{"id":73618,"date":"2025-12-18T11:47:13","date_gmt":"2025-12-18T10:47:13","guid":{"rendered":"https:\/\/www.teoresigroup.com\/?p=73618"},"modified":"2026-02-09T16:24:22","modified_gmt":"2026-02-09T15:24:22","slug":"european-health-data-space-medical-devices","status":"publish","type":"post","link":"https:\/\/www.teoresigroup.com\/de\/news\/european-health-data-space-medical-devices\/","title":{"rendered":"EHDS und Medizinprodukte: Was \u00e4ndert sich mit der neuen EU-Verordnung zum Europ\u00e4ischen Gesundheitsdatenraum?"},"content":{"rendered":"\n<div class=\"wp-block-columns row align-center row sezione\">\n<div class=\"wp-block-column column small-12 medium-10 large-8\">\n<p>Der Inkrafttreten der <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/IT\/TXT\/PDF\/?uri=OJ:L_202500327\">Verordnung <\/a>(EU) 2025\/327 zum europ\u00e4ischen Gesundheitsdatenraum (European Health Data Space \u2013 EHDS) markiert einen bedeutenden Wendepunkt f\u00fcr den digitalen Gesundheitssektor in Europa. Die neue Verordnung f\u00fchrt klare Regeln f\u00fcr die Interoperabilit\u00e4t von Gesundheitsdaten ein und f\u00f6rdert ein st\u00e4rker integriertes, transparentes und b\u00fcrgerzentriertes Gesundheitssystem.<\/p>\n\n\n\n<p><strong>Wie ist die EHDS-Verordnung aufgebaut und welche Anwendungsbereiche umfasst sie?<\/strong><\/p>\n\n\n\n<p>Die EHDS-Verordnung unterscheidet zwischen der prim\u00e4ren Nutzung elektronischer Gesundheitsdaten (f\u00fcr die Patientenversorgung) und der sekund\u00e4ren Nutzung (f\u00fcr Forschung, Innovation und Politikgestaltung). Sie legt strenge Anforderungen fest, um Datensicherheit, R\u00fcckverfolgbarkeit und klinische Zuverl\u00e4ssigkeit zu gew\u00e4hrleisten.<\/p>\n\n\n\n<p><strong>Wie erm\u00f6glicht die EHDS-Verordnung den Austausch von Gesundheitsdaten in Europa?<\/strong><\/p>\n\n\n\n<p>Die Verordnung gilt nicht nur f\u00fcr Anbieter elektronischer Patientenakten (EHR), sondern auch f\u00fcr Hersteller von Medizinprodukten, In-vitro-Diagnostika (IVD) und KI-Systemen mit hohem Risiko. Diese Akteure m\u00fcssen ihre technische Konformit\u00e4t mit den neuen gemeinsamen Spezifikationen f\u00fcr Interoperabilit\u00e4t nachweisen.<\/p>\n\n\n\n<p><strong>Zentrale Anforderungen sind unter anderem:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list wp-block-list\">\n<li>Einf\u00fchrung von Interoperabilit\u00e4tsstandards wie HL7 FHIR<\/li>\n\n\n\n<li>verpflichtende kontinuierliche Update- und Wartungsprozesse<\/li>\n\n\n\n<li>Konformit\u00e4t mit MyHealth@EU (f\u00fcr die prim\u00e4re Nutzung) und HealthData@EU (f\u00fcr die sekund\u00e4re Nutzung)<\/li>\n\n\n\n<li>Abstimmung mit dem EU-Gesetz \u00fcber k\u00fcnstliche Intelligenz f\u00fcr KI-Systeme mit hohem Risiko<\/li>\n<\/ul>\n\n\n\n<p>Diese Vorgaben wirken sich direkt auf das Design von Produkten, die technische Dokumentation und das Management des gesamten Produktlebenszyklus aus. Die Anpassung an diese neuen regulatorischen Rahmenbedingungen ist entscheidend, um Zugang zum EU-Markt zu erhalten und das Vertrauen von Patient:innen, Gesundheitsfachkr\u00e4ften und Aufsichtsbeh\u00f6rden zu sichern.<\/p>\n\n\n\n<p><strong>M\u00f6chten Sie mehr erfahren?<\/strong><br>F\u00fcllen Sie das Formular aus, um den vollst\u00e4ndigen Artikel herunterzuladen, oder entdecken Sie weitere technische Inhalte in unserem Bereich f\u00fcr <a href=\"https:\/\/www.teoresigroup.com\/de\/company\/medtech\/medtech-publications\/\">technical insights<\/a>.<\/p>\n\n\n        \n        <div id=\"block_2556d0675254a8c161b1427dfbbe5964\" class=\"file-attachment-repeater row sezione pt-0 align-center\">\n\n            <div class=\"column small-12\">\n\n                \n                     <a class=\"attachment flex align-middle p-3 mb-2 fs-p color-body\" href=\"https:\/\/www.teoresigroup.com\/wp-content\/uploads\/2025\/12\/ehds-teoresi-medtech-de.pdf\" target=\"_blank\" rel=\"nofollow noopener\" onclick=\"ga('send', 'event', 'Action-Link', 'Click', 'Download the article here');\"><svg class=\"icon download width-8 mr-4 color-primary\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 576 512\"><path d=\"M528 288h-92.1l46.1-46.1c30.1-30.1 8.8-81.9-33.9-81.9h-64V48c0-26.5-21.5-48-48-48h-96c-26.5 0-48 21.5-48 48v112h-64c-42.6 0-64.2 51.7-33.9 81.9l46.1 46.1H48c-26.5 0-48 21.5-48 48v128c0 26.5 21.5 48 48 48h480c26.5 0 48-21.5 48-48V336c0-26.5-21.5-48-48-48zm-400-80h112V48h96v160h112L288 368 128 208zm400 256H48V336h140.1l65.9 65.9c18.8 18.8 49.1 18.7 67.9 0l65.9-65.9H528v128zm-88-64c0-13.3 10.7-24 24-24s24 10.7 24 24-10.7 24-24 24-24-10.7-24-24z\"\/><\/svg>Download the article here<\/a>\n                \n            <\/div>\n\n        <\/div>\n\n    \n<\/div>\n<\/div>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p class=\"excerpt\">Der Inkrafttreten der Verordnung (EU) 2025\/327 zum europ\u00e4ischen Gesundheitsdatenraum (European Health Data Space \u2013 EHDS) markiert einen bedeutenden Wendepunkt f\u00fcr den digitalen Gesundheitssektor in Europa. Die neue Verordnung f\u00fchrt klare Regeln f\u00fcr die Interoperabilit\u00e4t von Gesundheitsdaten ein und f\u00f6rdert ein st\u00e4rker integriertes, transparentes und b\u00fcrgerzentriertes Gesundheitssystem. Wie ist die EHDS-Verordnung aufgebaut und welche Anwendungsbereiche umfasst sie? Die EHDS-Verordnung unterscheidet zwischen&#8230;<\/p>\n","protected":false},"author":16,"featured_media":73861,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12,568,764],"tags":[],"class_list":["post-73618","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-corporate","category-medtech-3","category-medtech-de"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EHDS und Medizinprodukte - Teoresi Group<\/title>\n<meta name=\"description\" content=\"Was bringt die neue EHDS-Verordnung? 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