{ "id": "hl7-eu-igs", "url": "/fr/guides-d-implementation-fhir-europeens-hl7-europe/", "md_url": "/fr/guides-d-implementation-fhir-europeens-hl7-europe.md", "json_url": "/fr/guides-d-implementation-fhir-europeens-hl7-europe.json", "claims_url": "/fr/guides-d-implementation-fhir-europeens-hl7-europe/beweringen/", "type": { "code": "Topic", "label": "Aperçu ou dossier" }, "schema_type": "Thing", "lang": "fr", "translation": { "lang": "fr", "source_url": "/hl7-eu-igs/", "date": "2026-11-13", "stale": false, "fields": [ "in_het_kort", "lifecycle_note", "sectie:fase", "sectie:onzekerheden-en-tegenstrijdige-informatie", "sectie:wat-betekent-het-voor-een-ziekenhuis", "sectie:wat-is-het", "summary", "title" ] }, "title": "Guides d'implémentation FHIR européens (HL7 Europe)", "aliases": [ "HL7 EU IG's", "HL7 Europe-gidsen", "EU-realm FHIR-gidsen", "hl7.fhir.eu" ], "names": { "nl": "Europese FHIR-implementatiegidsen (HL7 Europe)", "fr": "Guides d'implémentation FHIR européens (HL7 Europe)", "en": "HL7 Europe FHIR Implementation Guides", "de": null }, "jurisdiction": [ { "code": "eu", "label": "Union européenne" } ], "themes": [ { "code": "grensoverschrijdend", "label": "Échange transfrontalier" }, { "code": "standaardisatie-en-governance", "label": "Normalisation et gouvernance" }, { "code": "architectuur-en-infrastructuur", "label": "Architecture et infrastructure" } ], "lifecycle": { "code": "nvt", "label": "sans objet" }, "lifecycle_note_html": "Référence ; état des package-lists au 5 novembre 2026, vérifié le 12 novembre : quatre guides sont en STU, le résumé patient et l'imagerie sont encore en ballot.", "version": null, "vendor": null, "sectors": [], "homologations": [], "links": [ { "kind": { "code": "documentatie", "label": "Documentation" }, "url": "https://hl7.eu/fhir/", "label": "HL7 Europe FHIR IG Portal", "host": "hl7.eu", "lang": "en" } ], "summary_text": "HL7 Europe publie des guides d'implémentation FHIR dans le « EU-realm »: une couche de base commune (Base and Core) et, pour chaque catégorie prioritaire de données de l'EHDS, un guide de contenu, par exemple pour le rapport de sortie, le rapport de laboratoire et le résumé patient. Ils sont alignés sur les modèles logiques de la Joint Action Xt-EHR et veulent devenir la base des guides nationaux, du format européen d'échange (EEHRxF) et de MaSanté@UE. Une partie est une Standard for Trial Use, une autre est encore en ballot. Pour les hôpitaux et leurs fournisseurs, ils montrent comment les rapports européens seront probablement structurés; aucune désignation par la Commission n'a été trouvée.", "summary_html": "

HL7 Europe publie des guides d'implémentation FHIR dans le « EU-realm » : une couche de base commune (Base and Core) et, pour chaque catégorie prioritaire de données de l'EHDS, un guide de contenu, par exemple pour le rapport de sortie, le rapport de laboratoire et le résumé patient. Ils sont alignés sur les modèles logiques de la Joint Action Xt-EHR et veulent devenir la base des guides nationaux, du format européen d'échange (EEHRxF) et de MaSanté@UE. Une partie est une Standard for Trial Use, une autre est encore en ballot. Pour les hôpitaux et leurs fournisseurs, ils montrent comment les rapports européens seront probablement structurés ; aucune désignation par la Commission n'a été trouvée.

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Un guide d'implémentation FHIR (IG) fixe la manière dont la norme générale HL7 FHIR est concrétisée pour un objectif ou un domaine déterminé : quels profils, extensions et codes s'appliquent. HL7 Europe, le bureau européen de HL7 International (voir HL7 Europe), publie de tels guides pour le contexte européen, le « EU-realm », avec les noms de paquets hl7.fhir.eu.*. Ensemble, ils forment un ensemble de guides à l'appui des catégories prioritaires du règlement EHDS[1], et HL7 Europe a développé de tels guides pour les six catégories prioritaires, avec le soutien des affiliates de son équipe de coordination technique[15].

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Les guides sont alignés sur le modèle logique de la Joint Action Xt-EHR[2]. Selon HL7 Europe, les guides d'octobre 2026 soutiennent l'EHDS par un alignement sur les modèles logiques EHDS les plus récents et par de meilleurs mappings du modèle vers le profil[16]. Le livrable D6.2 de Xt-EHR considère les guides HL7 Europe comme partie intégrante du livrable ; outre la consultation Xt-EHR, ils suivent aussi le processus de ballot habituel de HL7 Europe[17]. Le déroulement de ce processus de ballot est décrit sur Besluitvorming en ballotprocedure van HL7 Europe.

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L'objectif est chaque fois le même : les guides de contenu veulent être la base des guides nationaux européens, du format européen d'échange des dossiers médicaux électroniques (EEHRxF) et, partant, des services transfrontaliers de MaSanté@UE[1][18]. C'est une ambition, pas une décision : la Commission doit établir, par voie d'actes d'exécution, les spécifications techniques de l'EEHRxF au plus tard le 26 mars 2027[11]. Selon le responsable technique de HL7 Europe, plus de 200 contributeurs de 29 pays ont participé aux publications d'octobre 2026[16].

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Chez HL7 Europe, un guide passe d'abord par un ballot, le vote formel sur une version de projet : chacun peut formuler des commentaires, mais seuls les affiliates votent officiellement[19]. Suit ensuite une publication en STU (Standard for Trial Use) ; dans la package-list, le statut « trial-use » désigne une spécification prête pour un usage à l'essai[20]. Une version de ballot n'est donc pas une release. À côté de ces publications, il existe pour chaque guide un build continu (CI-build) ; celui-ci n'est expressément pas une publication autorisée[21].

" }, { "id": "bouwstenen", "title": "Bouwstenen", "kind": "tekst", "html": "

De versie, datum en status per gids komen uit de package-list van elke gids, stand 5 november 2026. De EHDS-fase is het jaar waarin de EHDS-regels voor die categorie beginnen te gelden[11].

\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\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\n\n\n\n\n\n\n\n\n\n\n\n
Gids en pakketCategorie (EHDS-fase)Versie en datumStatusPaginaBron
Base and Core, hl7.fhir.eu.base (R4)basislaag2.0.1, 13 september 2026trial-use, STU 2HL7 Europe Base and Core[5]
Base and Core R5, hl7.fhir.eu.base-r5basislaag2.0.1, 13 september 2026trial-use, STU 2HL7 Europe Base and Core[22]
Extensions, hl7.fhir.eu.extensionsbasislaag1.3.1, 12 september 2026trial-use, reeks ReleaseHL7 Europe Base and Core[23]
European Patient Summary, hl7.fhir.eu.eps (R4)patiëntsamenvatting (2029)1.0.0-ballot, 6 juni 2026ballot, STU 1HL7 Europe European Patient Summary[9]
Medication Prescription and Dispense, hl7.fhir.eu.mpd (R4)e-voorschrift en e-aflevering (2029)1.0.0, 11 mei 2026trial-use, eerste STUHL7 Europe Medication Prescription and Dispense (MPD)[8]
Medication Prescription and Dispense R5, hl7.fhir.eu.mpd-r5e-voorschrift en e-aflevering (2029)1.0.0, 14 mei 2026trial-use, STU 1HL7 Europe Medication Prescription and Dispense (MPD)[24]
Laboratory Report, hl7.fhir.eu.laboratory (R4)testresultaten incl. labo (2031)2.1.0, 16 oktober 2026trial-use, STU 2HL7 Europe Laboratory Report[6]
Imaging Report, hl7.fhir.eu.imaging (R4)beeldvorming (2031)1.0.0-ballot, 16 maart 2026ballot, STU 1HL7 Europe Imaging Report en EU Imaging Manifest (EU-MADO)[10]
Imaging Study Report R5, hl7.fhir.eu.imaging-r5beeldvorming (2031)1.0.0-ballot, 20 maart 2026ballot, STU 1HL7 Europe Imaging Report en EU Imaging Manifest (EU-MADO)[25]
EU-MADO, hl7.fhir.eu.imaging-manifest (R4)beeldvorming (2031)1.0.0-ballot, 16 oktober 2026ballot, STU 1HL7 Europe Imaging Report en EU Imaging Manifest (EU-MADO)[26]
Hospital Discharge Report, hl7.fhir.eu.hdr (R4)ontslagverslag (2031)1.0.0, 16 oktober 2026trial-use, STU 1HL7 Europe Hospital Discharge Report[7]
EU Health Data API, hl7.fhir.eu.health-data-api (R4)uitwisseling (transport)1.0.0-ballot, 13 maart 2026ballotEEHRxF (format européen d'échange des dossiers de santé informatisés)[27]
Common Cancer Model, hl7.fhir.eu.cancer-common (R4)buiten de zes categorieën1.0.0-ballot, 14 juni 2026ballot, STU 1deze pagina[28]
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Basislaag en inhoudsgidsen

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De Base and Core-IG wil een basis zijn voor interoperabiliteit en hergebruik in nationale projecten, Europese initiatieven en afgeleide HL7 Europe-gidsen[3]; haar losse basisprofielen en strengere Core-profielen staan op HL7 Europe Base and Core. Het Extensions-pakket hoort bij die laag: versie 1.3.1 is een technische correctie van 1.3.0 die onder meer de extensie Laboratory Accredited uit de Laboratory Report-IG overneemt, met ongewijzigde canonical en inhoud[23].

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De inhoudsgidsen volgen de prioritaire categorieën. Volgens de EU Health Data API definiëren afzonderlijke content-IG's van HL7 Europe de structuur en inhoud van elke categorie[4]; ze koppelt de patiëntsamenvatting aan Patient Summary, de medische testresultaten aan Laboratory Report, het ontslagverslag aan Hospital Discharge Report en de beeldvorming aan Imaging Study/Report en Imaging Manifest, telkens via documentuitwisseling met het IHE-profiel MHD[4]. Per gids:\n- European Patient Summary beschrijft de patiëntsamenvatting in de Europese context, coherent met de richtsnoeren van het eHealth Network[18].\n- Medication Prescription and Dispense is bedoeld voor e-voorschriften en e-afleveringen voor grensoverschrijdende uitwisseling, afgestemd op het EHDS-model[29].\n- Laboratory Report beschrijft laboverslagen voor grensoverschrijdende uitwisseling, afgestemd op het EHDS-model Medical Test Results[29].\n- Imaging Report en EU-MADO dekken het beeldvormingsverslag en het manifest van een beeldvormingsstudie; verslag en manifest zijn bewust gescheiden[30].\n- Hospital Discharge Report legt inhoud en structuur van het ontslagverslag vast, maar beschrijft niet hoe het verslag wordt uitgewisseld[1].

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Common Cancer Model

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Het Common Cancer Model valt buiten de zes prioritaire categorieën. Het wil een model documenteren dat onafhankelijk is van kankertype en technische standaard, met mappings naar HL7 FHIR en naar OMOP om primaire uitwisseling en secundair gebruik in onderzoek te verbinden[31]. Het pakket verscheen op 14 juni 2026 als eerste ballot[28]; op 24 juni 2026 opende HL7 Europe de ballot als eerste STU van een gemeenschappelijk conceptueel en logisch informatiemodel voor kankergegevens in de Europese context[32]. Die ballot toetst vooral de conceptuele en logische modellen; de voorbeelden in FHIR en OMOP zijn louter informatief[32].

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Verwante gids buiten HL7 Europe: de Yellow Button van xShare

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De Yellow Button-IG van het project xShare is geen HL7 Europe-gids, maar bouwt op de Europese gidsen voort: versie 0.2.0 voegde verwijzingen toe naar de Europese gidsen voor ontslagverslag, voorschrift en aflevering, beeldvormingsverslag en beeldvormingsmanifest[33]. xShare wil dat iedereen zijn gezondheidsgegevens met één klik op de 'gele knop' in het EEHRxF kan delen, via gezondheidsportalen en patiëntenapps[33]. Versie 0.3.0 behandelt enkel de functies download en eenmalige link[34], en de gids wordt continu onderhouden[34].

" }, { "id": "phase", "title": "Phase", "kind": "tekst", "html": "

Maturité face à l'échelonnement légal (interprétation). Les règles de l'EHDS s'appliquent à partir du 26 mars 2029 au résumé patient, à la prescription électronique et à la dispensation électronique, et deux ans plus tard à l'imagerie, aux résultats d'examens et aux rapports de sortie[11]. La maturité des guides ne suit pas cet ordre : Hospital Discharge Report et Laboratory Report, des catégories de 2031, sont en STU[7][6], tandis que l'European Patient Summary, une catégorie de 2029, en est encore à la version de ballot de juin 2026[9]. Medication Prescription and Dispense (2029) est bien en STU[8], et l'imagerie (2031) est en ballot dans les trois guides[10][25][26].

\n

Statut formel. Au 5 novembre 2026, l'acte d'exécution qui fixe techniquement l'EEHRxF n'a pas encore paru sous forme de projet : l'étape de projet de l'initiative Have your say 17512 était alors encore sur « UPCOMING », sans annexes[14]. La Commission prévoit l'adoption au quatrième trimestre de 2026[14]. D'ici là, aucun guide HL7 Europe n'est une spécification légale de l'EEHRxF ; aucune information n'a été trouvée sur les guides que l'acte désignera.

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MaSanté@UE. Le plan de travail 2026 de MaSanté@UE de la Commission mentionne l'introduction de l'EEHRxF pour le résumé patient et la prescription électronique, avec comme date limite pour les propositions de modification le 30 septembre 2026 (wave 11)[12]. Pour les images médicales, les résultats de laboratoire et les rapports de sortie, cette date limite est fixée au 30 septembre 2027 (wave 12)[12]. Afin de préparer la discussion sur le passage à FHIR, le même plan de travail contient une preuve de concept (proof of concept) menée par un fournisseur de solutions avec FHIR pour la prescription électronique et le résumé patient[12]. La Commission souligne que le contenu effectif de ces waves dépend des actes d'exécution[12].

\n

Prochaine étape chez HL7 Europe. La Working Group Meeting de HL7 Europe à Malaga (16-20 novembre 2026, prévue) s'ouvre sur des sujets transversaux, comme les obligations découlant des articles 15 et 36 de l'EHDS et l'alignement sur les modèles logiques[35].

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

Trois des guides de contenu touchent directement des documents hospitaliers : le rapport de sortie, le rapport de laboratoire et le compte rendu d'imagerie. Ce sont des catégories auxquelles les règles de l'EHDS, dont l'EEHRxF de l'article 15, s'appliquent à partir du 26 mars 2031[11]. Un DPI doit pouvoir exporter et importer l'EEHRxF, mais n'est pas tenu de l'utiliser en interne[36]. Les guides veulent devenir la base de ce format[1], mais c'est la Commission qui fixe les spécifications techniques par voie d'actes d'exécution[11].

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Belgique. Aucun alignement sur les guides européens n'a été trouvé dans les guides FHIR belges : au 12 novembre 2026, les pages d'accueil des guides belges core, core-clinical, patient-dossier et medication et la page guidance de l'IG labo belge ne mentionnent aucun guide HL7 Europe, et les dépendances des CI-builds ne contiennent aucun paquet hl7.fhir.eu (interprétation)[13]. Cela renseigne sur les guides eux-mêmes, pas sur d'éventuels plans en dehors de ceux-ci ; aucune déclaration belge sur un alignement n'a été trouvée. Les guides belges sont présentés sur Guides d'implémentation FHIR belges.

\n

Recommandation. Demandez aux fournisseurs de DPI, de systèmes d'information de laboratoire (LIS) et de RIS quelle version des guides HL7 Europe ils suivent et comment ils prendront en charge côte à côte les profils belges et européens ; pour le résumé patient et l'imagerie, suivez le passage du ballot à la STU.

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"publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/hdr/index.html", "published": "2026-10-16" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-dd290e2d", "statement": "Les IG de HL7 Europe sont alignés sur le modèle logique de la Joint Action Xt-EHR.", "kind": "fact", "kind_label": "fait", "locator": "citaat", "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-79b9b828", "statement": "De HL7 Europe Base and Core-IG wil een basis zijn voor interoperabiliteit en hergebruik in nationale projecten, Europese initiatieven en afgeleide HL7 Europe-gidsen.", "kind": "fact", "kind_label": "fait", "locator": "secties 'Acknowledgment' en 'Scope'", "as_of": "2026-11-09", "source": { "id": "SRC-c19a0d3998", "title": "HL7 Europe Base and Core FHIR Implementation Guide", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/base/", "published": "2026-09-13" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-5b11ca85", "statement": "Volgens de EU Health Data API definiëren afzonderlijke content-IG's van HL7 Europe de structuur en inhoud van elke prioritaire categorie.", "kind": "fact", "kind_label": "fait", "locator": "sectie Scope", "as_of": "2026-11-05", "source": { "id": "SRC-5b23061c0d", "title": "EU Health Data API 1.0.0-ballot - Home", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/health-data-api/1.0.0-ballot/en/index.html", "published": "2026-03-13" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-d5aa80e1", "statement": "HL7 Europe Base and Core (pakket hl7.fhir.eu.base, FHIR R4) staat op 5 november 2026 op versie 2.0.1 van 13 september 2026, status trial-use, reeks STU 2, en is in de package-list gemarkeerd als huidige publicatie.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 2.0.1", "as_of": "2026-11-05", "source": { "id": "SRC-9f6b27edb5", "title": "package-list.json — HL7 Europe Base and Core", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/base/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-f8e19af6", "statement": "HL7 Europe Laboratory Report (pakket hl7.fhir.eu.laboratory, FHIR R4) staat op 5 november 2026 op versie 2.1.0 van 16 oktober 2026, status trial-use, STU 2, als huidige publicatie.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 2.1.0", "as_of": "2026-11-05", "source": { "id": "SRC-1739d1b051", "title": "HL7 Europe Laboratory Report – package-list (hl7.fhir.eu.laboratory)", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/laboratory/package-list.json", "published": "2026-05-05" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-e27d4d26", "statement": "HL7 Europe Hospital Discharge Report (pakket hl7.fhir.eu.hdr, FHIR R4) staat op 5 november 2026 op versie 1.0.0 van 16 oktober 2026, status trial-use, STU 1, als huidige publicatie.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 1.0.0", "as_of": "2026-11-05", "source": { "id": "SRC-89b34e5559", "title": "HL7 Europe Hospital Discharge Report – package-list (hl7.fhir.eu.hdr)", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/hdr/package-list.json", "published": "2025-06-03" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-315e7feb", "statement": "HL7 Europe Medication Prescription and Dispense version 1.0.0 (première STU, FHIR R4) a été publié le 11 mai 2026.", "kind": "fact", "kind_label": "fait", "locator": "lijstitem versie 1.0.0", "as_of": "2026-09-26", "source": { "id": "SRC-c6441eb32c", "title": "HL7 Europe Medication Prescription and Dispense – package-list (hl7.fhir.eu.mpd)", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/mpd/package-list.json", "published": "2026-05-11" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-46d7b917", "statement": "De HL7 Europe European Patient Summary (pakket hl7.fhir.eu.eps, FHIR R4) staat op 5 november 2026 nog op 1.0.0-ballot van 6 juni 2026 (status ballot, STU 1) als huidige publicatie.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 1.0.0-ballot", "as_of": "2026-11-05", "source": { "id": "SRC-ee68607979", "title": "package-list.json — HL7 Europe European Patient Summary", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/eps/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-43c4b269", "statement": "HL7 Europe Imaging Report (pakket hl7.fhir.eu.imaging, FHIR R4) staat op 5 november 2026 nog op 1.0.0-ballot van 16 maart 2026 (status ballot, STU 1) als huidige publicatie.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 1.0.0-ballot", "as_of": "2026-11-05", "source": { "id": "SRC-d24b4e187b", "title": "HL7 Europe Imaging Report – package-list (hl7.fhir.eu.imaging)", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/imaging/package-list.json", "published": "2026-03-16" }, "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-f0c11b24", "statement": "Hetzelfde werkplan noemt het invoeren van het EEHRxF voor patiëntsamenvatting en e-voorschrift in MyHealth@EU, met als deadline voor wijzigingsvoorstellen 30 september 2026 (wave 11).", "kind": "fact", "kind_label": "fait", "locator": "p. 12", "as_of": "2026-11-12", "source": { "id": "SRC-14eef3e115", "title": "European Health Data Space – State of play (keynote Europese Commissie, IHE-Europe Experience Days 2026)", "publisher": "Europese Commissie, DG SANTE Unit C1 (gepubliceerd door IHE-Europe)", "url": "https://connectathon.ihe-europe.net/sites/ihe-cat2014.org/files/IHE_EU_EXP_DAYS_2026_Fulvia_Raffaelli_European_Commission.pdf", "published": "2026-03-01" }, "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-3c7bb39c", "statement": "Interpretatie: de Engelstalige homepagina's van de gepubliceerde Belgische FHIR-gidsen core, core-clinical, patient-dossier en medication, en de guidance-pagina van de Belgische labo-IG, vermelden op 12 november 2026 geen HL7 Europe-gids, het EEHRxF of de EHDS; ook de dependsOn-lijsten van de ci-builds van core, lab, medication, allergy en core-clinical bevatten geen hl7.fhir.eu-pakket. Een expliciete Belgische afstemming op de Europese IG's werd in de IG's zelf niet gevonden.", "kind": "interpretation", "kind_label": "interprétation", "locator": "volledige pagina doorzocht op 'Europe', 'hl7.fhir.eu', 'EHDS', 'EEHRxF'", "as_of": "2026-11-12", "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-12a1a232", "statement": "Op 5 november 2026 staat de ontwerpfase (REG_IMPL_DRAFT) van het Have your say-initiatief 17512 over de EEHRxF-specificaties nog op 'UPCOMING', zonder bijlagen.", "kind": "fact", "kind_label": "fait", "locator": "publications[1], type REG_IMPL_DRAFT", "as_of": "2026-11-05", "source": { "id": "SRC-4864135425", "title": "Have your say – European Health Data Space – European Electronic Health Exchange Format specifications (initiatief 17512, API-JSON)", "publisher": "Europese Commissie (Better Regulation portal)", "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/17512", "published": "2026-03-30" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-f8cf0752", "statement": "HL7 Europe ontwikkelde FHIR-implementatiegidsen voor alle zes prioritaire gegevenscategorieën van de EHDS, met steun van de affiliates in het technische coördinatieteam.", "kind": "fact", "kind_label": "fait", "locator": "p. 7", "as_of": "2026-11-09", "source": { "id": "SRC-b25ffa6f86", "title": "HL7 Europe Annual Report 2025", "publisher": "HL7 Europe", "url": "https://hl7europe.org/wp-content/uploads/2026/07/AnnualReportHL7Europe2025-v4.pdf", "published": "2026-07-01" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-dc3f797c", "statement": "Volgens HL7 Europe ondersteunen haar gidsen van oktober 2026 de EHDS door afstemming op de recentste logische EHDS-modellen en betere model-naar-profielmappings.", "kind": "fact", "kind_label": "fait", "locator": "nieuwsbericht 16 oktober 2026", "as_of": "2026-11-12", "source": { "id": "SRC-2e6bb331e1", "title": "HL7 Europe publishes new Implementation Guides for EHDS priority categories of health data", "publisher": "HL7 Europe", "url": "https://hl7europe.org/hl7-europe-publishes-new-implementation-guides-for-ehds-priority-categories-of-health-data/", "published": "2026-10-16" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-4ffda25c", "statement": "D6.2 beschouwt de FHIR-IG's van HL7 Europe als integraal deel van de deliverable; ze doorlopen naast de Xt-EHR-consultatie ook het gewone ballotproces van HL7 Europe.", "kind": "fact", "kind_label": "fait", "locator": "p. 56", "as_of": "2026-11-05", "source": { "id": "SRC-2b0228d632", "title": "Xt-EHR D6.2 Electronic prescription and electronic dispensation: Implementation guides on EEHRxF, functional and technical requirements and specifications for EHR systems", "publisher": "Xt-EHR Joint Action", "url": "https://www.xt-ehr.eu/wp-content/uploads/2026/05/D6.2-2.pdf", "published": "2026-05-05" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-dc538e09", "statement": "HL7 Europe veut que l'IG Hospital Discharge Report serve de base aux guides nationaux européens, à l'EEHRxF et donc à MaSanté@UE.", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Purpose'", "as_of": "2026-10-27", "source": { "id": "SRC-7cb14d21d3", "title": "HL7 Europe Hospital Discharge Report v1.0.0 — Home", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/hdr/index.html", "published": "2026-10-16" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-53a28603", "statement": "Le guide d'implémentation européen Patient Summary veut constituer la base des guides nationaux, de l'EEHRxF et donc de MaSanté@UE.", "kind": "fact", "kind_label": "fait", "locator": "Home, sectie Purpose", "as_of": "2026-09-25", "source": { "id": "SRC-be3c37e977", "title": "HL7 Europe Patient Summary - Home", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/eps/", "published": "2026-06-06" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-f30ff8ac", "statement": "Volgens de technisch leider van HL7 Europe werkten aan de publicaties van oktober 2026 meer dan 200 bijdragers uit 29 landen mee.", "kind": "fact", "kind_label": "fait", "locator": "nieuwsbericht 16 oktober 2026, citaat van de technisch leider", "as_of": "2026-11-12", "source": { "id": "SRC-2e6bb331e1", "title": "HL7 Europe publishes new Implementation Guides for EHDS priority categories of health data", "publisher": "HL7 Europe", "url": "https://hl7europe.org/hl7-europe-publishes-new-implementation-guides-for-ehds-priority-categories-of-health-data/", "published": "2026-10-16" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-87abbcda", "statement": "Bij HL7 Europe mag iedereen commentaar geven op ballots voor Europese FHIR-IG's, maar alleen HL7 Europe-affiliates (zoals HL7 Belgium) mogen officieel stemmen. De ballotronde voor de Base- en Core-IG's liep tot 31 januari 2026.", "kind": "fact", "kind_label": "fait", "locator": "eerste alinea (5 januari 2026)", "as_of": "2026-09-26", "source": { "id": "SRC-fe0be74bae", "title": "New ballots opened for HL7 Europe Base and Core FHIR Implementation Guides", "publisher": "HL7 Europe", "url": "https://www.hl7europe.org/new-ballots-opened-for-hl7-europe-base-and-core-fhir-implementation-guides/", "published": "2026-01-05" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-575c15cd", "statement": "La valeur de statut « trial-use » (uniquement pour BE Lab 1.0.0) désigne, selon HL7, une spécification prête pour un usage d'essai; « normative » est une spécification entièrement normative.", "kind": "fact", "kind_label": "fait", "locator": "tabel 'Possible values for status', waarden trial-use en normative", "as_of": "2026-09-29", "source": { "id": "SRC-994914ebd1", "title": "FHIR Package List Documentation", "publisher": "HL7 International (FHIR Confluence)", "url": "https://confluence.hl7.org/spaces/FHIR/pages/288399849/FHIR+Package+List+Documentation", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-8f433876", "statement": "Le build continu de l'IG HL7 Europe Patient Summary est en 1.0.0-ci-build avec le statut Draft (état au 2026-10-05); il n'y a pas de publication autorisée.", "kind": "fact", "kind_label": "fait", "locator": "startpagina, statusregel", "as_of": "2026-10-08", "source": { "id": "SRC-9fdece6ac0", "title": "HL7 Europe Patient Summary IG (continuous build)", "publisher": "HL7 Europe", "url": "https://build.fhir.org/ig/hl7-eu/eps/", "published": null }, "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-2db83d51", "statement": "De R5-variant van HL7 Europe Base and Core (pakket hl7.fhir.eu.base-r5, FHIR 5.0.0) staat op dezelfde versie 2.0.1 van 13 september 2026, status trial-use, STU 2, als huidige publicatie.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 2.0.1", "as_of": "2026-11-05", "source": { "id": "SRC-6a27e97306", "title": "HL7 Europe Base and Core (R5) - package-list", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/base-r5/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-d0fc626e", "statement": "HL7 Europe Extensions (pakket hl7.fhir.eu.extensions) staat op versie 1.3.1 van 12 september 2026, status trial-use, reeks Release, als huidige publicatie.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 1.3.1", "as_of": "2026-11-05", "source": { "id": "SRC-7d4be16e59", "title": "HL7 Europe Extensions - package-list", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/extensions/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-60eab8ee", "statement": "Naast de R4-versie bestaat HL7 Europe Medication Prescription and Dispense voor FHIR R5 (pakket hl7.fhir.eu.mpd-r5), versie 1.0.0 van 14 mei 2026, status trial-use, STU 1, als huidige publicatie.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 1.0.0", "as_of": "2026-11-05", "source": { "id": "SRC-65e07dd033", "title": "HL7 Europe Medication Prescription and Dispense (R5) - package-list", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/mpd-r5/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-4035bee1", "statement": "De R5-variant (pakket hl7.fhir.eu.imaging-r5, titel Imaging Study Report) staat op 5 november 2026 nog op 1.0.0-ballot van 20 maart 2026 (status ballot, STU 1) als huidige publicatie.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 1.0.0-ballot", "as_of": "2026-11-05", "source": { "id": "SRC-a70b7f241e", "title": "package-list.json — HL7 Europe Imaging Report (FHIR R5)", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/imaging-r5/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-7e98af0b", "statement": "HL7 Europe publiceerde op 16 oktober 2026 de eerste ballot (1.0.0-ballot, STU 1, FHIR R4) van EU Manifest-based Access to DICOM Objects (EU-MADO), pakket hl7.fhir.eu.imaging-manifest.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 1.0.0-ballot", "as_of": "2026-11-05", "source": { "id": "SRC-4c88d2579f", "title": "EU Manifest-based Access to DICOM Objects (EU-MADO) - package-list", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/imaging-manifest/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-0994f551", "statement": "HL7 Europe publiceerde de EU Health Data API (pakket hl7.fhir.eu.health-data-api, FHIR R4) als 1.0.0-ballot van 13 maart 2026; dat is de huidige publicatie, status ballot.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 1.0.0-ballot", "as_of": "2026-11-05", "source": { "id": "SRC-1764592b2f", "title": "EU Health Data API - package-list", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/health-data-api/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-e63f1652", "statement": "HL7 Europe publiceerde op 14 juni 2026 de eerste ballot (1.0.0-ballot, STU 1, FHIR R4) van het Common Cancer Model, pakket hl7.fhir.eu.cancer-common.", "kind": "fact", "kind_label": "fait", "locator": "package-list, item versie 1.0.0-ballot", "as_of": "2026-11-05", "source": { "id": "SRC-d30678196f", "title": "HL7 Europe Common Cancer Model - package-list", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/cancer-common/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-a05ca1d2", "statement": "Extensions 1.3.1 is een technische correctie van 1.3.0 die onder meer de extensie Laboratory Accredited overneemt uit de HL7 Europe Laboratory Report-IG, met ongewijzigde canonical en inhoud.", "kind": "fact", "kind_label": "fait", "locator": "package-list, beschrijving versie 1.3.1", "as_of": "2026-11-05", "source": { "id": "SRC-7d4be16e59", "title": "HL7 Europe Extensions - package-list", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/extensions/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-c58db348", "statement": "De EU Health Data API koppelt de prioritaire categorieën aan content-IG's: patiëntsamenvatting aan HL7 Europe Patient Summary, medische testresultaten aan HL7 Europe Laboratory Report, ontslagverslag aan HL7 Europe Hospital Discharge Report en medische beeldvorming aan HL7 Europe Imaging Study/Report en Imaging Manifest, telkens via documentuitwisseling (MHD).", "kind": "fact", "kind_label": "fait", "locator": "sectie Priority Categories, tabel", "as_of": "2026-11-05", "source": { "id": "SRC-5b23061c0d", "title": "EU Health Data API 1.0.0-ballot - Home", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/health-data-api/1.0.0-ballot/en/index.html", "published": "2026-03-13" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-696cd7f8", "statement": "De HL7 Europe European Patient Summary-IG legt regels vast om een patiëntsamenvatting in de Europese context in FHIR voor te stellen, coherent met de eHN-richtsnoeren.", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Scope' (pagina van 1.0.0-ballot)", "as_of": "2026-11-12", "source": { "id": "SRC-be3c37e977", "title": "HL7 Europe Patient Summary - Home", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/eps/", "published": "2026-06-06" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-96626cf5", "statement": "Volgens het IG-portaal van HL7 Europe is de Medication Prescription and Dispense-IG bedoeld voor e-voorschriften en e-afleveringen voor grensoverschrijdende uitwisseling, afgestemd op het EHDS-model.", "kind": "fact", "kind_label": "fait", "locator": "portaal, sectie Publications", "as_of": "2026-11-05", "source": { "id": "SRC-461323f3ce", "title": "HL7 Europe FHIR IG Portal", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-84f6a35d", "statement": "Het IG-portaal van HL7 Europe beschrijft de Laboratory Report-IG als laboverslagen voor grensoverschrijdende uitwisseling, afgestemd op het EHDS-model Medical Test Results.", "kind": "fact", "kind_label": "fait", "locator": "portaal, sectie Publications", "as_of": "2026-11-05", "source": { "id": "SRC-461323f3ce", "title": "HL7 Europe FHIR IG Portal", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-1bd026d7", "statement": "Verslag en manifest zijn bewust gescheiden: het verslag draagt de interpretatie van de clinicus, het manifest de inventaris van de studie en de context om de DICOM-beelden op te halen.", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Relationship and scope boundaries'", "as_of": "2026-11-12", "source": { "id": "SRC-99f0556172", "title": "EU Imaging Manifest and Access (IHE-MADO additions) 1.0.0-ballot - Home", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/imaging-manifest/1.0.0-ballot/en/index.html", "published": "2026-10-16" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-e747b658", "statement": "De Hospital Discharge Report-IG legt de inhoudscomponenten en voorkeursstructuur van een ontslagverslag vast, voor nationale en grensoverschrijdende scenario's, maar beschrijft niet hoe het verslag wordt uitgewisseld.", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Scope'", "as_of": "2026-11-12", "source": { "id": "SRC-7cb14d21d3", "title": "HL7 Europe Hospital Discharge Report v1.0.0 — Home", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/hdr/index.html", "published": "2026-10-16" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-adc0767f", "statement": "Het Common Cancer Model wil een model documenteren dat onafhankelijk is van kankertype en technische standaard, met mappings naar HL7 FHIR en OMOP om primaire uitwisseling en secundair gebruik in onderzoek te verbinden.", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Scope'", "as_of": "2026-11-12", "source": { "id": "SRC-4875b7f99d", "title": "HL7 Europe Common Cancer Model 1.0.0-ballot - Home", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/cancer-common/1.0.0-ballot/", "published": "2026-06-14" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-075c3fda", "statement": "HL7 Europe opende op 24 juni 2026 een ballot (1.0.0-ballot, eerste STU) voor het Common Cancer Data Model, een gemeenschappelijk conceptueel en logisch informatiemodel voor kankergegevens in de Europese context.", "kind": "fact", "kind_label": "fait", "locator": "nieuwsbericht 24 juni 2026", "as_of": "2026-11-12", "source": { "id": "SRC-9d1d755538", "title": "New ballot opened for the HL7 Europe Common Cancer Data Model", "publisher": "HL7 Europe", "url": "https://hl7europe.org/new-ballot-opened-for-the-hl7-europe-common-cancer-data-model/", "published": "2026-06-24" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-018afc2b", "statement": "De ballot van het Common Cancer Data Model toetst vooral de conceptuele en logische modellen; de voorbeelden in FHIR en OMOP zijn louter informatief.", "kind": "fact", "kind_label": "fait", "locator": "nieuwsbericht 24 juni 2026", "as_of": "2026-11-12", "source": { "id": "SRC-9d1d755538", "title": "New ballot opened for the HL7 Europe Common Cancer Data Model", "publisher": "HL7 Europe", "url": "https://hl7europe.org/new-ballot-opened-for-the-hl7-europe-common-cancer-data-model/", "published": "2026-06-24" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-5ab14161", "statement": "Versie 0.2.0 van de Yellow Button-IG werkte de verwijzingen bij naar IPS 2.0 en voegde verwijzingen toe naar de Europese gidsen voor ontslagverslag, voorschrift en aflevering, beeldvormingsverslag en beeldvormingsmanifest.", "kind": "fact", "kind_label": "fait", "locator": "lijstitem versie 0.2.0", "as_of": "2026-11-12", "source": { "id": "SRC-0a58af95c0", "title": "xShare Project Yellow Button Implementation Guide - package-list", "publisher": "xShare Project (gepubliceerd op hl7.eu)", "url": "https://hl7.eu/fhir/ig/xshare-yb/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-7fcfacb7", "statement": "xShare wil dat iedereen zijn gezondheidsgegevens met één klik op de 'gele knop' in het EEHRxF kan delen, via gezondheidsportalen en patiëntenapps, om het recht op gegevensoverdraagbaarheid onder de AVG uit te oefenen.", "kind": "fact", "kind_label": "fait", "locator": "veld introduction", "as_of": "2026-11-12", "source": { "id": "SRC-0a58af95c0", "title": "xShare Project Yellow Button Implementation Guide - package-list", "publisher": "xShare Project (gepubliceerd op hl7.eu)", "url": "https://hl7.eu/fhir/ig/xshare-yb/package-list.json", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-43ac2ad2", "statement": "Versie 0.3.0 van de Yellow Button-specificatie behandelt enkel de eerste twee functies (download en eenmalige link).", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Purpose'", "as_of": "2026-11-12", "source": { "id": "SRC-9c48dd386f", "title": "xShare Project Yellow Button 0.3.0 - Home", "publisher": "xShare Project (gepubliceerd op hl7.eu)", "url": "https://hl7.eu/fhir/ig/xshare-yb/", "published": "2026-08-20" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-7c341272", "statement": "De Yellow Button-IG wordt continu onderhouden; scenario's en de technische referentiespecificatie kunnen nog wijzigen.", "kind": "fact", "kind_label": "fait", "locator": "inleiding homepagina", "as_of": "2026-11-12", "source": { "id": "SRC-9c48dd386f", "title": "xShare Project Yellow Button 0.3.0 - Home", "publisher": "xShare Project (gepubliceerd op hl7.eu)", "url": "https://hl7.eu/fhir/ig/xshare-yb/", "published": "2026-08-20" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-bdba50a0", "statement": "De vaststelling (REG_IMPL) van de EEHRxF-uitvoeringshandeling (initiatief 17512) blijft op 5 november 2026 gepland in het vierde kwartaal van 2026 (1 oktober - 31 december 2026).", "kind": "fact", "kind_label": "fait", "locator": "publications[2], type REG_IMPL", "as_of": "2026-11-05", "source": { "id": "SRC-4864135425", "title": "Have your say – European Health Data Space – European Electronic Health Exchange Format specifications (initiatief 17512, API-JSON)", "publisher": "Europese Commissie (Better Regulation portal)", "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/17512", "published": "2026-03-30" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-5bb3f29d", "statement": "Voor de invoering van het EEHRxF voor medische beelden, laboresultaten en ontslagverslagen in MyHealth@EU plant de Commissie een deadline voor wijzigingsvoorstellen op 30 september 2027 (wave 12) (planning, voorbehoud uitvoeringshandelingen).", "kind": "fact", "kind_label": "fait", "locator": "p. 12", "as_of": "2026-11-12", "source": { "id": "SRC-14eef3e115", "title": "European Health Data Space – State of play (keynote Europese Commissie, IHE-Europe Experience Days 2026)", "publisher": "Europese Commissie, DG SANTE Unit C1 (gepubliceerd door IHE-Europe)", "url": "https://connectathon.ihe-europe.net/sites/ihe-cat2014.org/files/IHE_EU_EXP_DAYS_2026_Fulvia_Raffaelli_European_Commission.pdf", "published": "2026-03-01" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-24ab5062", "statement": "In het MyHealth@EU-werkplan 2026 staat een proof of concept door een oplossingsleverancier met FHIR voor e-voorschrift en patiëntsamenvatting, om de discussie over de overgang naar FHIR voor te bereiden.", "kind": "fact", "kind_label": "fait", "locator": "p. 12, 'Adapting MyHealth@EU to the EHDS'", "as_of": "2026-11-12", "source": { "id": "SRC-14eef3e115", "title": "European Health Data Space – State of play (keynote Europese Commissie, IHE-Europe Experience Days 2026)", "publisher": "Europese Commissie, DG SANTE Unit C1 (gepubliceerd door IHE-Europe)", "url": "https://connectathon.ihe-europe.net/sites/ihe-cat2014.org/files/IHE_EU_EXP_DAYS_2026_Fulvia_Raffaelli_European_Commission.pdf", "published": "2026-03-01" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-c12be6c2", "statement": "De Commissie benadrukt dat de werkelijke inhoud van die MyHealth@EU-waves afhangt van de uitvoeringshandelingen.", "kind": "fact", "kind_label": "fait", "locator": "p. 12, disclaimer", "as_of": "2026-11-12", "source": { "id": "SRC-14eef3e115", "title": "European Health Data Space – State of play (keynote Europese Commissie, IHE-Europe Experience Days 2026)", "publisher": "Europese Commissie, DG SANTE Unit C1 (gepubliceerd door IHE-Europe)", "url": "https://connectathon.ihe-europe.net/sites/ihe-cat2014.org/files/IHE_EU_EXP_DAYS_2026_Fulvia_Raffaelli_European_Commission.pdf", "published": "2026-03-01" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-8eca2f79", "statement": "De Working Group Meeting van HL7 Europe in Málaga (16-20 november 2026, gepland) start met transversale onderwerpen zoals de verplichtingen uit de EHDS-artikelen 15 en 36 en de afstemming op de logische modellen.", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Tentative Agenda', 'Implementation Guide work'", "as_of": "2026-11-09", "source": { "id": "SRC-35bc16ecbe", "title": "HL7 Europe Working Group Meeting Malaga 2026", "publisher": "HL7 Europe", "url": "https://hl7europe.org/hl7-europe-working-group-meeting-malaga-2026/", "published": null }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-20fa6918", "statement": "Ziekenhuizen moeten gegevens in het EEHRxF kunnen exporteren en importeren; hoe ze dat doen (upgrade van het bestaande EPD of een vertaalsysteem tussen intern formaat en EEHRxF) laat de verordening aan hen over.", "kind": "fact", "kind_label": "fait", "locator": "p. 29, vraag 29", "as_of": "2026-09-26", "source": { "id": "SRC-7af8e7ccf5", "title": "Frequently Asked Questions on the European Health Data Space (DG SANTE Unit C.1 – Digital Health)", "publisher": "Europese Commissie, DG SANTE", "url": "https://health.ec.europa.eu/document/download/4dd47ec2-71dd-49fc-b036-ad7c14f6ed68_en?filename=ehealth_ehds_qa_en.pdf", "published": "2026-03-26" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-3cbc8a67", "statement": "Een EPD-systeem moet het EEHRxF niet intern gebruiken; de interoperabiliteitscomponent vereist enkel import en export van de prioritaire categorieën in het EEHRxF.", "kind": "fact", "kind_label": "fait", "locator": "p. 25, vraag 23", "as_of": "2026-09-26", "source": { "id": "SRC-7af8e7ccf5", "title": "Frequently Asked Questions on the European Health Data Space (DG SANTE Unit C.1 – Digital Health)", "publisher": "Europese Commissie, DG SANTE", "url": "https://health.ec.europa.eu/document/download/4dd47ec2-71dd-49fc-b036-ad7c14f6ed68_en?filename=ehealth_ehds_qa_en.pdf", "published": "2026-03-26" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true }, { "id": "CLM-54f63550", "statement": "Volgens de MPD-IG werken de grensoverschrijdende diensten voor e-voorschrift en e-aflevering van MyHealth@EU in de nabije toekomst nog met HL7 CDA, gebruiken nieuwe MyHealth@EU-diensten al HL7 FHIR en schakelen de bestaande diensten later over op FHIR (geen datum vermeld).", "kind": "fact", "kind_label": "fait", "locator": "sectie 'Crossborder initiative: from epSOS to MyHealth@EU'", "as_of": "2026-11-12", "source": { "id": "SRC-8404f812e8", "title": "HL7 Europe Medication Prescription and Dispense 1.0.0 - Background", "publisher": "HL7 Europe", "url": "https://hl7.eu/fhir/mpd/background.html", "published": "2026-05-11" }, "citaat": null, "figuur": null, "in_text": true, "on_page": true } ], "diagrams": [], "facets": { "type": [ "Topic" ], "jurisdiction": [ "eu" ], "theme": [ "grensoverschrijdend", "standaardisatie-en-governance", "architectuur-en-infrastructuur" ], "lifecycle": [ "nvt" ], "section": [ "landschap", "europa" ] }, "search_terms": [ "Guides d'implémentation FHIR européens (HL7 Europe)", "HL7 EU IG's", "HL7 Europe-gidsen", "EU-realm FHIR-gidsen", "hl7.fhir.eu", "Europese FHIR-implementatiegidsen (HL7 Europe)", "HL7 Europe FHIR Implementation Guides" ], "release_id": "2026.11.13-2", "license": "CC BY 4.0" }