{"id":7836,"date":"2025-03-12T08:25:50","date_gmt":"2025-03-12T08:25:50","guid":{"rendered":"https:\/\/www.bayoocare.com\/?p=7836"},"modified":"2025-03-12T08:25:50","modified_gmt":"2025-03-12T08:25:50","slug":"elektronische-patientenakte-seit-15-januar-2025-verbindlich-ein-blick-auf-die-rechtlichen-rahmenbedingungen","status":"publish","type":"post","link":"https:\/\/www.bayoocare.com\/en\/2025\/03\/12\/elektronische-patientenakte-seit-15-januar-2025-verbindlich-ein-blick-auf-die-rechtlichen-rahmenbedingungen\/","title":{"rendered":"Elektronische Patientenakte seit 15. Januar 2025 verbindlich: Ein Blick auf die rechtlichen Rahmenbedingungen"},"content":{"rendered":"<div id='av-layout-grid-1'  class='av-layout-grid-container av-3rm90u-c514ec72a7f03fa6df6c2ba8c3dcbddb entry-content-wrapper main_color av-flex-cells  avia-builder-el-0  el_before_av_section  avia-builder-el-first   container_wrap fullsize'  >\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lrugfidl-1962fce1f1afbb8248924bc342a05ebe\">\n.flex_cell.av-lrugfidl-1962fce1f1afbb8248924bc342a05ebe{\nvertical-align:bottom;\nbackground:url(https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/10\/2024\/01\/In-Vitro-Diagnostica-IVD.png) 50% 100% no-repeat scroll ;\n}\n.responsive #top #wrap_all .flex_cell.av-lrugfidl-1962fce1f1afbb8248924bc342a05ebe{\npadding:150px 150px 150px 150px !important;\n}\n<\/style>\n<div class='flex_cell av-lrugfidl-1962fce1f1afbb8248924bc342a05ebe av-gridrow-cell av_one_full no_margin  avia-builder-el-1  avia-builder-el-no-sibling  avia-full-stretch'  ><div class='flex_cell_inner'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bbihke-2894f1b84215c83e53d4fa643f76bfce\">\n.flex_column.av-bbihke-2894f1b84215c83e53d4fa643f76bfce{\nborder-radius:0px 0px 0px 0px;\npadding:20px 20px 20px 20px;\nbackground-color:#bcacd4;\n}\n<\/style>\n<div  class='flex_column av-bbihke-2894f1b84215c83e53d4fa643f76bfce av_one_half  avia-builder-el-2  avia-builder-el-no-sibling  first flex_column_div  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-amake-95a763d999185019056cd8cbf22053c7\">\n#top .av-special-heading.av-amake-95a763d999185019056cd8cbf22053c7{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-amake-95a763d999185019056cd8cbf22053c7 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-amake-95a763d999185019056cd8cbf22053c7 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-amake-95a763d999185019056cd8cbf22053c7 av-special-heading-h1 blockquote modern-quote  avia-builder-el-3  el_before_av_textblock  avia-builder-el-first '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Electronic patient file mandatory since January 15, 2025: A look at the legal framework<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-m7klxede-637d9f9964e62b37912d9310d3ab9d58 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The digitalization of the healthcare system in Germany has reached a new milestone: on 15 January 2025, the electronic patient file (ePA) was made mandatory for those with statutory health insurance. This step is part of the German government&#8217;s comprehensive digitalization strategy and has far-reaching legal, data protection and practical implications for insured persons, service providers and health insurance companies. Find out more in our blog article.<\/p>\n<\/div><\/section><\/p><\/div>\n<\/div><\/div><\/div><div id='av_section_1'  class='avia-section av-1de2nw-565055f7a02e8aa85604ea1d225e2a98 main_color avia-section-default avia-no-border-styling  avia-builder-el-5  el_after_av_layout_row  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7836'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-c3w95o-89a7326c18be20a21ab7e4fef6999a47\">\n.flex_column.av-c3w95o-89a7326c18be20a21ab7e4fef6999a47{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-c3w95o-89a7326c18be20a21ab7e4fef6999a47 av_four_fifth  avia-builder-el-6  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-m7klxl6e-2fe5eec16e1760c4d2f15ebc0cbf3db1\">\n#top .av-special-heading.av-m7klxl6e-2fe5eec16e1760c4d2f15ebc0cbf3db1{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-m7klxl6e-2fe5eec16e1760c4d2f15ebc0cbf3db1 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-m7klxl6e-2fe5eec16e1760c4d2f15ebc0cbf3db1 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-m7klxl6e-2fe5eec16e1760c4d2f15ebc0cbf3db1 av-special-heading-h2 blockquote modern-quote  avia-builder-el-7  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Background and legal basis<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-lrtbu3lu-5aadb50e7dac01aedeb56cb3138fb7e2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The ePA is enshrined in law in the Patient Data Protection Act (PDSG), which came into force in 2020. The aim is to enable better networking in the healthcare system and improve the quality of care. From the end of 2024, the electronic health record will become standard, which means that all people with statutory health insurance will automatically receive an electronic health record unless they object (opt-out model).<\/p>\n<p>The legal obligation to introduce the electronic health record goes hand in hand with extensive requirements for data protection and data security standards. The statutory health insurance funds are responsible for implementation and are creating the technical requirements together with gematik, the national agency for digital health applications.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4vgtq4-992ceefd652c790d09d6a4c096728acf\">\n#top .av-special-heading.av-4vgtq4-992ceefd652c790d09d6a4c096728acf{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-4vgtq4-992ceefd652c790d09d6a4c096728acf .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-4vgtq4-992ceefd652c790d09d6a4c096728acf .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-4vgtq4-992ceefd652c790d09d6a4c096728acf av-special-heading-h2 blockquote modern-quote  avia-builder-el-9  el_after_av_textblock  el_before_av_textblock '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >What does the binding nature of the ePA mean?<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-2zv1zg-549efe304c8cd1b81d507c35bf3dd088 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>From the cut-off date at the beginning of 2025, every person with statutory health insurance will have an ePA. It will be the central hub for digital communication between patients, doctors, pharmacies and other service providers. Insured persons will be able to view and manage diagnoses, treatment plans, medication overviews and other medical documents in their ePA.<\/p>\n<p>From a legal point of view, however, the use of the ePA remains voluntary for insured persons. No one is forced to actively use the file or store data in it. However, insured persons must actively object if they do not wish to have an electronic health record created. This \u201copt-out\u201d model is legally controversial, as it raises the question of informed consent and the autonomy of insured persons.<\/p>\n<\/div><\/section><\/p><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_2'  class='avia-section av-42tg3g-51570d062ade669b30552eedb2e51b70 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-11  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7836'><div class='entry-content-wrapper clearfix'>\n<div class='flex_column_table av-1wg5qk-429aabd14fc60ce53efd002bfb8b7203 sc-av_two_third av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1wg5qk-429aabd14fc60ce53efd002bfb8b7203\">\n.flex_column.av-1wg5qk-429aabd14fc60ce53efd002bfb8b7203{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1wg5qk-429aabd14fc60ce53efd002bfb8b7203 av_two_third  avia-builder-el-12  el_before_av_one_third  avia-builder-el-first  first flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-m7klzkmo-87c28cb8f7c9c2718c8ffa69023f6735\">\n#top .av-special-heading.av-m7klzkmo-87c28cb8f7c9c2718c8ffa69023f6735{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-m7klzkmo-87c28cb8f7c9c2718c8ffa69023f6735 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-m7klzkmo-87c28cb8f7c9c2718c8ffa69023f6735 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-m7klzkmo-87c28cb8f7c9c2718c8ffa69023f6735 av-special-heading-h2 blockquote modern-quote  avia-builder-el-13  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Data protection challenges<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-m7klzqck-bc407e10daf688c78c3c031d2fe2d67a '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The use of the ePA poses considerable data protection challenges. According to the General Data Protection Regulation (GDPR), health data is considered particularly sensitive personal data.<\/p>\n<p>The use of the ePA is based on the consent of the insured person, and they can control in detail which data is stored in the file and who can access it. Despite these control options, there is still criticism that the opt-out model potentially undermines the principle of data sovereignty. Data protectionists warn that many insured persons may not be sufficiently informed to make an informed decision.<\/p>\n<p>Another legal area of conflict concerns the technical implementation. Legislation requires health insurance companies to comply with the highest security standards, in particular encryption and access controls. Violations of these standards can have consequences under both civil and criminal law.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4l9o4s-1364c3f03bd804c33307c3a3f75b6681\">\n#top .av-special-heading.av-4l9o4s-1364c3f03bd804c33307c3a3f75b6681{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-4l9o4s-1364c3f03bd804c33307c3a3f75b6681 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-4l9o4s-1364c3f03bd804c33307c3a3f75b6681 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-4l9o4s-1364c3f03bd804c33307c3a3f75b6681 av-special-heading-h2 blockquote modern-quote  avia-builder-el-15  el_after_av_textblock  el_before_av_textblock '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Effects on doctors and other service providers<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-1woqdo-465606afecd6641675e71f0911bf91c6 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The ePA will also be mandatory for doctors and other service providers: from 2025, they must be able to upload medical documents to the ePA. This means not only adapting technical processes, but also complying with strict legal requirements, for example with regard to documentation obligations and liability.<\/p>\n<p>The legal responsibility of service providers for the correct use of the EPR will play a central role. Errors when filling in the ePA or unauthorized access can have legal consequences. Further training and the creation of technical infrastructures are therefore essential.<\/p>\n<\/div><\/section><\/p><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-8x3gak-60d6acca83c9df67893b276e8af1dae5\">\n.flex_column.av-8x3gak-60d6acca83c9df67893b276e8af1dae5{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-8x3gak-60d6acca83c9df67893b276e8af1dae5 av_one_third  avia-builder-el-17  el_after_av_two_third  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-84qd18-fca0e5b4917b253d9d654a9f7e4412e0\">\n.avia-image-container.av-84qd18-fca0e5b4917b253d9d654a9f7e4412e0 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-84qd18-fca0e5b4917b253d9d654a9f7e4412e0 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-84qd18-fca0e5b4917b253d9d654a9f7e4412e0 av-styling- avia-align-center  avia-builder-el-18  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-6457 avia-img-lazy-loading-not-6457 avia_image ' src=\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/10\/2024\/02\/OLG-Hamburg-zur-Risikoklassifizierung-von-Software.jpg\" alt='OLG Hamburg zur Risikoklassifizerung von Medizinsoftware' title='Design ohne Titel - 1'  height=\"1760\" width=\"1090\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/10\/2024\/02\/OLG-Hamburg-zur-Risikoklassifizierung-von-Software.jpg 1090w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/10\/2024\/02\/OLG-Hamburg-zur-Risikoklassifizierung-von-Software-186x300.jpg 186w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/10\/2024\/02\/OLG-Hamburg-zur-Risikoklassifizierung-von-Software-638x1030.jpg 638w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/10\/2024\/02\/OLG-Hamburg-zur-Risikoklassifizierung-von-Software-768x1240.jpg 768w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/10\/2024\/02\/OLG-Hamburg-zur-Risikoklassifizierung-von-Software-951x1536.jpg 951w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/10\/2024\/02\/OLG-Hamburg-zur-Risikoklassifizierung-von-Software-929x1500.jpg 929w, https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/10\/2024\/02\/OLG-Hamburg-zur-Risikoklassifizierung-von-Software-437x705.jpg 437w\" sizes=\"(max-width: 1090px) 100vw, 1090px\" \/><\/div><\/div><\/div><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_3'  class='avia-section av-4xhga6-85bc2226664e6a9bad28886d8c56d405 main_color avia-section-default avia-no-border-styling  avia-builder-el-19  el_after_av_section  avia-builder-el-last  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7836'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-369fjy-2d8d04affe03ae53f43b6c8b0b160ff4\">\n.flex_column.av-369fjy-2d8d04affe03ae53f43b6c8b0b160ff4{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-369fjy-2d8d04affe03ae53f43b6c8b0b160ff4 av_four_fifth  avia-builder-el-20  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-lrtbu3lu-9-5062d4f7346dc050e3b18dfb0de8ea37 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The binding nature of the ePA from January 2025 marks a paradigm shift in the German healthcare system. It offers opportunities for more efficient and patient-centered care, but also raises considerable legal questions.<\/p>\n<p>In particular, the tension between data protection, data sovereignty and technical feasibility remains a key point of discussion. It will be crucial for insured persons, service providers and health insurance companies to meet the new legal requirements in good time in order to take advantage of the opportunities offered by the ePA while minimizing legal risks.<\/p>\n<p>The coming years will show how the electronic patient record proves itself in practice &#8211; and whether the legal framework is actually sufficient to maintain the balance between the benefits and protection of sensitive health data.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lrtcdfui-241d8affbde4325bfe9b9b487a00cc47\">\n#top .hr.hr-invisible.av-lrtcdfui-241d8affbde4325bfe9b9b487a00cc47{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-lrtcdfui-241d8affbde4325bfe9b9b487a00cc47 hr-invisible  avia-builder-el-22  el_after_av_textblock  el_before_av_social_share '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='av-social-sharing-box av-lrtcdsii-a35667ee7d776957b6d6bb2329bde3ba av-social-sharing-box-default  avia-builder-el-23  el_after_av_hr  avia-builder-el-last  av-social-sharing-box-fullwidth'><div class=\"av-share-box\"><h5 class='av-share-link-description av-no-toc '>Sounds exciting? 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