{"id":3691,"date":"2024-10-15T06:30:41","date_gmt":"2024-10-15T04:30:41","guid":{"rendered":"https:\/\/www.bayoomed.com\/news\/the-new-digav-what-you-should-know\/"},"modified":"2024-11-20T14:09:36","modified_gmt":"2024-11-20T13:09:36","slug":"the-new-digav-what-you-should-know","status":"publish","type":"news","link":"https:\/\/www.bayoomed.com\/en\/news\/the-new-digav-what-you-should-know\/","title":{"rendered":"DiGAV: What you should know about the regulation"},"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-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-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-margin-bottom-large:20px;--awb-width-medium:100%;--awb-order-medium:0;--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-text fusion-text-1 fusion-text-no-margin\" style=\"--awb-margin-bottom:50px;\"><p>The Digital Health Applications Ordinance (DiGAV) forms a central building block for the app on prescription. The last amendment to the current DiGAV was made by the Hospital Nursing Relief Act (KHPflEG) of 20.12.2022. There have also been further changes this year. Which deadlines are important now? You can find the latest details here.  <\/p>\n<\/div><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-margin-bottom:-30px;--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>An overview of the innovations<br \/> of the DiGAV<\/h2><\/h2><\/div><div class=\"fusion-text fusion-text-2\"><p>The changes relate to deadlines that have been extended:<\/p>\n<\/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 \"><strong>\u00a7 4 Data protection and data security requirements<\/strong><\/p>\n<p>(7) The deadline for compliance with data security requirements has been postponed from 01.01.2023 to 01.01.2025. From this point onwards, a certificate from the Federal Office for Information Security (BSI) is required for all DiGAs already listed and for all DiGAs in the process of being listed. This will be issued after examination by <a href=\"https:\/\/www.bsi.bund.de\/DE\/Themen\/Unternehmen-und-Organisationen\/Standards-und-Zertifizierung\/Zertifizierung-und-Anerkennung\/Listen\/Liste-TR-Pruefstellen\/liste-tr-pruefstellen.html\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"color: var(--awb-color4)\">certified test centers<\/span><\/a> issued after testing by certified test centers. <\/p>\n<p>  (8) The deadline for compliance with data protection requirements has been postponed from 01.04.2023 to 01.08.2024. The certificate is currently still under development. There is currently no final list of criteria. However, it is recommended that you familiarize yourself with the test criteria.    <\/p>\n<\/header>\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 \"><strong>\u00a7 Section 6a Interoperability of digital health applications with the electronic patient record<br \/>\n<\/strong><\/p>\n<p>(1) The deadline for data transfer to the electronic patient file has been postponed from 01.01.2023 to 30.04.2024.<\/p>\n<p>  (2) The deadline for data export to the electronic patient record with regard to semantic and syntactic interoperability has been postponed from 01.01.2023 to 30.04.2024.<\/p>\n<p>(3) From this date, all DiGAs must be connected to the telematics infrastructure.  <a href=\"https:\/\/www.bayoomed.com\/en\/platform-medicalone-connect\/package-diga-services\/\" target=\"_blank\" rel=\"noopener noreferrer\" style=\"color: var(--awb-color4)\">Questions? <\/a><\/p>\n<\/header>\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 \"><strong>Annex 1 Questionnaire according to \u00a7 4 paragraph 6<br \/>\n<\/strong><\/p>\n<p>15a. Authentication<br \/> The deadline for authentication via the secure digital identity (health ID) in accordance with Section 291 (8) SGB V has been postponed from 01.01.2023 to 30.04.2024.<\/p>\n<\/header>\n<\/div>\n<\/div><\/li><\/ul><\/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-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_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-hand-holding-medical fas circle-yes\" style=\"--awb-circlecolor-hover:var(--awb-color4);--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-2 fusion_builder_column_4_5 4_5 fusion-flex-column\" style=\"--awb-padding-top:60px;--awb-padding-right:60px;--awb-padding-bottom:30px;--awb-padding-left:60px;--awb-padding-top-small:30px;--awb-padding-right-small:30px;--awb-padding-bottom-small:30px;--awb-padding-left-small:30px;--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;--awb-spacing-right-small:0px;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-3\" style=\"--awb-text-color:var(--awb-color1);\"><p>The experts at BAYOOMED and <a style=\"color: #ffffff\" href=\"https:\/\/www.bayoocare.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">BAYOOCARE<\/a> support you in the development of your digital health application &#8211; from regulatory consulting to post-market surveillance (PMS).<\/p>\n<p>Arrange an appointment for an initial consultation.<\/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:20px;--awb-margin-bottom: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 us now<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"author":5,"featured_media":3690,"template":"","categories":[74,45],"class_list":["post-3691","news","type-news","status-publish","has-post-thumbnail","hentry","category-diga-en","category-news-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>DiGAV: What you should know about the regulation - BAYOOMED<\/title>\n<meta name=\"description\" content=\"The Digital Health Applications Ordinance (DiGAV) forms a central building block for the app on prescription. 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