{"id":27708,"date":"2025-12-18T12:38:49","date_gmt":"2025-12-18T12:38:49","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=27708"},"modified":"2026-09-03T07:47:50","modified_gmt":"2026-09-03T07:47:50","slug":"updated-diga-guide-3-6-published","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/updated-diga-guide-3-6-published\/","title":{"rendered":"Updated Version of the DiGA Guide (3.6) Published"},"content":{"rendered":"<p class=\"mcePastedContent\">A new version of the <strong>DiGA guide (3.6)<\/strong> has been published.<\/p>\n<p>The update to reflect the legislative changes made since 2023, in particular from the <strong>Digital Act (DigiG)<\/strong> in March 2024, was long overdue. These are now reflected in the new version.<\/p>\n<p>The update is extensive. The guide has grown from 177 to 215 pages and many relevant topic areas have been added.<\/p>\n<p>The larger changes include, for example:<\/p>\n<ul>\n<li><strong>DigiG:<\/strong> new rules from the DigiG have now been incorporated into the DiGA guide as well (for DiGA in risk class IIb, for instance)<\/li>\n<li><strong>DiGAV update:<\/strong> new rules from the draft bill of the 2nd DiGAV amendment ordinance have been incorporated (mainly application-accompanying performance measurement, AbEM)<\/li>\n<li><strong>BSI TR-03161 as the standard:<\/strong> data security is fully covered by the BSI certificate. Demonstrating data security via the DiGAV checklist is no longer required<\/li>\n<li><strong>DiGA qualification clarified:<\/strong> a clearer distinction between DiGA and non-DiGA, including a new decision tree on DiGA eligibility (intended purpose, individualisation, control of active medical devices, risk class IIb)<\/li>\n<li><strong>Evidence requirements specified:<\/strong> clarifications on study design, significance level (5%), randomisation, study reports and analysis<\/li>\n<li><strong>Interoperability updated:<\/strong> &#8220;vesta&#8221; replaced by &#8220;INA&#8221; as the reference for interoperable e-health infrastructure<\/li>\n<li><strong>Process clarifications:<\/strong> more detailed rules on deadlines, the application portal, the lifecycle, and obligations after listing and delisting<\/li>\n<li><strong>Scope &amp; structure extended:<\/strong> a substantial expansion of the guide overall (177 \u2192 215 pages) with new chapters, FAQs and examples<\/li>\n<\/ul>\n<p class=\"last-child\">We have analysed and summarised all the changes in a structured way and additionally provide a PDF document with the exact changes: <a href=\"https:\/\/quickbirdmedical.com\/en\/diga-guide-history-of-all-changes\/\" target=\"_blank\" rel=\"noopener\">To the analysis of the changes<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27708","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Updated Version of the DiGA Guide (3.6) Published<\/title>\n<meta name=\"description\" content=\"The DiGA Guide 3.6 brings major updates on DigiG, BSI TR-03161, evidence, interoperability and DiGA eligibility. 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