{"id":26009,"date":"2026-07-30T07:44:42","date_gmt":"2026-07-30T05:44:42","guid":{"rendered":"https:\/\/kloepfel-consulting.com\/?p=26009"},"modified":"2026-07-30T07:44:42","modified_gmt":"2026-07-30T05:44:42","slug":"reglementation-europeenne-hopitaux-approvisionnement","status":"publish","type":"post","link":"https:\/\/kloepfel-consulting.com\/fr\/supply-chain-news\/eu-regulierung-krankenhaeuser-beschaffung-26009\/","title":{"rendered":"R\u00e9glementation europ\u00e9enne modifie les achats dans les h\u00f4pitaux"},"content":{"rendered":"<p><strong>De nouvelles r\u00e9glementations europ\u00e9ennes (EHDS, NIS-2, r\u00e8glement sur l'IA et CRA) bouleversent compl\u00e8tement les r\u00e8gles d'approvisionnement informatique dans les h\u00f4pitaux. Ceux qui ach\u00e8tent de nouveaux syst\u00e8mes doivent penser \u00e0 la protection des donn\u00e9es, \u00e0 la s\u00e9curit\u00e9 informatique et \u00e0 la conformit\u00e9 l\u00e9gale d\u00e8s le d\u00e9part. Par cons\u00e9quent, les achats passent d'une simple fonction de commande \u00e0 un acteur d\u00e9cisionnel cl\u00e9 pour la s\u00e9curit\u00e9 juridique au quotidien de la clinique.<\/strong><\/p>\n<h2>Les points cl\u00e9s en un coup d'\u0153il :<\/h2>\n<p>&nbsp;<\/p>\n<ul>\n<li>EHDS &amp; MyHealth@EU : Des normes europ\u00e9ennes harmonis\u00e9es obligent les cliniques \u00e0 adapter leurs syst\u00e8mes pour l'\u00e9change de donn\u00e9es transfrontalier.<\/li>\n<li>Directive NIS-2 : Pratiquement tous les h\u00f4pitaux devront prouver leur cybers\u00e9curit\u00e9, et ce, non seulement au sein de leur propre \u00e9tablissement, mais \u00e9galement aupr\u00e8s des prestataires de services externes et des fournisseurs de logiciels.<\/li>\n<li>R\u00e8glement sur l'IA : l'IA m\u00e9dicale est presque toujours consid\u00e9r\u00e9e comme une technologie \u00e0 haut risque. Cela entra\u00eene des obligations strictes de contr\u00f4le et de documentation pour les op\u00e9rateurs.<\/li>\n<li>Loi sur la r\u00e9silience cybern\u00e9tique (CRA) : Les fabricants doivent garantir les mises \u00e0 jour de s\u00e9curit\u00e9. Les cliniques doivent exiger cela de mani\u00e8re contraignante avant l'achat.<\/li>\n<li>R\u00e9inventer les achats : Droit et informatique doivent se r\u00e9unir t\u00f4t, les fournisseurs \u00eatre rigoureusement contr\u00f4l\u00e9s et les contrats s\u00e9curis\u00e9s sur le long terme.<\/li>\n<\/ul>\n<h2>Les exigences europ\u00e9ennes obligent les cliniques \u00e0 disposer d'un espace de donn\u00e9es et d'une cybers\u00e9curit\u00e9.<\/h2>\n<p>Selon les informations contenues dans le texte, l'Espace europ\u00e9en des donn\u00e9es de sant\u00e9 (EEDS) \u00e9tablit pour la premi\u00e8re fois des r\u00e8gles du jeu contraignantes pour l'\u00e9change de donn\u00e9es de sant\u00e9 dans l'UE. Pour les h\u00f4pitaux, cela signifie concr\u00e8tement que leur informatique devra \u00e0 l'avenir interagir de mani\u00e8re transparente avec les r\u00e9seaux de donn\u00e9es europ\u00e9ens tels que MyHealth@EU et satisfaire \u00e0 des exigences strictes en mati\u00e8re de protection d'acc\u00e8s et de formats de donn\u00e9es.<\/p>\n<p>Parall\u00e8lement, la directive NIS 2 resserre l'\u00e9tau sur la s\u00e9curit\u00e9 informatique. Selon le communiqu\u00e9 de presse, cela concernera \u00e0 l'avenir la quasi-totalit\u00e9 des h\u00f4pitaux, quelle que soit leur taille. La cybers\u00e9curit\u00e9 devient ainsi une affaire de direction et une obligation organisationnelle. Particuli\u00e8rement sensible : la responsabilit\u00e9 ne s'arr\u00eate pas \u00e0 sa propre porte, mais inclut toute la cha\u00eene d'approvisionnement num\u00e9rique, du fournisseur de logiciels au prestataire externe.<\/p>\n<h2>Exigences strictes pour l'intelligence artificielle et les produits num\u00e9riques<\/h2>\n<p>Selon les dispositions de la proposition, le r\u00e8glement europ\u00e9en sur l'IA classe g\u00e9n\u00e9ralement les syst\u00e8mes d'IA m\u00e9dicale comme des applications \u00e0 haut risque. Pour les cliniques, cela signifie qu'elles ne sont plus seulement des utilisatrices, mais qu'elles ont des obligations en tant qu'exploitantes. Elles doivent garantir la transparence, la qualit\u00e9 des donn\u00e9es et une supervision humaine en cours d'exploitation. Seuls les produits enti\u00e8rement certifi\u00e9s peuvent \u00eatre achet\u00e9s.<\/p>\n<p>En compl\u00e9ment, le Cyber Resilience Act (CRA) responsabilise les fabricants de mat\u00e9riel et de logiciels. Selon le communiqu\u00e9 de presse, les fournisseurs devront fournir des mises \u00e0 jour de s\u00e9curit\u00e9 pour leurs produits tout au long de leur cycle de vie. Les acheteurs des h\u00f4pitaux devront donc examiner attentivement, avant m\u00eame la conclusion d'un contrat, si un fournisseur est capable d'assumer ces t\u00e2ches continues, afin d'\u00e9viter d'\u00e9ventuels pi\u00e8ges en mati\u00e8re de responsabilit\u00e9.<\/p>\n<h2>L'achat en clinique comme nouvel instrument de pilotage strat\u00e9gique<\/h2>\n<p>Pour g\u00e9rer ce r\u00e8glement au quotidien, les auteurs conseillent un changement de cap clair dans le d\u00e9partement des achats. Le savoir-faire juridique et technique doit \u00eatre pr\u00e9sent d\u00e8s le premier jour de la planification des besoins. Des contr\u00f4les de conformit\u00e9 stricts, des preuves de s\u00e9curit\u00e9 et des garanties de mise \u00e0 jour claires doivent devenir la norme dans chaque proc\u00e9dure d'attribution.<\/p>\n<p>Selon les rapports, les contrats d'achat classiques ne suffisent plus. Les contrats doivent pr\u00e9voir des obligations \u00e0 long terme \u2013 telles que des obligations claires de notification en cas d'urgence, des droits d'audit et des sc\u00e9narios de sortie r\u00e9glement\u00e9s. Avec des directives internes claires et des listes de contr\u00f4le, l'approvisionnement passe ainsi du goulot d'\u00e9tranglement bureaucratique \u00e0 un levier central pour une num\u00e9risation s\u00e9curis\u00e9e des cliniques.<\/p>","protected":false},"excerpt":{"rendered":"<p>Neue EU-Gesetze (EHDS, NIS-2, KI-Verordnung und CRA) drehen die Regeln f\u00fcr die IT-Beschaffung in Krankenh\u00e4usern komplett um. Wer neue Systeme einkauft, muss Datenschutz, IT-Sicherheit und Rechtskonformit\u00e4t von Anfang an mitdenken. Der Einkauf wandelt sich dadurch von der reinen Bestellabteilung zum entscheidenden Weichensteller f\u00fcr die Rechtssicherheit im Klinikalltag. Die Kernfakten auf einen Blick: &nbsp; EHDS &amp; [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":26010,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[88],"tags":[],"referenzkategorie":[],"class_list":["post-26009","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-supply-chain-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.1 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU-Regulierung ver\u00e4ndert Beschaffung in Krankenh\u00e4usern | KLOEPFEL by EPSA<\/title>\n<meta name=\"description\" content=\"Die EU-Regulierung zwingt Krankenh\u00e4user zur Neugestaltung von Beschaffung und Lieferketten. 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