The regulation establishing the European Health Data Space (EHDS) aims to create the first common EU framework for data management and exchange in the health sector.
More specifically, the main objectives of the EHDS framework are to develop the eHealth Digital Service Infrastructure (eHDSI, branded MyHealth@EU) to ensure the continuity of care of EU citizens travelling between member states (primary use) as well as to enable trustworthy and efficient exchange of health data to foster clinical research and development of new tools (secondary use).
To achieve these objectives, the regulator should ensure that the data can flow effortlessly across borders and thus should promote a high level of interoperability between European health actors.
What is interoperability?
According to the ISO/IEC 2382:2015 (Information technology—vocabulary), interoperability refers to the “capability to communicate, execute programs, or transfer data among various functional units in a manner that requires the user to have little or no knowledge of the unique characteristics of those units”. Interoperability refers to the ability of information systems to interact with each other and exchange information that is readable by both of them.
Interoperability requires a common framework and widely adopted international standards. The concept is broken down into five levels:
Legal and organisational interoperability concerns issues of governance and the construction of a coherent, structured, and binding framework for interoperability.
Semantic interoperability refers to the ability of information systems not just to exchange data but to understand it. The semantic framework gives meaning and significance to the transmitted information. Professionals have to agree on the precise meaning and definition of each term and process. Several semantic norms exist and lay down a common vocabulary for many health specialities, such as medical laboratories (e.g., LOINC) or for general medicine (e.g., SNOMED).
The structural and foundational interoperability refers, respectively, to the format of data exchange and the communication techniques used so the data may securely flow between systems. One of the most widely adopted data formats (including in the EU) is HL7 FHIR (Fast Healthcare Interoperability Resources), which is integrated into the wider HL7 standards framework.
Challenges faced
The achievement of complete interoperability is impeded by numerous factors, including:
- The fragmented legacy systems and data silos: many health organisations are still using legacy systems, often old and hard to make compatible with more recent ones. Because of the lack of a culture of sharing data, many valuable data are kept in these fragmented systems.
- Lack of standardisation: although various standards and norms already exist, they are not effective without common governance. In France, the ANS (Agence du numérique en santé) developed the interoperability framework (CI-SIS) in order to lay the common bases of interoperability in the health sector.
- Increasing workload: collecting quality health data in the right format means that the professionals (nurses, doctors, etc.) need to adapt their process to match the requirements. Often, they don’t have the time to fill in the forms thoroughly. They also have to convince the patient, give out all the mandatory information (e.g., under GDPR), and collect their consent. This time-consuming task adds to an already heavy workload.
- Limited budget and resources: implementing interoperable systems can be costly, and health organisations do not often have plenty of resources. Several fundings exist at the French and EU levels (e.g., SEGUR, EU4Health…).
Expected positive effects
For primary use, effective data exchange brings positive output for both patients and professionals. The former benefits of improved and facilitated care, as they can share the full or partial medical record with the practitioners regardless of the country they are in or from. For the latter, it also means that most information is already collected and accessible for them, which reduces the administrative load and gives more time to listen to and treat the patient.
As for secondary use, the researchers could access an incredibly large, exhaustive, and diversified data pool, which can only significantly increase the quality of the research.
Interoperability is thus an essential part of the EHDS, as it allows both the development of electronic patient records and accessible health platforms and the agglomeration of a comprehensive health data lake to enhance research and development in the EU. Both primary and secondary use of health data depends on the ability of the member states and the EU to establish a common governance on interoperability. The construction of that governance has already begun, and many institutions and actors are part of it.
The EDPB (European Data Protection Board) ensures the protection of personal privacy according to GDPR rules and provides opinions on eHealth Network guidelines, the EHDSB (European Health Data Space Board), created by the EHDS regulation will assume the governance of the EHDS and MyHealth@EU platform. Meanwhile, the TEHDAS (Towards the European Health Data Space) coordinates stakeholders for secondary use of health data, identifies EU best practices, and develops frameworks for effective secondary health data use.
Finally, the eHealth Network provides non-binding technical guidelines and is supported by the technical and scientific expertise of the eHAction.
This structure reflects Europe’s effort to create a comprehensive framework for health data governance while ensuring privacy protection and standardisation across member states.
To read more:
https://www.ibm.com/think/topics/interoperability-in-healthcare
https://www.ncbi.nlm.nih.gov/books/NBK594855/
