{"id":11317,"date":"2023-03-15T14:04:24","date_gmt":"2023-03-15T13:04:24","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=11317"},"modified":"2023-03-15T14:04:24","modified_gmt":"2023-03-15T13:04:24","slug":"critis-iec-80001-1","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2023\/03\/15\/critis-iec-80001-1\/","title":{"rendered":"Are you sure that your CRITIS is secure?"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2nm1kc3-f7eeef1a5f02f7902b3992e2caaa328b\">\n.avia-section.av-2nm1kc3-f7eeef1a5f02f7902b3992e2caaa328b{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2023\/03\/IEC-80001-1-Risikomanagement-KRITIS.png);\nbackground-position:0% 0%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-2nm1kc3-f7eeef1a5f02f7902b3992e2caaa328b main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-scroll av-minimum-height av-minimum-height-custom av-height-custom  container_wrap fullsize'  data-section-bg-repeat='stretch' data-av_minimum_height_px='650'><div class='container av-section-cont-open' style='height:650px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-11317'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id='av_section_2'  class='avia-section av-25r5pbn-134ff036bd2355034aab12794be9afa2 main_color avia-section-default avia-no-border-styling  avia-builder-el-1  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-11317'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1lg9z3n-75b749d72ff3ec24d069ea9f9a2891ba\">\n.flex_column.av-1lg9z3n-75b749d72ff3ec24d069ea9f9a2891ba{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1lg9z3n-75b749d72ff3ec24d069ea9f9a2891ba av_three_fourth  avia-builder-el-2  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-lf9mrojc-5451918baa0e9b30afa50b1be0768dcb\">\n#top .av-special-heading.av-lf9mrojc-5451918baa0e9b30afa50b1be0768dcb{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-lf9mrojc-5451918baa0e9b30afa50b1be0768dcb .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-lf9mrojc-5451918baa0e9b30afa50b1be0768dcb .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-lf9mrojc-5451918baa0e9b30afa50b1be0768dcb 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\"  >IEC 80001-1: Risk management in hospitals &#8211; how safe are you?<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-11lpiur-84024b288bf4e851b9c02225ae35009b '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Are you sure that your CRITIS is secure? This is a question that is closely linked to the IEC 80001-1 standard. Because this describes the risk management for the operation of IT systems and networks in critical infrastructures (CRITIS), such as hospitals, over the entire product life cycle.<\/p>\n<p>Hacker attacks, sabotage or manual errors in the interconnection of medical and IT networks &#8211; all this can cause harm to people. That&#8217;s why IEC 80001-1 specifies protection goals and defines roles. What are these? And who decides what? We have summarised it for you.<\/p>\n<\/div><\/section><\/p><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_3'  class='avia-section av-p9x0j7-b15bde56f592b818a25fd0f875b10f0a alternate_color avia-section-default avia-no-border-styling  avia-builder-el-5  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-11317'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1lg9z3n-75b749d72ff3ec24d069ea9f9a2891ba\">\n.flex_column.av-1lg9z3n-75b749d72ff3ec24d069ea9f9a2891ba{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1lg9z3n-75b749d72ff3ec24d069ea9f9a2891ba av_three_fourth  avia-builder-el-6  el_before_av_one_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-11lpiur-84024b288bf4e851b9c02225ae35009b '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p><strong>A case study from the VDE:<\/strong> In a large hospital, a ventilator is connected to an intensive care information management system (IMS) so that data can be easily transmitted. After an unspecified period of time, the ventilator suddenly switched off &#8211; without any prior error message or alarm signal. What happened?<\/p>\n<p>The device driver of the PDMS regularly repeated a data request. Each time, a new process was generated in the ventilator without releasing the memory area. In the course of time, a memory overflow occurred. The memory area essential for the operation of the ventilator was overwritten and the operating software crashed completely.<\/p>\n<p>An error that can have fatal consequences. In order to avoid such cases, IEC 80001-1 describes objectives to protect patients, users and third parties.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-sqrm37-a032345579ca074759c742dd6b507c8a\">\n.flex_column.av-sqrm37-a032345579ca074759c742dd6b507c8a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-sqrm37-a032345579ca074759c742dd6b507c8a av_one_fifth  avia-builder-el-8  el_after_av_three_fourth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><article  class='iconbox iconbox_left av-lf9grktn-45d4e12fa5296481470f7adcf4bc6d23  avia-builder-el-9  avia-builder-el-no-sibling '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: \"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue81f' data-av_iconfont='entypo-fontello'><\/div><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p><em>Source:<\/em><\/p>\n<p><em>Position paper of the German Association for Electrical, Electronic &amp; Information Technologies DGBMT &#8211; German Society for Biomedical Engineering in the VDE (date: November 2012).<\/em><\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_4'  class='avia-section av-3hr1x6b-59db08c916638a45a54b232937ea189d main_color avia-section-default avia-no-border-styling  avia-builder-el-10  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-11317'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-36cd437-4c0f77da9244e308abc60ada8f4a2aa1\">\n.flex_column.av-36cd437-4c0f77da9244e308abc60ada8f4a2aa1{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-36cd437-4c0f77da9244e308abc60ada8f4a2aa1 av_three_fourth  avia-builder-el-11  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-lf9nk1rv-90f68a8df1a0498d2a431c22cb5bb678\">\n#top .av-special-heading.av-lf9nk1rv-90f68a8df1a0498d2a431c22cb5bb678{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-lf9nk1rv-90f68a8df1a0498d2a431c22cb5bb678 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-lf9nk1rv-90f68a8df1a0498d2a431c22cb5bb678 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-lf9nk1rv-90f68a8df1a0498d2a431c22cb5bb678 av-special-heading-h2 blockquote modern-quote  avia-builder-el-12  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >What are the protection goals of the IEC 80001-1 standard?<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-lf9gwdl0-85821d64077087bee20c526299a7cda3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>IEC 80001-1 specifies three protection goals:<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-icon-list-container av-lf9h3rgo-2398ac66fbc006f82a256c0cd272df54  avia-builder-el-14  el_after_av_textblock  el_before_av_textblock '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-lf9h3rgo-2398ac66fbc006f82a256c0cd272df54 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-av_iconlist_item-7142fc2599a17d558aaf2cbeccc740eb avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue879' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Safety for patients\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Safety for patients<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-av_iconlist_item-0f5d671cc9d25c24a7f6023a0948a8fa avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue879' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Effectivity\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Effectivity<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-av_iconlist_item-5562b77280247f0dec2b83b7145cd2e6 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue879' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Data and system security \"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Data and system security <\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><br \/>\n<section  class='av_textblock_section av-lf9gwdl0-85821d64077087bee20c526299a7cda3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Just like risk management for IT networks containing medical devices, the protection goals also apply to the entire life cycle. However, the three objectives cannot be considered separately, because they are interdependent.<\/p>\n<p>So how do you ensure that no one hacks the IT system? How can you integrate a new medical device securely into the CRITIS network so that the day-to-day operations in the hospital run effectively? In order to fulfil questions like these and thus the protection goals, the standard specifies processes and defines responsibilities.<\/p>\n<\/div><\/section><\/p><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_5'  class='avia-section av-12hds8j-786d2407ea57ca96aebfb7778dd1e83f alternate_color avia-section-default avia-no-border-styling  avia-builder-el-16  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-11317'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ux49ar-6903890d70f9d9d606a0ce813e8f0adc\">\n.flex_column.av-ux49ar-6903890d70f9d9d606a0ce813e8f0adc{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-ux49ar-6903890d70f9d9d606a0ce813e8f0adc av_three_fourth  avia-builder-el-17  el_before_av_one_fourth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lf9nn56m-657439374a4f631d84d9e49ca5e03ee3\">\n#top .av-special-heading.av-lf9nn56m-657439374a4f631d84d9e49ca5e03ee3{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-lf9nn56m-657439374a4f631d84d9e49ca5e03ee3 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-lf9nn56m-657439374a4f631d84d9e49ca5e03ee3 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-lf9nn56m-657439374a4f631d84d9e49ca5e03ee3 av-special-heading-h2 blockquote modern-quote  avia-builder-el-18  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >What processes does the standard mention? And who is responsible?<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-lf9gwdl0-85821d64077087bee20c526299a7cda3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>In order to create an acceptable level of safety for patients, users and third parties, IEC 80001-1 specifies various requirements and processes as well as responsible parties.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-729l4tv-0c21c60eb3256994282c9d5f16132d83\">\n.flex_column.av-729l4tv-0c21c60eb3256994282c9d5f16132d83{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-729l4tv-0c21c60eb3256994282c9d5f16132d83 av_one_fourth  avia-builder-el-20  el_after_av_three_fourth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6kcutub-e7123d6c76a823a0056abdeeb6ca9296\">\n.flex_column.av-6kcutub-e7123d6c76a823a0056abdeeb6ca9296{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-6kcutub-e7123d6c76a823a0056abdeeb6ca9296 av_one_fifth  avia-builder-el-21  el_after_av_one_fourth  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><article  class='iconbox iconbox_top av-lf9hbe4j-1bae1072249760a918ef299d4ceabe6e  avia-builder-el-22  avia-builder-el-no-sibling  main_color'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Responsible organisation\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue821' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Responsible organisation<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-62d37o3-a1b0f53e5e0c8a7c6238f7ddd0e0de11\">\n.flex_column.av-62d37o3-a1b0f53e5e0c8a7c6238f7ddd0e0de11{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-62d37o3-a1b0f53e5e0c8a7c6238f7ddd0e0de11 av_three_fifth  avia-builder-el-23  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-lf9gwdl0-85821d64077087bee20c526299a7cda3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>According to IEC 80001-1, you have the overall responsibility for the risk management of the medical IT network. This includes the entire process from planning, development and installation of medical devices to connection, configuration, safe use, maintenance and ultimately decommissioning. Thus, the responsible organisation assumes the liability risk, as it is responsible for the proper operation of the devices.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5vxjqib-75dbda9686b20be60f2c5aa11760bacd\">\n.flex_column.av-5vxjqib-75dbda9686b20be60f2c5aa11760bacd{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5vxjqib-75dbda9686b20be60f2c5aa11760bacd av_one_fifth  avia-builder-el-25  el_after_av_three_fifth  el_before_av_four_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-28pukxf-92591cbfb9fd5bae2abe09a9ab6e4f48\">\n.flex_column.av-28pukxf-92591cbfb9fd5bae2abe09a9ab6e4f48{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-28pukxf-92591cbfb9fd5bae2abe09a9ab6e4f48 av_four_fifth  avia-builder-el-26  el_after_av_one_fifth  el_before_av_one_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><div  class='hr av-lf9ijugi-70e513a35b4738be47122631cb48391a hr-big  avia-builder-el-27  avia-builder-el-no-sibling '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5vxjqib-75dbda9686b20be60f2c5aa11760bacd\">\n.flex_column.av-5vxjqib-75dbda9686b20be60f2c5aa11760bacd{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5vxjqib-75dbda9686b20be60f2c5aa11760bacd av_one_fifth  avia-builder-el-28  el_after_av_four_fifth  el_before_av_three_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5fy4ac3-f4c964e2b3a713e11260f183361297b9\">\n.flex_column.av-5fy4ac3-f4c964e2b3a713e11260f183361297b9{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5fy4ac3-f4c964e2b3a713e11260f183361297b9 av_three_fifth  avia-builder-el-29  el_after_av_one_fifth  el_before_av_one_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-lf9gwdl0-85821d64077087bee20c526299a7cda3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>As top management, you create guidelines, provide and coordinate resources (including appointing a Med-IT risk manager) and monitor the risk management process. The risk management includes a 10-point plan with the main topics:<\/p>\n<ul>\n<li>Risk analysis<\/li>\n<li>Risk assessment<\/li>\n<li>Risk governance<\/li>\n<li>Residual risk assessment and report<\/li>\n<\/ul>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5140bjn-344c1c6997fc6c72ad780f7dbef4db45\">\n.flex_column.av-5140bjn-344c1c6997fc6c72ad780f7dbef4db45{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5140bjn-344c1c6997fc6c72ad780f7dbef4db45 av_one_fifth  avia-builder-el-31  el_after_av_three_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><article  class='iconbox iconbox_top av-lf9hbe4j-ca43ff1fd87cebb778d3069286c8a45a  avia-builder-el-32  avia-builder-el-no-sibling  main_color'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Top management\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue80b' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Top management<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4gve1f7-0824ce632ff6aaa5d7c63da493e8684d\">\n.flex_column.av-4gve1f7-0824ce632ff6aaa5d7c63da493e8684d{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4gve1f7-0824ce632ff6aaa5d7c63da493e8684d av_one_fifth  avia-builder-el-33  el_after_av_one_fifth  el_before_av_four_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1kmkg0j-01940a6cd5dba174cc3f0979e442d615\">\n.flex_column.av-1kmkg0j-01940a6cd5dba174cc3f0979e442d615{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1kmkg0j-01940a6cd5dba174cc3f0979e442d615 av_four_fifth  avia-builder-el-34  el_after_av_one_fifth  el_before_av_one_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><div  class='hr av-lf9ijugi-70e513a35b4738be47122631cb48391a hr-big  avia-builder-el-35  avia-builder-el-no-sibling '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4gve1f7-0824ce632ff6aaa5d7c63da493e8684d\">\n.flex_column.av-4gve1f7-0824ce632ff6aaa5d7c63da493e8684d{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4gve1f7-0824ce632ff6aaa5d7c63da493e8684d av_one_fifth  avia-builder-el-36  el_after_av_four_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3zh210z-3ef1217b87122b17aba97d5889bfe75e\">\n.flex_column.av-3zh210z-3ef1217b87122b17aba97d5889bfe75e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3zh210z-3ef1217b87122b17aba97d5889bfe75e av_one_fifth  avia-builder-el-37  el_after_av_one_fifth  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><article  class='iconbox iconbox_top av-lf9hbe4j-adfd70042a85967b5f15e10c05c6228f  avia-builder-el-38  avia-builder-el-no-sibling  main_color'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Med-IT risk manager\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue80a' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Med-IT risk manager<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3gfpykz-c0b553c40573a664dabc92535f7e53b5\">\n.flex_column.av-3gfpykz-c0b553c40573a664dabc92535f7e53b5{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3gfpykz-c0b553c40573a664dabc92535f7e53b5 av_three_fifth  avia-builder-el-39  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-lf9gwdl0-85821d64077087bee20c526299a7cda3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>As the designated risk manager, you organise and implement the risk management process with a view to the defined protection goals. While you report to top management, internal and external communication (e.g. with the manufacturer) is also part of the responsibility. Even if tasks such as carrying out the risk management process are delegated, the responsibility still remains with the Med-IT risk manager.<\/p>\n<p>What needs to be considered if the medical device is not used as standalone software but integrated into the IT network? Questions like these are answered by the medical device manufacturers.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2vz8r9v-39983a0ef99bbcff72bf17c8590290f3\">\n.flex_column.av-2vz8r9v-39983a0ef99bbcff72bf17c8590290f3{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2vz8r9v-39983a0ef99bbcff72bf17c8590290f3 av_one_fifth  avia-builder-el-41  el_after_av_three_fifth  el_before_av_four_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3lsqkz-37e9a63927da1a18814ac9bb2e3c3bcd\">\n.flex_column.av-3lsqkz-37e9a63927da1a18814ac9bb2e3c3bcd{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3lsqkz-37e9a63927da1a18814ac9bb2e3c3bcd av_four_fifth  avia-builder-el-42  el_after_av_one_fifth  el_before_av_one_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><div  class='hr av-lf9ijugi-70e513a35b4738be47122631cb48391a hr-big  avia-builder-el-43  avia-builder-el-no-sibling '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2vz8r9v-39983a0ef99bbcff72bf17c8590290f3\">\n.flex_column.av-2vz8r9v-39983a0ef99bbcff72bf17c8590290f3{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2vz8r9v-39983a0ef99bbcff72bf17c8590290f3 av_one_fifth  avia-builder-el-44  el_after_av_four_fifth  el_before_av_three_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2oeuy0j-1c18b23235b893acb15e19854b513877\">\n.flex_column.av-2oeuy0j-1c18b23235b893acb15e19854b513877{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2oeuy0j-1c18b23235b893acb15e19854b513877 av_three_fifth  avia-builder-el-45  el_after_av_one_fifth  el_before_av_one_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-lf9gwdl0-85821d64077087bee20c526299a7cda3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>You must provide information about the product and its intended use. You must also include the requirements necessary for the integration of the medical device in the IT network of the CRITIS, such as technical specifications.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-28eprwz-56832b7d0d98ade767eb1ccfd30b251e\">\n.flex_column.av-28eprwz-56832b7d0d98ade767eb1ccfd30b251e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-28eprwz-56832b7d0d98ade767eb1ccfd30b251e av_one_fifth  avia-builder-el-47  el_after_av_three_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><article  class='iconbox iconbox_top av-lf9hbe4j-379583b7cb952b1237f46d0ed2eba20d  avia-builder-el-48  avia-builder-el-no-sibling  main_color'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Medical device manufacturer\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue856' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Medical device manufacturer<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1mrhndf-774a941109731e56fe759dd11a532d9c\">\n.flex_column.av-1mrhndf-774a941109731e56fe759dd11a532d9c{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1mrhndf-774a941109731e56fe759dd11a532d9c av_one_fifth  avia-builder-el-49  el_after_av_one_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_6'  class='avia-section av-197xs37-3c790dde6a3cc0f9f34db73fa0cd8b4c main_color avia-section-default avia-no-border-styling  avia-builder-el-50  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-11317'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mveqc3-ffdfd43fd060fcf8808ab8af71faafea\">\n@keyframes av_boxShadowEffect_av-mveqc3-ffdfd43fd060fcf8808ab8af71faafea-column {\n0%   { box-shadow:  0 0 0 0 #e5e5e5; opacity: 1; }\n100% { box-shadow:  0 0 10px 0 #e5e5e5; opacity: 1; }\n}\n.flex_column.av-mveqc3-ffdfd43fd060fcf8808ab8af71faafea{\nbox-shadow: 0 0 10px 0 #e5e5e5;\nborder-width:2px;\nborder-color:rgba(212,128,2,0.65);\nborder-style:solid;\nborder-radius:0px 0px 0px 0px;\npadding:25px 25px 25px 25px;\nbackground-color:rgba(212,128,2,0.65);\n}\n<\/style>\n<div  class='flex_column av-mveqc3-ffdfd43fd060fcf8808ab8af71faafea av_two_third  avia-builder-el-51  el_before_av_three_fourth  avia-builder-el-first  first flex_column_div shadow-not-animated  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lf9gwdl0-d1dcbfd71422092838104f9541376160\">\n#top .av_textblock_section.av-lf9gwdl0-d1dcbfd71422092838104f9541376160 .avia_textblock{\ncolor:#000000;\n}\n<\/style>\n<section  class='av_textblock_section av-lf9gwdl0-d1dcbfd71422092838104f9541376160 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p><strong>Goot to know: <\/strong><\/p>\n<p>The responsible organisation is required by IEC 80001-1 to create and maintain a risk management file for the medical IT network. Information about the associated configuration management must also be included &#8211; as a document or by reference.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ux49ar-6903890d70f9d9d606a0ce813e8f0adc\">\n.flex_column.av-ux49ar-6903890d70f9d9d606a0ce813e8f0adc{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-ux49ar-6903890d70f9d9d606a0ce813e8f0adc av_three_fourth  avia-builder-el-53  el_after_av_two_third  avia-builder-el-last  first flex_column_div av-zero-column-padding  column-top-margin'     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lf9nwzn8-cf9e210ce76afafaf6e47b2dd1009359\">\n#top .av-special-heading.av-lf9nwzn8-cf9e210ce76afafaf6e47b2dd1009359{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-lf9nwzn8-cf9e210ce76afafaf6e47b2dd1009359 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-lf9nwzn8-cf9e210ce76afafaf6e47b2dd1009359 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-lf9nwzn8-cf9e210ce76afafaf6e47b2dd1009359 av-special-heading-h2 blockquote modern-quote  avia-builder-el-54  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Who decides what?<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-lf9gwdl0-85821d64077087bee20c526299a7cda3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>With responsibility, of course, comes decision-making power. We have shown you above who has what responsibilities according to IEC 80001-1. Delegating tasks in order to be able to fulfil the requirements does not, of course, exclude responsibility. And this responsibility &#8211; for the overall process of compliance with risk management &#8211; is borne by the top management.<\/p>\n<\/div><\/section><\/p><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_7'  class='avia-section av-mv40j7-b2a7db4d5997d48ef24a643132b9c69e alternate_color avia-section-default avia-no-border-styling  avia-builder-el-56  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-11317'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ux49ar-6903890d70f9d9d606a0ce813e8f0adc\">\n.flex_column.av-ux49ar-6903890d70f9d9d606a0ce813e8f0adc{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-ux49ar-6903890d70f9d9d606a0ce813e8f0adc av_three_fourth  avia-builder-el-57  el_before_av_hr  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lf9ooz0n-e9213c017da4b0403bb71b2272d16d7b\">\n#top .av-special-heading.av-lf9ooz0n-e9213c017da4b0403bb71b2272d16d7b{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-lf9ooz0n-e9213c017da4b0403bb71b2272d16d7b .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-lf9ooz0n-e9213c017da4b0403bb71b2272d16d7b .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-lf9ooz0n-e9213c017da4b0403bb71b2272d16d7b av-special-heading-h2 blockquote modern-quote  avia-builder-el-58  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >How can the goals of IEC 80001-1 be reached and processes fully documented? <\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-lf9gwdl0-85821d64077087bee20c526299a7cda3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Hospital operators are required to ensure that the operation of a medical IT network is trouble-free and fail-safe and to identify potential risks at an early stage. Documentation of risk management activities that is always comprehensible and focuses on the dependency of critical processes contributes significantly to the safety of patients. Software solutions that focus on comprehensible documentation and completeness support this process.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lf9jfudn-889711106f9886369c10d0b7bf3e5308\">\n#top .hr.hr-invisible.av-lf9jfudn-889711106f9886369c10d0b7bf3e5308{\nheight:100px;\n}\n<\/style>\n<div  class='hr av-lf9jfudn-889711106f9886369c10d0b7bf3e5308 hr-invisible  avia-builder-el-60  el_after_av_three_fourth  el_before_av_social_share '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<div  class='av-social-sharing-box av-lf9jf3sj-6b4e90f7b521d4a1567a6a44ee06062a av-social-sharing-box-minimal  avia-builder-el-61  el_after_av_hr  el_before_av_hr  av-social-sharing-box-fullwidth'><div class=\"av-share-box\"><h5 class='av-share-link-description av-no-toc '>Sounds interesting? 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