{"id":10776,"date":"2026-07-22T17:02:17","date_gmt":"2026-07-22T09:02:17","guid":{"rendered":"https:\/\/regask.com\/?p=10776"},"modified":"2026-07-22T17:07:31","modified_gmt":"2026-07-22T09:07:31","slug":"regask-und-apacmed-wenn-regler-ai-verwenden","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/regask-and-apacmed-when-regulators-use-ai\/","title":{"rendered":"RegASK und APACMed: Wenn Regulierungsbeh\u00f6rden KI einsetzen"},"content":{"rendered":"<p>Wir freuen uns, Ihnen mitteilen zu k\u00f6nnen, dass <a href=\"https:\/\/apacmed.org\/\">APACMed<\/a> hat einen gemeinsamen Geheimdienstbericht ver\u00f6ffentlicht von <a href=\"https:\/\/regask.com\/de\/\">RegASK<\/a>\u2018&#039;S <a href=\"https:\/\/www.linkedin.com\/in\/patricia-teysseyre-96750bb\/\">Patricia Teysseyre<\/a>, Wir untersuchen, wie Regulierungsbeh\u00f6rden im asiatisch-pazifischen Raum KI intern einsetzen und was das f\u00fcr MedTech-Teams bedeutet.<!-- notionvc: 5d4e0c68-0ed2-4cde-bf72-da98fe6361f4 --><\/p>\n<p><a href=\"https:\/\/apacmed.org\/when-regulators-use-ai-what-it-means-for-medtech-teams\/\"><strong>Wenn Regulierungsbeh\u00f6rden KI einsetzen: Was bedeutet das f\u00fcr Medizintechnik-Teams?<\/strong><\/a> Die Studie untersucht, wie Regulierungsbeh\u00f6rden KI einsetzen, um Antr\u00e4ge zu pr\u00fcfen, Sicherheitsdaten auszuwerten und Entscheidungen zu beschleunigen. Sie zeigt den aktuellen Stand der wichtigsten Beh\u00f6rden auf, vom Risikoklassifizierungstool der HSA in Singapur \u00fcber den KI-Assistenten der japanischen PMDA bis hin zum Abfragetool der chinesischen NMPA.<\/p>\n<p>Der Artikel untersucht auch die Schnittstelle zwischen den beiden Entwicklungen: Indem Regulierungsbeh\u00f6rden KI im Pr\u00fcfprozess einsetzen, passen sie die Rahmenbedingungen f\u00fcr KI-gest\u00fctzte Ger\u00e4te an. Er beschreibt die zu beachtenden operationellen Risiken \u2013 von der Modellrevalidierung bis zur menschlichen Aufsicht \u2013 und die konkreten Schritte, die Teams jetzt unternehmen k\u00f6nnen.<\/p>\n<p>Da KI zunehmend in die Arbeitsweise von Regulierungsbeh\u00f6rden Einzug h\u00e4lt, kommt es bei der Vorbereitung auf diese Ver\u00e4nderungen auf strukturierte, maschinenlesbare und nachvollziehbare Nachweise sowie eine vertretbare KI-Governance an \u2013 markt\u00fcbergreifend und unter immer k\u00fcrzeren Zeitvorgaben. Regulierungsteams nutzen RegASK, um diese Ver\u00e4nderungen zu verfolgen, ihre Auswirkungen auf ein Portfolio zu bewerten und fr\u00fchzeitig darauf zu reagieren.<\/p>\n<p><!-- notionvc: 0523d20d-6f1e-45f8-b366-51a1aa92a1db --><\/p>\n\t<div id=\"gap-388781567\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-388781567 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<a href=\"https:\/\/apacmed.org\/when-regulators-use-ai-what-it-means-for-medtech-teams\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" style=\"border-radius:10px;\">\n\t\t<span>Lesen Sie den vollst\u00e4ndigen Artikel auf APACMed.<\/span>\n\t<\/a>","protected":false},"excerpt":{"rendered":"<p>Wir freuen uns, Ihnen mitteilen zu k\u00f6nnen, dass APACMed einen gemeinsamen Artikel von Patricia Teysseyre (RegASK) ver\u00f6ffentlicht hat. Darin wird untersucht, wie Aufsichtsbeh\u00f6rden im asiatisch-pazifischen Raum KI intern einsetzen und welche Auswirkungen dies auf Medizintechnik-Teams hat. Der Artikel \u2018Wenn Aufsichtsbeh\u00f6rden KI nutzen: Was das f\u00fcr Medizintechnik-Teams bedeutet\u201c beleuchtet, wie Aufsichtsbeh\u00f6rden KI zur Pr\u00fcfung von Antr\u00e4gen und zur \u00dcberpr\u00fcfung der Sicherheit einsetzen.<\/p>","protected":false},"author":32,"featured_media":10780,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[528],"tags":[],"class_list":["post-10776","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>RegASK and APACMed: When Regulators Use AI<\/title>\n<meta name=\"description\" content=\"Discover the insights from RegASK and APACMed on AI adoption by regulators and its implications for MedTech teams.\" 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