{
 "id": "ehds-uitvoeringshandelingen",
 "url": "/fr/actes-d-execution-de-l-ehds/",
 "md_url": "/fr/actes-d-execution-de-l-ehds.md",
 "json_url": "/fr/actes-d-execution-de-l-ehds.json",
 "claims_url": "/fr/actes-d-execution-de-l-ehds/beweringen/",
 "type": {
  "code": "LegalAct",
  "label": "Acte législatif"
 },
 "schema_type": "Legislation",
 "lang": "fr",
 "translation": {
  "lang": "fr",
  "source_url": "/ehds-uitvoeringshandelingen/",
  "date": "2026-10-29",
  "stale": true,
  "fields": [
   "lifecycle_note",
   "sectie:in-werking-sinds-en-wat-volgt",
   "sectie:onzekerheden-en-tegenstrijdige-informatie",
   "sectie:wat-betekent-het-voor-een-ziekenhuis",
   "sectie:wat-is-het",
   "sectie:wat-moet-voor-wie-en-onder-welke-voorwaarden",
   "summary",
   "title"
  ]
 },
 "title": "Actes d'exécution de l'EHDS (état des lieux)",
 "aliases": [
  "EHDS-uitvoeringshandelingen",
  "EHDS implementing acts",
  "Uitvoeringsverordening (EU) 2026/2099",
  "EHDS-identificatie en -authenticatie",
  "EHDS-comité",
  "Committee on the European Health Data Space"
 ],
 "names": {
  "nl": "EHDS-uitvoeringshandelingen",
  "fr": "Actes d'exécution de l'EHDS",
  "en": "EHDS implementing acts",
  "de": "EHDS-Durchführungsrechtsakte"
 },
 "jurisdiction": [
  {
   "code": "eu",
   "label": "Union européenne"
  },
  {
   "code": "belgie",
   "label": "Belgique (fédéral/interfédéral)"
  }
 ],
 "themes": [
  {
   "code": "grensoverschrijdend",
   "label": "Échange transfrontalier"
  },
  {
   "code": "regelgeving",
   "label": "Réglementation"
  },
  {
   "code": "secundair-gebruik",
   "label": "Utilisation secondaire et registres"
  },
  {
   "code": "architectuur-en-infrastructuur",
   "label": "Architecture et infrastructure"
  }
 ],
 "lifecycle": {
  "code": "gedeeltelijk-in-werking",
  "label": "partiellement en vigueur"
 },
 "lifecycle_note_html": "Partiellement en vigueur : quatre règlements d'exécution étaient adoptés au 29 septembre 2026 ; DonnéesDeSanté@UE était à l'état de projet et six autres actes étaient seulement planifiés.",
 "version": null,
 "vendor": null,
 "sectors": [],
 "homologations": [],
 "links": [
  {
   "kind": {
    "code": "website",
    "label": "Site web"
   },
   "url": "https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en",
   "label": "EHDS (Europese Commissie)",
   "host": "health.ec.europa.eu",
   "lang": "en"
  }
 ],
 "summary_text": "Les actes d'exécution de l'EHDS précisent, sur les plans technique et procédural, des parties du règlement européen relatif aux données de santé. Quatre actes sont adoptés; d'autres, dont le format européen d'échange des dossiers de santé informatisés et des règles pour l'utilisation secondaire, sont encore à l'état de projet ou de planification. Pour les hôpitaux, c'est surtout le règlement 2026/2099 qui détermine comment les patients, les professionnels de la santé et les prestataires de soins s'identifient et s'authentifient lors d'un échange transfrontalier. La désignation belge des instances compétentes et des attributs de soins est encore inconnue.",
 "summary_html": "<p>Les actes d'exécution de l'EHDS précisent, sur les plans technique et procédural, des parties du règlement européen relatif aux données de santé. Quatre actes sont adoptés ; d'autres, dont le format européen d'échange des dossiers de santé informatisés et des règles pour l'utilisation secondaire, sont encore à l'état de projet ou de planification. Pour les hôpitaux, c'est surtout le règlement 2026/2099 qui détermine comment les patients, les professionnels de la santé et les prestataires de soins s'identifient et s'authentifient lors d'un échange transfrontalier. La désignation belge des instances compétentes et des attributs de soins est encore inconnue.</p>",
 "last_verified": "2026-11-10",
 "verification_outdated": false,
 "sections": [
  {
   "id": "in-het-kort",
   "title": "In het kort",
   "kind": "in-het-kort",
   "html": "<ul>\n<li><strong>Wat</strong>: uitvoeringshandelingen werken de <a href=\"/fr/espace-europeen-des-donnees-de-sante/\">EHDS-verordening</a> uit; de Commissie noemt negen kernhandelingen\n  met als deadline 26 maart 2027<sup class=\"cite\" id=\"t-CLM-fb7a00a9\" data-claims=\"CLM-fb7a00a9\"><a class=\"cite-ref\" href=\"#bron-1\" aria-label=\"Source 1\">[1]</a></sup>.</li>\n<li><strong>Hoe</strong>: ontwerpen passeren het EHDS-comité van de lidstaten, dat in juni 2026 met ruime meerderheid instemde met\n  de handelingen bij art. 77, 23 en 16<span class=\"cite-anchor\" id=\"t-CLM-d9998992\"></span><span class=\"cite-anchor\" id=\"t-CLM-6059c472\"></span><sup class=\"cite\" id=\"t-CLM-7b2e372e\" data-claims=\"CLM-7b2e372e CLM-d9998992 CLM-6059c472\"><a class=\"cite-ref\" href=\"#bron-2\" aria-label=\"Source 2\">[2]</a></sup>.</li>\n<li><strong>Stand</strong>: vier handelingen zijn aangenomen (2026/771, 2026/2083, 2026/2098 en 2026/2099)\n<span class=\"cite-anchor\" id=\"t-CLM-aa2f31be\"></span><span class=\"cite-anchor\" id=\"t-CLM-c55764df\"></span><span class=\"cite-anchor\" id=\"t-CLM-40494193\"></span><sup class=\"cite\" id=\"t-CLM-6384e4c6\" data-claims=\"CLM-6384e4c6 CLM-aa2f31be CLM-c55764df CLM-40494193\"><a class=\"cite-ref\" href=\"#bron-3\" aria-label=\"Source 3\">[3]</a><a class=\"cite-ref\" href=\"#bron-4\" aria-label=\"Source 4\">[4]</a><a class=\"cite-ref\" href=\"#bron-5\" aria-label=\"Source 5\">[5]</a><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup>; het ontwerp met sjablonen voor secundair gebruik ligt\n  sinds 16 oktober 2026 ter feedback tot 13 november<span class=\"cite-anchor\" id=\"t-CLM-6d2e57dc\"></span><sup class=\"cite\" id=\"t-CLM-9c1022c9\" data-claims=\"CLM-9c1022c9 CLM-6d2e57dc\"><a class=\"cite-ref\" href=\"#bron-7\" aria-label=\"Source 7\">[7]</a></sup>.</li>\n<li><strong>Planning</strong>: voor het EEHRxF, de EPD-componenten en de testomgeving staat de ontwerpfase op 5 november 2026 nog op\n  'UPCOMING', met vaststelling gepland in het vierde kwartaal van 2026 of het eerste van 2027\n<span class=\"cite-anchor\" id=\"t-CLM-9f600397\"></span><span class=\"cite-anchor\" id=\"t-CLM-d68f4136\"></span><span class=\"cite-anchor\" id=\"t-CLM-4705b2ce\"></span><span class=\"cite-anchor\" id=\"t-CLM-abf6cfa1\"></span><span class=\"cite-anchor\" id=\"t-CLM-7dca953c\"></span><sup class=\"cite\" id=\"t-CLM-53779cd0\" data-claims=\"CLM-53779cd0 CLM-9f600397 CLM-d68f4136 CLM-4705b2ce CLM-abf6cfa1 CLM-7dca953c\"><a class=\"cite-ref\" href=\"#bron-8\" aria-label=\"Source 8\">[8]</a><a class=\"cite-ref\" href=\"#bron-9\" aria-label=\"Source 9\">[9]</a><a class=\"cite-ref\" href=\"#bron-10\" aria-label=\"Source 10\">[10]</a></sup>.</li>\n<li><strong>Ziekenhuis</strong>: Verordening 2026/2099 vraagt dat elke lidstaat de instanties aanwijst die zorgverleners en\n  zorgaanbieders voor <a href=\"/fr/masante-ue/\">MyHealth@EU</a> identificeren en authenticeren<sup class=\"cite\" id=\"t-CLM-29a34ac4\" data-claims=\"CLM-29a34ac4\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup>.</li>\n<li><strong>België</strong>: op de comitévergadering van 30 september 2026 zaten de KSZ, het Belgisch Gezondheidsdata-Agentschap en\n  Vlaanderen aan tafel<sup class=\"cite\" id=\"t-CLM-40c40cba\" data-claims=\"CLM-40c40cba\"><a class=\"cite-ref\" href=\"#bron-11\" aria-label=\"Source 11\">[11]</a></sup>.</li>\n<li><strong>Grootste onzekerheid</strong>: of het EEHRxF eind 2026 wordt vastgesteld, nu het comité op 30 september nog een derde\n  versie van het werkdocument besprak en lidstaten ruimte vroegen voor nationale formaten\n<span class=\"cite-anchor\" id=\"t-CLM-0b35bd60\"></span><sup class=\"cite\" id=\"t-CLM-e43dd084\" data-claims=\"CLM-e43dd084 CLM-0b35bd60 CLM-4705b2ce\"><a class=\"cite-ref\" href=\"#bron-11\" aria-label=\"Source 11\">[11]</a><a class=\"cite-ref\" href=\"#bron-8\" aria-label=\"Source 8\">[8]</a></sup>.</li>\n</ul>"
  },
  {
   "id": "qu-est-ce-que-c-est",
   "title": "Qu'est-ce que c'est ?",
   "kind": "tekst",
   "html": "<p>Les actes d'exécution complètent le règlement <a href=\"/fr/espace-europeen-des-donnees-de-sante/\">Espace européen des données de santé (EHDS)</a> par des règles techniques et procédurales contraignantes<sup class=\"cite\" data-claims=\"CLM-fb7a00a9\"><a class=\"cite-ref\" href=\"#bron-1\" aria-label=\"Source 1\">[1]</a></sup>. La Commission mentionne neuf actes d'exécution avec une échéance au 26 mars 2027, dont la qualité des données, l'EEHRxF, MaSanté@UE, les common specifications pour les composants de DME, DonnéesDeSanté@UE, les descriptions de jeux de données et le label de qualité<sup class=\"cite\" data-claims=\"CLM-fb7a00a9\"><a class=\"cite-ref\" href=\"#bron-1\" aria-label=\"Source 1\">[1]</a></sup>. Ceux qui portent sur la qualité des données, l'EEHRxF, MaSanté@UE et les composants de DME ne deviennent applicables qu'aux dates échelonnées de 2029 ou 2031<sup class=\"cite\" id=\"t-CLM-a494d4a9\" data-claims=\"CLM-a494d4a9\"><a class=\"cite-ref\" href=\"#bron-12\" aria-label=\"Source 12\">[12]</a></sup>.</p>\n<p>Dans les tableaux, <strong>adopté</strong> signifie que le texte est paru de manière contraignante au Journal officiel, <strong>projet</strong> qu'un texte a été soumis à feedback et <strong>planification</strong> qu'une initiative avait seulement été annoncée<span class=\"cite-anchor\" id=\"t-CLM-baad4be4\"></span><sup class=\"cite\" id=\"t-CLM-c2b714f3\" data-claims=\"CLM-40494193 CLM-c2b714f3 CLM-baad4be4\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a><a class=\"cite-ref\" href=\"#bron-13\" aria-label=\"Source 13\">[13]</a><a class=\"cite-ref\" href=\"#bron-8\" aria-label=\"Source 8\">[8]</a></sup>. <strong>Non trouvé</strong> indique une lacune et n'est pas une preuve d'absence.</p>"
  },
  {
   "id": "que-faut-il-faire-pour-qui-et-a-quelles-conditions",
   "title": "Que faut-il faire, pour qui et à quelles conditions ?",
   "kind": "tekst",
   "html": "<p>Le règlement d'exécution (UE) 2026/2099 fixe des exigences pour le mécanisme interopérable et transfrontalier d'identification et d'authentification des personnes physiques, des professionnels de la santé et des prestataires de soins de santé<sup class=\"cite\" id=\"t-CLM-c3f6e622\" data-claims=\"CLM-c3f6e622\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup>.</p>\n<table>\n<thead>\n<tr>\n<th>Qui</th>\n<th>Obligation</th>\n<th>Quand</th>\n<th>Source</th>\n</tr>\n</thead>\n<tbody>\n<tr>\n<td>État membre, donc aussi la Belgique</td>\n<td>Communiquer à la Commission l'ensemble d'attributs de soins de santé</td>\n<td>au plus tard le 26 mars 2028</td>\n<td><sup class=\"cite\" id=\"t-CLM-4ae7b8db\" data-claims=\"CLM-4ae7b8db\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup></td>\n</tr>\n<tr>\n<td>État membre, donc aussi la Belgique</td>\n<td>Désigner les instances qui identifient, authentifient et autorisent les professionnels de la santé et les prestataires de soins de santé pour <a href=\"/fr/masante-ue/\">MaSanté@UE</a></td>\n<td>aucune date mentionnée dans la claim</td>\n<td><sup class=\"cite\" data-claims=\"CLM-29a34ac4\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup></td>\n</tr>\n<tr>\n<td>Patient</td>\n<td>Authentification en ligne au moins au niveau « substantiel », plus tard « élevé »</td>\n<td>« élevé » à partir du 26 mars 2030</td>\n<td><sup class=\"cite\" id=\"t-CLM-0aa1883b\" data-claims=\"CLM-0aa1883b\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup></td>\n</tr>\n<tr>\n<td>Professionnel de la santé</td>\n<td>Authentification au moins au niveau « substantiel », plus tard « élevé »</td>\n<td>« élevé » à partir du 26 mars 2032</td>\n<td><sup class=\"cite\" id=\"t-CLM-292adf82\" data-claims=\"CLM-292adf82\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup></td>\n</tr>\n<tr>\n<td>Professionnel de la santé ou prestataire de soins de santé</td>\n<td>Accepter les attributs de soins de santé du patient provenant d'un portefeuille européen d'identité numérique</td>\n<td>à partir du 26 mars 2029</td>\n<td><sup class=\"cite\" id=\"t-CLM-0aaf9627\" data-claims=\"CLM-0aaf9627\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup></td>\n</tr>\n</tbody>\n</table>\n<p>La liste belge des instances désignées et l'ensemble belge d'attributs de soins de santé n'avaient pas été trouvés au 29 septembre 2026.</p>"
  },
  {
   "id": "en-vigueur-depuis-et-ce-qui-suit",
   "title": "En vigueur depuis, et ce qui suit",
   "kind": "tekst",
   "html": "<table>\n<thead>\n<tr>\n<th>Acte (initiative)</th>\n<th>Statut</th>\n<th>Dates</th>\n<th>Date de référence</th>\n<th>Source</th>\n</tr>\n</thead>\n<tbody>\n<tr>\n<td>comité de l'EEDS, règlement d'exécution (UE) 2026/771 du 7 avril 2026</td>\n<td><strong>adopté</strong></td>\n<td>-</td>\n<td>26/09</td>\n<td><sup class=\"cite\" data-claims=\"CLM-6384e4c6\"><a class=\"cite-ref\" href=\"#bron-3\" aria-label=\"Source 3\">[3]</a></sup></td>\n</tr>\n<tr>\n<td>MaSanté@UE, règlement d'exécution (UE) 2026/2083 du 18 septembre 2026</td>\n<td><strong>adopté</strong></td>\n<td>effet le 11 octobre 2026 ; applicable le 26 mars 2027</td>\n<td>26/09</td>\n<td><span class=\"cite-anchor\" id=\"t-CLM-02b74ad9\"></span><sup class=\"cite\" id=\"t-CLM-d600b745\" data-claims=\"CLM-aa2f31be CLM-d600b745 CLM-02b74ad9\"><a class=\"cite-ref\" href=\"#bron-4\" aria-label=\"Source 4\">[4]</a></sup></td>\n</tr>\n<tr>\n<td>Descriptions de jeux de données (HealthDCAT-AP), règlement d'exécution (UE) 2026/2098 du 18 septembre 2026</td>\n<td><strong>adopté</strong></td>\n<td>applicable le 26 mars 2029</td>\n<td>26/09</td>\n<td><sup class=\"cite\" id=\"t-CLM-6e982699\" data-claims=\"CLM-6e982699 CLM-c55764df\"><a class=\"cite-ref\" href=\"#bron-5\" aria-label=\"Source 5\">[5]</a></sup></td>\n</tr>\n<tr>\n<td>Identification et authentification (15353), règlement d'exécution (UE) 2026/2099 du 21 septembre 2026, JO du 22 septembre 2026</td>\n<td><strong>adopté</strong></td>\n<td>applicable le 26 mars 2027 ; art. 3(3) et 5(2) à partir du 26 mars 2029</td>\n<td>29/09</td>\n<td><span class=\"cite-anchor\" id=\"t-CLM-9c02b74e\"></span><sup class=\"cite\" id=\"t-CLM-60dbe160\" data-claims=\"CLM-40494193 CLM-60dbe160 CLM-9c02b74e\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup></td>\n</tr>\n<tr>\n<td>DonnéesDeSanté@UE (16155), décision d'exécution</td>\n<td><strong>projet</strong> (feedback 1-29 septembre 2026)</td>\n<td>adoption prévue au Q4 2026</td>\n<td>26/09</td>\n<td><sup class=\"cite\" id=\"t-CLM-48a77f99\" data-claims=\"CLM-c2b714f3 CLM-48a77f99\"><a class=\"cite-ref\" href=\"#bron-13\" aria-label=\"Source 13\">[13]</a></sup></td>\n</tr>\n<tr>\n<td>Modèles pour les demandes d'accès aux données, les demandes de données et les autorisations de données (16712)</td>\n<td><strong>planification</strong>, pas encore de projet</td>\n<td>adoption prévue au Q4 2026</td>\n<td>29/09</td>\n<td><span class=\"cite-anchor\" id=\"t-CLM-3a874825\"></span><sup class=\"cite\" id=\"t-CLM-3f9649f1\" data-claims=\"CLM-3f9649f1 CLM-3a874825\"><a class=\"cite-ref\" href=\"#bron-7\" aria-label=\"Source 7\">[7]</a></sup></td>\n</tr>\n<tr>\n<td>EEHRxF, art. 15(1) (17512)</td>\n<td><strong>planification</strong>, phase de projet « UPCOMING »</td>\n<td>adoption prévue au Q4 2026</td>\n<td>26/09</td>\n<td><span class=\"cite-anchor\" id=\"t-CLM-4314c26e\"></span><sup class=\"cite\" id=\"t-CLM-f4a6843c\" data-claims=\"CLM-baad4be4 CLM-f4a6843c CLM-4314c26e\"><a class=\"cite-ref\" href=\"#bron-8\" aria-label=\"Source 8\">[8]</a></sup></td>\n</tr>\n<tr>\n<td>Common specifications pour les composants de DME, art. 36(1) (18579)</td>\n<td><strong>planification</strong>, phase de projet « UPCOMING »</td>\n<td>adoption prévue au Q4 2026</td>\n<td>26/09</td>\n<td><span class=\"cite-anchor\" id=\"t-CLM-9b5379a9\"></span><span class=\"cite-anchor\" id=\"t-CLM-aff5b496\"></span><sup class=\"cite\" id=\"t-CLM-3d8a138e\" data-claims=\"CLM-3d8a138e CLM-9b5379a9 CLM-aff5b496\"><a class=\"cite-ref\" href=\"#bron-9\" aria-label=\"Source 9\">[9]</a></sup></td>\n</tr>\n<tr>\n<td>Environnement de test numérique (17513)</td>\n<td><strong>planification</strong></td>\n<td>adoption prévue au Q1 2027</td>\n<td>26/09</td>\n<td><span class=\"cite-anchor\" id=\"t-CLM-109c379a\"></span><sup class=\"cite\" id=\"t-CLM-848e5db0\" data-claims=\"CLM-848e5db0 CLM-109c379a\"><a class=\"cite-ref\" href=\"#bron-10\" aria-label=\"Source 10\">[10]</a></sup></td>\n</tr>\n<tr>\n<td>Environnements de traitement sécurisés (SPE) pour l'utilisation secondaire (17192)</td>\n<td><strong>planification</strong>, pas encore de projet</td>\n<td>adoption prévue au Q1 2027</td>\n<td>29/09</td>\n<td><span class=\"cite-anchor\" id=\"t-CLM-f63e4079\"></span><sup class=\"cite\" id=\"t-CLM-0ddd4436\" data-claims=\"CLM-0ddd4436 CLM-f63e4079\"><a class=\"cite-ref\" href=\"#bron-14\" aria-label=\"Source 14\">[14]</a></sup></td>\n</tr>\n<tr>\n<td>Label de qualité et d'utilité (18853, lancée le 27 juillet 2026)</td>\n<td><strong>planification</strong>, pas encore de projet</td>\n<td>adoption prévue au Q1 2027</td>\n<td>29/09</td>\n<td><span class=\"cite-anchor\" id=\"t-CLM-a3653759\"></span><sup class=\"cite\" id=\"t-CLM-d97e3e47\" data-claims=\"CLM-d97e3e47 CLM-a3653759\"><a class=\"cite-ref\" href=\"#bron-15\" aria-label=\"Source 15\">[15]</a></sup></td>\n</tr>\n<tr>\n<td>Exigences de qualité des données, art. 13(4)</td>\n<td><strong>non trouvé</strong> (aucune initiative)</td>\n<td>échéance au 26 mars 2027</td>\n<td>29/09</td>\n<td><sup class=\"cite\" id=\"t-CLM-d394171b\" data-claims=\"CLM-d394171b\"><a class=\"cite-ref\" href=\"#bron-12\" aria-label=\"Source 12\">[12]</a></sup></td>\n</tr>\n</tbody>\n</table>\n<p>Le projet de règlement d'exécution MaSanté@UE renvoyait au règlement d'exécution EEHRxF comme à un acte encore à adopter<sup class=\"cite\" id=\"t-CLM-ed470fae\" data-claims=\"CLM-ed470fae\"><a class=\"cite-ref\" href=\"#bron-16\" aria-label=\"Source 16\">[16]</a></sup>. Les exigences techniques pour les systèmes de DME ne sont donc pas encore fixées ; voir <a href=\"/fr/format-europeen-d-echange-des-dossiers-de-sante-informatises/\">EEHRxF (format européen d'échange des dossiers de santé informatisés)</a> et <a href=\"/fr/exigences-ehds-pour-les-systemes-de-dse/\">Exigences EHDS pour les systèmes de DME (chapitre III)</a>. Les actes relatifs à l'utilisation secondaire (DonnéesDeSanté@UE, modèles, SPE, label) sont expliqués plus en détail sur <a href=\"/fr/donneessante-ue/\">DonnéesDeSanté@UE</a>.</p>\n<p>Le règlement 2026/2099 entre en vigueur le vingtième jour suivant sa publication et s'applique à partir du 26 mars 2027 ; les dispositions relatives aux attributs de soins de santé via le portefeuille européen d'identité numérique s'appliquent à partir du 26 mars 2029<sup class=\"cite\" data-claims=\"CLM-9c02b74e CLM-60dbe160\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup>. Comme déduction propre, la date de publication du 22 septembre 2026 donne le 12 octobre 2026 comme date d'entrée en vigueur<sup class=\"cite\" data-claims=\"CLM-9c02b74e CLM-40494193\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup>.</p>"
  },
  {
   "id": "qu-est-ce-que-cela-signifie-pour-un-hopital",
   "title": "Qu'est-ce que cela signifie pour un hôpital ?",
   "kind": "tekst",
   "html": "<p>Pour les hôpitaux, le règlement 2026/2099 détermine par quelle instance désignée leurs prestataires de soins s'identifient et s'authentifient lors d'un échange transfrontalier<sup class=\"cite\" data-claims=\"CLM-29a34ac4\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup>. Au 26 septembre 2026, les exigences techniques pour les systèmes de DME et l'EEHRxF n'avaient pas encore été publiées en projet<sup class=\"cite\" data-claims=\"CLM-baad4be4 CLM-3d8a138e CLM-109c379a\"><a class=\"cite-ref\" href=\"#bron-8\" aria-label=\"Source 8\">[8]</a><a class=\"cite-ref\" href=\"#bron-9\" aria-label=\"Source 9\">[9]</a><a class=\"cite-ref\" href=\"#bron-10\" aria-label=\"Source 10\">[10]</a></sup>.</p>\n<p class=\"aanbeveling\"><strong>Recommandation :</strong> lors de la préparation de l'échange transfrontalier, faites vérifier quelle authentification belge des prestataires de soins et des patients atteint le niveau « élevé » d'ici 2030 et 2032, et suivez la désignation belge au titre de l'art. 6(1), parce que celle-ci détermine par quelle instance les prestataires de soins d'un hôpital s'authentifient pour MaSanté@UE.</p>"
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   "html": "<ul>\n<li><strong>Le portail est en retard sur EUR-Lex</strong> : la base de connaissances indiquait auparavant que l'adoption de 15353 était prévue au Q2 2026 sans qu'un texte adopté ait été trouvé<span class=\"cite-anchor\" id=\"t-CLM-561852ab\"></span><sup class=\"cite\" id=\"t-CLM-0f41175e\" data-claims=\"CLM-0f41175e CLM-561852ab\"><a class=\"cite-ref\" href=\"#bron-17\" aria-label=\"Source 17\">[17]</a></sup>. Cette affirmation est dépassée depuis le 22 septembre 2026 : EUR-Lex publie le règlement d'exécution (UE) 2026/2099<sup class=\"cite\" data-claims=\"CLM-40494193 CLM-c3f6e622\"><a class=\"cite-ref\" href=\"#bron-6\" aria-label=\"Source 6\">[6]</a></sup>. Le 29 septembre 2026, Have your say ne présentait pas encore l'initiative comme adoptée ; il s'agit d'un retard du portail, non d'une contradiction de fond.</li>\n<li><strong>Date d'application de 2026/2083</strong> : le 26 mars 2027 selon le règlement lui-même<sup class=\"cite\" data-claims=\"CLM-02b74ad9\"><a class=\"cite-ref\" href=\"#bron-4\" aria-label=\"Source 4\">[4]</a></sup>, alors que l'art. 105 ne rend les actes pris sur la base de l'art. 23(4) applicables qu'aux dates échelonnées de 2029/2031<sup class=\"cite\" data-claims=\"CLM-a494d4a9\"><a class=\"cite-ref\" href=\"#bron-12\" aria-label=\"Source 12\">[12]</a></sup> ; voir <a href=\"/fr/masante-ue/\">MaSanté@UE (MyHealth@EU)</a>.</li>\n<li>Les dates de planification (Q4 2026, Q1 2027) ne constituent pas une décision ; pour l'EEHRxF, les composants de DME et l'environnement de test, il n'existait pas encore de projet au 26 septembre 2026<sup class=\"cite\" data-claims=\"CLM-baad4be4 CLM-3d8a138e CLM-109c379a\"><a class=\"cite-ref\" href=\"#bron-8\" aria-label=\"Source 8\">[8]</a><a class=\"cite-ref\" href=\"#bron-9\" aria-label=\"Source 9\">[9]</a><a class=\"cite-ref\" href=\"#bron-10\" aria-label=\"Source 10\">[10]</a></sup>. La question de savoir si l'échéance du 26 mars 2027 sera respectée est incertaine.</li>\n<li>Les votes en comité sur les projets n'ont pas été trouvés.</li>\n</ul>"
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   "text": "Welke set zorgattributen meldt België aan de Commissie (uiterlijk 26 maart 2028), en halen de Belgische authenticatiemiddelen voor patiënten (2030) en zorgverleners (2032) het betrouwbaarheidsniveau 'hoog'?"
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   "html": "Komt er een initiatief voor de datakwaliteitseisen van art. 13(4), na het achtergronddocument van mei 2026? Niet gevonden op 5/11/2026.",
   "text": "Komt er een initiatief voor de datakwaliteitseisen van art. 13(4), na het achtergronddocument van mei 2026? Niet gevonden op 5/11/2026."
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   "text": "Wat besprak en besliste het EHDS-comité op zijn elfde vergadering van 22 oktober 2026? Het verslag stond op 5/11/2026 niet in het comitologieregister."
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   "text": "Welke bijgewerkte tijdlijn voor de uitvoeringshandelingen legde de Commissie op 30 september 2026 aan het comité voor?"
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  {
   "id": "CLM-e43dd084",
   "statement": "Op 30 september 2026 presenteerde de Commissie het EHDS-comité de derde versie van het non-paper over artikel 15 (EEHRxF).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "p. 2, punt 7 'Non-paper on Article 15'",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-1a01232a5d",
    "title": "Committee on the European Health Data Space – Summary record, 30 September 2026 (10th meeting)",
    "publisher": "Europese Commissie, DG Gezondheid en Voedselveiligheid (comitologieregister)",
    "url": "https://ec.europa.eu/transparency/comitology-register/core/api/integration/ers/549880/118652/1/attachment",
    "published": "2026-10-22"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-0b35bd60",
   "statement": "Lidstaten vroegen op 30 september 2026 dat de EEHRxF-tekst uitdrukkelijk de ruimte vermeldt voor nationale digitale gezondheidsinfrastructuren om alternatieve formaten te gebruiken.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "p. 2, punt 7",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-1a01232a5d",
    "title": "Committee on the European Health Data Space – Summary record, 30 September 2026 (10th meeting)",
    "publisher": "Europese Commissie, DG Gezondheid en Voedselveiligheid (comitologieregister)",
    "url": "https://ec.europa.eu/transparency/comitology-register/core/api/integration/ers/549880/118652/1/attachment",
    "published": "2026-10-22"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-a494d4a9",
   "statement": "De uitvoeringshandelingen over datakwaliteit (art. 13(4)), het EEHRxF (art. 15(1)), MyHealth@EU (art. 23(4)) en de common specifications voor EPD-systemen (art. 36(1)) worden pas van toepassing op de fasedata 2029 of 2031, afhankelijk van de categorie gegevens.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "art. 105, vijfde 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-c2b714f3",
   "statement": "Het ontwerp van de HealthData@EU-uitvoeringshandeling (initiatief 16155) stond open voor feedback van 1 tot en met 29 september 2026.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type REG_IMPL_DRAFT",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-a277aa19c8",
    "title": "Have your say – European Health Data Space HealthData@EU requirements (initiatief 16155, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/16155",
    "published": "2026-09-01"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-baad4be4",
   "statement": "Au 26 septembre 2026, aucun projet n'a encore été publié pour commentaires pour l'acte d'exécution EEHRxF: la phase de projet est sur « UPCOMING » sans période de commentaires.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type REG_IMPL_DRAFT",
   "as_of": "2026-09-26",
   "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-c3f6e622",
   "statement": "Le règlement d'exécution (UE) 2026/2099 fixe les exigences applicables au mécanisme interopérable et transfrontière\nd'identification et d'authentification des personnes physiques, des professionnels de la santé et des prestataires de\nsoins de santé lors de l'échange transfrontalier de données de santé électroniques à caractère personnel.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "art. 1 (onderwerp)",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-a101f70ab0",
    "title": "Uitvoeringsverordening (EU) 2026/2099 van de Commissie van 21 september 2026 (interoperabel grensoverschrijdend identificatie- en authenticatiemechanisme, EHDS)",
    "publisher": "Europese Commissie / Publicatiebureau (EUR-Lex)",
    "url": "https://eur-lex.europa.eu/eli/reg_impl/2026/2099/oj/eng",
    "published": "2026-09-22"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-4ae7b8db",
   "statement": "Chaque État membre, et donc aussi la Belgique, doit notifier à la Commission, au plus tard le 26 mars 2028, l'ensemble\nd'attributs de soins de santé qu'il utilise pour vérifier l'identité des personnes lors d'un échange transfrontalier\n(obligation de l'État membre).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "art. 3(2)",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-a101f70ab0",
    "title": "Uitvoeringsverordening (EU) 2026/2099 van de Commissie van 21 september 2026 (interoperabel grensoverschrijdend identificatie- en authenticatiemechanisme, EHDS)",
    "publisher": "Europese Commissie / Publicatiebureau (EUR-Lex)",
    "url": "https://eur-lex.europa.eu/eli/reg_impl/2026/2099/oj/eng",
    "published": "2026-09-22"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-0aa1883b",
   "statement": "Selon le règlement d'exécution (UE) 2026/2099, le niveau de garantie « substantiel » (eIDAS) suffit d'abord pour\nl'identification du patient lors d'une demande en ligne d'échange transfrontalier via MaSanté@UE; à partir du\n26 mars 2030, le niveau « élevé » est requis.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "art. 4(2)",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-a101f70ab0",
    "title": "Uitvoeringsverordening (EU) 2026/2099 van de Commissie van 21 september 2026 (interoperabel grensoverschrijdend identificatie- en authenticatiemechanisme, EHDS)",
    "publisher": "Europese Commissie / Publicatiebureau (EUR-Lex)",
    "url": "https://eur-lex.europa.eu/eli/reg_impl/2026/2099/oj/eng",
    "published": "2026-09-22"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-292adf82",
   "statement": "Les professionnels de la santé doivent s'authentifier, pour un échange transfrontalier, avec au moins le niveau de garantie\n« substantiel »; à partir du 26 mars 2032, le niveau « élevé » est requis.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "art. 6(3)",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-a101f70ab0",
    "title": "Uitvoeringsverordening (EU) 2026/2099 van de Commissie van 21 september 2026 (interoperabel grensoverschrijdend identificatie- en authenticatiemechanisme, EHDS)",
    "publisher": "Europese Commissie / Publicatiebureau (EUR-Lex)",
    "url": "https://eur-lex.europa.eu/eli/reg_impl/2026/2099/oj/eng",
    "published": "2026-09-22"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-0aaf9627",
   "statement": "Le professionnel de la santé ou le prestataire de soins qui demande un échange transfrontalier doit accepter les attributs\nde soins de santé du patient lorsque ceux-ci sont fournis sous la forme d'une attestation électronique d'attributs par\nl'intermédiaire d'un portefeuille européen d'identité numérique (applicable à partir du 26 mars 2029).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "art. 5(2)",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-a101f70ab0",
    "title": "Uitvoeringsverordening (EU) 2026/2099 van de Commissie van 21 september 2026 (interoperabel grensoverschrijdend identificatie- en authenticatiemechanisme, EHDS)",
    "publisher": "Europese Commissie / Publicatiebureau (EUR-Lex)",
    "url": "https://eur-lex.europa.eu/eli/reg_impl/2026/2099/oj/eng",
    "published": "2026-09-22"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-d600b745",
   "statement": "Volgens EUR-Lex heeft Uitvoeringsverordening (EU) 2026/2083 effect vanaf 11 oktober 2026 (twintigste dag na publicatie op 21 september 2026); de inwerkingtredingsdatum stond per 26 september 2026 als nog niet bevestigd.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "EUR-Lex documentinformatie",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-403fc76309",
    "title": "Implementing regulation - EU - 2026/2083 - EN - EUR-Lex",
    "publisher": "Europese Commissie (EUR-Lex)",
    "url": "https://eur-lex.europa.eu/eli/reg_impl/2026/2083/oj/eng",
    "published": "2026-09-21"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-02b74ad9",
   "statement": "Art. 19 van Uitvoeringsverordening (EU) 2026/2083 bepaalt dat ze van toepassing is vanaf 26 maart 2027.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "art. 19",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-403fc76309",
    "title": "Implementing regulation - EU - 2026/2083 - EN - EUR-Lex",
    "publisher": "Europese Commissie (EUR-Lex)",
    "url": "https://eur-lex.europa.eu/eli/reg_impl/2026/2083/oj/eng",
    "published": "2026-09-21"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-6e982699",
   "statement": "Uitvoeringsverordening (EU) 2026/2098 van 18 september 2026 legt de minimale metadata vast die gegevenshouders voor datasetbeschrijvingen moeten aanleveren, uitgedrukt volgens HealthDCAT-AP.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "art. 3",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-e523def078",
    "title": "Implementing regulation - EU - 2026/2098 - EN - EUR-Lex",
    "publisher": "Europese Commissie (EUR-Lex)",
    "url": "https://eur-lex.europa.eu/eli/reg_impl/2026/2098/oj/eng",
    "published": "2026-09-21"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-60dbe160",
   "statement": "Le règlement d'exécution (UE) 2026/2099 est applicable à partir du 26 mars 2027 (à l'exception des art. 3(3) et 5(2)).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "art. 9, tweede alinea, en slotformule",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-a101f70ab0",
    "title": "Uitvoeringsverordening (EU) 2026/2099 van de Commissie van 21 september 2026 (interoperabel grensoverschrijdend identificatie- en authenticatiemechanisme, EHDS)",
    "publisher": "Europese Commissie / Publicatiebureau (EUR-Lex)",
    "url": "https://eur-lex.europa.eu/eli/reg_impl/2026/2099/oj/eng",
    "published": "2026-09-22"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-9c02b74e",
   "statement": "Le règlement d'exécution (UE) 2026/2099 entre en vigueur le vingtième jour suivant celui de sa publication; l'article\n3(3) et l'article 5(2) (délivrance et acceptation des attributs de soins de santé par l'intermédiaire du portefeuille\neuropéen d'identité numérique) ne s'appliquent qu'à partir du 26 mars 2029.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "art. 9 (inwerkingtreding en toepassing)",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-a101f70ab0",
    "title": "Uitvoeringsverordening (EU) 2026/2099 van de Commissie van 21 september 2026 (interoperabel grensoverschrijdend identificatie- en authenticatiemechanisme, EHDS)",
    "publisher": "Europese Commissie / Publicatiebureau (EUR-Lex)",
    "url": "https://eur-lex.europa.eu/eli/reg_impl/2026/2099/oj/eng",
    "published": "2026-09-22"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-48a77f99",
   "statement": "Het definitieve instrument voor HealthData@EU (initiatief 16155) is een uitvoeringsbesluit, met geplande vaststelling in het vierde kwartaal van 2026 (planning).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type DEC_IMPL",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-a277aa19c8",
    "title": "Have your say – European Health Data Space HealthData@EU requirements (initiatief 16155, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/16155",
    "published": "2026-09-01"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-3f9649f1",
   "statement": "Initiatief 16712 (aangekondigd 9 februari 2026) moet gemeenschappelijke sjablonen vastleggen voor gegevenstoegangsaanvragen, gegevensverzoeken en gegevensvergunningen die gezondheidsgegevenstoegangsinstanties en aanvragers gebruiken (planning, nog geen ontwerp).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, veld dossierSummary",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-1994bcd14d",
    "title": "Have your say – Templates for health data access applications, health data requests, data permits and decisions on a data request (initiatief 16712, API-JSON)",
    "publisher": "Europese Commissie (Have your say)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/16712",
    "published": "2026-02-09"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-3a874825",
   "statement": "De Commissie plant de vaststelling van de sjablonen voor gegevenstoegang (initiatief 16712) in het vierde kwartaal van 2026 (planning, geen besluit).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type REG_IMPL (ADOPTION_WORKFLOW)",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-1994bcd14d",
    "title": "Have your say – Templates for health data access applications, health data requests, data permits and decisions on a data request (initiatief 16712, API-JSON)",
    "publisher": "Europese Commissie (Have your say)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/16712",
    "published": "2026-02-09"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-f4a6843c",
   "statement": "L'acte d'exécution EEHRxF prévu (initiative Have your say 17512, planifié depuis le 30 mars 2026) fixera les spécifications pour les six catégories prioritaires: résumé patient, prescription électronique, dispensation électronique, imagerie avec comptes rendus, résultats d'examens y compris de laboratoire, et rapports de sortie.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON-veld dossierSummary",
   "as_of": "2026-09-26",
   "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-4314c26e",
   "statement": "La Commission prévoit l'adoption du règlement d'exécution EEHRxF (initiative 17512) au quatrième trimestre de 2026 (planification, pas une décision).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type REG_IMPL (ADOPTION_WORKFLOW)",
   "as_of": "2026-09-26",
   "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-3d8a138e",
   "statement": "Per 26 september 2026 is voor de common specifications van de EPD-componenten nog geen ontwerp ter feedback gepubliceerd (status \"UPCOMING\").",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type REG_IMPL_DRAFT",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-149f974d98",
    "title": "Have your say – European Health Data Space – common specifications for the harmonised software components of EHR systems (initiatief 18579, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/18579",
    "published": "2026-06-30"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-9b5379a9",
   "statement": "De geplande uitvoeringshandeling met common specifications voor de geharmoniseerde EPD-componenten (interoperabiliteit en logging) werd op 30 juni 2026 aangekondigd (initiatief 18579).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON-veld dossierSummary",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-149f974d98",
    "title": "Have your say – European Health Data Space – common specifications for the harmonised software components of EHR systems (initiatief 18579, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/18579",
    "published": "2026-06-30"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-aff5b496",
   "statement": "La Commission planifie l'adoption des common specifications pour les composants de DME (initiative 18579) au quatrième\ntrimestre de 2026 (planification, pas de décision).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type REG_IMPL (ADOPTION_WORKFLOW)",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-149f974d98",
    "title": "Have your say – European Health Data Space – common specifications for the harmonised software components of EHR systems (initiatief 18579, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/18579",
    "published": "2026-06-30"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-848e5db0",
   "statement": "De Commissie levert de Europese digitale testomgeving als open-source referentie-implementatie; de lidstaten rollen hun eigen testomgevingen uit en baten die uit (uitvoeringshandeling gepland, initiatief 17513).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON-veld dossierSummary",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-daeb3acd35",
    "title": "Have your say – European Health Data Space – common specifications for the European digital testing environment (initiatief 17513, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/17513",
    "published": "2026-03-30"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-109c379a",
   "statement": "La Commission planifie l'adoption de l'acte relatif à l'environnement d'essai numérique (initiative 17513) au premier\ntrimestre de 2027 (planification).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type REG_IMPL (ADOPTION_WORKFLOW)",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-daeb3acd35",
    "title": "Have your say – European Health Data Space – common specifications for the European digital testing environment (initiatief 17513, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/17513",
    "published": "2026-03-30"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-0ddd4436",
   "statement": "Initiatief 17192 (aangekondigd 9 maart 2026) betreft een uitvoeringsverordening met technische, organisatorische, beveiligings-, gegevensbeschermings- en interoperabiliteitseisen voor beveiligde verwerkingsomgevingen (SPE) voor secundair gebruik (planning, nog geen ontwerp).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, veld dossierSummary",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-3c7e9908a4",
    "title": "Have your say – European Health Data Space – Requirements for Secure Processing Environments (initiatief 17192, API-JSON)",
    "publisher": "Europese Commissie (Have your say)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/17192",
    "published": "2026-03-09"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-f63e4079",
   "statement": "De Commissie plant de vaststelling van de SPE-uitvoeringsverordening (initiatief 17192) in het eerste kwartaal van 2027 (planning, geen besluit).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type REG_IMPL (ADOPTION_WORKFLOW)",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-3c7e9908a4",
    "title": "Have your say – European Health Data Space – Requirements for Secure Processing Environments (initiatief 17192, API-JSON)",
    "publisher": "Europese Commissie (Have your say)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/17192",
    "published": "2026-03-09"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-d97e3e47",
   "statement": "Pour le label EHDS de qualité et d'utilité des données, la Commission a lancé le 27 juillet 2026 une initiative distincte\n(18853) pour un acte d'exécution relatif aux caractéristiques visuelles et aux spécifications techniques du label\n(planification, pas encore de projet).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, veld dossierSummary",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-b52b2770a3",
    "title": "Have your say – European Health Data Space – Data Quality and Utility Label (initiatief 18853, API-JSON)",
    "publisher": "Europese Commissie (Have your say)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/18853",
    "published": "2026-07-27"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-a3653759",
   "statement": "La Commission planifie l'adoption de l'acte relatif au label de qualité et d'utilité des données (initiative 18853) au\npremier trimestre de 2027 (planification, pas de décision).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type REG_IMPL (ADOPTION_WORKFLOW)",
   "as_of": "2026-09-29",
   "source": {
    "id": "SRC-b52b2770a3",
    "title": "Have your say – European Health Data Space – Data Quality and Utility Label (initiatief 18853, API-JSON)",
    "publisher": "Europese Commissie (Have your say)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/18853",
    "published": "2026-07-27"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-d394171b",
   "statement": "Tegen 26 maart 2027 moet de Commissie via uitvoeringshandelingen datakwaliteitseisen (semantiek, uniformiteit, consistentie, nauwkeurigheid, volledigheid) vastleggen voor de registratie van gezondheidsgegevens in een EPD.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "art. 13(4), eerste 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-ed470fae",
   "statement": "Het ontwerp van de MyHealth@EU-uitvoeringsverordening (april 2026) verwees naar de EEHRxF-uitvoeringsverordening op basis van art. 15(1) als een nog aan te nemen handeling.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "p. 3, overweging 7",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-e68969d010",
    "title": "Draft Commission Implementing Regulation (EU) …/... on MyHealth@EU (Ares(2026)3673221, Have your say-ontwerp)",
    "publisher": "Europese Commissie, DG SANTE",
    "url": "https://ec.europa.eu/info/law/better-regulation/api/download/090166e52be0f21d",
    "published": "2026-04-09"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-0f41175e",
   "statement": "Pour l'identification et l'authentification transfrontalières (initiative 15353), l'adoption était prévue au deuxième\ntrimestre de 2026; cette période est écoulée sans qu'un texte adopté ait été trouvé.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type DEC_IMPL (ADOPTION_WORKFLOW)",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-cd555342e5",
    "title": "Have your say – European Health Data Space identification management (initiatief 15353, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/15353",
    "published": "2026-04-09"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-561852ab",
   "statement": "Het ontwerp over grensoverschrijdende identificatie en authenticatie van personen, gezondheidswerkers en zorgverleners (initiatief 15353) had een feedbackperiode die op 7 mei 2026 sloot; een aangenomen tekst werd niet gevonden.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "JSON, publicatie type REG_IMPL_DRAFT",
   "as_of": "2026-09-26",
   "source": {
    "id": "SRC-cd555342e5",
    "title": "Have your say – European Health Data Space identification management (initiatief 15353, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/15353",
    "published": "2026-04-09"
   },
   "citaat": null,
   "figuur": null,
   "in_text": true,
   "on_page": true
  },
  {
   "id": "CLM-03ad2aed",
   "statement": "Een Commissiepresentatie (IHE-Europe Experience Days 2026) meldt dat de eerste uitvoeringshandeling, over de EHDS-raad (art. 92), de volle steun van de lidstaten kreeg.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "dia 8",
   "as_of": "2026-10-08",
   "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": false,
   "on_page": false
  },
  {
   "id": "CLM-0c1965d7",
   "statement": "De EHDS-verordening verplicht EPD-systemen twee geharmoniseerde softwarecomponenten te bevatten, een interoperabiliteitscomponent en een loggingcomponent, en de Commissie moet daarvoor via uitvoeringshandelingen common specifications vaststellen.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "veld dossierSummary",
   "as_of": "2026-10-27",
   "source": {
    "id": "SRC-149f974d98",
    "title": "Have your say – European Health Data Space – common specifications for the harmonised software components of EHR systems (initiatief 18579, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/18579",
    "published": "2026-06-30"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-1719b70f",
   "statement": "De vaststelling van het uitvoeringsbesluit over HealthData@EU (initiatief 16155) staat gepland in het vierde kwartaal van 2026 (stand 5 november 2026).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "publications, item type DEC_IMPL",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-a277aa19c8",
    "title": "Have your say – European Health Data Space HealthData@EU requirements (initiatief 16155, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/16155",
    "published": "2026-09-01"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-1a414115",
   "statement": "De Health Policy Platform van de Commissie kondigt voor 9 oktober 2026 een webinar aan dat de aangenomen uitvoeringshandelingen bij art. 16, 23, 77 en 92 van Verordening (EU) 2025/327 behandelt.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "programma van het webinar",
   "as_of": "2026-10-08",
   "source": {
    "id": "SRC-fe6e03ce49",
    "title": "Webinar 0.1 European Health Data Space: State of Play and Supporting Initiatives",
    "publisher": "Europese Commissie (Health Policy Platform)",
    "url": "https://webgate.ec.europa.eu/hpf/public-agora/76591",
    "published": null
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-1ddc2754",
   "statement": "Op 27 oktober 2026 staat de ontwerpfase van het Have your say-initiatief 18579 over de common specifications voor de geharmoniseerde softwarecomponenten van EPD-systemen nog op 'UPCOMING'.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "publications, item type REG_IMPL_DRAFT",
   "as_of": "2026-10-27",
   "source": {
    "id": "SRC-149f974d98",
    "title": "Have your say – European Health Data Space – common specifications for the harmonised software components of EHR systems (initiatief 18579, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/18579",
    "published": "2026-06-30"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-22fdc659",
   "statement": "Het ontwerp over de sjablonen is uitdrukkelijk niet door de Commissie aangenomen of onderschreven.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "titelblad, disclaimer",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-4d0a1d3a6f",
    "title": "Draft Commission Implementing Regulation laying down templates for the application of Regulation (EU) 2025/327 as regards procedures supporting access to electronic health data for secondary use",
    "publisher": "Europese Commissie",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/download/090166e535516da1",
    "published": "2026-10-16"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-2356cf38",
   "statement": "Initiatief 18579 steunt op artikel 36(1) van Verordening (EU) 2025/327.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "veld legalBasis",
   "as_of": "2026-10-27",
   "source": {
    "id": "SRC-149f974d98",
    "title": "Have your say – European Health Data Space – common specifications for the harmonised software components of EHR systems (initiatief 18579, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/18579",
    "published": "2026-06-30"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-2d2c6dac",
   "statement": "Op 28 mei 2026 rapporteerde de Commissie over de werkgroep voor artikel 15 (EEHRxF), met vijf thema's: gestructureerde en ongestructureerde gegevens, FHIR en de versies ervan, codestelsels, value sets en de bijlagen.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "p. 1, punt 4 'Report from the Working Group (WG) on Article 15'",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-efc8d0e785",
    "title": "Committee on the European Health Data Space – Summary report, 28 May 2026 (8th meeting)",
    "publisher": "Europese Commissie, DG Gezondheid en Voedselveiligheid (comitologieregister)",
    "url": "https://ec.europa.eu/transparency/comitology-register/core/api/integration/ers/534761/116504/1/attachment",
    "published": null
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-2e52ab1a",
   "statement": "Op 30 september 2026 legde de Commissie het EHDS-comité een non-paper voor over artikel 40, met common specifications voor de Europese digitale testomgevingen (EU DTE).",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "p. 2, punt 8 'Non-paper on Article 40'",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-1a01232a5d",
    "title": "Committee on the European Health Data Space – Summary record, 30 September 2026 (10th meeting)",
    "publisher": "Europese Commissie, DG Gezondheid en Voedselveiligheid (comitologieregister)",
    "url": "https://ec.europa.eu/transparency/comitology-register/core/api/integration/ers/549880/118652/1/attachment",
    "published": "2026-10-22"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-2f033a65",
   "statement": "Het ontwerp over de sjablonen voor secundair gebruik zou van toepassing worden vanaf 26 maart 2029.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "artikel 2",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-4d0a1d3a6f",
    "title": "Draft Commission Implementing Regulation laying down templates for the application of Regulation (EU) 2025/327 as regards procedures supporting access to electronic health data for secondary use",
    "publisher": "Europese Commissie",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/download/090166e535516da1",
    "published": "2026-10-16"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-412423a8",
   "statement": "Overweging 24 van Uitvoeringsverordening (EU) 2026/2083 stelt dat die verordening de gedetailleerde regels voor de werking van MyHealth@EU vastlegt en dat de plicht voor de nationale contactpunten om de prioritaire categorieën uit te wisselen van toepassing wordt overeenkomstig art. 105 van Verordening (EU) 2025/327.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "overweging 24",
   "as_of": "2026-10-08",
   "source": {
    "id": "SRC-4a9d711546",
    "title": "Commission Implementing Regulation (EU) 2026/2083 of 18 September 2026 on MyHealth@EU",
    "publisher": "Europese Commissie (EUR-Lex)",
    "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L_202602083",
    "published": "2026-09-21"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-5a60bedf",
   "statement": "Het ontwerp van 16 oktober 2026 schrijft voor dat aanvragers het sjabloon van bijlage I gebruiken voor gegevenstoegangsaanvragen onder artikel 67 van Verordening (EU) 2025/327.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "artikel 1, lid 1",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-4d0a1d3a6f",
    "title": "Draft Commission Implementing Regulation laying down templates for the application of Regulation (EU) 2025/327 as regards procedures supporting access to electronic health data for secondary use",
    "publisher": "Europese Commissie",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/download/090166e535516da1",
    "published": "2026-10-16"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-62051858",
   "statement": "Volgens Nictiz valt het verder uitwerken en beheren van value sets buiten de scope van Xt-EHR; Europese werkgroepen onder het eHealth Network werken dat uit.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "sectie 4 'Wat het project heeft gerealiseerd'",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-423d758fd7",
    "title": "Drie jaar eXtended Electronic Health Record (Xt-EHR): bouwen aan de basis voor EHDS",
    "publisher": "Nictiz",
    "url": "https://www.nictiz.nl/document/artikel-xt-ehr-terugblikpdf",
    "published": null
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-65bb9c5b",
   "statement": "Bij de tweede versie van het non-paper over artikel 15 (EEHRxF) brachten lidstaten in juni 2026 voorstellen in over governance, door de patiënt ingevoerde gegevens, mapping tussen codestelsels, verplichtingen op gegevensniveau voor EPD-systemen en de samenhang tussen de handelingen onder artikel 15 en 36.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "p. 3, punt 7 'Non paper on Article 15'",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-0f154563aa",
    "title": "Committee on the European Health Data Space – Summary record, 23 and 24 June 2026 (9th meeting)",
    "publisher": "Europese Commissie, DG Gezondheid en Voedselveiligheid (comitologieregister)",
    "url": "https://ec.europa.eu/transparency/comitology-register/core/api/integration/ers/539573/117154/1/attachment",
    "published": "2026-07-16"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-6b2c464a",
   "statement": "Op 27 oktober 2026 staat de ontwerpfase van het Have your say-initiatief 17513 over de common specifications voor de Europese digitale testomgeving nog op 'UPCOMING'.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "publications, item type REG_IMPL_DRAFT",
   "as_of": "2026-10-27",
   "source": {
    "id": "SRC-daeb3acd35",
    "title": "Have your say – European Health Data Space – common specifications for the European digital testing environment (initiatief 17513, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/17513",
    "published": "2026-03-30"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-6e9a9284",
   "statement": "Eigen lezing: art. 40(4) laat de Commissie de common specifications voor de Europese digitale testomgeving bij uitvoeringshandeling vastleggen, maar noemt daarvoor geen termijn (anders dan art. 36(1), dat 26 maart 2027 vastlegt); ook art. 105 geeft geen datum voor de testomgeving.",
   "kind": "interpretation",
   "kind_label": "interprétation",
   "locator": "art. 40(4); vergeleken met art. 36(1) en art. 105",
   "as_of": "2026-11-10",
   "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-80bed36e",
   "statement": "Initiatief 18579 steunt op artikel 36(1) van Verordening (EU) 2025/327.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "veld legalBasis",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-149f974d98",
    "title": "Have your say – European Health Data Space – common specifications for the harmonised software components of EHR systems (initiatief 18579, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/18579",
    "published": "2026-06-30"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-865e3b11",
   "statement": "Op 30 september 2026 gaf de Commissie het EHDS-comité een stand van zaken over artikel 70 (sjablonen voor secundair gebruik), met de belangrijkste herzieningen na de opmerkingen van de lidstaten op de vergadering van mei.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "p. 2, punt 4",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-1a01232a5d",
    "title": "Committee on the European Health Data Space – Summary record, 30 September 2026 (10th meeting)",
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   "citaat": null,
   "figuur": null,
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  },
  {
   "id": "CLM-86d7f72b",
   "statement": "Xt-EHR was een samenwerking van tweeënhalf jaar (2023-2026) met meer dan 50 partners uit 27 Europese landen.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "sectie 3 'Tweeënhalf jaar samenwerking in Europa'",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-423d758fd7",
    "title": "Drie jaar eXtended Electronic Health Record (Xt-EHR): bouwen aan de basis voor EHDS",
    "publisher": "Nictiz",
    "url": "https://www.nictiz.nl/document/artikel-xt-ehr-terugblikpdf",
    "published": null
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-9fe78d5d",
   "statement": "De vaststelling van de uitvoeringshandeling over de Europese digitale testomgeving (initiatief 17513, artikel 40(4)) is gepland in het eerste kwartaal van 2027.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "publications, item type REG_IMPL",
   "as_of": "2026-10-27",
   "source": {
    "id": "SRC-daeb3acd35",
    "title": "Have your say – European Health Data Space – common specifications for the European digital testing environment (initiatief 17513, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/17513",
    "published": "2026-03-30"
   },
   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-a1bd562a",
   "statement": "Op 28 mei 2026 besprak het EHDS-comité een achtergronddocument over de datakwaliteitseisen van artikel 13, met vragen over meting, terugwerkende kracht en de gevolgen voor de gegevensregistratie aan het zorgpunt.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "p. 1, punt 3 'Background document on Data quality requirements (Article 13)'",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-efc8d0e785",
    "title": "Committee on the European Health Data Space – Summary report, 28 May 2026 (8th meeting)",
    "publisher": "Europese Commissie, DG Gezondheid en Voedselveiligheid (comitologieregister)",
    "url": "https://ec.europa.eu/transparency/comitology-register/core/api/integration/ers/534761/116504/1/attachment",
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   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-ac668c0e",
   "statement": "Bij de stemming over artikel 16 herhaalden sommige lidstaten hun standpunt om zorgaanbieders buiten het toepassingsgebied te laten en het betrouwbaarheidsniveau 'hoog' voor de elektronische identificatie van zowel burgers als zorgverleners op 2032 af te stemmen.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "p. 2, punt 6",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-0f154563aa",
    "title": "Committee on the European Health Data Space – Summary record, 23 and 24 June 2026 (9th meeting)",
    "publisher": "Europese Commissie, DG Gezondheid en Voedselveiligheid (comitologieregister)",
    "url": "https://ec.europa.eu/transparency/comitology-register/core/api/integration/ers/539573/117154/1/attachment",
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   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
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  {
   "id": "CLM-b4cbd5be",
   "statement": "Op de tiende vergadering van het EHDS-comité (30 september 2026) presenteerde de Commissie een bijgewerkte tijdlijn van de uitvoeringshandelingen in voorbereiding met enkele wijzigingen; verschillende lidstaten vroegen de besprekingen van de non-papers over artikel 15 (EEHRxF) en artikel 36 (common specifications voor EPD-systemen) op elkaar afgestemd te houden.",
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   "kind_label": "fait",
   "locator": "p. 1, punt 2 'Information point on timing and planning of work'",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-1a01232a5d",
    "title": "Committee on the European Health Data Space – Summary record, 30 September 2026 (10th meeting)",
    "publisher": "Europese Commissie, DG Gezondheid en Voedselveiligheid (comitologieregister)",
    "url": "https://ec.europa.eu/transparency/comitology-register/core/api/integration/ers/549880/118652/1/attachment",
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   "citaat": null,
   "figuur": null,
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  },
  {
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   "statement": "De vaststelling van de uitvoeringshandeling met de common specifications voor de softwarecomponenten van EPD-systemen (initiatief 18579) is gepland in het vierde kwartaal van 2026.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "publications, item type REG_IMPL",
   "as_of": "2026-10-27",
   "source": {
    "id": "SRC-149f974d98",
    "title": "Have your say – European Health Data Space – common specifications for the harmonised software components of EHR systems (initiatief 18579, API-JSON)",
    "publisher": "Europese Commissie (Better Regulation portal)",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/groupInitiatives/18579",
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   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
  {
   "id": "CLM-d6748167",
   "statement": "Over het non-paper voor het kwaliteits- en bruikbaarheidslabel (artikel 78) uitten lidstaten op 30 september 2026 bezorgdheid over de last van de zelfbeoordeling voor kleine gegevenshouders.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "p. 1, punt 3 'Non paper on Article 78'",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-1a01232a5d",
    "title": "Committee on the European Health Data Space – Summary record, 30 September 2026 (10th meeting)",
    "publisher": "Europese Commissie, DG Gezondheid en Voedselveiligheid (comitologieregister)",
    "url": "https://ec.europa.eu/transparency/comitology-register/core/api/integration/ers/549880/118652/1/attachment",
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   "citaat": null,
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  {
   "id": "CLM-ddfb1016",
   "statement": "Het beknopt verslag van 30 september 2026 plant de elfde vergadering van het EHDS-comité op 22 oktober 2026.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "p. 3, punt 10 'Closing'",
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   "source": {
    "id": "SRC-1a01232a5d",
    "title": "Committee on the European Health Data Space – Summary record, 30 September 2026 (10th meeting)",
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  {
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   "statement": "Het comitologieregister vermeldt de elfde vergadering van het EHDS-comité onder code CMTD(2026)1615, met startdatum 2026-10-21T22:00:00Z (UTC).",
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   "kind_label": "fait",
   "locator": "content, vergadering id 49279",
   "as_of": "2026-11-05",
   "source": {
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    "title": "Comitologieregister – vergaderingen van comité C131500 (Committee on the European Health Data Space)",
    "publisher": "Europese Commissie (comitologieregister)",
    "url": "https://ec.europa.eu/transparency/comitology-register/core/api/front/committees/C131500/meetings?size=100",
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  {
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   "statement": "Volgens het ontwerp gebruiken de gezondheidsgegevenstoegangsinstanties, ook de Commissie als dienst voor toegang tot gezondheidsgegevens van de Unie, het sjabloon van bijlage II voor het afgeven en wijzigen van gegevensvergunningen onder artikel 68.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "artikel 1, lid 2",
   "as_of": "2026-11-05",
   "source": {
    "id": "SRC-4d0a1d3a6f",
    "title": "Draft Commission Implementing Regulation laying down templates for the application of Regulation (EU) 2025/327 as regards procedures supporting access to electronic health data for secondary use",
    "publisher": "Europese Commissie",
    "url": "https://ec.europa.eu/info/law/better-regulation/brpapi/download/090166e535516da1",
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   "citaat": null,
   "figuur": null,
   "in_text": false,
   "on_page": false
  },
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   "statement": "Volgens Nictiz worden de resultaten van Xt-EHR, waaronder de implementatierichtlijnen, actief meegenomen in het comitologieproces voor de EHDS-uitvoeringshandelingen.",
   "kind": "fact",
   "kind_label": "fait",
   "locator": "sectie 7 'Wat komt hierna'",
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   "source": {
    "id": "SRC-423d758fd7",
    "title": "Drie jaar eXtended Electronic Health Record (Xt-EHR): bouwen aan de basis voor EHDS",
    "publisher": "Nictiz",
    "url": "https://www.nictiz.nl/document/artikel-xt-ehr-terugblikpdf",
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