Define the operating boundary
A useful definition names the triggering event, required inputs, governing source, accountable owner, decision or action, exception path, evidence retained, and downstream handoff. Buyers should adapt those elements to their own population, jurisdictions, policies, systems, and control model before writing requirements.
The most important distinction is between a label and an operational capability. A provider may document terminology normalization and value-set management while depending on customer-supplied policy, licensed content, third-party data, integration partners, manual review, or services. The demonstration should expose those dependencies rather than hiding them behind a completed interface.
What a demonstration should prove
- Begin with representative source records and a named policy, standard, or controlled rule.
- Show the normal path, an ambiguous case, missing data, an exception, an override, and a material source change.
- Identify who can change rules, who can approve or reject, and how accountability is preserved.
- Trace every output back to inputs, versions, timestamps, user actions, and governing evidence.
- Export the resulting record and reconcile it with downstream systems and retained obligations.
Authority and operating context
FHIR R4 4.0.1
FHIR R4 defines resources, RESTful interactions, data types, terminology bindings, conformance artifacts, security considerations, and exchange patterns. It includes the first normative FHIR content and remains the base for major U.S. implementation guides. Buyers must distinguish base R4 support from support for a named profile or implementation guide. FHIR R4 does not establish production connectivity, semantic quality, authorization design, or conformity for a particular product.
FHIR R5 5.0.0
FHIR R5 is HL7's current overall published release and adds substantial content beyond R4. HL7 labels the release trial use while individual artifacts can have their own standards status. The newest overall release and the dominant regulatory implementation baseline are not the same thing. Buyers need an explicit version-transition plan rather than treating current FHIR as one undifferentiated feature.
US Core 9.0.0
US Core defines U.S. FHIR profiles, interactions, search expectations, and guidance for exchanging common clinical data. Version 9.0.0 remains based on FHIR R4 and incorporates current USCDI-oriented development. US Core version support is more decision-useful than a generic FHIR statement. Current publication, regulatory adoption, and voluntary SVAP availability must be recorded separately.
USCDI v6
USCDI v6 defines an expanded national set of health-data classes and elements intended to support interoperable exchange. Publication, regulatory adoption, and voluntary certification advancement are distinct status records. USCDI version determines the content baseline around which profiles, certification, mapping, and exchange programs are designed. Buyers should demand a version-aware roadmap and evidence for missing or newly added elements.
Operating domains
Semantic integrity and terminology
Risk that data move successfully but lose or distort meaning because codes, units, value sets, local terms, context, negation, status, and version provenance are incomplete or transformed incorrectly.
Data quality, completeness, and provenance
Risk that exchanged information lacks source, time, status, authorship, context, completeness, or transformation history, preventing the receiving organization from evaluating whether and how to use it.
Evidence and comparison limits
Official provider documentation can establish product positioning. Provider confirmation can clarify package or availability. Independent observation requires a disclosed scenario, environment, date, inputs, and reproducible result. None of those sources alone establishes buyer-specific legal, clinical, regulatory, quality, or operational fitness.
Buyer questions
- What exact outcome and evidence should terminology normalization and value-set management produce?
- Which source, version, and customer facts govern the workflow?
- Which decisions remain human and who is accountable for them?
- What is native, configured, integrated, service-delivered, or planned?
- How does a changed source affect open and historical records?
Recent changes
ASTP/ONC approves USCDI v6 through the 2026 SVAP — Developers and buyers need separate records for the mandatory baseline, voluntarily advanced version, and version actually deployed in a customer environment.
HL7 publishes C-CDA 5.0.0 — Enterprise exchange programs need explicit document-ingestion, validation, reconciliation, and extraction evidence in addition to FHIR API capability.