{"id":27615,"date":"2026-08-04T08:23:46","date_gmt":"2026-08-04T08:23:46","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=27615"},"modified":"2026-08-20T13:12:30","modified_gmt":"2026-08-20T13:12:30","slug":"gedig-cabinet-draft-approved","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/gedig-cabinet-draft-approved\/","title":{"rendered":"GeDIG: Cabinet Draft Approved"},"content":{"rendered":"<p>The German federal government has approved the <strong>draft of the Act on Data and Digital Innovation in Healthcare (GeDIG)<\/strong>. It addresses nearly all areas relevant to digitalization, supports the national implementation of the European Health Data Space (EHDS), and is intended to advance healthcare, research, and interoperability.<\/p>\n<p>Essentially, there are <strong>three key areas<\/strong>:<\/p>\n<ul>\n<li><strong>Primary Use of Health Data<\/strong>: In the future, health data should be consistently interoperable and available for healthcare purposes.<\/li>\n<li><strong>Secondary Use for Research and Innovation<\/strong>: Through the EHDS data access procedure, the enhanced research data center, and new real-world laboratories, health data will become more widely available for research and innovation.<\/li>\n<li><strong>Added Value Through Digital Applications<\/strong>: New digital care pathways, such as e-referrals, digital access to care via the ePA, and an enhanced DiGA framework, are designed to make everyday life easier for insured individuals and healthcare providers.<\/li>\n<\/ul>\n<p><strong>What does this mean for manufacturers of digital solutions?<\/strong><\/p>\n<p>The <strong>new interoperability requirement<\/strong> will have the most immediate impact: Providers of hospital information systems, practice management systems, or specialized systems must design their systems so that healthcare providers can store health data in an interoperable format in the future.<\/p>\n<p>As the digital health agency and certification authority, <strong>gematik<\/strong> <strong>will play<\/strong> a <strong>significantly greater role in ensuring compliance and operational stability<\/strong>. The BSI will assume responsibility for market surveillance of EHR systems. The <strong>use of KIM<\/strong> will become <strong>mandatory<\/strong> for all service providers connected to the TI, and the <strong>ePA will be opened up to value-added applications<\/strong>.<\/p>\n<p>Overall, new market opportunities are emerging in the areas of ePA and data usage, while at the same time, requirements for interoperability, approval, and cybersecurity are increasing.<\/p>\n<p class=\"mcePastedContent\"><em>The bill is now going through the legislative process. Changes are still possible. <\/em><\/p>\n<p class=\"last-child\">You can find the law here: <a href=\"https:\/\/www.bundesgesundheitsministerium.de\/service\/gesetze-und-verordnungen\/detail\/gedig\/\" target=\"_blank\" rel=\"noopener\">Law on Data and Digital Innovation in Healthcare (GeDIG) | BMG<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27615","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>GeDIG: Cabinet Draft Approved<\/title>\n<meta name=\"description\" content=\"The German government approved the GeDIG draft. It implements the European Health Data Space nationally and touches DiGA and interoperability.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/quickbirdmedical.com\/en\/news\/gedig-cabinet-draft-approved\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GeDIG: Cabinet Draft Approved\" \/>\n<meta property=\"og:description\" content=\"The German government approved the GeDIG draft. It implements the European Health Data Space nationally and touches DiGA and interoperability.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/quickbirdmedical.com\/en\/news\/gedig-cabinet-draft-approved\/\" \/>\n<meta property=\"og:site_name\" content=\"QuickBird Medical\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-20T13:12:30+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/gedig-cabinet-draft-approved\\\/\",\"url\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/gedig-cabinet-draft-approved\\\/\",\"name\":\"GeDIG: Cabinet Draft Approved\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#website\"},\"datePublished\":\"2026-08-04T08:23:46+00:00\",\"dateModified\":\"2026-08-20T13:12:30+00:00\",\"description\":\"The German government approved the GeDIG draft. 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