{"id":6498,"date":"2023-12-12T10:23:25","date_gmt":"2023-12-12T09:23:25","guid":{"rendered":"https:\/\/sananet.com\/?page_id=6498"},"modified":"2023-12-18T09:18:46","modified_gmt":"2023-12-18T08:18:46","slug":"dipa-reimbursement-germany","status":"publish","type":"page","link":"https:\/\/sananet.com\/en\/medical-device-consulting\/sales-marketing\/reimbursement-for-medical-technology\/dipa-reimbursement-germany\/","title":{"rendered":"DiPA Reimbursement Germany"},"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 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src=\"https:\/\/sananet.com\/wp-content\/uploads\/2019\/10\/sananet-textquadrat-1-70px.png\" alt=\"\" width=\"70\" height=\"62\" \/><br \/>\nDiPA Reimbursement Germany<\/h1>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k3zunulp-7-7e11b2e04b87aad621f2108dc510665b\">\n#top .hr.hr-invisible.av-k3zunulp-7-7e11b2e04b87aad621f2108dc510665b{\nmargin-top:-40px;\nheight:1px;\n}\n<\/style>\n<div  class='hr av-k3zunulp-7-7e11b2e04b87aad621f2108dc510665b 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-6498'><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-e4ac905e1706e3192b0c160a14e2844f\">\n.avia-image-container.av-k1lxmsbe-e4ac905e1706e3192b0c160a14e2844f img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-k1lxmsbe-e4ac905e1706e3192b0c160a14e2844f .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-k1lxmsbe-e4ac905e1706e3192b0c160a14e2844f 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-6490 avia-img-lazy-loading-not-6490 avia_image ' src=\"https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/modern-technologies-1263422_1280-300x296.jpg\" alt='DiPA-Reimbursement-Germany' title='DiPA-Reimbursement-Germany'  height=\"296\" width=\"300\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/modern-technologies-1263422_1280-300x296.jpg 300w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/modern-technologies-1263422_1280-80x80.jpg 80w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/modern-technologies-1263422_1280-768x757.jpg 768w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/modern-technologies-1263422_1280-36x36.jpg 36w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/modern-technologies-1263422_1280-705x695.jpg 705w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/modern-technologies-1263422_1280.jpg 788w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><\/div><\/div>\n<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-e1d1f0bd05826a216cda51d1577e55c4\">\n#top .av-special-heading.av-9lqjo-e1d1f0bd05826a216cda51d1577e55c4{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-9lqjo-e1d1f0bd05826a216cda51d1577e55c4 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-9lqjo-e1d1f0bd05826a216cda51d1577e55c4 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-9lqjo-e1d1f0bd05826a216cda51d1577e55c4 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\"  >Consulting to get your Medical Software listed as DiPA<\/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><strong>Introducton of DiPA in Germany<\/strong><\/p>\n<p>Digital care applications (DiPA, German for <em>digitale Pflegeanwendung<\/em>) are applications for mobile devices such as smartphones or tablets as well as web-based applications for laptops or PCs. It can be software or medical devices or a combination. The aim of DiPA is to relieve the burden on carers through digital systems.<\/p>\n<p>In principle, a DiPA can be a native app as well as a desktop or browser application. In addition to the software, a DiPA can also include devices, sensors or other hardware such as wearable sensors or sensors placed in the home environment, as long as the main function is a predominantly digital one.<\/p>\n<p>Now that digital health applications (DiGA) have already provided a relevant impetus for the digitalization of healthcare, the health care software and medical products brought to long-term care as DiPA are now also intended to systematically advance the innovation potential in care in Germany. With the experience sananet consulting agency has with DiGA, we would strongly recommend for health care software and medical product manufacturers to consider to list your life science product as DiPA.<\/p>\n<p><strong>What Impact on your Market Access has it to list your medical Software as DiPA?<\/strong><\/p>\n<p>In Germany, with the Digital Care and Nursing Modernization Act (DVPMG) on 09.06.2021, digital care applications (digitale Pflegeanwendungen or DiPA) were introduced into outpatient care provision. This means that around 4 million people in need of home care are now entitled to care with DiPA, regardless of their individual care level and regardless of whether the care is provided by their relatives alone or by outpatient nursing and care services. So, if your medical software or product is listed as DiPA, it opens a great opportunity in the German health care market.<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-button-wrap av-k3zvra8x-a73444de21842c7d7b56655176ea04a3-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-a73444de21842c7d7b56655176ea04a3\">\n#top #wrap_all .avia-button.av-k3zvra8x-a73444de21842c7d7b56655176ea04a3{\nbackground-color:#fdc62b;\nborder-color:#fdc62b;\ncolor:#474747;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-k3zvra8x-a73444de21842c7d7b56655176ea04a3 .avia-svg-icon svg:first-child{\nfill:#474747;\nstroke:#474747;\n}\n<\/style>\n<a href='#contact'  class='avia-button av-k3zvra8x-a73444de21842c7d7b56655176ea04a3 av-link-btn avia-icon_select-yes-left-icon avia-size-medium avia-position-left'   aria-label=\"Contact us if you want to get your medical Software listed as DiPA in Germany\"><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' >Contact us if you want to get your medical Software listed as DiPA in Germany<\/span><\/a><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k3zunulp-5-62b197b7eb2012a22e1cf661504633e4\">\n#top .hr.hr-invisible.av-k3zunulp-5-62b197b7eb2012a22e1cf661504633e4{\nheight:10px;\n}\n<\/style>\n<div  class='hr av-k3zunulp-5-62b197b7eb2012a22e1cf661504633e4 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-3-7d538561c8104015a3bfbe0eac331d9a '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p><strong>How to get your medical Software listed as DiPA in Germany?<\/strong><\/p>\n<p>sananet consulting agency can help you to get your medical Software listed as DiPA in Germany.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-6487\" src=\"https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/Reimbursement-DiPA-application-process-Germany-300x122.jpg\" alt=\"\" width=\"600\" height=\"244\" srcset=\"https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/Reimbursement-DiPA-application-process-Germany-300x122.jpg 300w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/Reimbursement-DiPA-application-process-Germany-768x312.jpg 768w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/Reimbursement-DiPA-application-process-Germany-705x287.jpg 705w, https:\/\/sananet.com\/wp-content\/uploads\/2023\/12\/Reimbursement-DiPA-application-process-Germany.jpg 853w\" sizes=\"auto, (max-width: 600px) 100vw, 600px\" \/><\/p>\n<p>One of the prerequisites for reimbursement by the long-term care insurance funds is that the DiPA has successfully undergone a test procedure at the BfArM and is listed in the so called <em>\u201cVerzeichnis erstattungsf\u00e4higer digitaler Pflegeanwendungen (DiPA-Verzeichnis)\u201d<\/em> or English directory of reimbursable digital care applications (DiPA directory) in accordance with Section 78a (3) of the Eleventh Book of the German Social Code (SGB XI).<\/p>\n<p><strong>Definition of DiPA in Germany<\/strong><\/p>\n<p>Per definition a digital care applications (digitale Pflegeanwendungen or DiPA) is a health care software or medical products that has the following properties:<\/p>\n<ul>\n<li>A DiPA may or may not be a medical device. DiPA as medical devices must meet the CE approval in accordance with Regulation (EU) 2017\/745 (Medical Device Regulation, MDR) or within the scope of the MDR transitional provisions in accordance with Directive 93\/42\/EEC Medical Device Directive (MDD) and must belong to low risk class I or IIa.<\/li>\n<li>The DiPA is essentially based on digital technologies (medical software).<\/li>\n<li>The nursing benefit is achieved by the DiPA and (if applicable) the eUL required for the DiPA.The DiPA is not a digital application that merely serves to reading or controlling a medical device.<\/li>\n<li>The purpose of the DiPA is to minimize the impairment of the independence of the person in need of long term medical care or to counteract a worsening of the need for care and thus unfolds its nursing benefits.<\/li>\n<li>The DiPA can be provided by the person in need of care alone or by the person in need of care in interaction with relatives or nursing services.<\/li>\n<li>The DiPA can also support family caregivers or other volunteer caregivers in the care of those in need of care.<\/li>\n<li>The DiPA serves to support those in need of care exclusively in the home context.<\/li>\n<\/ul>\n<p><strong>What if your Server for DiPA Data Processing outside Germany?<\/strong><\/p>\n<p>Germany is especially thorough about data privacy. Therefore the permissibility of data processing for medical Software listed as DiPA outside Germany is very strict. BfArM&#8217;s reviews procedure pursuant to Section 139e of the Fifth Book of the German Social Code (SGB V). There is a handout on data processing outside Germany <em>(Handreichung zur Datenverarbeitung au\u00dferhalb Deutschlands<\/em>) available which contains up-to-date information.<\/p>\n<\/div><\/section><\/p><\/div><\/div><!--close column table wrapper. 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