Stakeholder Perspectives on Affinity Domains in Digital Health Interoperability: Qualitative Study

Area of Science:

• Health Informatics
• Health Systems Research
• Digital Health Governance

Background:

• Operational health data interoperability hinges on both technical standards and enforceable governance.
• Affinity domains (IHE XDS) offer a structured model for cross-enterprise document sharing.
• Limited evidence exists on affinity domain governance feasibility in fragmented Central/Eastern European health systems.

Purpose of the Study:

• Examine stakeholder perceptions of affinity domain implementation prerequisites, risks, benefits, and governance in the Czech healthcare system.
• Identify system-level readiness factors for national interoperability initiatives, considering the European Health Data Space regulation.

Main Methods:

• Conducted 18 semistructured interviews with diverse Czech healthcare stakeholders (policymakers, providers, vendors, etc.).
• Explored governance roles, data liability, standards enforcement, financing, and technical readiness.
• Analyzed data using inductive thematic analysis, interpreting findings against affinity domain governance dimensions.

Main Results:

• Key themes included ambiguous roles, fragmented mandates, institutional distrust, legal uncertainty, and technical fragmentation.
• System prerequisites identified: empowered coordinating authority, binding standards (IHE XDS, HL7 FHIR), sustainable financing, and capacity building.
• Feasibility linked to clear responsibility/liability, enforceable technical requirements, and integrated financing models.

Conclusions:

• Affinity domains are viable for Czech interoperability but hindered by governance deficits, not technical immaturity.
• Establishing an empowered coordinating authority and piloting enforceable domain structures are crucial steps.
• Aligning national governance with European Health Data Space requirements is necessary for operational interoperability.