{"id":12758,"date":"2023-11-13T15:01:06","date_gmt":"2023-11-13T14:01:06","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=12758"},"modified":"2024-05-03T14:39:20","modified_gmt":"2024-05-03T12:39:20","slug":"cadre-transatlantique-transfert-donnees-clinique","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/cadre-transatlantique-transfert-donnees-clinique\/","title":{"rendered":"CADRE TRANSATLANTIQUE: TRANSFERT DE DONN\u00c9ES CLINIQUE"},"content":{"rendered":"

Le nouveau cadre transatlantique de protection des donn\u00e9es<\/strong>\u00a0cliniques<\/strong><\/p>\r\n\r\n\r\n\r\n

L\u2019histoire d\u2019(d\u00e9s)amour(s) entre l\u2019Union Europ\u00e9enne et les \u00c9tats-Unis sur la protection des donn\u00e9es cliniques<\/strong> dure depuis si longtemps que nous pourrions pratiquement en faire un film.<\/p>\r\n\r\n\r\n\r\n

Commen\u00e7ons par retourner dans le temps. A l\u2019aube des ann\u00e9es 2000,\u202fun ensemble de principes appel\u00e9 \u00ab\u202fSafe Harbor\u202f\u00bb, avait \u00e9t\u00e9 mis en place afin de permettre \u00e0 certaines entreprises am\u00e9ricaines de certifier qu\u2019elles \u00e9taient conformes \u00e0 la l\u00e9gislation de l\u2019Union europ\u00e9enne. Cette certification leur permettait donc d\u2019obtenir l\u2019autorisation de transfert pour les donn\u00e9es cliniques de l\u2019Union europ\u00e9enne vers les Etats-Unis.\u00a0\u00a0<\/p>\r\n\r\n\r\n\r\n

Le cadre transatlantique et son histoire de protection de donn\u00e9es<\/h2>\r\n\r\n\r\n\r\n

En 2015, le Safe Harbor a \u00e9t\u00e9 invalid\u00e9 par la Cour de Justice de l\u2019Union Europ\u00e9enne aux motifs que la l\u00e9gislation am\u00e9ricaine, permettant \u00ab\u202faux pouvoirs publics d\u2019acc\u00e9der de mani\u00e8re g\u00e9n\u00e9ralis\u00e9e au contenu des communications \u00e9lectroniques, doit \u00eatre consid\u00e9r\u00e9e comme compromettante pour l\u2019essence m\u00eame du droit fondamental au respect de la vie priv\u00e9e<\/em> \u00bb. Ainsi, le niveau de protection ad\u00e9quat des donn\u00e9es \u00e0 caract\u00e8re personnel<\/a> n\u2019\u00e9tait pas garanti.\u00a0\u00a0<\/p>\r\n\r\n\r\n\r\n

En 2016, c\u2019est au tour du Privacy Shield de venir tenter d\u2019encadrer les transferts de donn\u00e9es de l\u2019Union europ\u00e9enne vers les \u00c9tats-Unis. Le Privacy Shield \u00e9tait un bouclier de protection des donn\u00e9es<\/strong>, lui aussi approuv\u00e9 par la Commission europ\u00e9enne, par la formule\u202f: \u00ab\u202fLes garanties pour le transfert des donn\u00e9es sur la base de la nouvelle protection des donn\u00e9es UE-\u00c9tats-Unis prot\u00e8gent selon les normes de protection des donn\u00e9es dans l’U.E<\/em>.\u202f\u00bb\u00a0<\/p>\r\n\r\n\r\n\r\n

A l\u2019instar de son grand fr\u00e8re, le Privacy Shield a \u00e9t\u00e9 invalid\u00e9 en 2020 par la Cour de Justice de l\u2019Union Europ\u00e9enne. D\u00e8s lors, depuis cette date, nous \u00e9tions dans un vide entre n\u00e9cessit\u00e9 de transfert de donn\u00e9es vers les Etats-Unis, dans la mesure o\u00f9 l\u2019utilisation m\u00eame d\u2019un ordinateur suppose pratiquement syst\u00e9matiquement le transfert de donn\u00e9es vers les Etats-Unis (par l\u2019utilisation d\u2019outils tels que Microsoft, Dropbox\u2026), et complexit\u00e9 dans l\u2019encadrement de celui-ci. Pendant les deux derni\u00e8res ann\u00e9es, \u00ab\u202ftransfert de donn\u00e9es vers les \u00c9tats-Unis\u202f\u00bb rimait alors, le plus souvent avec \u00ab\u202fclauses contractuelles types\u202f\u00bb.\u00a0<\/p>\r\n\r\n\r\n\r\n

\"\"<\/figure>\r\n\r\n\r\n\r\n

Nouvelle d\u00e9cision d’ad\u00e9quation en faveur des Etats-Unis<\/h2>\r\n\r\n\r\n\r\n

Or, le 10 juillet 2023 (date d\u2019entr\u00e9e en application), la Commission europ\u00e9enne a adopt\u00e9 une nouvelle d\u00e9cision d\u2019ad\u00e9quation en faveur des \u00c9tats-Unis, consid\u00e9rant qu\u2019ils assurent d\u00e9sormais un niveau de protection de donn\u00e9es \u00e9quivalent \u00e0 celui de l\u2019Union europ\u00e9enne. D\u00e8s lors, dans certaines conditions, transfert de donn\u00e9es personnelles<\/strong> vers ce pays pourra donc d\u00e9sormais s\u2019effectuer sans exigences suppl\u00e9mentaires (et donc, sans avoir besoin de mettre en place des clauses contractuelles types).\u00a0\u00a0<\/p>\r\n\r\n\r\n\r\n

Comme pour le Privacy Shield, le choix d\u2019un m\u00e9canisme d\u2019auto-certification a \u00e9t\u00e9 fait. C\u2019est-\u00e0-dire que les entreprises \u00e9tasuniennes peuvent s\u2019auto-certifier afin de d\u00e9clarer qu\u2019elles sont conformes aux obligations et y adh\u00e8rent. Ce faisant, elles s\u2019engagent publiquement et annuellement.\u00a0\u00a0<\/p>\r\n\r\n\r\n\r\n

Une fois auto-certifi\u00e9es, elles seront ensuite inscrites sur la Liste du D\u00e9partement du Commerce \u00e9tatsunien. Ainsi, seul le transfert de donn\u00e9es<\/strong> vers des organismes inscrits sur cette liste entre dans le m\u00e9canisme d\u2019ad\u00e9quation et permet d\u2019\u00eatre dispens\u00e9 de la mise en \u0153uvre de tout autre transfert. Le transfert s\u2019effectue alors comme n\u2019importe quel transfert entre deux pays de l\u2019Union europ\u00e9enne, par exemple.\u00a0\u00a0<\/p>\r\n\r\n\r\n\r\n

Attention\u202f: cela ne dispense pas de r\u00e9aliser les autres obligations du RGPD (registres de traitement, information\u2026).\u00a0<\/p>\r\n\r\n\r\n\r\n

\u00a0La recherche clinique est \u00e9galement concern\u00e9e par ce cadre, car les essais cliniques<\/strong><\/a> se concentrent sur les donn\u00e9es \u00e0 caract\u00e8re personnel (informations sur les patients…)<\/p>\r\n\r\n\r\n\r\n

A ce jour, ce sont presque 2500 organismes qui sont d\u00e9j\u00e0 inscrits sur cette liste, dont Microsoft, META, ou encore Dropbox. Vous pourrez retrouver la liste compl\u00e8te du D\u00e9partement du Commerce \u00e9tatsunien \u00e0 l\u2019adresse suivante\u202f: https:\/\/www.dataprivacyframework.gov\/s\/participant-search<\/a>.\u00a0\u00a0<\/p>\r\n\r\n\r\n\r\n

Pour l\u2019industrie pharmaceutique, il peut \u00eatre int\u00e9ressant de se reporter \u00e0 la liste afin de choisir les prestataires conformes, ce qui \u00e9vitera d\u2019alourdir la charge administrative \u2013 et donc, les co\u00fbts \u2013 d\u2019une \u00e9tude.\u00a0\u00a0<\/p>\r\n\r\n\r\n\r\n

\"\"<\/figure>\r\n\r\n\r\n\r\n

Il est \u00e0 noter que cette d\u00e9cision d\u2019ad\u00e9quation reste applicable jusqu\u2019\u00e0 sa modification, son remplacement ou son abrogation par la Commission europ\u00e9enne, le cas \u00e9ch\u00e9ant. La CNIL indique tout de m\u00eame qu\u2019une premi\u00e8re revue aura lieu dans un an, et que selon le r\u00e9sultat de ce premier examen, la Commission d\u00e9cidera, en consultation avec les \u00c9tats membres, de la p\u00e9riodicit\u00e9 des revues suivantes, qui ne pourra pas exc\u00e9der 4 ans.\u00a0<\/p>\r\n\r\n\r\n\r\n

Nous ne sommes donc pas encore \u00e0 l\u2019abri d\u2019une nouvelle invalidation\u2026 Jamais deux sans trois\u202f?\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

A l\u2019aube des ann\u00e9es 2000,\u202fun ensemble de principes appel\u00e9 \u00ab\u202fSafe Harbor\u202f\u00bb, avait \u00e9t\u00e9 mis en place afin de permettre \u00e0 certaines entreprises am\u00e9ricaines de certifier qu\u2019elles \u00e9taient conformes \u00e0 la l\u00e9gislation de l\u2019Union europ\u00e9enne. Cette certification leur permettait donc d\u2019obtenir l\u2019autorisation de transfert pour les donn\u00e9es cliniques de l\u2019Union europ\u00e9enne vers les Etats-Unis.\u00a0<\/p>","protected":false},"author":4,"featured_media":12923,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"facebook_122143508198123560_331463380343150":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","_sitemap_exclude":false,"_sitemap_priority":"","_sitemap_frequency":"","_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[389],"tags":[359,360,202,358],"class_list":{"0":"post-12758","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-reglementaires","8":"tag-protection-de-donnees","9":"tag-rgpd","10":"tag-safe-harbor","11":"tag-transfert-donnees"},"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fr","en"],"languages":{"fr":{"title":true,"content":true,"excerpt":true},"en":{"title":false,"content":false,"excerpt":false}}},"yoast_head":"\nCadre 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