current digital infrastructure: Review whether health information systems (HIS, EHR, electronic medical record) are compatible with EHDS technical standards and authentication protocols required by eIDAS.
2. Identify the technology gap: Determine what adaptations are necessary to comply with the regulation's interoperability and robust authentication requirements.
3. Contact technology providers: Require healthcare software providers to provide a concrete roadmap for adaptation to Regulation (EU) 2026/2099.
4. Plan the acquisition of European credentials: Initiate the process for healthcare professionals at the center to obtain authentication credentials recognized at European level.
5. Review data protection policy: Ensure that cross-border health data exchange processes comply with the GDPR with the enhanced authentication required by the regulation.
6. Follow Ministry of Health instructions: Regional governments will receive specific implementation guidelines. Stay informed of national adaptation timelines and requirements.

Official source

Consult complete regulation in official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202602099