The digitization of European healthcare takes a new step with the entry into force of the European Health Data Area (EHDS) Regulation , an initiative that establishes a common framework for the secure exchange and reuse of health data throughout the European Union.
Adaptation to the EHDS is mandatory for all entities that generate health data, both public and private. One of the key requirements is that, by 2029, all entities must be able to exchange electronic prescriptions and medical record summaries, with the aim of gradually expanding the catalog of shared data on EU citizens by 2035.
The regulation pursues two main objectives: firstly, to facilitate the primary use of data , allowing the secure exchange and control of electronic health information by patients and professionals throughout the EU; secondly, to promote the secondary use of data through its regulated reuse for research, innovation, planning and evaluation activities of health systems.
Many healthcare organizations are facing the same questions today: Where do we begin? How far are we from compliance? Does our data meet the required interoperability standards? How do we connect our current systems with the new European requirements? And, with deadlines already set on the European calendar, the most urgent question is: When do we need to start taking action?
A timeline that demands action starting today.
Although the phased implementation of the regulation will extend over the next few years, the timetable set by the European Union marks specific milestones that organizations must start preparing for now.
The deadlines may seem far off, but the technological, organizational and governance changes required by the EHDS cannot be improvised: the sooner you start, the less urgency there will be and the greater the guarantees of quality, success and cost control.
It addresses compliance with the EHDS
At ALTIA, we don't just implement technology; we support organizations with a deep understanding of the healthcare sector. This allows us to understand how the EHDS adaptation will affect them globally, combining that strategic vision with regulatory expertise and our technical and functional capacity to integrate complex systems.
We don't offer a single, fixed path, but rather a catalog of services that organizations can activate according to their needs, maturity level, and priorities. Therefore, our EHDS offering is structured into three independent services:
Assessment & Diagnosis
We assess the organization's overall and operational readiness level with respect to the EHDS. We conduct a comprehensive maturity assessment to define a clear and prioritized roadmap that considers the organization as a whole, addressing adaptation in a planned manner and avoiding unnecessary or misdirected efforts.
Interoperability Bridge
Whether an organization lacks any interoperability standard or uses one different from that required by the EHDS, we adapt systems to European requirements. We implement the EEHRxF framework, ensure semantic and syntactic interoperability using standards such as FHIR, SNOMED-CT, LOINC, or ICD-10, map legacy systems, catalog information assets according to the HealthDCAT-AP metadata standard, and support the adaptation of data governance to the new requirements of the European regulation.
Connect & Operate
We developed the operational integration with European infrastructures. We built the necessary functionalities to guarantee compliance with the regulations, such as the visualization, rectification, portability, access restriction, and complete traceability of health data.
Knowledge and support
Beyond technology, at ALTIA we offer expert knowledge of regulations and their requirements , combined with business acumen in the healthcare sector . We understand that these processes are not merely technical: they involve sustained effort and change management, with teams needing to adopt new ways of working. Therefore, our support includes the necessary experience to transform regulatory compliance into a real and sustainable transformation.
This new framework opens up a real opportunity for the organization itself: to have interoperable and high-quality data, to gain operational efficiency and, above all, to be able to exploit its own information to make better decisions, innovate and improve patient care.
