MedVertical
Open menu

BlogFHIR operations

Three Questions Every FHIR Team Should Be Able to Answer

What did we check, what changed between comparable observations, and what can the next reviewer verify? Three practical questions for a FHIR handover.

Timeline visual showing three FHIR data quality questions leading to historical evidence
3 min readUpdated
fhirdata-qualityvalidationconformanceaudit-evidenceobservability

Written with AI assistance.

A FHIR validation result should help a team decide what to investigate, what to accept and what to check again. Three questions make that conversation concrete.

Question 1: What did we check, and when?

Start with the latest completed evaluation. Identify the source, selected resource types, filters, time window and limits. Keep the profile packages, terminology basis, validator and configuration with the result.

If twelve Patients were checked, the conclusion concerns those twelve Patients under those checks. It does not establish that every resource on the server is valid now. Data may have changed since the run, and some checks may have been unavailable.

Completion and coverage matter alongside errors and warnings. A missing dependency, failed retrieval or truncated analysis can leave a question unanswered. Say which part remains unverified.

FHIR conformance also differs from suitability for a particular use. A resource can satisfy selected profile constraints while the dataset lacks information a research question needs. Dataset-quality measures add their own scope, evaluated population and interpretation.

Question 2: What changed between comparable observations?

Suppose a partner reports a new finding. A preserved earlier result can help establish whether the same issue was observed before and what changed in the measured selection.

It usually cannot tell you the exact moment the defect began. If checks ran on Monday and Thursday, the first observed failure on Thursday may narrow the investigation window; it is not proof that the source changed at the validation timestamp.

Compare the evaluation contexts before assigning a cause. A lower count can reflect a source correction, fewer selected resources, a profile update, a terminology change or a validator fix. Changed requirements and changed data need separate explanations.

Records compares eligible runs with compatible recorded contexts. Those comparisons support investigation within the measured scope. They do not automatically identify every cause or cover the intervals between observations.

Question 3: What can the next reviewer verify?

A receiving team needs to connect the result to the delivery it is reviewing. Preserve the finding context, selected scope, completion status, relevant versions and any unresolved limitations.

A timestamp shows when an evaluation ran. An integrity hash can help compare a report with a trusted expected artifact. Neither establishes clinical correctness or guarantees that the original evaluation can be replayed.

Replay also needs the original source data and usable dependencies. Records retains bounded findings and context rather than persisting source clinical payloads as application data. The organization needs suitable arrangements for any source data it must retain.

These are practical review questions, not a claim that every regulator requires a particular report format or that a Records report replaces an official assessment.

Use the answers to assign the next action

A report becomes useful when the team can name an owner and a verification step. Investigate the requirement and affected data, decide whether a correction is appropriate, then repeat the agreed evaluation.

Keep the meaning of closure clear. A task may close because it was duplicated or an exception was accepted. A verified correction needs a suitable follow-up result and review of the remaining occurrences.

The Records quality loop follows that process through a synthetic twelve-Patient delivery. It provides an example to compare with your current handover process. A scheduled pipeline, an operator-triggered run or a release workflow can all support the same questions when they preserve the necessary context.

André Sheydin

About the author

André Sheydin

André is the founder of MedVertical and a product and design lead based in Cologne. He has spent more than 25 years shaping digital products, platforms, and design systems across complex domains, including healthcare, pharma, automotive, and SaaS. His work focuses on turning technical requirements into product structures that teams can actually build and operate.

Your next step

Turn the signal into a release decision.

See how one validation basis connects the gate signal, investigation, re-run, and evidence for the next release.