{"id":7061,"date":"2022-11-28T05:47:00","date_gmt":"2022-11-28T04:47:00","guid":{"rendered":"https:\/\/www.cabinet-magar.fr\/actualites\/acces-derogatoires-aux-medicaments-la-cnil-fixe-ses-attentes\/"},"modified":"2022-11-28T05:47:00","modified_gmt":"2022-11-28T04:47:00","slug":"acces-derogatoires-aux-medicaments-la-cnil-fixe-ses-attentes","status":"publish","type":"post","link":"https:\/\/www.cabinet-magar.fr\/de\/actualites\/acces-derogatoires-aux-medicaments-la-cnil-fixe-ses-attentes\/","title":{"rendered":"Acc\u00e8s d\u00e9rogatoires aux m\u00e9dicaments : la CNIL fixe ses attentes"},"content":{"rendered":"

Avant qu\u2019un m\u00e9dicament puisse \u00eatre mis \u00e0 la disposition du public, il doit \u00eatre soumis \u00e0 une s\u00e9rie de tests et de contr\u00f4les permettant d\u2019aboutir \u00e0 la d\u00e9livrance d\u2019une autorisation de mise sur le march\u00e9 (AMM). Cependant, dans certains cas pr\u00e9cis, des laboratoires peuvent se passer de cette AMM. Soucieuse de la protection des donn\u00e9es personnelles d\u2019ordre m\u00e9dical des patients, la CNIL veille\u2026<\/p>\n

\n

Traitement des donn\u00e9es de sant\u00e9 : 2 outils pour v\u00e9rifier votre conformit\u00e9 facilement<\/h2>\n

Les protocoles d\u2019acc\u00e8s pr\u00e9coces et les protocoles d\u2019acc\u00e8s compassionnels permettent \u00e0 des laboratoires pharmaceutiques de mettre \u00e0 disposition de certains patients des m\u00e9dicaments qui n\u2019ont pas encore obtenu d\u2019autorisation de mise sur le march\u00e9 (AMM).<\/p>\n

Ces protocoles s\u2019adressent \u00e0 des patients atteints de maladies graves pour lesquels les traitements pr\u00e9sents sur le march\u00e9 ne sont pas suffisants.<\/p>\n

Les laboratoires qui sont autoris\u00e9s \u00e0 distribuer leurs produits en fonction de ces protocoles doivent effectuer un suivi des patients concern\u00e9s. C\u2019est \u00e0 ce titre qu\u2019intervient la Commission nationale de l\u2019informatique et des libert\u00e9s (CNIL), garante de la protection des donn\u00e9es \u00e0 caract\u00e8re personnel des Fran\u00e7ais.<\/p>\n

Les donn\u00e9es personnelles relatives \u00e0 la sant\u00e9 faisant l\u2019objet d\u2019une protection renforc\u00e9e, la CNIL publie deux r\u00e9f\u00e9rentiels : un pour l\u2019acc\u00e8s pr\u00e9coce<\/a> et un pour l\u2019acc\u00e8s compassionnel<\/a>.<\/p>\n

Ces outils permettent aux laboratoires de v\u00e9rifier ais\u00e9ment la conformit\u00e9 de leurs pratiques avec les obligations impos\u00e9es par la r\u00e9glementation sur la protection des donn\u00e9es \u00e0 caract\u00e8re personnel.<\/p>\n

Si en utilisant ces r\u00e9f\u00e9rentiels, un professionnel s\u2019aper\u00e7oit qu\u2019il n\u2019est pas en conformit\u00e9, il est alors invit\u00e9 \u00e0 se rapprocher de la CNIL, afin que sa situation puisse \u00eatre \u00e9tudi\u00e9e et son traitement \u00e9ventuellement autoris\u00e9.<\/p>\n

Source : Actualit\u00e9 de la CNIL du 16 novembre 2022 : \u00ab Sant\u00e9 : la CNIL adopte deux r\u00e9f\u00e9rentiels concernant les acc\u00e8s pr\u00e9coces et les acc\u00e8s compassionnels \u00bb<\/p>\n

Acc\u00e8s d\u00e9rogatoires aux m\u00e9dicaments : la CNIL fixe ses attentes<\/a> \u00a9 Copyright WebLex – 2022<\/p>\n<\/div>\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Avant qu\u2019un m\u00e9dicament puisse \u00eatre mis \u00e0 la disposition du public, il doit \u00eatre soumis \u00e0 une s\u00e9rie de tests et de contr\u00f4les permettant d\u2019aboutir \u00e0 la d\u00e9livrance d\u2019une autorisation de mise sur le march\u00e9 (AMM). Cependant, dans certains cas pr\u00e9cis, des laboratoires peuvent se passer de cette AMM. Soucieuse de la protection des donn\u00e9es personnelles d\u2019ordre m\u00e9dical des patients, la CNIL veille\u2026<\/p>\n","protected":false},"author":0,"featured_media":7062,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[9,7],"tags":[],"class_list":["post-7061","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actu-juridique","category-actualites"],"acf":[],"yoast_head":"\nAcc\u00e8s d\u00e9rogatoires aux m\u00e9dicaments : la CNIL fixe ses attentes - Cabinet Magar<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.cabinet-magar.fr\/actualites\/acces-derogatoires-aux-medicaments-la-cnil-fixe-ses-attentes\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Acc\u00e8s d\u00e9rogatoires aux m\u00e9dicaments : la CNIL fixe ses attentes - Cabinet Magar\" \/>\n<meta property=\"og:description\" content=\"Avant qu\u2019un m\u00e9dicament puisse \u00eatre mis \u00e0 la disposition du public, il doit \u00eatre soumis \u00e0 une s\u00e9rie de tests et de contr\u00f4les permettant d\u2019aboutir \u00e0 la d\u00e9livrance d\u2019une autorisation de mise sur le march\u00e9 (AMM). 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