{"id":4959,"date":"2023-06-14T10:57:21","date_gmt":"2023-06-14T08:57:21","guid":{"rendered":"https:\/\/sananet.com\/?page_id=4959"},"modified":"2023-12-20T09:11:39","modified_gmt":"2023-12-20T08:11:39","slug":"diga","status":"publish","type":"page","link":"https:\/\/sananet.com\/en\/medical-device-consulting\/sales-marketing\/reimbursement-for-medical-technology\/diga\/","title":{"rendered":"DiGA"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k1lx1yci-a1d7f2166056346c0cbaca20a0cff57f\">\n.avia-section.av-k1lx1yci-a1d7f2166056346c0cbaca20a0cff57f{\nbackground-color:#f2f2f2;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-k1lx1yci-a1d7f2166056346c0cbaca20a0cff57f main_color avia-section-no-padding avia-no-shadow  avia-builder-el-0  el_before_av_one_third  avia-builder-el-first  head-top avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><main  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width=\"70\" height=\"62\" \/><br \/>\nDiGA<\/h1>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k3zunulp-5-47bbd2156209cc7afff82cd85a6fd7ae\">\n#top .hr.hr-invisible.av-k3zunulp-5-47bbd2156209cc7afff82cd85a6fd7ae{\nmargin-top:-40px;\nheight:1px;\n}\n<\/style>\n<div  class='hr av-k3zunulp-5-47bbd2156209cc7afff82cd85a6fd7ae hr-invisible  avia-builder-el-4  el_after_av_textblock  avia-builder-el-last  av-desktop-hide av-medium-hide'><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id='after_section_1'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-4959'><div class='entry-content-wrapper clearfix'>\n<div class='flex_column_table av-e0dys-f8ea593a1a05f7e8de983227ac9c191b sc-av_one_third av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-e0dys-f8ea593a1a05f7e8de983227ac9c191b\">\n.flex_column.av-e0dys-f8ea593a1a05f7e8de983227ac9c191b{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\nbackground-color:#ffffff;\n}\n<\/style>\n<div  class='flex_column av-e0dys-f8ea593a1a05f7e8de983227ac9c191b av_one_third  avia-builder-el-5  el_after_av_section  el_before_av_two_third  avia-builder-el-first  first flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k1lxmsbe-7ab68d7308f51f42acf2561972243062\">\n.avia-image-container.av-k1lxmsbe-7ab68d7308f51f42acf2561972243062 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-k1lxmsbe-7ab68d7308f51f42acf2561972243062 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-k1lxmsbe-7ab68d7308f51f42acf2561972243062 av-styling- avia_animated_image av-animated-when-visible-95 bottom-to-top avia-align-center  avia-builder-el-6  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-6867 avia-img-lazy-loading-not-6867 avia_image ' src=\"https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/telemedicine-7520691_1280-300x300.jpg\" alt='DiGa' title='DiGa Telemedizin'  height=\"300\" width=\"300\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/telemedicine-7520691_1280-300x300.jpg 300w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/telemedicine-7520691_1280-80x80.jpg 80w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/telemedicine-7520691_1280-768x768.jpg 768w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/telemedicine-7520691_1280-36x36.jpg 36w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/telemedicine-7520691_1280-180x180.jpg 180w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/telemedicine-7520691_1280-705x705.jpg 705w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/telemedicine-7520691_1280.jpg 853w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><\/div><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-b0yok-90d40f3b73cc11a95decc5e105021a85\">\n.flex_column.av-b0yok-90d40f3b73cc11a95decc5e105021a85{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-b0yok-90d40f3b73cc11a95decc5e105021a85 av_two_third  avia-builder-el-7  el_after_av_one_third  el_before_av_postcontent  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-top av-animated-generic bottom-to-top av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9lqjo-6c77a3336c43b01dc9ab63e73fc90da0\">\n#top .av-special-heading.av-9lqjo-6c77a3336c43b01dc9ab63e73fc90da0{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-9lqjo-6c77a3336c43b01dc9ab63e73fc90da0 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-9lqjo-6c77a3336c43b01dc9ab63e73fc90da0 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-9lqjo-6c77a3336c43b01dc9ab63e73fc90da0 av-special-heading-h3 blockquote modern-quote  avia-builder-el-8  el_before_av_textblock  avia-builder-el-first  av-linked-heading'><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >Reimbursement of Medical APPs in Germany &#8211; DiGA Fast Track &#8211; Your Chance for fast Market Access<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-k1lxo6db-7324021a4be5c9baa7a332a5827e97d6 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>If you offer a health software as an APP, inclusion in the Directory of Digital Health Applications (DiGA) at the Federal Office for Drugs and Medical Devices (BfArM) is a great opportunity for fast access to the German healthcare market.<\/p>\n<p>Digital health applications (DiGA) can receive provisional reimbursement in Germany via a fast-track application.<\/p>\n<p><strong>Advice on DiGA in Germany<\/strong><\/p>\n<p>It all seems transparent, and the BfArM has published a guide to the fast-track process that provides an overview of the regulations.<\/p>\n<p>While the application process for digital health apps looks simple enough, there are some pitfalls, especially with timing, that can lead to a negative long-term outcome.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-3999\" src=\"https:\/\/sananet.com\/wp-content\/uploads\/2022\/12\/Reimbursement-DiGA-health-APP-Germany-300x160.jpg\" alt=\"\" width=\"546\" height=\"291\" srcset=\"https:\/\/sananet.com\/wp-content\/uploads\/2022\/12\/Reimbursement-DiGA-health-APP-Germany-300x160.jpg 300w, https:\/\/sananet.com\/wp-content\/uploads\/2022\/12\/Reimbursement-DiGA-health-APP-Germany.jpg 659w\" sizes=\"auto, (max-width: 546px) 100vw, 546px\" \/><\/p>\n<p>sananet can help you register your Digital Health APP as a Digital Health App, and our guidance can prevent you from ending up with a denial after receiving preliminary reimbursement via a Fast Track application.<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-button-wrap av-k3zvra8x-322472bd8b575fb87413c7f6de184538-wrap avia-button-left  avia-builder-el-10  el_after_av_textblock  el_before_av_hr  contactbutton'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k3zvra8x-322472bd8b575fb87413c7f6de184538\">\n#top #wrap_all .avia-button.av-k3zvra8x-322472bd8b575fb87413c7f6de184538{\nbackground-color:#fdc62b;\nborder-color:#fdc62b;\ncolor:#474747;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-k3zvra8x-322472bd8b575fb87413c7f6de184538 .avia-svg-icon svg:first-child{\nfill:#474747;\nstroke:#474747;\n}\n<\/style>\n<a href='#contact'  class='avia-button av-k3zvra8x-322472bd8b575fb87413c7f6de184538 av-link-btn avia-icon_select-yes-left-icon avia-size-medium avia-position-left'   aria-label=\"Nehmen Sie gerne Kontakt mit uns auf!\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue832' data-av_iconfont='entypo-fontello' ><\/span><span class='avia_iconbox_title' >Nehmen Sie gerne Kontakt mit uns auf!<\/span><\/a><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k3zunulp-3-843d98ead0d3d60f17ce30d04a8901d2\">\n#top .hr.hr-invisible.av-k3zunulp-3-843d98ead0d3d60f17ce30d04a8901d2{\nheight:10px;\n}\n<\/style>\n<div  class='hr av-k3zunulp-3-843d98ead0d3d60f17ce30d04a8901d2 hr-invisible  avia-builder-el-11  el_after_av_button  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-k1lxo6db-1-783808351f4035ea19220a4307d6a378 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p><strong>What is a DiGA and what are the basic requirements for reimbursement in Germany?<\/strong><\/p>\n<p>A DiGA is a medical device with the following characteristics:<\/p>\n<ul>\n<li>A medical device of risk class I or IIa (according to the Medical Devices Ordinance).<\/li>\n<li>The main function of the digital health app is based on digital technologies, so it is generally a software or health AP<\/li>\n<li>The medical purpose is essentially achieved through the main digital function<\/li>\n<li>DiGA supports the detection, monitoring, treatment or mitigation of disease or the detection, treatment, mitigation or compensation of injury or disability<\/li>\n<li>DiGA is shared by the patient or the healthcare provider and the patient.<\/li>\n<\/ul>\n<p><strong>Is DiGA Fast Track really fast in Germany?<\/strong><\/p>\n<p>In principle, yes, because the evaluation of digital health apps follows a fast track to reimbursement and market entry.<\/p>\n<p>The BfArM must decide whether to approve a digital health app (DiGA) within three months of receiving the manufacturer&#8217;s application.<\/p>\n<p>Digital health companies can apply for either final or provisional approval (according to Section 139e (2) and (3) SGB V).<\/p>\n<p>Preliminary listing initiates a 12-month trial period, after which the manufacturer must demonstrate &#8220;positive supply effects&#8221; (pVE) as the basis for final listing.<\/p>\n<p>The DiGA APP is prescribable and reimbursable in Germany throughout the 12-month trial period. It seems that DiGA fast track with the option of a trial year is a good way to accelerate market entry into the German healthcare market.<\/p>\n<p>However, if you do not use this period prudently and properly, you may end up with a rejection, which will exclude you from the German market permanently or at least for a longer period of time.<\/p>\n<p>sananet advises you on how to make the most of DiGA reimbursement in Germany.<\/p>\n<p><strong>What are the pitfalls in marketing<\/strong><\/p>\n<p>Once you have provisional or permanent reimbursement for your DiGA, you want to start selling it. However, there are other hidden rules in the German healthcare market that can hinder success. sananet would like to share two specific examples:<\/p>\n<p><strong>Benefits of DiGA<\/strong><\/p>\n<p>German physicians work in a sectoral reimbursement system. They are not there to perform procedures that benefit other sectors (e.g., hospitals) or reduce overall health care spending. Understanding this system, it becomes clear that the benefit of DiGA must be directly to the prescribing physician.<\/p>\n<p>Since the benefit of the DiGA must be directly to the prescribing physician, either there must be direct payment (which is possible in principle in the DiGA system in Germany) or the physician must work under a selective contract as a DMP or &#8220;integrated care,&#8221; to name just two examples. A hidden rule is that some DiGAs can reduce the normal remuneration and in this case are not so attractive.<\/p>\n<p>The most important way is to provide a direct benefit to the prescribing physician, as shown above. If this is the case, the physician will recommend it to his patients. An indirect route is patient organizations, which can be helpful. The typical DiGA patient would also search the internet and social media. Advertising is tricky in Germany because there are legal issues.<\/p>\n<p><strong>Privacy security management<\/strong><\/p>\n<p>DiGAs typically process sensitive personal health data, so data protection is a key concern. For this reason, every new DiGA must be covered by an ISO 27001 information security management system (ISMS) from 2022. But that may not be enough. Germany takes data protection much more seriously than many other countries. A server outside Germany can be a big problem for acceptance, a server outside the EU even a killer for your project.<\/p>\n<p>sananet not only advises you on the fast reimbursement of digital health apps, but also takes care of the successful entry into the German digital health market.<\/p>\n<h5><\/h5>\n<\/div><\/section><\/p><\/div><\/div><!--close column table wrapper. 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