{"id":79647,"date":"2026-03-20T08:28:00","date_gmt":"2026-03-20T07:28:00","guid":{"rendered":"https:\/\/www.teoresigroup.com\/?p=79647"},"modified":"2026-03-24T17:29:33","modified_gmt":"2026-03-24T16:29:33","slug":"cybersecurity-by-design-iec-81001-5-1","status":"publish","type":"post","link":"https:\/\/www.teoresigroup.com\/it\/news\/cybersecurity-by-design-iec-81001-5-1\/","title":{"rendered":"Cybersecurity by Design \u2013 IEC 81001-5-1\u00a0"},"content":{"rendered":"\n<div class=\"wp-block-columns row align-center row sezione\">\n<div class=\"wp-block-column column small-12 medium-10 large-8\">\n<p>Nel contesto della progettazione dei dispositivi medici, il tema della cybersecurity assume un ruolo centrale. Dopo aver affrontato gli aspetti regolatori legati al<strong>&nbsp;<\/strong><a href=\"https:\/\/www.teoresigroup.com\/it\/news\/cybersecurity-per-dispositivi-medici-soluzioni-hardware-e-software-per-sistemi-embedded-a-prova-di-regolamento-europeo\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Medical Device Regulation<\/strong><\/a><strong>&nbsp;(MDR) 2017\/745&nbsp;<\/strong>e alcune soluzioni hardware e software per soddisfare i requisiti di sicurezza informatica, questo nuovo approfondimento analizza il concetto di&nbsp;<strong>Security-by-Design<\/strong>&nbsp;nello standard&nbsp;<strong>IEC 81001-5-1:2021<\/strong>.&nbsp;<\/p>\n\n\n\n<p>Lo standard introduce le attivit\u00e0 necessarie per garantire la sicurezza del<strong>&nbsp;health&nbsp;software<\/strong>&nbsp;o&nbsp;<strong>health software<\/strong>&nbsp;durante i processi del suo ciclo di vita. Con il termine health software si intende il software destinato a gestire, mantenere o migliorare la salute delle persone, oppure sviluppato per essere incorporato in un dispositivo medico.&nbsp;<\/p>\n\n\n\n<p>In questo contesto, la sicurezza diventa un obiettivo da perseguire fin dalle prime fasi di sviluppo del software, secondo l\u2019approccio&nbsp;<strong>Security-by-Design<\/strong>.&nbsp;<\/p>\n\n\n\n<p>Lo standard richiama inoltre diversi concetti presenti nello standard&nbsp;<strong>IEC 62304<\/strong>, che definisce i processi del ciclo di vita del software per dispositivi medici. Tra i due standard esistono diverse corrispondenze: mentre IEC 62304 \u00e8 orientato agli aspetti di&nbsp;<strong>safety<\/strong>, IEC 81001-5-1 introduce requisiti specifici legati alla security, come i&nbsp;<strong>security&nbsp;requirements&nbsp;<\/strong>e attivit\u00e0 dedicate alla sicurezza dell\u2019architettura software.&nbsp;<\/p>\n\n\n\n<p>Tra gli elementi chiave dello standard emerge l\u2019approccio&nbsp;<strong>defense-in-depth<\/strong>, che prevede l\u2019implementazione di diversi livelli di protezione all\u2019interno dell\u2019architettura del sistema per proteggere gli&nbsp;asset&nbsp;e&nbsp;idurre&nbsp;l\u2019impatto di eventuali attacchi.&nbsp;<\/p>\n\n\n\n<p>Lo standard identifica inoltre alcune&nbsp;<strong>secure&nbsp;design&nbsp;best&nbsp;practices<\/strong>, tra cui:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list wp-block-list\">\n<li>documentazione delle&nbsp;<strong>Trust&nbsp;Boundaries<\/strong>&nbsp;tra le diverse aree del sistema&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list wp-block-list\">\n<li>applicazione del&nbsp;<strong>principio del minimo privilegio<\/strong>&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list wp-block-list\">\n<li>utilizzo di&nbsp;<strong>software sicuro e certificato<\/strong>&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list wp-block-list\">\n<li>riduzione delle<strong>&nbsp;superfici di attacco&nbsp;<\/strong>attraverso analisi dei rischi e mitigazioni&nbsp;<\/li>\n<\/ul>\n\n\n\n<p>Un altro elemento fondamentale \u00e8 il processo di&nbsp;<strong>Threat&nbsp;Modeling,&nbsp;<\/strong>utilizzato per identificare potenziali minacce e definire strategie di mitigazione. Tra i metodi pi\u00f9 diffusi citati dallo standard rientra il modello&nbsp;<strong>STRIDE<\/strong>, utilizzato per analizzare diverse tipologie di minacce come spoofing, tampering o&nbsp;denial&nbsp;of service.&nbsp;<\/p>\n\n\n\n<p>Lo standard cita inoltre altri metodi di analisi delle minacce, tra cui&nbsp;<strong>DREAD<\/strong>,&nbsp;<strong>CVSS<\/strong>, A<strong>ttack-Defense Tree, OCTAVE e VAST.<\/strong>&nbsp;<\/p>\n\n\n\n<p>Vuoi approfondire il tema della cybersecurity nel software medico e scoprire come lo standard IEC 81001-5-1 applica il principio di Security-by-Design?&nbsp;<\/p>\n\n\n\n<p>Scarica il PDF dell\u2019articolo completo&nbsp;di&nbsp;<a href=\"https:\/\/www.linkedin.com\/in\/gaia-di-federico\/\" target=\"_blank\" rel=\"noreferrer noopener\">Gaia Di Federico<\/a>&nbsp;oppure scopri gli altri approfondimenti tecnici nella sezione&nbsp;<a href=\"https:\/\/medtech-publications\/#subpage-anchor\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>MedTech Publications<\/strong><\/a>.&nbsp;<\/p>\n\n\n        \n        <div id=\"block_ff4a50922d85bc8b7724ec763a0a3477\" class=\"file-attachment-repeater row sezione pt-0 align-center\">\n\n            <div class=\"column small-12\">\n\n                \n                     <a class=\"attachment flex align-middle p-3 mb-2 fs-p color-body\" href=\"https:\/\/www.teoresigroup.com\/wp-content\/uploads\/2026\/03\/security-by-design-lapproccio-alla-cybersecurity-secondo-lo-standard-iec-81001-5-1.pdf\" target=\"_blank\" rel=\"nofollow noopener\" onclick=\"ga('send', 'event', 'Action-Link', 'Click', 'Leggi l'articolo completo qui');\"><svg class=\"icon download width-8 mr-4 color-primary\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 576 512\"><path d=\"M528 288h-92.1l46.1-46.1c30.1-30.1 8.8-81.9-33.9-81.9h-64V48c0-26.5-21.5-48-48-48h-96c-26.5 0-48 21.5-48 48v112h-64c-42.6 0-64.2 51.7-33.9 81.9l46.1 46.1H48c-26.5 0-48 21.5-48 48v128c0 26.5 21.5 48 48 48h480c26.5 0 48-21.5 48-48V336c0-26.5-21.5-48-48-48zm-400-80h112V48h96v160h112L288 368 128 208zm400 256H48V336h140.1l65.9 65.9c18.8 18.8 49.1 18.7 67.9 0l65.9-65.9H528v128zm-88-64c0-13.3 10.7-24 24-24s24 10.7 24 24-10.7 24-24 24-24-10.7-24-24z\"\/><\/svg>Leggi l&#8217;articolo completo qui<\/a>\n                \n            <\/div>\n\n        <\/div>\n\n    \n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p class=\"excerpt\">Nel contesto della progettazione dei dispositivi medici, il tema della cybersecurity assume un ruolo centrale. Dopo aver affrontato gli aspetti regolatori legati al&nbsp;Medical Device Regulation&nbsp;(MDR) 2017\/745&nbsp;e alcune soluzioni hardware e software per soddisfare i requisiti di sicurezza informatica, questo nuovo approfondimento analizza il concetto di&nbsp;Security-by-Design&nbsp;nello standard&nbsp;IEC 81001-5-1:2021.&nbsp; Lo standard introduce le attivit\u00e0 necessarie per garantire la sicurezza del&nbsp;health&nbsp;software&nbsp;o&nbsp;health software&nbsp;durante i&#8230;<\/p>\n","protected":false},"author":16,"featured_media":79650,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[13,767,726],"tags":[],"class_list":["post-79647","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-corporate","category-medbeat","category-medtech-it"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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