FHIR's $apply operation evaluates a PlanDefinition once and hands back a plan. It has no concept of a process that waits three days for a lab result. Here is how to compile PlanDefinitions into BPMN 2.0 and run them on a real process engine, and where a naive compiler breaks on a live clinical protocol.
DORA assumes every deployment costs the same. Simon Wardley's explorers/villagers/town-planners model assumes every team handoff costs the same. Regulated software breaks both assumptions in the same place, and two live regulatory changes this year prove it.
The Digital Omnibus has pushed AI Act application for medical devices to August 2028. That sounds like good news. It is not. The work the regulator is catching up on is not the work you have to do, and the obligations that do not map cleanly to MDR are the ones most engineering organisations have not started.
Passing $validate is not the same as being clinically correct. Here is what semantic validation looks like in practice: terminology coherence using SNOMED CT and LOINC's internal structure, and CQL-based clinical invariants that span resources and time.
Most medical device software teams treat compliance as a gate at the end of development, and pay for it in slow releases and audit scrambles. Here's how to encode regulatory requirements directly into your CI/CD pipeline, so compliance becomes a property of every build, not a phase at the end of your roadmap.
Explore how logical models and FISH mapping work together to enable sophisticated FHIR data modeling scenarios with advanced QA workflows, derived results tracking, and comprehensive testing strategies.
Why treating FHIR as a domain model—not just a protocol—matters for clinical platforms, regulatory compliance, and team efficiency. Lessons from building a FHIR-native stack for ePRO, EDC, and imaging in a German regulatory context.
How a FHIR-native architecture and Structured Data Capture (SDC) helped us survive an FDA mandate and eliminate the 'Translation Tax' between clinical and engineering teams.
How to move past simple interoperability and treat FHIR and clinical ontologies as the essential base layer for LLM grounding and automated data capture.
Plain text logs are for humans; structured logs are for automation. Learn how to implement JSON logging that makes debugging FHIR traffic easy.