Related work¶
The following section describes all related work on interoperability from a legal, organisational, semantic, and technical perspective. The related reference architectures and projects are also listed.
Legal¶
Data Protection & Privacy Laws
General Data Protection Regulation
The General Data Protection Regulation (GDPR) treats health data as a special category of personal data, allowing processing only under strict legal bases such as healthcare delivery, public health, or explicit consent, each supported by additional safeguards.
For a reference architecture, this implies purpose-bound and data-minimised exchange, ensuring that only necessary clinical or public health information is shared across borders. Clear allocation of responsibility through controller–processor or joint controller agreements is essential to maintain accountability across jurisdictions.
Systems must also include strong access control and full auditability, so that all access to health data is traceable and reviewable. This supports oversight in multi-actor, cross-border environments.
Finally, the principles of privacy by design and by default require that data protection is embedded into the architecture from the outset. This means privacy-preserving choices are the default setting (e.g., minimal data exposure, restricted access), and system design actively integrates security, identity management, and controlled data exchange rather than treating them as add-ons.
Legacy EU Data Protection Directive (95/46/EC)
US federal sectoral regime (HIPAA etc.)
Other
EHR-regulations
Cross-Border Data Exchange Laws & Agreements
European Health Data Space
The European Health Data Space (EHDS) is a European Union initiative that establishes a common framework for the access and exchange of electronic health data across member states. It supports both primary use of data for healthcare delivery and secondary use for research, innovation, and policy-making. Within EHDS, the MyHealth@EU infrastructure enables the cross-border exchange of health data for direct patient care, defining common standards, governance, and operational processes. Compared to TEFCA, EHDS is broader in scope and more strongly embedded in legislation, combining legal, organisational, and technical foundations to enable interoperable data sharing.
Trusted Exchange Framework and Common Agreement (TEFCA)
Landelijk vertrouwensstelsel
In the Netherlands, a national trust framework (landelijk vertrouwensstelsel) is being developed to enable secure and reliable exchange of health data across organisations. It defines the agreements, roles, and conditions under which parties can trust each other, including identity verification, authentication, authorization, and compliance with legal and security requirements. Similar to TEFCA, it focuses on establishing explicit trust relationships, but is more nationally scoped and closely aligned with existing healthcare infrastructure and governance models.
Organisational¶
Trusted Exchange Framework and Common Agreement (TEFCA)
Semantics¶
SNOMED CT
SNOMED International maintains the most comprehensive clinical terminology, covering diseases, procedures, findings, and more. It enables detailed, computable clinical data and is widely used in national health systems. Strong but complex to implement and maintain.
ICD (ICD-10 / ICD-11)
World Health Organization maintains a global standard for disease classification, mainly used for reporting, statistics, and billing. Less granular than SNOMED CT, but universally adopted and essential for comparability across countries.
LOINC
Regenstrief Institute maintains a standard for laboratory tests and clinical measurements. Critical for lab interoperability and widely adopted globally, often used alongside SNOMED CT.
Technical¶
Protocols and datastructures FHIR
HL7 International maintains the terminology services which determines how terminology systems are used in practice (e.g. value sets, code systems, mappings). Provides APIs for validation, lookup, and translation. Increasingly the operational layer for semantics.
OpenEHR
The OpenEHR Foundation maintains the OpenEHR archetypes which defines clinical models (archetypes) with embedded semantics. Strong for structured clinical data, but less globally dominant than SNOMED/LOINC.
Implementation guides Integrating the Healthcare Enterprise
Integrating the Healthcare Enterprise (IHE) is an international initiative that develops practical guidance for implementing interoperability in healthcare systems. Rather than creating new standards, IHE defines integration profiles that specify how existing standards should be used together to support real-world use cases. These profiles describe workflows, roles, and technical interactions between systems, helping vendors and organisations implement interoperable solutions in a consistent and testable way.
Regional Reference Architectures¶
Sigra's Regional Reference Architecture
While focused on the region of Amsterdam in the Netherlands, many of the architecure is inspired by the regional reference architecture of Sigra where data availability is desired for public health and wellbeing. The reference architecture uses a similar structure and base components to then adapt it to the needs of the Caribbean region.
Hospital Reference Architecture (ZiRA)
While focused on an architecture for hospitals in the Netherlands, many reference architectures (e.g., Sigra) is based on the principles and capabilities described in the ZiRA.
Digital Public Infrastructure Digital Public Infrastructure (DPI) is an WHO initiative and refers to foundational, interoperable digital systems—such as digital ID, payments, and data exchange—that enable essential public and private services at scale.
Digital Public Infrastucture for Health Digital Public Infrastructure for Health is an WHO initiative and refers to foundational, interoperable digital health systems—such as data exchange—that enable essential health services at scale.
Digital health platform handbook: building a digital information infrastructure (infostructure) for health
World Health Organization, & International Telecommunication Union. (2020). Digital health platform handbook: building a digital information infrastructure (infostructure) for health. World Health Organization.
Projects¶
Paving the Pan American Highway for Digital Health
The Pan-American Highway for Digital Health (PH4H) is a collaborative initiative led by the IDB, PAHO, and participating countries to enable "connected health for all" across Latin America and the Caribbean. In 2026 and 2027, it will conduct needs assessments across participating countries to map existing digital health infrastructure and identify gaps; develop and deploy interoperable digital health tools such as EHR modules, telemedicine platforms, and mobile health applications aligned with HL7 FHIR and SNOMED CT standards; create and update implementation guidelines and reference architectures for health data exchange; build a certification platform with sandbox environments to test whether national systems can securely exchange data; run regional Connectathons where countries test cross-border interoperability in practice; train and certify public sector professionals in interoperability standards and cybersecurity; develop change management plans to drive adoption at country level; and organize regional meetings to share best practices and coordinate implementation. Through these activities, PH4H aims to allow individuals—including mobile populations such as workers, students, and migrants—to access and share their health history across borders, while strengthening public health surveillance and pandemic preparedness across the region.