{ "id": "vgl-fhir-openehr-omop", "url": "/fr/fhir-openehr-et-omop-comparaison/", "md_url": "/fr/fhir-openehr-et-omop-comparaison.md", "json_url": "/fr/fhir-openehr-et-omop-comparaison.json", "claims_url": "/fr/fhir-openehr-et-omop-comparaison/beweringen/", "type": { "code": "Topic", "label": "Aperçu ou dossier" }, "schema_type": "Thing", "lang": "fr", "translation": { "lang": "fr", "source_url": "/vgl-fhir-openehr-omop/", "date": "2026-10-29", "stale": true, "fields": [ "lifecycle_note", "sectie:bouwstenen", "sectie:fase-en-verplichtingen", "sectie:onzekerheden-en-tegenstrijdige-informatie", "sectie:wat-betekent-het-voor-een-ziekenhuis", "sectie:wat-is-het", "summary", "title" ] }, "title": "FHIR, openEHR et OMOP : comparaison", "aliases": [ "FHIR vs openEHR vs OMOP", "FHIR, openEHR en OMOP CDM", "uitwisseling vs persistentie vs analyse" ], "names": { "nl": "FHIR, openEHR en OMOP: vergelijking", "fr": "FHIR, openEHR et OMOP : comparaison", "en": "FHIR, openEHR and OMOP compared", "de": null }, "jurisdiction": [ { "code": "internationaal", "label": "International" }, { "code": "eu", "label": "Union européenne" }, { "code": "belgie", "label": "Belgique (fédéral/interfédéral)" } ], "themes": [ { "code": "architectuur-en-infrastructuur", "label": "Architecture et infrastructure" }, { "code": "terminologie", "label": "Terminologie et codage" }, { "code": "secundair-gebruik", "label": "Utilisation secondaire et registres" } ], "lifecycle": { "code": "onbekend", "label": "inconnu" }, "lifecycle_note_html": "Sans objet : il s'agit d'une page de comparaison. Au 5 octobre 2026, FHIR→OMOP était publié à titre informatif, tandis qu'openEHR↔FHIR consistait encore en un guide de développement et des prototypes de recherche.", "version": null, "vendor": null, "sectors": [], "homologations": [], "links": [], "summary_text": "FHIR, openEHR et OMOP CDM résolvent des problèmes différents: l'échange, la modélisation clinique et la persistance, et l'analyse pour l'usage secondaire. Ils peuvent utiliser les mêmes terminologies et sont, selon les sources consultées, complémentaires, mais les conversions font perdre de l'information. L'EHDS fixera des exigences techniques pour le format européen d'échange; aucune obligation relative à openEHR ou OMOP n'a été trouvée. Pour les hôpitaux, la distinction importe dans les choix en matière d'interfaces, de stockage clinique et de données de recherche.", "summary_html": "

FHIR, openEHR et OMOP CDM résolvent des problèmes différents : l'échange, la modélisation clinique et la persistance, et l'analyse pour l'usage secondaire. Ils peuvent utiliser les mêmes terminologies et sont, selon les sources consultées, complémentaires, mais les conversions font perdre de l'information. L'EHDS fixera des exigences techniques pour le format européen d'échange ; aucune obligation relative à openEHR ou OMOP n'a été trouvée. Pour les hôpitaux, la distinction importe dans les choix en matière d'interfaces, de stockage clinique et de données de recherche.

", "last_verified": "2026-10-05", "verification_outdated": false, "sections": [ { "id": "qu-est-ce-que-c-est", "title": "Qu'est-ce que c'est ?", "kind": "tekst", "html": "

Quel rôle jouent HL7 FHIR, openEHR et OMOP CDM côte à côte, et que doit en connaître un hôpital\nflamand à la lumière de l'EHDS (Espace européen des données de santé) ? Comme cadre, cette page utilise les trois domaines de données du guide\nd'implémentation HL7 FHIR-to-OMOP : soins cliniques et administration, échange de données et analyse longitudinale\n[1]. Ce guide d'implémentation considère FHIR et OMOP comme complémentaires et non comme concurrents\n[1]. Un panel d'experts aboutit à la même conclusion pour openEHR, ISO 13606 et FHIR : chacun est\nutile pour un objectif propre et ils sont utilisables ensemble[2].

" }, { "id": "composantes", "title": "Composantes", "kind": "tekst", "html": "\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
DimensionHL7 FHIRopenEHROMOP CDM (OHDSI)
ObjectifÉchange électronique d'informations de soins[3] ; domaine : échange de données (API REST, resources)[1]Séparer le stockage technique et la signification clinique, afin que les systèmes évoluent sans perte de données[4] ; modèle de plate-forme complet pour l'enregistrement, la persistance et l'interrogation[2]Standardiser la structure et le contenu de données observationnelles pour l'analyse[5] ; domaine : analyse longitudinale[1]
GestionHL7 International ; en Belgique, HL7 Belgium est l'affilié[6], des groupes de travail de HL7 Belgium élaborent des profils FHIR[7] et la plate-forme eHealth publie des profils FHIR[8]openEHR International (opérationnel, depuis 2019), propriété intellectuelle auprès de la openEHR Foundation[9] ; spécifications CC-BY-ND[9]OHDSI CDM Working Group[5]
GranularitéLa resource est la brique de base[3]Modèle de référence stable avec des archétypes et des templates comme niveau de domaine[10] ; les templates forment des Compositions complètes (p. ex. une lettre de sortie)[10]Centré sur la personne : toutes les tables d'événements cliniques sont reliées à PERSON[11]
InterrogationL'API REST est l'une des possibilités[1], mais REST n'est pas requis pour utiliser des resources[3]AQL[10]Modèle relationnel, réalisable dans n'importe quelle base de données relationnelle (p. ex. des bases SQL)[11] ; aucun langage de requête distinct trouvé dans les sources
Maturité et versionR5 (5.0.0) est la version actuelle[12] ; R4 (4.0.1) mêle contenu normatif et STU[13]Architecture Overview BASE 1.2.0, statut STABLE[10]v5.5[5], uniquement des ajouts optionnels par rapport à la v5.4[14]
Rôle de la terminologieModule de terminologie avec CodeSystem, ValueSet, ConceptMap[15] ; chaque système de codes a une URL (p. ex. LOINC, SNOMED)[16]Archétypes et templates comme porte d'entrée sémantique vers les terminologies[10]Standardized Vocabularies au centre[5] ; un seul Standard Concept par événement, SNOMED pour les affections[17]
Usage en BelgiqueNorme privilégiée pour les nouveaux flux (depuis l'Actieplan e-Gezondheid 2019-2021)[18] ; guides d'implémentation belges en R4[19]Non trouvé (lacune ; cela ne signifie pas que cela n'existe pas)Nœud OHDSI belge issu de la communauté EHDEN[20] ; 14 partenaires de données EHDEN belges[21]
\n

Selon un article du JMIR (2025), FHIR et OMOP utilisent les mêmes terminologies internationales, et OMOP convient mieux à l'analyse qu'à l'échange opérationnel[22]. Dans les profils FHIR belges, SNOMED CT est le codage privilégié[23], et dans le guide d'implémentation FHIR belge pour les résultats de laboratoire (v1.0.0, trial use), la plupart des mesures de laboratoire courantes doivent être codées en LOINC selon le sous-ensemble du SPF[24]. La classification d'enregistrement ICD-10-BE se situe en dehors de ces trois modèles ; dans OMOP, les codes ICD sont mappés, comme codes sources, sur des concepts standard SNOMED[17].

\n

Mappings et perte d'information

\n" }, { "id": "phase-et-obligations", "title": "Phase et obligations", "kind": "tekst", "html": "" }, { "id": "qu-est-ce-que-cela-signifie-pour-un-hopital", "title": "Qu'est-ce que cela signifie pour un hôpital ?", "kind": "tekst", "html": "\n

Conditions d'implémentation et limites

\n

Les guides d'implémentation belges sont en R4, alors que le guide d'implémentation FHIR-to-OMOP repose sur R5 et\nUS Core[19][1] ; une application directe demande donc une traduction. Pour l'utilisation\nde SNOMED CT dans les profils core-clinical belges, une licence Affiliate est nécessaire[32].

" }, { "id": "incertitudes-et-informations-contradictoires", "title": "Incertitudes et informations contradictoires", "kind": "tekst", "html": "" } ], "relation_groups": [ { "type": "about", "direction": "uit", "label": "porte sur", "relations": [ { "direction": "uit", "type": "about", "label": "porte sur", "other": { "id": "fhir", "title": "HL7 FHIR", "url": "/fr/hl7-fhir/" }, "status": "established", "status_label": "établi", "note_html": null, "valid_from": null, "valid_to": null, "historical": false, "refs": [ 1, 3 ] }, { "direction": "uit", "type": "about", "label": "porte sur", "other": { "id": "openehr", "title": "openEHR", "url": "/fr/openehr/" }, "status": "established", "status_label": "établi", "note_html": null, "valid_from": null, "valid_to": null, "historical": false, "refs": [ 2, 4 ] }, { "direction": "uit", "type": "about", "label": "porte sur", "other": { "id": "omop-cdm", "title": "OMOP CDM et OHDSI", "url": "/fr/omop-cdm-et-ohdsi/" }, "status": "established", "status_label": "établi", "note_html": null, "valid_from": null, "valid_to": null, "historical": false, "refs": [ 1, 5 ] }, { "direction": "uit", "type": "about", "label": "porte sur", "other": { "id": "snomed-ct", "title": "SNOMED CT", "url": "/fr/snomed-ct/" }, "status": "established", "status_label": "établi", "note_html": null, "valid_from": null, "valid_to": null, "historical": false, "refs": [ 22, 17 ] }, { "direction": "uit", "type": "about", "label": "porte sur", "other": { "id": "loinc", "title": "LOINC et le sous-ensemble belge (ReTaM)", "url": "/fr/loinc-et-le-sous-ensemble-belge-retam/" }, "status": "established", "status_label": "établi", "note_html": null, "valid_from": null, "valid_to": null, "historical": false, "refs": [ 22, 16 ] }, { "direction": "uit", "type": "about", "label": "porte sur", "other": { "id": "ehds", "title": "EHDS (Espace européen des données de santé)", "url": "/fr/espace-europeen-des-donnees-de-sante/" }, "status": "established", "status_label": "établi", "note_html": "De EHDS laat de technische specificaties van het uitwisselingsformaat via uitvoeringshandelingen vastleggen; voor persistentie- of analysemodellen werd geen EHDS-verplichting gevonden.", "valid_from": null, "valid_to": null, "historical": false, "refs": [ 28, 2 ] }, { "direction": "uit", "type": "about", "label": "porte sur", "other": { "id": "be-fhir-igs", "title": "Guides d'implémentation FHIR belges", "url": "/fr/guides-d-implementation-fhir-belges/" }, "status": "established", "status_label": "établi", "note_html": null, "valid_from": null, "valid_to": null, "historical": false, "refs": [ 19, 23 ] }, { "direction": "uit", "type": "about", "label": "porte sur", "other": { "id": "eehrxf", "title": "EEHRxF (format européen d'échange des dossiers de santé informatisés)", "url": "/fr/format-europeen-d-echange-des-dossiers-de-sante-informatises/" }, "status": "established", "status_label": "établi", "note_html": null, "valid_from": null, "valid_to": null, "historical": false, "refs": [ 28 ] }, { "direction": "uit", "type": "about", "label": "porte sur", "other": { "id": "healthdata-at-eu", "title": "DonnéesDeSanté@UE", "url": "/fr/donneessante-ue/" }, "status": "established", "status_label": "établi", "note_html": "OMOP was in de HealthData@EU-pilot een optie, geen verplichting.", "valid_from": null, "valid_to": null, "historical": false, "refs": [ 31 ] } ] }, { "type": "comparedWith", "direction": "in", "label": "est comparé à (entrant)", "relations": [ { "direction": "in", "type": "comparedWith", "label": "est comparé à (entrant)", "other": { "id": "omop-cdm", "title": "OMOP CDM et OHDSI", "url": "/fr/omop-cdm-et-ohdsi/" }, "status": "established", "status_label": "établi", "note_html": null, "valid_from": null, "valid_to": null, "historical": false, "refs": [ 1 ] }, { "direction": "in", "type": "comparedWith", "label": "est comparé à (entrant)", "other": { "id": "openehr", "title": "openEHR", "url": "/fr/openehr/" }, "status": "established", "status_label": "établi", "note_html": null, "valid_from": null, "valid_to": null, "historical": false, "refs": [ 2 ] } ] } ], "relation_count": 11, "hypothesis_count": 0, "neighbours": [ { "id": "fhir", "title": "HL7 FHIR", "url": "/fr/hl7-fhir/", "type": { "code": "Specification", "label": "Norme ou spécification" }, "status": "established" }, { "id": "openehr", "title": "openEHR", "url": "/fr/openehr/", "type": { "code": "Specification", "label": "Norme ou spécification" }, "status": "established" }, { "id": "omop-cdm", "title": "OMOP CDM et OHDSI", "url": "/fr/omop-cdm-et-ohdsi/", "type": { "code": "Specification", "label": "Norme ou spécification" }, "status": "established" }, { "id": "snomed-ct", "title": "SNOMED CT", "url": "/fr/snomed-ct/", "type": { "code": "Terminology", "label": "Terminologie ou classification" }, "status": "established" }, { "id": "loinc", "title": "LOINC et le sous-ensemble belge (ReTaM)", "url": "/fr/loinc-et-le-sous-ensemble-belge-retam/", "type": { "code": "Terminology", "label": "Terminologie ou classification" }, "status": "established" }, { "id": "ehds", "title": "EHDS (Espace européen des données de santé)", "url": "/fr/espace-europeen-des-donnees-de-sante/", "type": { "code": "LegalAct", "label": "Acte législatif" }, "status": "established" }, { "id": "be-fhir-igs", "title": "Guides d'implémentation FHIR belges", "url": "/fr/guides-d-implementation-fhir-belges/", "type": { "code": "Specification", "label": "Norme ou spécification" }, "status": "established" }, { "id": "eehrxf", "title": "EEHRxF (format européen d'échange des dossiers de santé informatisés)", "url": "/fr/format-europeen-d-echange-des-dossiers-de-sante-informatises/", "type": { "code": "Specification", "label": "Norme ou spécification" }, "status": "established" }, { "id": "healthdata-at-eu", "title": "DonnéesDeSanté@UE", "url": "/fr/donneessante-ue/", "type": { "code": "Platform", "label": "Plateforme ou service" }, "status": "established" } ], "open_questions_html": [ "Welke Belgische of Europese referentiearchitectuur combineert FHIR, openEHR en OMOP expliciet (bv. richtlijnen van de Health Data Agency)?", "Wanneer volgt de HL7 FHIR-to-OMOP IG op OMOP CDM v5.5, en komt er een R4-variant die aansluit op de Belgische R4-IG's?", "Wordt openEHR in België gebruikt door ziekenhuizen of EPD-leveranciers? Niet gevonden.", "Bestaat er een officiële mappingstandaard openEHR↔OMOP? Niet gevonden.", "Verwijzen de EEHRxF-uitvoeringshandelingen (verwacht begin 2027) normatief naar FHIR?", "Komt er een Atlas-conceptpagina voor openEHR (relatie nu naar een nog aan te maken concept)?" ], "open_questions": [ { "id": "oq-b2207a", "html": "Welke Belgische of Europese referentiearchitectuur combineert FHIR, openEHR en OMOP expliciet (bv. richtlijnen van de Health Data Agency)?", "text": "Welke Belgische of Europese referentiearchitectuur combineert FHIR, openEHR en OMOP expliciet (bv. richtlijnen van de Health Data Agency)?" }, { "id": "oq-af3637", "html": "Wanneer volgt de HL7 FHIR-to-OMOP IG op OMOP CDM v5.5, en komt er een R4-variant die aansluit op de Belgische R4-IG's?", "text": "Wanneer volgt de HL7 FHIR-to-OMOP IG op OMOP CDM v5.5, en komt er een R4-variant die aansluit op de Belgische R4-IG's?" }, { "id": "oq-3f16b8", "html": "Wordt openEHR in België gebruikt door ziekenhuizen of EPD-leveranciers? Niet gevonden.", "text": "Wordt openEHR in België gebruikt door ziekenhuizen of EPD-leveranciers? Niet gevonden." }, { "id": "oq-dd36c7", "html": "Bestaat er een officiële mappingstandaard openEHR↔OMOP? Niet gevonden.", "text": "Bestaat er een officiële mappingstandaard openEHR↔OMOP? Niet gevonden." }, { "id": "oq-493197", "html": "Verwijzen de EEHRxF-uitvoeringshandelingen (verwacht begin 2027) normatief naar FHIR?", "text": "Verwijzen de EEHRxF-uitvoeringshandelingen (verwacht begin 2027) normatief naar FHIR?" }, { "id": "oq-415aee", "html": "Komt er een Atlas-conceptpagina voor openEHR (relatie nu naar een nog aan te maken concept)?", "text": "Komt er een Atlas-conceptpagina voor openEHR (relatie nu naar een nog aan te maken concept)?" } ], "exchanges": [], "sources": [ { "n": 1, "id": "SRC-4762fc1944", "title": "Vulcan FHIR to OMOP FHIR Implementation Guide", "publisher": "HL7 International / Biomedical Research and Regulation", "url": "https://hl7.org/fhir/uv/omop/en/index.html", "published": null, "first_retrieved": "2026-09-25T20:37:23+00:00", "last_checked": "2026-09-26T05:59:20+00:00", "content_sha256": "99216bdc130a3b77ab7741f5d19a4676b50144790b4f7d2b39367b890761540e", "link_unreachable_since": null }, { "n": 2, "id": "SRC-b22ee5ef19", "title": "Can OpenEHR, ISO 13606, and HL7 FHIR Work Together? 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REST est courant, mais n'est pas obligatoire pour utiliser des ressources.", "kind": "fact", "kind_label": "fait", "locator": "Overview", "as_of": "2026-09-25", "source": { "id": "SRC-8086ca6f2b", "title": "FHIR Overview (R4)", "publisher": "HL7 International", "url": "https://hl7.org/fhir/R4/overview.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-5472e46b", "statement": "Bij multi-level modelling is het referentiemodel een stabiel objectmodel waarop software en data worden gebouwd; archetypes en templates vormen het domeinniveau.", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Archetypes and Templates'", "as_of": "2026-09-25", "source": { "id": "SRC-33f54a15dd", "title": "openEHR Architecture Overview", "publisher": "openEHR Specification Program", "url": "https://specifications.openehr.org/releases/BASE/latest/architecture_overview.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-f3a32110", "statement": "Templates combineren archetypes tot volledige Compositions (bv. ontslagbrief) en zijn meestal lokaal, terwijl archetypes breed hergebruikt worden.", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Archetypes and Templates'", "as_of": "2026-09-25", "source": { "id": "SRC-33f54a15dd", "title": "openEHR Architecture Overview", "publisher": "openEHR Specification Program", "url": "https://specifications.openehr.org/releases/BASE/latest/architecture_overview.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-b378c72d", "statement": "De CDM is een persoonsgericht model: alle klinische event-tabellen hangen aan de PERSON-tabel voor een longitudinaal beeld.", "kind": "fact", "kind_label": "fait", "locator": "hoofdstuk 4.1", "as_of": "2026-09-25", "source": { "id": "SRC-277609bbe8", "title": "The Book of OHDSI - Chapter 4 The Common Data Model", "publisher": "OHDSI", "url": "https://ohdsi.github.io/TheBookOfOhdsi/CommonDataModel.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-22b16816", "statement": "Volgens de FHIR R4-specificatie hoeft men geen REST te gebruiken om FHIR-resources te gebruiken.", "kind": "fact", "kind_label": "fait", "locator": "Overview, sectie resources", "as_of": "2026-09-26", "source": { "id": "SRC-8086ca6f2b", "title": "FHIR Overview (R4)", "publisher": "HL7 International", "url": "https://hl7.org/fhir/R4/overview.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-8025c8fd", "statement": "Queries gebeuren in AQL (Archetype Query Language), een synthese van SQL en XPath-achtige paden uit archetypes.", "kind": "fact", "kind_label": "fait", "locator": "sectie over querying", "as_of": "2026-09-25", "source": { "id": "SRC-33f54a15dd", "title": "openEHR Architecture Overview", "publisher": "openEHR Specification Program", "url": "https://specifications.openehr.org/releases/BASE/latest/architecture_overview.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-5eaebd11", "statement": "De OMOP CDM schrijft geen specifieke technologie voor; ze kan in elke relationele database (bv. Oracle, SQL Server) of als SAS-analysedatasets worden gerealiseerd.", "kind": "fact", "kind_label": "fait", "locator": "sectie 4.1 (design principles, technology neutrality)", "as_of": "2026-09-26", "source": { "id": "SRC-277609bbe8", "title": "The Book of OHDSI - Chapter 4 The Common Data Model", "publisher": "OHDSI", "url": "https://ohdsi.github.io/TheBookOfOhdsi/CommonDataModel.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-9566eb8c", "statement": "FHIR R5 (v5.0.0) a été publié le 26 mars 2023 et constitue la version actuellement publiée de FHIR (statut STU).", "kind": "fact", "kind_label": "fait", "locator": "voettekst", "as_of": "2026-09-25", "source": { "id": "SRC-ec315cc0fc", "title": "FHIR R5 (v5.0.0)", "publisher": "HL7 International", "url": "https://hl7.org/fhir/R5/index.html", "published": "2023-03-26" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-1badcbfb", "statement": "FHIR R4 (v4.0.1, Technical Correction #1) est un mélange de contenu normatif et de contenu STU; la publication 4.0.1 date du 1er novembre 2019.", "kind": "fact", "kind_label": "fait", "locator": "voettekst", "as_of": "2026-09-25", "source": { "id": "SRC-ec16ae26c1", "title": "FHIR R4 (v4.0.1)", "publisher": "HL7 International", "url": "https://hl7.org/fhir/R4/index.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-f00aa165", "statement": "De geraadpleegde Architecture Overview is BASE Release-1.2.0 met status STABLE.", "kind": "fact", "kind_label": "fait", "locator": "documentkop", "as_of": "2026-09-25", "source": { "id": "SRC-33f54a15dd", "title": "openEHR Architecture Overview", "publisher": "openEHR Specification Program", "url": "https://specifications.openehr.org/releases/BASE/latest/architecture_overview.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-ac400acb", "statement": "v5.5 voegt enkel niet-verplichte velden en vocabulariummetadatatabellen toe; er werd niets verwijderd of hernoemd ten opzichte van v5.4.", "kind": "fact", "kind_label": "fait", "locator": "sectie Summary", "as_of": "2026-09-25", "source": { "id": "SRC-cf9241837b", "title": "CDM v5.5 (release v5.5.0)", "publisher": "OHDSI", "url": "https://github.com/OHDSI/CommonDataModel/releases/tag/v5.5.0", "published": "2026-08-25" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-81841f02", "statement": "Le module de terminologie (CodeSystem, ValueSet, ConceptMap, services de terminologie) permet d'exprimer et de communiquer des données codées en FHIR.", "kind": "fact", "kind_label": "fait", "locator": "Introduction", "as_of": "2026-09-25", "source": { "id": "SRC-ddc1f2b720", "title": "FHIR Terminology Module (R4)", "publisher": "HL7 International, Vocabulary Work Group", "url": "https://hl7.org/fhir/R4/terminology-module.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-89c84b92", "statement": "Pour l'échange, chaque système de codes reçoit une URL (p. ex. http://loinc.org, http://snomed.info/sct), de sorte que l'origine de chaque code soit explicite.", "kind": "fact", "kind_label": "fait", "locator": "sectie over code systems en value sets", "as_of": "2026-09-25", "source": { "id": "SRC-6f62e628f5", "title": "Using Codes in resources (R4)", "publisher": "HL7 International", "url": "https://hl7.org/fhir/R4/terminologies.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-19680c4c", "statement": "Archetypes en templates vormen de semantische toegangspoort naar terminologieën en classificaties.", "kind": "fact", "kind_label": "fait", "locator": "sectie 4.1.1 Multi-level Modelling and Archetypes", "as_of": "2026-09-25", "source": { "id": "SRC-33f54a15dd", "title": "openEHR Architecture Overview", "publisher": "openEHR Specification Program", "url": "https://specifications.openehr.org/releases/BASE/latest/architecture_overview.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-5068e15a", "statement": "De OHDSI Standardized Vocabularies zijn een centraal onderdeel van de OMOP CDM.", "kind": "fact", "kind_label": "fait", "locator": "Home", "as_of": "2026-09-25", "source": { "id": "SRC-51838ad661", "title": "OMOP Common Data Model", "publisher": "OHDSI CDM Working Group", "url": "https://ohdsi.github.io/CommonDataModel/", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-8b25e1f2", "statement": "Per klinisch event wordt één Standard Concept gekozen; bij aandoeningen is dat SNOMED, en ICD- of andere broncodes worden erop gemapt.", "kind": "fact", "kind_label": "fait", "locator": "sectie 5.2.6 Standard Concepts", "as_of": "2026-09-25", "source": { "id": "SRC-9a557cfa23", "title": "The Book of OHDSI - Chapter 5 Standardized Vocabularies", "publisher": "OHDSI", "url": "https://ohdsi.github.io/TheBookOfOhdsi/StandardizedVocabularies.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-a8067de8", "statement": "Dans le cadre du plan d'action e-Santé 2019-2021 (cluster 0.5), HL7 FHIR est la norme préférentielle en Belgique: les nouveaux flux de données utilisent de préférence FHIR, les nouvelles interfaces de préférence FHIR REST.", "kind": "fact", "kind_label": "fait", "locator": "sectie 'concerning FHIR'", "as_of": "2026-09-25", "source": { "id": "SRC-bd069bf1c8", "title": "eHealth Platform Standards - Home (KMEHR)", "publisher": "eHealth-platform", "url": "https://www.ehealth.fgov.be/standards/kmehr/en", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-4c97a5a4", "statement": "Les IG belges sont des IG R4 également utilisables avec des systèmes R4B; des paquets R4 et R4B sont proposés. Aucun IG belge publié n'est basé sur FHIR R5; les éléments R5 sont utilisés dans R4 au moyen d'extensions cross-version.", "kind": "fact", "kind_label": "fait", "locator": "sectie cross-version analysis / dependencies", "as_of": "2026-09-25", "source": { "id": "SRC-c0c4b77571", "title": "BE Medication - Home", "publisher": "eHealth-platform", "url": "https://www.ehealth.fgov.be/standards/fhir/medication/en/index.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-ba340bd5", "statement": "De Belgische OHDSI-node ontstond spontaan uit de Belgische EHDEN-gemeenschap en behoort tot de meest actieve in Europa.", "kind": "fact", "kind_label": "fait", "locator": "inleiding", "as_of": "2026-09-25", "source": { "id": "SRC-8af9dba3d7", "title": "OHDSI Belgium - national node", "publisher": "OHDSI Europe", "url": "https://www.ohdsi-europe.org/index.php/national-nodes/belgium", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-23727b49", "statement": "EHDEN lijst 14 Belgische datapartners (Brussel en Vlaanderen): overwegend ziekenhuizen, aangevuld met enkele bedrijven en een universitair MS-centrum.", "kind": "fact", "kind_label": "fait", "locator": "lijst BENELUX > Belgium (14)", "as_of": "2026-09-25", "source": { "id": "SRC-88258db489", "title": "Data Partners – EHDEN Foundation", "publisher": "EHDEN Foundation", "url": "https://www.ehden.eu/datapartners/", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-85e934d1", "statement": "Volgens een JMIR-artikel (2025) gebruiken FHIR (CodeSystems) en OMOP (OHDSI-vocabularia) dezelfde internationale terminologieën; OMOP past beter bij analyse dan bij operationele uitwisseling.", "kind": "research-finding", "kind_label": "résultat de recherche", "locator": "sectie Discussion (FHIR vs OMOP)", "as_of": "2026-09-25", "source": { "id": "SRC-55ef771c33", "title": "Interoperability Framework of the European Health Data Space for the Secondary Use of Data: Interactive European Interoperability Framework-Based Standards Compliance Toolkit for AI-Driven Projects", "publisher": "Journal of Medical Internet Research", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12059490/", "published": "2025" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-530b635f", "statement": "Selon la guidance des profils FHIR fédéraux (Federal Core Profiles v2.1.1) de la Plate-forme eHealth, SNOMED CT est le codage préférentiel dans le contexte belge, soutenu par le SPF Santé publique.", "kind": "fact", "kind_label": "fait", "locator": "sectie SNOMED-CT", "as_of": "2026-09-25", "source": { "id": "SRC-4688612825", "title": "Guidance - eHealth Platform Federal Core Profiles v2.1.1", "publisher": "eHealth-platform", "url": "https://www.ehealth.fgov.be/standards/fhir/core/2.1.1/guidance.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-e0e48933", "statement": "Dans le Lab-IG FHIR belge (v1.0.0, Trial Use), les résultats de laboratoire doivent (SHALL) être codés en LOINC selon le sous-ensemble du SPF Santé publique; sinon des codes Albert.", "kind": "fact", "kind_label": "fait", "locator": "sectie codering observaties", "as_of": "2026-09-25", "source": { "id": "SRC-fb93029bf0", "title": "HL7 Belgium FHIR IG - Lab related profiles: Guidance", "publisher": "eHealth-platform / HL7 Belgium", "url": "https://www.ehealth.fgov.be/standards/fhir/lab/guidance.html", "published": "2022-09-08" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-71837b87", "statement": "De omzetting van bronconcepten naar Standard Concepts heet 'mapping'; niet-standaardconcepten blijven als 'source concepts' in de vocabularia.", "kind": "fact", "kind_label": "fait", "locator": "sectie 5.2.7 Non-Standard Concepts", "as_of": "2026-09-25", "source": { "id": "SRC-9a557cfa23", "title": "The Book of OHDSI - Chapter 5 Standardized Vocabularies", "publisher": "OHDSI", "url": "https://ohdsi.github.io/TheBookOfOhdsi/StandardizedVocabularies.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-77f1c57f", "statement": "De Vulcan FHIR-to-OMOP IG v1.0.0 (Informative, FHIR R5) behandelt enkel de richting FHIR→OMOP, voor een IPA-kern plus Encounter en Procedure (US Core), met OMOP CDM v5.4 als doel.", "kind": "fact", "kind_label": "fait", "locator": "Home, sectie Scope", "as_of": "2026-09-25", "source": { "id": "SRC-4762fc1944", "title": "Vulcan FHIR to OMOP FHIR Implementation Guide", "publisher": "HL7 International / Biomedical Research and Regulation", "url": "https://hl7.org/fhir/uv/omop/en/index.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-2eb05c91", "statement": "Een volgende versie van de FHIR-to-OMOP IG (2.0.0-ballot) staat als continuous build op build.fhir.org (ontwerp).", "kind": "fact", "kind_label": "fait", "locator": "publicatiebanner", "as_of": "2026-09-25", "source": { "id": "SRC-5f6318ee1a", "title": "FHIR to OMOP FHIR IG (continuous build 2.0.0-ballot)", "publisher": "HL7 International / Biomedical Research and Regulation", "url": "https://build.fhir.org/ig/HL7/fhir-omop-ig/", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-cd749309", "statement": "Een FHIR-naar-OMOP-transformatie kan niet verliesvrij zijn; de IG noemt vier soorten verlies: fideliteit, informatie, relaties en accuraatheid.", "kind": "fact", "kind_label": "fait", "locator": "Home, sectie over informatieverlies", "as_of": "2026-09-25", "source": { "id": "SRC-4762fc1944", "title": "Vulcan FHIR to OMOP FHIR Implementation Guide", "publisher": "HL7 International / Biomedical Research and Regulation", "url": "https://hl7.org/fhir/uv/omop/en/index.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-4d28e36b", "statement": "Er is een HL7-implementatiegids in ontwikkeling (broncode op GitHub, FHIR R5, HL7 FHIR Infrastructure) die openEHR-datatypes op FHIR-datatypes mapt voor uitwisseling en persistentie zonder betekenisverlies.", "kind": "fact", "kind_label": "fait", "locator": "README", "as_of": "2026-09-25", "source": { "id": "SRC-c911dbe4d4", "title": "openEHR-FHIR Data Type Mapping IG (broncode)", "publisher": "openehr-fhir (GitHub)", "url": "https://github.com/openehr-fhir/data-type-mapping-ig", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-dc514fc0", "statement": "Het onderzoeksvoorstel FHIRconnect (preprint 2025) biedt een DSL en open-source engine (openFHIR) voor bidirectionele openEHR-FHIR-transformatie en mapte 24 archetypes naar 15 FHIR-profielen.", "kind": "research-finding", "kind_label": "résultat de recherche", "locator": "Abstract", "as_of": "2026-09-25", "source": { "id": "SRC-36bd69feaa", "title": "FHIRconnect: Towards a seamless integration of openEHR and FHIR", "publisher": "arXiv (preprint)", "url": "https://arxiv.org/abs/2511.14618", "published": "2025-11-18" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-96d3720e", "statement": "Le règlement est applicable à partir du 26 mars 2027; l'art. 105 y apporte une exception: les articles 3 à 15,\nl'art. 23(2) à (6) et les articles 25, 26, 27, 47, 48 et 49 s'appliquent de manière échelonnée par catégorie\n(26 mars 2029 pour l'art. 14(1)(a)-(c), 26 mars 2031 pour l'art. 14(1)(d)-(f)).", "kind": "fact", "kind_label": "fait", "locator": "art. 105, derde alinea", "as_of": "2026-09-26", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-14501017", "statement": "Les articles 3 à 15 (dont l'obligation d'enregistrement de l'art. 13 et l'EEHRxF de l'art. 15) s'appliquent à partir du\n26 mars 2029 au résumé patient, à l'e-prescription et à l'e-dispensation, ainsi qu'aux systèmes de DME que le fabricant\ndestine à ces catégories; pour l'imagerie, les résultats de tests et les rapports de sortie, à partir du 26 mars 2031.", "kind": "fact", "kind_label": "fait", "locator": "art. 105, derde alinea, punt (a)", "as_of": "2026-09-26", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-c01f0160", "statement": "Pour le deuxième groupe de catégories prioritaires (art. 14(1) d-f: imagerie médicale avec comptes rendus, résultats de\ntests y compris de laboratoire, rapports de sortie), ces dispositions s'appliquent à partir du 26 mars 2031.", "kind": "fact", "kind_label": "fait", "locator": "artikel 105, derde alinea, punt (b)", "as_of": "2026-09-25", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-943c06f1", "statement": "Le chapitre IV (utilisation secondaire) est applicable à partir du 26 mars 2029, certaines dispositions (dont l'art. 75(1)\nsur les points de contact DonnéesDeSanté@UE) l'étant déjà à partir du 26 mars 2027.", "kind": "fact", "kind_label": "fait", "locator": "artikel 105", "as_of": "2026-09-25", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-4a614894", "statement": "Volgens de verordening is art. 75(5) (aansluiting van derde landen/internationale organisaties op HealthData@EU) pas van toepassing vanaf 26 maart 2035.", "kind": "fact", "kind_label": "fait", "locator": "art. 105, zesde alinea", "as_of": "2026-09-26", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-14a07bfc", "statement": "Au plus tard le 26 mars 2027, la Commission doit fixer par des actes d'exécution, pour les catégories prioritaires, les spécifications techniques qui forment ensemble le format européen d'échange des dossiers médicaux électroniques (EEHRxF).", "kind": "fact", "kind_label": "fait", "locator": "artikel 15(1)", "as_of": "2026-09-25", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-08580fc7", "statement": "Les prestataires de soins doivent enregistrer sous forme électronique, dans un système de DME, les données qui relèvent\n(en partie) des catégories prioritaires.", "kind": "fact", "kind_label": "fait", "locator": "artikel 13(1)", "as_of": "2026-09-25", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-eb2f08a7", "statement": "Les détenteurs de données (dont les hôpitaux, sauf exemption) doivent mettre au minimum certaines catégories à disposition\npour l'utilisation secondaire, en commençant par les données de santé électroniques issues des DME.", "kind": "fact", "kind_label": "fait", "locator": "artikel 51(1)(a)", "as_of": "2026-09-25", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-c6b73f2f", "statement": "À l'automne 2025, HL7 Europe a publié des IG FHIR Base et Core (STU, R4 et R5) et un paquet Extensions à l'appui de l'EHDS; les actes d'exécution relatifs à l'EEHRxF sont attendus début 2027.", "kind": "fact", "kind_label": "fait", "locator": "alinea's 1 en 5", "as_of": "2026-09-25", "source": { "id": "SRC-f046cd4082", "title": "New HL7 Europe FHIR Implementation Guides to support the European Health Data Space", "publisher": "HL7 International (HL7 News)", "url": "https://hl7news.hl7.org/2026/01/02/new-hl7-europe-fhir-implementation-guides-to-support-the-european-health-data-space/", "published": "2026-01-02" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-c444a1e8", "statement": "La Belgique plaide pour un seul standard technique FHIR européen par type de message (résumé patient, e-prescription,\ne-dispensation, imagerie, résultats de tests, rapports de sortie).", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Organisatie in België'", "as_of": "2026-09-25", "source": { "id": "SRC-41ee539e0b", "title": "EHDS (European Health Data Space) - De Europese Verordening betreffende de Europese ruimte voor gezondheidsgegevens", "publisher": "eHealth-platform", "url": "https://www.ehealth.fgov.be/nl/page/ehds-european-health-data-space-de-europese-verordening-betreffende-de-europese-ruimte-voor-gezondheidsgegevens", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-2906b45d", "statement": "Selon un panel d'experts (JMIR Med Inform, 2023), l'EHDS vise l'harmonisation et la réutilisation sans régler les normes\nconcrètes à utiliser.", "kind": "research-finding", "kind_label": "résultat de recherche", "locator": "sectie Discussion/Conclusions", "as_of": "2026-09-25", "source": { "id": "SRC-b22ee5ef19", "title": "Can OpenEHR, ISO 13606, and HL7 FHIR Work Together? An Agnostic Approach for the Selection and Application of Electronic Health Record Standards to the Next-Generation Health Data Spaces", "publisher": "JMIR Medical Informatics (Pedrera-Jiménez et al.)", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784985/", "published": "2023-12-28" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-c4f61547", "statement": "In de EMA-use case van de pilot gebruikte DARWIN EU de OMOP CDM; andere knooppunten mochten kiezen tussen analyse op brondata of conversie naar OMOP. OMOP was dus een optie in de pilot, geen verplichting.", "kind": "research-finding", "kind_label": "résultat de recherche", "locator": "sectie 'Summary of the EMA use case'", "as_of": "2026-09-25", "source": { "id": "SRC-b280053090", "title": "The European Health Data Space in communicable diseases surveillance and monitoring of medicines and vaccines: achievements of a pilot project examining the user journey", "publisher": "European Journal of Public Health", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12420905/", "published": "2025" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-f8e9a39f", "statement": "Een interoperabiliteitsraamwerk voor EHDS-secundair gebruik (JMIR 2025) noemt OMOP CDM als standaard voor semantische interoperabiliteit (academisch voorstel, geen EU-besluit).", "kind": "research-finding", "kind_label": "résultat de recherche", "locator": "sectie Results, semantische laag", "as_of": "2026-09-25", "source": { "id": "SRC-55ef771c33", "title": "Interoperability Framework of the European Health Data Space for the Secondary Use of Data: Interactive European Interoperability Framework-Based Standards Compliance Toolkit for AI-Driven Projects", "publisher": "Journal of Medical Internet Research", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12059490/", "published": "2025" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-57376d36", "statement": "La Belgique choisit d'utiliser aussi les champs des types de messages européens dans les caresets belges; un message\ntransfrontalier est créé le plus près possible de la source, pour les informations se trouvant dans le DPI par le logiciel\ndu DPI.", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Organisatie in België'", "as_of": "2026-09-25", "source": { "id": "SRC-41ee539e0b", "title": "EHDS (European Health Data Space) - De Europese Verordening betreffende de Europese ruimte voor gezondheidsgegevens", "publisher": "eHealth-platform", "url": "https://www.ehealth.fgov.be/nl/page/ehds-european-health-data-space-de-europese-verordening-betreffende-de-europese-ruimte-voor-gezondheidsgegevens", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-ac8d824b", "statement": "Les implémenteurs des spécifications FHIR core-clinical belges doivent disposer d'une licence SNOMED CT Affiliate.", "kind": "fact", "kind_label": "fait", "locator": "sectie IP statements", "as_of": "2026-09-25", "source": { "id": "SRC-854e8cb270", "title": "HL7 Belgium FHIR IG - core-clinical profiles: Home", "publisher": "eHealth-platform / HL7 Belgium", "url": "https://www.ehealth.fgov.be/standards/fhir/core-clinical/en/index.html", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-0537aba1", "statement": "Voor primair gebruik legt de EHDS geen persistentiemodel op, alleen het uitwisselingsformaat (EEHRxF) voor de prioritaire categorieën, en België vraagt daarvoor één FHIR-standaard. Voor een Belgisch ziekenhuis is FHIR (EU-/BE-profielen met SNOMED CT/LOINC) daarom de directe verplichting. openEHR en OMOP zijn architectuurkeuzes en worden niet door de EHDS opgelegd.", "kind": "interpretation", "kind_label": "interprétation", "locator": "synthese van eehrxf-01/02, ehds-12/13/15, ehds-16", "as_of": "2026-09-25", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": false, "on_page": false }, { "id": "CLM-1e57ae00", "statement": "Synthese: FHIR is een uitwisselingsstandaard (API/berichten, EEHRxF-richting), openEHR een standaard voor klinische modellering en persistentie in het EPD, OMOP CDM een analysemodel voor secundair gebruik; SNOMED CT en LOINC zijn de gedeelde semantische laag die in alle drie wordt gebruikt (FHIR via CodeSystem/ValueSet-binding, openEHR via terminologiebinding in archetypes, OMOP als Standard Concepts). Ze zijn complementair: een ziekenhuis kan intern openEHR of een leveranciersmodel gebruiken, extern FHIR aanbieden en een OMOP-kopie voeden voor onderzoek.", "kind": "interpretation", "kind_label": "interprétation", "locator": "synthese van vgl-01..10, openehr-03/06, omop-cdm-07, fhir-03/04", "as_of": "2026-09-25", "source": { "id": "SRC-4762fc1944", "title": "Vulcan FHIR to OMOP FHIR Implementation Guide", "publisher": "HL7 International / Biomedical Research and Regulation", "url": "https://hl7.org/fhir/uv/omop/en/index.html", "published": null }, "citaat": null, "figuur": null, "in_text": false, "on_page": false }, { "id": "CLM-9933480b", "statement": "Onder de EHDS wordt deelname aan MyHealth@EU, dat vroeger vrijwillig was, verplicht voor de lidstaten.", "kind": "fact", "kind_label": "fait", "locator": "overweging 33", "as_of": "2026-09-25", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": false, "on_page": true }, { "id": "CLM-23e1f00b", "statement": "HealthData@EU is de grensoverschrijdende infrastructuur voor secundair gebruik; nationale contactpunten voor secundair gebruik en de Union health data access service moeten erop aansluiten.", "kind": "fact", "kind_label": "fait", "locator": "artikel 75(3)", "as_of": "2026-09-25", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": false, "on_page": true }, { "id": "CLM-1a78183e", "statement": "Elk nationaal contactpunt voor digitale gezondheid maakt de uitwisseling van de persoonlijke elektronische gezondheidsgegevens van artikel 14(1) met de contactpunten van andere lidstaten via MyHealth@EU mogelijk; die uitwisseling steunt op het EEHRxF.", "kind": "fact", "kind_label": "fait", "locator": "artikel 23(3)", "as_of": "2026-09-25", "source": { "id": "SRC-af26b6d770", "title": "Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847", "publisher": "Europees Parlement en Raad van de EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng", "published": "2025-03-05" }, "citaat": null, "figuur": null, "in_text": false, "on_page": true } ], "diagrams": [ { "id": "fhir-openehr-omop-terminologie", "kind": "lagen", "title": "FHIR, openEHR, OMOP en terminologieën: conceptueel model", "alt": "Drie lagen: de Europese laag (EHDS, EEHRxF, MyHealth@EU, HealthData@EU), de modellen voor uitwisseling, klinische modellering en analyse (HL7 FHIR, Belgische FHIR-IG's, openEHR, OMOP CDM) en de semantische laag (SNOMED CT, LOINC, ICD-10-BE), met veertien genummerde verbanden.", "note": "Toont de verhouding tussen standaarden volgens de bronnen; geen ziekenhuisarchitectuur en geen bewezen operationele koppelingen. Gestippeld = ontwerp, voorstel of standpunt.", "layers": [ { "title": "Europese laag", "subtitle": "EHDS", "nodes": [ { "id": "ehds", "label": "EHDS", "sublabel": "Verordening (EU) 2025/327", "type": { "code": "LegalAct", "label": "Acte législatif" }, "url": "/fr/espace-europeen-des-donnees-de-sante/", "title": "EHDS (Verordening (EU) 2025/327)" }, { "id": "eehrxf", "label": "EEHRxF", "sublabel": "Europees uitwisselingsformaat", "type": { "code": "Specification", "label": "Norme ou spécification" }, "url": "/fr/format-europeen-d-echange-des-dossiers-de-sante-informatises/", "title": "EEHRxF (Europees uitwisselingsformaat)" }, { "id": "mh", "label": "MyHealth@EU", "sublabel": "BE-NCPeH: eHealth-platform", "type": { "code": "Platform", "label": "Plateforme ou service" }, "url": "/fr/masante-ue/", "title": "MyHealth@EU (BE-NCPeH: eHealth-platform)" }, { "id": "hd", "label": "HealthData@EU", "sublabel": "BE: Health Data Agency", "type": { "code": "Platform", "label": "Plateforme ou service" }, "url": "/fr/donneessante-ue/", "title": "HealthData@EU (BE: Health Data Agency)" } ] }, { "title": "Modellen", "subtitle": "uitwisseling · klinische modellering · analyse", "nodes": [ { "id": "fhir", "label": "HL7 FHIR", "sublabel": "uitwisseling", "type": { "code": "Specification", "label": "Norme ou spécification" }, "url": "/fr/hl7-fhir/", "title": "HL7 FHIR (uitwisseling)" }, { "id": "beig", "label": "Belgische FHIR-IG's", "sublabel": "R4 4.0.1", "type": { "code": "Specification", "label": "Norme ou spécification" }, "url": "/fr/guides-d-implementation-fhir-belges/", "title": "Belgische FHIR-IG's (R4 4.0.1)" }, { "id": "oehr", "label": "openEHR", "sublabel": "klinische modellering, archetypes", "type": null, "url": null, "title": "openEHR (klinische modellering, archetypes)" }, { "id": "omop", "label": "OMOP CDM v5.5", "sublabel": "analyse en onderzoek", "type": { "code": "Specification", "label": "Norme ou spécification" }, "url": "/fr/omop-cdm-et-ohdsi/", "title": "OMOP CDM v5.5 (analyse en onderzoek)" } ] }, { "title": "Semantische laag", "subtitle": "terminologie en classificatie", "nodes": [ { "id": "snomed", "label": "SNOMED CT", "sublabel": "Belgian Edition", "type": { "code": "Terminology", "label": "Terminologie ou classification" }, "url": "/fr/snomed-ct/", "title": "SNOMED CT (Belgian Edition)" }, { "id": "loinc", "label": "LOINC", "sublabel": "Belgische subset", "type": { "code": "Terminology", "label": "Terminologie ou classification" }, "url": "/fr/loinc-et-le-sous-ensemble-belge-retam/", "title": "LOINC (Belgische subset)" }, { "id": "icd", "label": "ICD-10-BE", "sublabel": null, "type": { "code": "Terminology", "label": "Terminologie ou classification" }, "url": "/fr/icd-10-be/", "title": "ICD-10-BE" } ] } ], "participants": [], "edges": [ { "n": "1", "source": "ehds", "target": "eehrxf", "text": "EHDS: de Commissie legt de EEHRxF-specificaties vast (tegen 26/3/2027)", "status": "established", "reply": false, "claims": [ "CLM-14a07bfc" ], "refs": [ 28 ] }, { "n": "2", "source": "ehds", "target": "mh", "text": "EHDS: deelname aan MyHealth@EU verplicht voor lidstaten", "status": "established", "reply": false, "claims": [ "CLM-9933480b" ], "refs": [ 28 ] }, { "n": "3", "source": "ehds", "target": "hd", "text": "EHDS: secundair gebruik via HealthData@EU; OMOP enkel een optie in de pilot", "status": "established", "reply": false, "claims": [ "CLM-23e1f00b", "CLM-c4f61547" ], "refs": [ 28, 31 ] }, { "n": "4", "source": "mh", "target": "eehrxf", "text": "MyHealth@EU-uitwisseling steunt op EEHRxF", "status": "established", "reply": false, "claims": [ "CLM-1a78183e" ], "refs": [ 28 ] }, { "n": "5", "source": "eehrxf", "target": "fhir", "text": "HL7 Europe Base/Core-IG's (STU); uitvoeringshandelingen verwacht begin 2027", "status": "hypothesis", "reply": false, "claims": [ "CLM-c6b73f2f" ], "refs": [ 29 ] }, { "n": "6", "source": "beig", "target": "fhir", "text": "Belgische IG's profileren FHIR R4 (geen R5)", "status": "established", "reply": false, "claims": [ "CLM-4c97a5a4" ], "refs": [ 19 ] }, { "n": "7", "source": "beig", "target": "eehrxf", "text": "EU-velden ook in Belgische CareSets (Belgisch standpunt)", "status": "hypothesis", "reply": false, "claims": [ "CLM-57376d36" ], "refs": [ 30 ] }, { "n": "8", "source": "beig", "target": "snomed", "text": "SNOMED CT als voorkeurscodering in Belgische IG's", "status": "established", "reply": false, "claims": [ "CLM-530b635f" ], "refs": [ 23 ] }, { "n": "9", "source": "beig", "target": "loinc", "text": "BE Lab-IG: LOINC verplicht (FOD-subset)", "status": "established", "reply": false, "claims": [ "CLM-e0e48933" ], "refs": [ 24 ] }, { "n": "10", "source": "oehr", "target": "snomed", "text": "openEHR: terminologiebinding via archetypes (SNOMED CT als voorbeeld is een interpretatie)", "status": "established", "reply": false, "claims": [ "CLM-19680c4c" ], "refs": [ 10 ] }, { "n": "11", "source": "oehr", "target": "fhir", "text": "Een openEHR↔FHIR-IG voor datatype-mapping is in ontwikkeling", "status": "hypothesis", "reply": false, "claims": [ "CLM-4d28e36b" ], "refs": [ 26 ] }, { "n": "12", "source": "fhir", "target": "omop", "text": "HL7 Vulcan FHIR-to-OMOP IG v1.0.0 (Informative; CDM v5.4); niet verliesvrij", "status": "established", "reply": false, "claims": [ "CLM-77f1c57f", "CLM-cd749309" ], "refs": [ 1 ] }, { "n": "13", "source": "omop", "target": "snomed", "text": "OMOP: SNOMED CT als standaardconcept voor aandoeningen", "status": "established", "reply": false, "claims": [ "CLM-8b25e1f2" ], "refs": [ 17 ] }, { "n": "14", "source": "icd", "target": "omop", "text": "ICD als broncode, gemapt op een standaardconcept (ICD-10-BE specifiek is een interpretatie)", "status": "established", "reply": false, "claims": [ "CLM-8b25e1f2", "CLM-71837b87" ], "refs": [ 17 ] } ], "footer": null } ], "facets": { "type": [ "Topic" ], "jurisdiction": [ "internationaal", "eu", "belgie" ], "theme": [ "architectuur-en-infrastructuur", "terminologie", "secundair-gebruik" ], "lifecycle": [ "onbekend" ], "section": [ "terminologie", "europa" ] }, "search_terms": [ "FHIR, openEHR et OMOP : comparaison", "FHIR vs openEHR vs OMOP", "FHIR, openEHR en OMOP CDM", "uitwisseling vs persistentie vs analyse", "FHIR, openEHR en OMOP: vergelijking", "FHIR, openEHR and OMOP compared" ], "release_id": "2026.11.12-3", "license": "CC BY 4.0" }