{"id":4735,"date":"2024-11-26T15:35:34","date_gmt":"2024-11-26T14:35:34","guid":{"rendered":"https:\/\/www.bayoomed.com\/?post_type=begleitprozesse&#038;p=4735"},"modified":"2024-11-26T16:17:04","modified_gmt":"2024-11-26T15:17:04","slug":"bsi-tr-03161-certificate","status":"publish","type":"begleitprozesse","link":"https:\/\/www.bayoomed.com\/en\/begleitprozesse\/bsi-tr-03161-certificate\/","title":{"rendered":"BSI TR-03161: Gap analysis and consulting"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-margin-bottom:60px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 70vw + 0px );margin-left: calc(-0px \/ 2 );margin-right: calc(-0px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-margin-bottom-large:20px;--awb-spacing-left-large:0px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:0px;--awb-spacing-left-small:0px;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:0px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:39;line-height:var(--awb-typography1-line-height);\"><h2>Why your DiGA now needs the BSI TR-03161 certificate<\/h2><\/h2><\/div><div class=\"fusion-text fusion-text-1\"><p>Digital health applications (DiGA) must meet data security criteria in accordance with Section 139e (10) SGB V and Section 78a (7) SGB XI &#8211; and be certified with the BSI TR-03161 certificate by 2025. This is intended to protect patient data even more effectively. This obligation applies equally to DiGAs that are already listed and to current or new applications for inclusion in the DiGA directory, although the verification deadlines differ. Does my DiGA really meet all the requirements of the data security criteria? Anyone who already has an application listed in the directory must act quickly. This is because <span style=\"color: var(--awb-text-color);font-family: var(--awb-text-font-family);font-size: var(--awb-font-size);font-style: var(--awb-text-font-style);font-weight: var(--awb-text-font-weight);letter-spacing: var(--awb-letter-spacing);text-align: var(--awb-content-alignment);text-transform: var(--awb-text-transform);background-color: var(--awb-bg-color-medium)\">a BSI TR-03161 certificate must confirm correctness<\/span> by <span style=\"color: var(--awb-text-color);font-family: var(--awb-text-font-family);font-size: var(--awb-font-size);font-style: var(--awb-text-font-style);font-weight: var(--awb-text-font-weight);letter-spacing: var(--awb-letter-spacing);text-align: var(--awb-content-alignment);text-transform: var(--awb-text-transform);background-color: var(--awb-bg-color-medium)\">January 1, 2025.<\/span><\/p>\n<\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--awb-margin-top:15px;--button-border-radius-top-left:30px;--button-border-radius-top-right:30px;--button-border-radius-bottom-right:30px;--button-border-radius-bottom-left:30px;\" target=\"_self\" href=\"https:\/\/www.bayoomed.com\/en\/begleitprozesse\/bsi-tr-03161-certificate\/#gap-analyse\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">directly to the gap analysis<\/span><\/a><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-left:0px;--awb-margin-bottom:60px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 70vw + );margin-left: calc(- \/ 2 );margin-right: calc(- \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-margin-bottom-large:20px;--awb-spacing-left-large:calc( 0 * calc( 100% - ) );--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-left-medium:calc( 0 * calc( 100% - ) );--awb-width-small:100%;--awb-order-small:0;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:0px;--awb-margin-left-small:0px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\"><h3>These deadlines apply to the BSI TR-03161 certification for DiGA<\/h3><\/h3><\/div><ul style=\"--awb-item-padding-bottom:30px;--awb-line-height:30.6px;--awb-icon-width:30.6px;--awb-icon-height:30.6px;--awb-icon-margin:12.6px;--awb-content-margin:43.2px;--awb-circlecolor:var(--awb-color4);--awb-circle-yes-font-size:15.84px;\" class=\"fusion-checklist fusion-checklist-1 fusion-checklist-default type-icons\"><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<div class=\"iconlist_content_wrap\">\n<header class=\"entry-content-header\">\n<p class=\"av_iconlist_title iconlist_title \"><b>January 01, 2025<\/b><\/p>\n<\/header>\n<div class=\"iconlist_content \">\n<p>DiGAs that are already listed must have a BSI TR-03161 certificate by this date to prove that they meet the data security requirements.<\/p>\n<p>If the deadline cannot be met, the Federal Institute for Drugs and Medical Devices (BfArM) must be contacted in advance.<\/p>\n<p>If the deadline is not met and no contact is made, the DiGA may be removed from the list.<\/p>\n<\/div>\n<\/div>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<div class=\"iconlist_content_wrap\">\n<header class=\"entry-content-header\">\n<p class=\"av_iconlist_title iconlist_title \"><b>June 30, 2025<\/b><\/p>\n<\/header>\n<div class=\"iconlist_content \">\n<p>Current or new applications must also submit a BSI TR-03161 certificate from January 1, 2025 in order to prove the completeness of the application and thus data security. However, there is a transitional period for new applications until the end of June 2025, during which the certificate can be submitted later in the review process. The prerequisite for this is an appointment confirmation from the responsible certification body when the application is submitted.<\/p>\n<\/div>\n<\/div>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" id=\"gap-analyse\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 70vw + );margin-left: calc(- \/ 2 );margin-right: calc(- \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_5 1_5 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-margin-bottom-large:20px;--awb-width-medium:20%;--awb-order-medium:0;--awb-width-small:100%;--awb-order-small:0;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-1 fb-icon-element fontawesome-icon fa-shield-alt fas circle-yes\" style=\"--awb-circlebordersize:0px;--awb-font-size:70.4px;--awb-width:140.8px;--awb-height:140.8px;--awb-line-height:140.8px;--awb-margin-top:0;--awb-margin-right:0;--awb-margin-bottom:0;--awb-margin-left:0;--awb-align-self:center;\"><\/i><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_4_5 4_5 fusion-flex-column\" style=\"--awb-padding-top:60px;--awb-padding-right:60px;--awb-padding-bottom:60px;--awb-padding-left:60px;--awb-overflow:hidden;--awb-bg-color:var(--awb-color7);--awb-bg-color-hover:var(--awb-color7);--awb-bg-size:cover;--awb-border-radius:60px 60px 60px 60px;--awb-width-large:80%;--awb-margin-top-large:0px;--awb-margin-bottom-large:60px;--awb-spacing-left-large:calc( 0 * calc( 100% - ) );--awb-width-medium:80%;--awb-order-medium:0;--awb-spacing-left-medium:calc( 0 * calc( 100% - ) );--awb-width-small:100%;--awb-order-small:0;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:0px;--awb-margin-left-small:0px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\"><h3>Your gap analysis and advice<\/h3><\/h3><\/div><div class=\"fusion-text fusion-text-2\"><p style=\"color: var(--awb-color1)\">Do you want to take matters into your own hands, but don&#8217;t know exactly how to get through the process safely? Our specialized team will guide you through all the requirements of BSI TR-03161 and ensure that your systems meet the strict security standards. <span style=\"color: var(--awb-color1);font-family: var(--awb-text-font-family);font-size: var(--awb-font-size);font-style: var(--awb-text-font-style);font-weight: var(--awb-text-font-weight);letter-spacing: var(--awb-letter-spacing);text-align: var(--awb-content-alignment);text-transform: var(--awb-text-transform);background-color: var(--awb-bg-color-medium-hover)\"><br \/>\n<\/span><\/p>\n<p style=\"color: var(--awb-color1)\"><span style=\"color: var(--awb-color1);font-family: var(--awb-text-font-family);font-size: var(--awb-font-size);font-style: var(--awb-text-font-style);font-weight: var(--awb-text-font-weight);letter-spacing: var(--awb-letter-spacing);text-align: var(--awb-content-alignment);text-transform: var(--awb-text-transform);background-color: var(--awb-bg-color-medium-hover)\">From initial assessment to full implementation, we support you in complying with this BSI Technical Guideline to protect your data and increase the trustworthiness of your DiGA.<\/span><\/p>\n<\/div><div style=\"text-align:left;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-2 fusion-button-default-span fusion-button-default-type\" style=\"--awb-margin-top:20px;--button-border-radius-top-left:30px;--button-border-radius-top-right:30px;--button-border-radius-bottom-right:30px;--button-border-radius-bottom-left:30px;\" target=\"_self\" href=\"https:\/\/www.bayoomed.com\/en\/#contact\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">contact now<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"featured_media":4733,"template":"","categories":[74,33],"class_list":["post-4735","begleitprozesse","type-begleitprozesse","status-publish","has-post-thumbnail","hentry","category-diga-en","category-service"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>BSI TR-03161: Gap analysis and consulting - BAYOOMED<\/title>\n<meta name=\"description\" content=\"The BSI TR-03161 certificate is mandatory for DiGA from January 2025. 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