{"id":33030,"date":"2024-08-29T09:30:54","date_gmt":"2024-08-29T07:30:54","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/08\/29\/ue-in-gazzetta-ufficiale-lartificial-intelligence-act-aia\/"},"modified":"2024-08-29T11:44:49","modified_gmt":"2024-08-29T09:44:49","slug":"ue-in-gazzetta-ufficiale-lartificial-intelligence-act-aia","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2024\/08\/29\/ue-in-gazzetta-ufficiale-lartificial-intelligence-act-aia\/","title":{"rendered":"UE: En el Diario Oficial la Ley sobre Inteligencia Artificial (AIA)"},"content":{"rendered":"<h2>La Comisi\u00f3n Europea ha hecho p\u00fablico el texto definitivo de la Ley de Inteligencia Artificial (AIA), el primer marco regulador completo del mundo dedicado a la inteligencia artificial. Este reglamento define un conjunto armonizado de normas para fomentar una inteligencia artificial \u00abfiable y centrada en el ser humano\u00bb, aplicable a los productos sanitarios, los de diagn\u00f3stico in vitro (IVD) y otros productos. El objetivo de la AIA es garantizar la comercializaci\u00f3n segura de estos productos, como tambi\u00e9n reconoce el Parlamento Europeo.<\/h2>\n<p>Publicado en <strong>el Diario Oficial el<\/strong> <strong>12 de julio<\/strong>, el Reglamento <strong>entr\u00f3 en vigor el 2<\/strong> <strong>de<\/strong> <strong>agosto<\/strong> <strong>de 2024, <\/strong>y <strong>los requisitos aplicables a los productos de alto riesgo<\/strong> ser\u00e1n obligatorios <strong>a partir del<\/strong> <strong>2 de agosto de 2026.<\/strong><\/p>\n<p>La AIA pretende mejorar el funcionamiento del mercado prohibiendo determinadas pr\u00e1cticas de IA e introduciendo obligaciones adicionales para los sistemas de IA de alto riesgo. Adem\u00e1s, el reglamento exige a los proveedores y operadores de sistemas de IA que garanticen que su personal tiene un nivel adecuado de conocimientos.<\/p>\n<h2><strong>Obligaciones para los dispositivos de IA de alto riesgo <\/strong><\/h2>\n<p>La Ley de IA incluye varias disposiciones pertinentes para <strong>los productos sanitarios que integran inteligencia artificial o se basan en ella.<\/strong> Sin embargo, la legislaci\u00f3n no trata todas las aplicaciones de la misma manera: al adoptar un enfoque basado en el riesgo, gran parte de las nuevas obligaciones de cumplimiento, notificaci\u00f3n y responsabilidad recaer\u00e1n principalmente en los \u00abproveedores\u00bb (art. 3(3), Ley de IA) de componentes o soluciones de IA considerados <strong>de \u00abalto riesgo\u00bb<\/strong>, <strong>Clase<\/strong><strong> IIa o superior<\/strong>.<\/p>\n<p>El reglamento especifica que los fabricantes de productos sanitarios de alto riesgo deben implantar un <strong>sistema de gesti\u00f3n de riesgos para todo el ciclo de vida del producto<\/strong>, garantizar la gobernanza para certificar que los datos no contienen errores y presentar documentaci\u00f3n t\u00e9cnica que demuestre el cumplimiento del reglamento.<\/p>\n<p>Entre las muchas obligaciones del fabricante se incluye:<\/p>\n<ul>\n<li>Adoptar un <strong>sistema de gesti\u00f3n de la calidad<\/strong> conforme al art.17, rigurosamente documentado mediante pol\u00edticas, procedimientos e instrucciones escritas.<\/li>\n<li>Garantizar que el sistema de IA de alto riesgo cumple los requisitos del Reglamento sobre IA y se somete al <strong>procedimiento de evaluaci\u00f3n de la conformidad<\/strong> necesario para su comercializaci\u00f3n.<\/li>\n<li>Colocar el <strong>marcado CE en el sistema de IA de alto riesgo<\/strong> o, si no es posible, en un embalaje o documento de acompa\u00f1amiento.<\/li>\n<li>Establecer un sistema de<strong> seguimiento posterior a la comercializaci\u00f3n<\/strong> para recopilar y analizar datos sobre el funcionamiento del sistema de IA, como registros generados autom\u00e1ticamente (art.19) y proporcionar las actualizaciones necesarias.<\/li>\n<li>Garantizar que el sistema de IA de alto riesgo cumple los <strong>requisitos de accesibilidad<\/strong> ex Directivas 2016\/2102 y 2019\/992.<\/li>\n<\/ul>\n<p>Adem\u00e1s, las <strong>obligaciones en virtud del GDPR<\/strong> con respecto al tratamiento de datos personales para los proveedores, en su papel de controladores o procesadores de datos, contin\u00faan aplic\u00e1ndose regularmente.<\/p>\n<p>Por \u00faltimo, el proveedor deber\u00e1 identificar las <strong>medidas<\/strong> adecuadas <strong>de vigilancia humana<\/strong> previas a la comercializaci\u00f3n<strong>.<\/strong>\u00a0 Los sistemas de IA de alto riesgo deben dise\u00f1arse para ofrecer transparencia y permitir a los operadores comprender e interpretar los resultados proporcionados por el sistema. Las <strong>instrucciones de uso<\/strong> deben ser \u00abconcisas, completas, correctas y claras\u00bb.<\/p>\n<p>Para los <strong>productos de bajo riesgo<\/strong>, el Reglamento establece requisitos menos estrictos que para los de alto riesgo.<\/p>\n<h2><strong>Cambios y estrategias normativas<\/strong><\/h2>\n<p>Seg\u00fan an\u00e1lisis recientes, una gran proporci\u00f3n de las aplicaciones de IA en la atenci\u00f3n sanitaria se clasificar\u00e1n como de \u00abalto riesgo\u00bb y estar\u00e1n sujetas a exigentes requisitos de conformidad.<\/p>\n<p>La Ley de IA modifica la normativa sobre productos sanitarios, introduciendo nuevas normas y definiciones para el uso de la inteligencia artificial en la asistencia sanitaria. Esto representa un cambio significativo en el desarrollo y uso de tecnolog\u00edas avanzadas en medicina, lo que obliga a las empresas a <strong>revisar sus estrategias de cumplimiento e innovaci\u00f3n<\/strong>.<\/p>\n<p>Lo fundamental, en primer lugar, es entender cu\u00e1ndo un <strong>producto sanitario <\/strong>que utiliza inteligencia artificial entra en la categor\u00eda de <strong>alto riesgo<\/strong>.<\/p>\n<p><strong>&gt;&gt;&gt;<\/strong> Los expertos de Thema est\u00e1n preparados para <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\">guiarle<\/a> en cada paso necesario para lograr y demostrar la conformidad de los productos sanitarios mediante inteligencia artificial, acompa\u00f1\u00e1ndole durante todo el ciclo de vida del producto.<\/p>\n<p><strong>FUENTE:<\/strong><br \/>\n<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=OJ:L_202401689\">https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=OJ:L_202401689<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La Comisi\u00f3n Europea ha hecho p\u00fablico el texto definitivo de la Ley de Inteligencia Artificial (AIA), el primer marco regulador completo  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33010,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-33030","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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