<?xml version="1.0" encoding="UTF-8" ?><!-- generator=Zoho Sites --><rss version="2.0" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:content="http://purl.org/rss/1.0/modules/content/"><channel><atom:link href="https://www.itsmf.ch/blogs/tag/EU/feed" rel="self" type="application/rss+xml"/><title>itSMF Switzerland - Blog #EU</title><description>itSMF Switzerland - Blog #EU</description><link>https://www.itsmf.ch/blogs/tag/EU</link><lastBuildDate>Wed, 09 Sep 2026 13:03:24 +0200</lastBuildDate><generator>http://zoho.com/sites/</generator><item><title><![CDATA[The EU Artificial Intelligence Act: a structured step toward trustworthy AI]]></title><link>https://www.itsmf.ch/blogs/post/the-eu-artificial-intelligence-act-a-structured-step-toward-trustworthy-ai</link><description><![CDATA[<img align="left" hspace="5" src="https://www.itsmf.ch/the-eu-artificial-intelligence-act-a-structured-step-toward-trustworthy-ai-itsmf-switzerland-bl.png"/>The Act reflects the EU’s commitment to a human-centric approach to technology, balancing innovation with fundamental rights through a harmonized risk-based legal framework.]]></description><content:encoded><![CDATA[<div class="zpcontent-container blogpost-container "><div data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA" data-element-type="section" class="zpsection "><style type="text/css"> [data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA"].zpsection{ border-radius:1px; } </style><div class="zpcontainer-fluid zpcontainer"><div data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw" data-element-type="row" class="zprow zprow-container zpalign-items-flex-start zpjustify-content- " data-equal-column="false"><style type="text/css"> [data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw"].zprow{ border-radius:1px; } </style><div data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g" data-element-type="column" class="zpelem-col zpcol-12 zpcol-md-8 zpcol-sm-12 zpalign-self- "><style type="text/css"> [data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g"].zpelem-col{ border-radius:1px; } </style><div data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><p><span style="font-style:italic;">Reading time: ~ 2 min.</span><br/></p></div>
</div><div data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width: 703px ; height: 468.85px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width:723px ; height:481.80px ; } } @media (max-width: 767px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width:415px ; height:276.55px ; } } [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-tablet-align-center zpimage-mobile-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/the-eu-artificial-intelligence-act-a-structured-step-toward-trustworthy-ai-itsmf-switzerland-bl.jpg" width="415" height="276.55" loading="lazy" size="fit" alt="direttiva sulla responsabilità da intelligenza artificiale itsmf blog" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">Background and legislative path of AI act</h2></div>
<div data-element-id="elm_IXDYbYLLeRo4wQNVxPvAbw" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><p style="text-align:left;"><span><span></span></span></p><div><div><p>After nearly three years of negotiation, the <strong><span>European Union Artificial Intelligence Act (AI Act)</span></strong> has become the <span style="background-color:rgb(234, 234, 4);">world’s first comprehensive regulatory framework for artificial intelligence</span>. <span>Initially proposed on <strong><span>April 21, 2021</span></strong>, the Act underwent multiple readings and amendments before final approval by the European Parliament on <strong><span>March 13, 2024</span></strong> (</span><a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0206"><span>EUR-Lex</span></a><span>).</span></p><p><span><br/></span></p> The Act reflects the EU’s commitment to a <strong>human-centric approach to technology</strong>, balancing innovation with fundamental rights. It aims to establish a <span style="font-weight:bold;">harmonized, risk-based legal framework</span> that ensures AI systems introduced in the European market are <span style="font-weight:bold;">safe, transparent, and compliant</span> with EU values such as privacy, dignity, and fairness. <style>@font-face {}@font-face {}@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0cm; font-size: 12pt; font-family: "Liberation Serif", serif }p.MsoBodyText, li.MsoBodyText, div.MsoBodyText { margin-top: 0cm; margin-right: 0cm; margin-bottom: 7pt; margin-left: 0cm; line-height: 115%; font-size: 12pt; font-family: "Liberation Serif", serif }a:link, span.MsoHyperlink { color: navy; text-decoration: underline }a:visited, span.MsoHyperlinkFollowed { color: rgb(85, 26, 139); text-decoration: underline }span.CorpotestoCarattere { }.MsoChpDefault { font-family: "Liberation Serif", serif }.MsoPapDefault { }div.WordSection1 { page: WordSection1 }</style></div></div><p></p><p></p></div>
</div><div data-element-id="elm_JjD8tlosrYxfDmn2ItzCcA" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_JjD8tlosrYxfDmn2ItzCcA"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">Objectives and scope of the regulation<div><style>@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin-top: 0cm; margin-right: 0cm; margin-bottom: 8pt; margin-left: 0cm; line-height: 107%; font-size: 11pt; font-family: "Calibri", sans-serif }.MsoChpDefault { font-size: 11pt; font-family: "Calibri", sans-serif }.MsoPapDefault { margin-bottom: 8pt; line-height: 107% }div.WordSection1 { page: WordSection1 }</style></div></h2></div>
<div data-element-id="elm_w0Saj7kXqosIO_ZYZm3xVA" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div><div> The AI Act’s overarching goal is to <span style="font-weight:bold;">guarantee the safety and ethical use of AI</span> while <span style="font-weight:bold;">promoting innovation</span> across the Union. Specifically, it seeks to: <style>@font-face {}@font-face {}@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0cm; font-size: 12pt; font-family: "Liberation Serif", serif }.MsoChpDefault { font-family: "Liberation Serif", serif }.MsoPapDefault { }div.WordSection1 { page: WordSection1 }</style></div></div></div>
</div><div data-element-id="elm_7OdWPenIrnY39RWmlqyVoA" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><ul><li>Ensure that <span style="background-color:rgb(234, 234, 4);">AI systems respect <span style="font-weight:bold;">fundamental rights and European values</span></span>;</li><li>Foster <span style="background-color:rgb(4, 234, 4);"><span style="font-weight:bold;">legal certainty</span> to encourage investment and innovation</span>;</li><li>Strengthen <span style="font-weight:bold;background-color:rgb(244, 244, 78);">governance and oversight mechanisms</span><span style="background-color:rgb(244, 244, 78);"> for AI deployment</span>;</li><li>Promote a <span style="font-weight:bold;">single European market</span> for legitimate, trustworthy AI solutions.</li></ul></div>
</div><div data-element-id="elm_9r_HIuzzuZXtME_e0toZ2Q" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><p></p><div><p>The law applies to <strong><span>developers, providers, and users</span></strong> of AI systems within the EU, as well as to entities outside the EU whose systems affect EU citizens — mirroring the <span style="background-color:rgb(234, 234, 4);">extraterritorial principle also seen in modern data protection laws</span>.</p><style>@font-face {}@font-face {}@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0cm; font-size: 12pt; font-family: "Liberation Serif", serif }p.MsoBodyText, li.MsoBodyText, div.MsoBodyText { margin-top: 0cm; margin-right: 0cm; margin-bottom: 7pt; margin-left: 0cm; line-height: 115%; font-size: 12pt; font-family: "Liberation Serif", serif }span.CorpotestoCarattere { }.MsoChpDefault { font-family: "Liberation Serif", serif }.MsoPapDefault { }div.WordSection1 { page: WordSection1 }</style></div><p></p></div>
</div><div data-element-id="elm_8FQI4Cjro0v8pKUlqtyp6g" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_8FQI4Cjro0v8pKUlqtyp6g"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">A harmonized risk-based framework</h2></div>
<div data-element-id="elm_YL0X5frm4hbkkpkeEY5h1w" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_YL0X5frm4hbkkpkeEY5h1w"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div> At the heart of the regulation lies its <span style="font-weight:bold;background-color:rgb(234, 234, 4);">risk-based classification</span><span style="background-color:rgb(234, 234, 4);"> of AI systems</span>.</div><div><br/></div><div>The Act defines AI as “<span style="font-style:italic;background-color:rgb(4, 234, 119);">a machine-based system that operates with varying levels of autonomy and may exhibit adaptiveness after deployment, inferring from inputs how to generate outputs such as predictions, content, or decisions</span>” — a <span style="font-weight:bold;">future-proof definition</span> intended to encompass evolving AI forms.<style>@font-face {}@font-face {}@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0cm; font-size: 12pt; font-family: "Liberation Serif", serif }.MsoChpDefault { font-family: "Liberation Serif", serif }.MsoPapDefault { }div.WordSection1 { page: WordSection1 }</style></div></div>
</div><div data-element-id="elm_JtbCTqrCOfx1rAWrk6Myog" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div> The regulation distinguishes between <span style="font-weight:bold;">three primary risk categories</span>: <style>@font-face {}@font-face {}@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0cm; font-size: 12pt; font-family: "Liberation Serif", serif }.MsoChpDefault { font-family: "Liberation Serif", serif }.MsoPapDefault { }div.WordSection1 { page: WordSection1 }</style></div></div>
</div><div data-element-id="elm_cz7fZbLJ70hjHlUNc3WCGw" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div><ol><li><span><strong><span>Unacceptable risk</span></strong> – <span style="background-color:rgb(244, 244, 78);">Systems that pose a clear threat to people's safety or rights</span> are <span style="font-weight:bold;">banned outright</span>. These include AI used for <span style="font-style:italic;background-color:rgb(4, 234, 119);">social scoring</span> (as in China’s credit system), <span style="font-style:italic;background-color:rgb(4, 234, 119);">real-time biometric surveillance</span> in public spaces (except in narrowly defined cases), and <span style="font-style:italic;background-color:rgb(4, 234, 119);">manipulative or exploitative applications</span> targeting vulnerable groups such as minors or disabled persons.</span></li><li><span><strong><span>High risk</span></strong> – <span style="background-color:rgb(234, 234, 4);">Systems that can significantly impact fundamental rights or safety</span> are subject to <span style="font-weight:bold;">strict obligations</span>. Examples include AI used in <span style="font-weight:bold;">critical infrastructure</span>, <span style="font-weight:bold;">education and employment</span>, <span style="font-weight:bold;">law enforcement</span>, <span style="font-weight:bold;">migration</span>, or <span style="font-weight:bold;">judicial administration</span> (Annex III). Developers must perform <span style="font-weight:bold;">conformity assessments</span>, maintain <span style="font-weight:bold;">traceability</span>, and ensure <span style="font-weight:bold;">data quality and transparency</span> throughout the system’s lifecycle.</span></li><li><span><strong><span>Limited and minimal risk</span></strong> – Systems such as chatbots or generative AI tools fall into this category and face <span style="font-weight:bold;">transparency requirements</span> (e.g., disclosing that the <span style="background-color:rgb(244, 244, 78);">user is interacting with an AI</span>, or <span style="background-color:rgb(234, 234, 4);">labeling synthetic content such as <span style="font-style:italic;">deepfakes</span></span>).</span></li></ol></div></div>
</div><div data-element-id="elm_p13DqRshhogIdB372HDASg" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div> This graduated approach aims to ensure <span style="font-weight:bold;">proportionate regulation</span>, preventing excessive administrative burden for low-risk AI while tightening controls on high-impact applications. <style>@font-face {}@font-face {}@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0cm; font-size: 12pt; font-family: "Liberation Serif", serif }.MsoChpDefault { font-family: "Liberation Serif", serif }.MsoPapDefault { }div.WordSection1 { page: WordSection1 }</style></div></div>
</div><div data-element-id="elm_XkeJl6amRzDf49OrbufXKQ" data-element-type="heading" class="zpelement zpelem-heading "><style></style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">AI growth led by transparency, privacy and compliance</h2></div>
<div data-element-id="elm_oMUO_EKxPYre6tJIEJMcPg" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div><div><p><span>Even for non-high-risk systems, the <span style="background-color:rgb(234, 234, 4);">AI Act encourages providers to adopt <strong><span>voluntary codes of conduct</span></strong></span> addressing values like <span style="background-color:rgb(4, 234, 119);">environmental sustainability, accessibility, and diversity</span>.</span></p><p><span><br/></span></p><p><span>The <span style="background-color:rgb(234, 234, 4);">Act interacts closely with existing data protection laws</span> such as <strong><span>Switzerland’s Federal Act on Data Protection (LPD)</span></strong> and the <strong><span>EU General Data Protection Regulation (GDPR)</span></strong>. While these frameworks primarily safeguard <strong><span>personal data and individual consent</span></strong>, the <span style="background-color:rgb(4, 234, 119);">AI Act takes a <strong><span>systemic approach</span></strong>, addressing <strong><span>collective and ethical risks</span></strong> associated with automated decision-making</span>. Privacy protection remains integral, particularly where AI systems process biometric, behavioral, or sensitive personal data.</span></p><p><span><br/></span></p><p><span>Privacy protection appears explicitly in <strong><span>Chapter X</span></strong>, where the Act underscores the human factor as a persistent challenge.</span></p><p><span><br/></span></p><p><span>The regulation also underscores the importance of <strong><span>human oversight</span></strong> and <strong><span>accountability</span></strong> in AI operations. <span style="background-color:rgb(234, 234, 4);">Human judgment remains essential to interpret AI outputs, detect bias, and prevent misuse</span> — a reminder that compliance cannot rely solely on technical safeguards.</span></p><p><span><br/></span></p> Notably, the AI Act specifies that anonymized or aggregated data, as referenced for instance in OpenAI’s <a href="https://openai.com/policies/data-processing-addendum" title="Data Processing Addendum" rel="">Data Processing Addendum</a>, must still be handled with caution to avoid potential re-identification and ensure adherence to applicable data protection standards. <style>@font-face {}@font-face {}@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0cm; font-size: 12pt; font-family: "Liberation Serif", serif }p.MsoBodyText, li.MsoBodyText, div.MsoBodyText { margin-top: 0cm; margin-right: 0cm; margin-bottom: 7pt; margin-left: 0cm; line-height: 115%; font-size: 12pt; font-family: "Liberation Serif", serif }a:link, span.MsoHyperlink { color: navy; text-decoration: underline }a:visited, span.MsoHyperlinkFollowed { color: rgb(85, 26, 139); text-decoration: underline }span.CorpotestoCarattere { }.MsoChpDefault { font-family: "Liberation Serif", serif }.MsoPapDefault { }div.WordSection1 { page: WordSection1 }</style></div></div></div>
</div><div data-element-id="elm_9fdxSRyb-tUAl_doEt1PYA" data-element-type="heading" class="zpelement zpelem-heading "><style></style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">AI Act enforcement and penalties</h2></div>
<div data-element-id="elm_Q0E91dgAckmSU6VtFuWhHg" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div><p><span>The AI Act introduces <strong><span>significant financial sanctions</span></strong> for non-compliance, modeled partly after the GDPR. Depending on the violation, penalties can reach up to <strong><span>€35 million or 7% of global annual turnover</span></strong> for prohibited practices, <strong><span>€15 million or 3%</span></strong> for breaches of obligations, and <strong><span>€7.5 million or 1.5%</span></strong> for providing misleading information to authorities.</span></p><p><span><br/></span></p> Supervisory authorities will be empowered to <span style="font-weight:bold;">issue warnings, suspend systems, or prohibit market access</span> if risks are not adequately mitigated. This structure complements, rather than replaces, national laws like the <span style="font-weight:bold;">LPD (FADP)</span>, which remain the cornerstone for personal data protection within Switzerland’s jurisdiction. <style>@font-face {}@font-face {}@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0cm; font-size: 12pt; font-family: "Liberation Serif", serif }p.MsoBodyText, li.MsoBodyText, div.MsoBodyText { margin-top: 0cm; margin-right: 0cm; margin-bottom: 7pt; margin-left: 0cm; line-height: 115%; font-size: 12pt; font-family: "Liberation Serif", serif }span.CorpotestoCarattere { }.MsoChpDefault { font-family: "Liberation Serif", serif }.MsoPapDefault { }div.WordSection1 { page: WordSection1 }</style></div></div>
</div><div data-element-id="elm_n4lyesZ9O1vRM3RKcM_v2w" data-element-type="heading" class="zpelement zpelem-heading "><style></style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">Fostering innovation: regulatory sandboxes</h2></div>
<div data-element-id="elm_mY2YKO7wTU770jhqGkRTyQ" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div><p><span>Recognizing the need to balance compliance with innovation, the Act establishes <strong><span>Regulatory Sandboxes</span></strong> — controlled environments that allow AI developers, particularly <strong><span>startups and SMEs</span></strong>, to test systems under regulatory supervision before full deployment.</span></p><p><span><br/></span></p> This approach aims to <span style="font-weight:bold;">lower entry barriers</span> for smaller entities while ensuring alignment with safety and ethics standards. It embodies the EU’s vision of <span style="font-style:italic;">responsible innovation</span> — where progress is guided, not constrained, by regulation. <style>@font-face {}@font-face {}@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0cm; font-size: 12pt; font-family: "Liberation Serif", serif }p.MsoBodyText, li.MsoBodyText, div.MsoBodyText { margin-top: 0cm; margin-right: 0cm; margin-bottom: 7pt; margin-left: 0cm; line-height: 115%; font-size: 12pt; font-family: "Liberation Serif", serif }span.CorpotestoCarattere { }.MsoChpDefault { font-family: "Liberation Serif", serif }.MsoPapDefault { }div.WordSection1 { page: WordSection1 }</style></div></div>
</div><div data-element-id="elm_Nzk_nPDZ0NKgKUSu1SwG7Q" data-element-type="heading" class="zpelement zpelem-heading "><style></style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">What to expect</h2></div>
<div data-element-id="elm_gjlahIlItt0etGhcfW69Sw" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div><p><span>As the AI Act enters into force, Europe — <span style="background-color:rgb(234, 234, 4);">and by extension, Switzerland, through market interoperability</span> — faces a new era of AI governance. The coming years will likely bring <strong><span>adjustments, refinements, and resistance</span></strong>, as organizations learn to align innovation strategies with compliance obligations.</span></p><p><span><br/></span></p><p><span>Over time, however, the framework could <strong><span>strengthen public trust in AI</span></strong> and encourage the development of transparent, human-centered systems. For businesses and institutions, success will depend on <span style="background-color:rgb(234, 234, 4);">how effectively they integrate <strong><span>ethical awareness</span></strong> into technological design and governance</span>.</span></p> In this sense, the AI Act may represent not only a legal milestone but also the foundation of a <span style="font-weight:bold;">new digital social contract</span> — one that defines how humans and intelligent machines can coexist responsibly in the years ahead.</div><div><span style="font-weight:bold;"><br/></span></div><div><span style="font-weight:bold;">Author: Mattia Munari</span>&nbsp;</div><div><style>@font-face {}@font-face {}@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0cm; font-size: 12pt; font-family: "Liberation Serif", serif }p.MsoBodyText, li.MsoBodyText, div.MsoBodyText { margin-top: 0cm; margin-right: 0cm; margin-bottom: 7pt; margin-left: 0cm; line-height: 115%; font-size: 12pt; font-family: "Liberation Serif", serif }span.CorpotestoCarattere { }.MsoChpDefault { font-family: "Liberation Serif", serif }.MsoPapDefault { }div.WordSection1 { page: WordSection1 }</style></div></div>
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</div></div></div></div></div></div> ]]></content:encoded><pubDate>Wed, 26 Nov 2025 07:00:00 +0100</pubDate></item><item><title><![CDATA[Europe and Switzerland's strategic dilemma: tariffs, tech, and data governance]]></title><link>https://www.itsmf.ch/blogs/post/europe-and-switzerland-s-strategic-dilemma-tariffs-tech-and-data-governance</link><description><![CDATA[<img align="left" hspace="5" src="https://www.itsmf.ch/Europe-and-Switzerland-strategic-dilemma-tariffs-tech-and-data-governance-itsmf-switzerland-blo.png"/>Tariffs, technological restrictions, and conflicting regulations are testing supply chains and companies’ operating models: how can European businesses balance strategic autonomy and US historical ties?]]></description><content:encoded><![CDATA[<div class="zpcontent-container blogpost-container "><div data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA" data-element-type="section" class="zpsection "><style type="text/css"> [data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA"].zpsection{ border-radius:1px; } </style><div class="zpcontainer-fluid zpcontainer"><div data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw" data-element-type="row" class="zprow zprow-container zpalign-items-flex-start zpjustify-content- " data-equal-column="false"><style type="text/css"> [data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw"].zprow{ border-radius:1px; } </style><div data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g" data-element-type="column" class="zpelem-col zpcol-12 zpcol-md-8 zpcol-sm-12 zpalign-self- "><style type="text/css"> [data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g"].zpelem-col{ border-radius:1px; } </style><div data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><p><span style="font-style:italic;">Reading time: ~ 4 min.</span><br/></p></div>
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                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/Europe-and-Switzerland-strategic-dilemma-tariffs-tech-and-data-governance-itsmf-switzerland-blo.jpg" width="415" height="276.55" loading="lazy" size="fit" alt="direttiva sulla responsabilità da intelligenza artificiale itsmf blog" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">Introduction</h2></div>
<div data-element-id="elm_IXDYbYLLeRo4wQNVxPvAbw" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><p style="text-align:left;"><span><span>The global economic landscape is increasingly marked by strategic competition that goes beyond simple trade rivalry.&nbsp;<span style="background-color:rgb(244, 244, 78);">Tariffs, technological restrictions, and conflicting regulations are testing supply chains and companies’ operating models</span>.</span></span></p><p style="text-align:left;"><span><span><br/></span></span></p><p style="text-align:left;"><span><span>In this complex scenario, European businesses, including Swiss firms, must <span style="font-weight:bold;">balance two opposing needs</span>: maintaining historical ties with the United States while pursuing greater strategic autonomy.</span></span></p><p></p></div>
</div><div data-element-id="elm_JjD8tlosrYxfDmn2ItzCcA" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_JjD8tlosrYxfDmn2ItzCcA"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">US pressure: tariffs and technological influence<div><style>@font-face {}@font-face {}p.MsoNormal, li.MsoNormal, div.MsoNormal { margin-top: 0cm; margin-right: 0cm; margin-bottom: 8pt; margin-left: 0cm; line-height: 107%; font-size: 11pt; font-family: "Calibri", sans-serif }.MsoChpDefault { font-size: 11pt; font-family: "Calibri", sans-serif }.MsoPapDefault { margin-bottom: 8pt; line-height: 107% }div.WordSection1 { page: WordSection1 }</style></div></h2></div>
<div data-element-id="elm_w0Saj7kXqosIO_ZYZm3xVA" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div>The economic and political alliance between Europe and the United States has long been a cornerstone. However, in recent years, protectionist policies have strained this relationship.</div><div><br/></div><div><span style="background-color:rgb(4, 234, 119);">The U.S. has imposed tariffs not only to protect its industries but also as a geopolitical lever</span>, creating uncertainty for companies operating across the Atlantic.&nbsp;<span style="font-weight:bold;">This pressure also extends to the tech sector</span>, where U.S. regulations exert significant control, often at the expense of European interests.</div></div>
</div><div data-element-id="elm_8FQI4Cjro0v8pKUlqtyp6g" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_8FQI4Cjro0v8pKUlqtyp6g"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">The European response: the «Latombe's case» as a sign of change</h2></div>
<div data-element-id="elm_YL0X5frm4hbkkpkeEY5h1w" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_YL0X5frm4hbkkpkeEY5h1w"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div>In response to these dynamics, <span style="font-weight:bold;">Europe is seeking to assert its strategic independence</span>.</div><div><br/></div><div>A significant example is the initiative of <span style="background-color:rgb(244, 244, 78);">French MEP Philippe Latombe, who questioned the legitimacy of data transfers to the United States</span> by criticizing the Data Privacy Framework (DPF). This move is <span style="font-weight:bold;">not just a technical dispute</span> but a strong political signal reflecting the <span style="background-color:rgb(4, 234, 119);">will to strengthen European digital sovereignty</span>.</div><div><br/></div><div>Latombe’s position highlights <span style="font-weight:bold;">growing dissatisfaction with agreements that fail to adequately protect European data</span> from external interference, despite regulations such as LPD/GDPR.</div></div>
</div><div data-element-id="elm_XkeJl6amRzDf49OrbufXKQ" data-element-type="heading" class="zpelement zpelem-heading "><style></style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">Companies at the centre of tension: a delicate balance</h2></div>
<div data-element-id="elm_oMUO_EKxPYre6tJIEJMcPg" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div>In this clash between geopolitical blocs, <span style="font-weight:bold;">companies find themselves in a vulnerable position</span>.</div><div><br/></div><div>On the one hand, they must c<span style="background-color:rgb(234, 234, 4);">omply with strict European regulations</span>, risking sanctions in the event of violations. On the other hand, they <span style="background-color:rgb(4, 234, 119);">are heavily dependent on American technologies and services</span>, such as cloud providers and essential software.</div><div><br/></div><div>This creates a dilemma: adopt alternative solutions to comply with regulations, often at higher costs, or maintain existing dependencies, exposing themselves to legal and operational risks.</div></div>
</div><div data-element-id="elm_9fdxSRyb-tUAl_doEt1PYA" data-element-type="heading" class="zpelement zpelem-heading "><style></style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">The most at-risk sectors and strategies for the future</h2></div>
<div data-element-id="elm_Q0E91dgAckmSU6VtFuWhHg" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div>The most vulnerable companies are those managing <span style="background-color:rgb(234, 234, 4);">large volumes of sensitive data belonging to European citizens or relying on U.S. technological infrastructures</span>. For these businesses, the challenge is not only compliance but also operational continuity. Possible solutions focus on three main directions:</div></div>
</div><div data-element-id="elm_gzdZCRbKkEBPOIhvha4uuw" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><ul><li><span><span style="background-color:rgb(4, 234, 119);font-weight:bold;">Diversifying technological partnerships</span>: reducing reliance on a single provider by exploring global alternatives.</span></li><li><span><span style="background-color:rgb(4, 234, 119);font-weight:bold;">Investing in European technologies</span>: favouring cloud and software providers based in Europe, fully compliant with local regulations such as LPD/GDPR.</span></li><li><span><span style="background-color:rgb(4, 234, 119);font-weight:bold;">Advanced data management</span>: implementing strategies to map and control data flows, minimizing extra-European transfers.</span></li></ul></div>
</div><div data-element-id="elm_sl_ImPmWHit8heN2HOLUcg" data-element-type="heading" class="zpelement zpelem-heading "><style></style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">Strategic alignment between CEO and CIO: solutions in an uncertain context</h2></div>
<div data-element-id="elm_R8v3DicXDm0J3kd_-2XXCQ" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div>In a landscape of extreme uncertainty, it is difficult for companies to directly influence political activities or anticipate geopolitical moves.</div><div><br/></div><div>However, strategic alignment between CEOs and CIOs can guide concrete actions to mitigate risks. Business leaders can focus on <span style="background-color:rgb(234, 234, 4);">diversifying markets and investing in EU-based digital solutions that are fully GDPR compliant</span>. This approach not only reduces vulnerability but also strengthens operational resilience.</div><div><br/>If the DPF were annulled in the future — a possibility that remains despite the court’s recent confirmation — there would no longer be a solid legal basis for transatlantic data transfers, leading to service disruptions, operational issues, and potential sanctions. In such a scenario, companies should prepare contingency plans, including:</div></div>
</div><div data-element-id="elm_RG5TRgNTthbU9IigVsLjWw" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><ul><li><span><span style="font-weight:bold;background-color:rgb(4, 234, 119);">Immediate assessment of data flows</span>: identifying and quantifying transfers to the U.S. to prioritize interventions.</span></li><li><span><span style="font-weight:bold;background-color:rgb(4, 234, 119);">Accelerated transition to European providers</span>: speeding up migration to EU-compliant alternatives such as sovereign clouds or hybrid solutions.</span></li><li><span><span style="font-weight:bold;background-color:rgb(4, 234, 119);">Development of data localization strategies</span>: implementing data residency policies to keep both sensitive and non-sensitive data within European borders.</span></li><li><span><span style="font-weight:bold;background-color:rgb(4, 234, 119);">Training and internal governance</span>: aligning IT teams and executives on risk protocols, with scenario-based disruption simulations.</span></li></ul></div>
</div><div data-element-id="elm__lURoIuAIP0uAAKrF6Mu3Q" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div>This alignment between strategic vision (CEO) and technological implementation (CIO) transforms uncertainty into opportunity, promoting a «Europe-first» approach that balances innovation and compliance.</div></div>
</div><div data-element-id="elm_OH5Xd9mwY9OPEpbduuB1-A" data-element-type="heading" class="zpelement zpelem-heading "><style></style><h2
 class="zpheading zpheading-style-none zpheading-align-left zpheading-align-mobile-left zpheading-align-tablet-left " data-editor="true">Conclusion: an opportunity for new European leadership</h2></div>
<div data-element-id="elm_km-fcN-1kx_704obzpdbuw" data-element-type="text" class="zpelement zpelem-text "><style></style><div class="zptext zptext-align-left zptext-align-mobile-left zptext-align-tablet-left " data-editor="true"><div><div><div><div><strong>Geopolitical tensions</strong>, while creating uncertainty, may r<span style="background-color:rgb(244, 244, 78);">epresent a unique opportunity for Europe</span>. Current challenges push <strong>companies to</strong><strong>rethink their technological dependence and invest in a more autonomous digital ecosystem</strong>.</div><div><br/></div><div>This shift toward greater sovereignty could foster the emergence of European leadership not only in regulation but also in technology. Companies that anticipate this trend by <span style="background-color:rgb(234, 234, 4);">embracing digital sovereignty will not only protect themselves from future instability but also position themselves as key players</span> in a new era, guided by values of autonomy and innovation.</div><div><br/></div><div><span style="font-weight:bold;">Author: Angela Pedàlina</span></div></div></div></div></div>
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</div></div></div></div></div></div> ]]></content:encoded><pubDate>Wed, 05 Nov 2025 07:00:00 +0100</pubDate></item><item><title><![CDATA[The medical devices data protection compliance: EU Regulation 745/2017, GDPR and ISO 27001]]></title><link>https://www.itsmf.ch/blogs/post/the-eu-regulation-745-2017-on-medical-devices</link><description><![CDATA[<img align="left" hspace="5" src="https://www.itsmf.ch/medical-devices-data-protection-compliance-eu-regulation-2017-gdpr-iso-27001-itsmf-switzerland.png"/>Let's check out our approach to the medical devices data protection compliance between EU and Switzerland according to EU Regulation 745/2017, GDPR, FADP and ISO 27001.]]></description><content:encoded><![CDATA[<div class="zpcontent-container blogpost-container "><div data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA" data-element-type="section" class="zpsection "><style type="text/css"> [data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA"].zpsection{ border-radius:1px; } </style><div class="zpcontainer-fluid zpcontainer"><div data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw" data-element-type="row" class="zprow zprow-container zpalign-items- zpjustify-content- " data-equal-column=""><style type="text/css"> [data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw"].zprow{ border-radius:1px; } </style><div data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g" data-element-type="column" class="zpelem-col zpcol-12 zpcol-md-8 zpcol-sm-12 zpalign-self- "><style type="text/css"> [data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g"].zpelem-col{ border-radius:1px; } </style><div data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p><span style="font-style:italic;">Reading time: ~ 2 min.</span><br></p></div>
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</div><div data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">The data protection compliance on medical devices<br></h2></div>
<div data-element-id="elm_MA7yDYFPfnWBQlmFKNXRhQ" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_MA7yDYFPfnWBQlmFKNXRhQ"].zpelem-text { border-radius:1px; margin-block-start:14px; } @media (max-width: 767px) { [data-element-id="elm_MA7yDYFPfnWBQlmFKNXRhQ"].zpelem-text { border-radius:1px; } } @media all and (min-width: 768px) and (max-width:991px){ [data-element-id="elm_MA7yDYFPfnWBQlmFKNXRhQ"].zpelem-text { border-radius:1px; } } </style><div class="zptext zptext-align-left " data-editor="true"><div><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1.5;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span>In our <a href="https://www.itsmf.ch/blogs/post/software-as-a-medical-device-swaamd-and-the-iso-management-systems" title="previous post" rel="">previous post</a> on «<span style="font-weight:bold;">Software as a Medical Device</span>», we took a look in particular at the main related ISO management standards. In this new article, we are going to consider the <span style="background-color:rgb(234, 234, 4);">data protection compliance on medical devices</span>.</span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span><br></span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span>The first regulation that grab our attention is the «<span style="font-weight:bold;">EU Regulation 2017/745</span><span style="font-weight:bold;"> on Medical Devices</span>» of the European Parliament and of the Council, of 5 April 2017 that came into force on 27 May 2017. It is known also as «<span style="font-weight:bold;">MDR</span>».</span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span><br></span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span>The Regulation (EU) 2017/745:</span></span></div></div></div><div style="color:inherit;text-align:left;"><ul><li style="text-align:left;"><span style="color:inherit;"><span><span style="background-color:rgb(4, 234, 119);">amends the Directive 2001/83/EC</span></span></span><span style="color:inherit;"></span><span style="color:inherit;">on the Community code relating to medicinal products for human use</span><span style="color:inherit;">;</span></li><li style="text-align:left;"><span style="color:inherit;background-color:rgb(4, 234, 119);">amends the Regulation (EC) no. 178/2002</span><span style="color:inherit;"></span><span style="color:inherit;">laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety</span><span style="color:inherit;">;</span></li><li style="text-align:left;"><span><span style="background-color:rgb(4, 234, 119);">amends the Regulation (EC) no. 1223/2009</span></span><span style="color:inherit;">on cosmetic products</span><span>;<br></span></li><li style="text-align:left;"><span style="color:inherit;"></span><span style="color:inherit;"><span style="background-color:rgb(4, 234, 119);">repeals the Council Directive 90/385/EEC&nbsp; </span></span><span style="color:inherit;">on the approximation of the laws of the Member States relating to active implantable medical devices;</span></li><li style="text-align:left;"><span style="color:inherit;"></span><span style="color:inherit;"><span style="background-color:rgb(4, 234, 119);">repeals the Council Directive 93/42/EEC</span></span><span style="color:inherit;"><span> concerning medical devices.</span></span></li></ul></div>
<div style="color:inherit;text-align:left;"><span style="color:inherit;"><br></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;">In its Article 110, the regulation on medical devices establishes that the <span style="background-color:rgb(234, 234, 4);">medical devices that process personal data must comply with the applicable EU requirements</span>. So we must take into consideration the General Data Protection Regulation (GDPR).<br></span></div></div>
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</div></div></div></div></div></div></div></div></div><div data-element-id="elm_wzAvgkL-VAqKMkrpmOE2rA" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_wzAvgkL-VAqKMkrpmOE2rA"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">Medical devices and the data protection compliance according to the European GDPR<br></h2></div>
<div data-element-id="elm_ekP4jKQdUJxC3VCyF1FaFw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_ekP4jKQdUJxC3VCyF1FaFw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="line-height:2;"><div style="line-height:2;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><div style="color:inherit;"><span style="font-size:16px;"><span>Medical Devices software that process personal data must therefore comply with <span style="font-weight:bold;">European General Data Protection Regulation (GDPR) 2016/679 requirements</span> and in particular with:<br></span></span></div><span style="font-size:16px;"><span style="color:inherit;"><span><br></span></span></span></div><div style="color:inherit;line-height:2;"><span style="font-size:16px;"><span style="color:inherit;"><span>🔖 <span style="font-weight:bold;">Article 25</span>, on «Data protection by design and by default»;</span></span></span><div style="color:inherit;"><div style="color:inherit;line-height:2;"><span style="font-size:16px;"><span style="color:inherit;"><span><br></span></span></span></div><div style="color:inherit;line-height:2;"><span style="font-size:16px;"><span style="color:inherit;"><span>🔖 <span style="font-weight:bold;">Article 32</span>, on «Security of processing».</span></span></span></div><div style="color:inherit;line-height:2;"><span style="font-size:16px;"><span style="color:inherit;"><span><br></span></span></span></div><div style="color:inherit;line-height:2;"><span style="font-size:16px;"><span style="color:inherit;"><span><span style="font-weight:bold;">Swiss companies</span> aiming to launch Software as a Medical Device (SWas a MD) into the EU market must manage the <span style="background-color:rgb(234, 234, 4);">compliance with the aforementioned GDPR articles as well as with the LPD/DSG,</span> in particular with:</span></span></span></div><div style="color:inherit;line-height:2;"><br></div><div style="color:inherit;line-height:2;"><span style="font-size:16px;"><span style="color:inherit;"><span>📘 </span></span><span style="color:inherit;"><span><span style="font-weight:bold;">Article 7</span>, on «Protection of personal data by design and by default»;</span></span></span></div><div style="color:inherit;line-height:2;"><div style="color:inherit;line-height:2;"><span style="font-size:16px;"><span style="color:inherit;"><span style="font-weight:bold;"><br></span></span></span></div><div style="color:inherit;line-height:2;"><span style="color:inherit;font-size:16px;"><span>📘 <span style="font-weight:bold;">Article 8</span>, on «Security of Data».</span></span></div><div style="color:inherit;line-height:2;"><span style="color:inherit;font-size:16px;"><span><br></span></span></div><div style="color:inherit;line-height:2;"><span style="color:inherit;font-size:16px;"><span>These companies can take advantage of an <span style="font-weight:bold;">integrated compliance model</span> between the two regulations, adopting the most relevant ISO standard.<br></span></span></div><div style="color:inherit;line-height:2;"><span style="color:inherit;"><span style="font-size:14pt;"></span></span></div></div>
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</div></div></div></div><div data-element-id="elm_L-8Ak19AFmgNUielZdXr8g" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_L-8Ak19AFmgNUielZdXr8g"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">The ISO 27001:2022 standard for the medical devices data protection compliance integration between EU and Switzerland<br></h2></div>
<div data-element-id="elm_8Q2q2zyRcF4wA8xrFDXLNw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_8Q2q2zyRcF4wA8xrFDXLNw"].zpelem-text { border-radius:1px; margin-block-start:14px; } </style><div class="zptext zptext-align-left " data-editor="true"><div><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1.5;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><span style="color:inherit;"><span></span></span>The medical data protection compliance integration can be managed with the help of the <span style="font-weight:bold;">ISO/IEC 27001:2022 standard</span> on «information security, cybersecurity and privacy protection – information security management systems – requirements».</div><div style="color:inherit;text-align:left;line-height:2;"><br></div><div style="color:inherit;text-align:left;line-height:2;">To better figure out the «big picture», take a look at our <span style="background-color:rgb(244, 244, 78);">infographic on medical devices data protection compliance integration</span> according to the ISO 27001:2022 standard.<br></div></div>
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<p></p><p></p><p></p></div></div><div data-element-id="elm_GJ3NT9jCQU0ivFXDnpKrvQ" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_GJ3NT9jCQU0ivFXDnpKrvQ"] .zpimage-container figure img { width: 703px ; height: 527.25px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_GJ3NT9jCQU0ivFXDnpKrvQ"] .zpimage-container figure img { width:723px ; height:542.25px ; } } @media (max-width: 767px) { [data-element-id="elm_GJ3NT9jCQU0ivFXDnpKrvQ"] .zpimage-container figure img { width:415px ; height:311.25px ; } } [data-element-id="elm_GJ3NT9jCQU0ivFXDnpKrvQ"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-tablet-align-center zpimage-mobile-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
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                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/regulation-eu-2017-745-on-medical-devices-itsmf-switzerland-blog-infopgraphic.jpg" width="415" height="311.25" loading="lazy" size="fit" data-lightbox="true"/></picture></span><figcaption class="zpimage-caption zpimage-caption-align-center"><span class="zpimage-caption-content">By Andrea Leonardi (VP @ Minerva Group Service, MP @ Alpemi Consulting &amp; itSMF Swizerland board member).</span></figcaption></figure></div>
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</div></div></div></div></div></div> ]]></content:encoded><pubDate>Tue, 02 Jul 2024 10:09:53 +0200</pubDate></item><item><title><![CDATA[The EU Network & Information Security 2 (NIS 2) Directive: a GRC approach with the main related ISO standards]]></title><link>https://www.itsmf.ch/blogs/post/the-eu-network-information-security-2-nis-2-directive-a-grc-approach-with-the-main-related-iso-stand</link><description><![CDATA[<img align="left" hspace="5" src="https://www.itsmf.ch/UE-directive-Network-and-information-security-nis-2-cybersecurity-grc-approach-main-iso-standar.png"/>The Network & Information Security 2 EU Directive set a new high common level of cybersecurity across the Union: let's check out more details about it.]]></description><content:encoded><![CDATA[<div class="zpcontent-container blogpost-container "><div data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA" data-element-type="section" class="zpsection "><style type="text/css"> [data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA"].zpsection{ border-radius:1px; } </style><div class="zpcontainer-fluid zpcontainer"><div data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw" data-element-type="row" class="zprow zprow-container zpalign-items- zpjustify-content- " data-equal-column=""><style type="text/css"> [data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw"].zprow{ border-radius:1px; } </style><div data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g" data-element-type="column" class="zpelem-col zpcol-12 zpcol-md-8 zpcol-sm-12 zpalign-self- "><style type="text/css"> [data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g"].zpelem-col{ border-radius:1px; } </style><div data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p><span style="font-style:italic;">Reading time: ~ 2 min.</span><br></p></div>
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                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/UE-directive-Network-and-information-security-nis-2-cybersecurity-grc-approach-and-main-related.jpg" width="415" height="276.56" loading="lazy" size="fit" alt="direttiva sulla responsabilità da intelligenza artificiale itsmf blog" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">The EU Network &amp; Information Security 2 Directive (NIS 2)<br></h2></div>
<div data-element-id="elm_MA7yDYFPfnWBQlmFKNXRhQ" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_MA7yDYFPfnWBQlmFKNXRhQ"].zpelem-text { border-radius:1px; margin-block-start:14px; } </style><div class="zptext zptext-align-left " data-editor="true"><div><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1.5;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span>Our today post is focused primarily on the <span style="font-weight:bold;">Directive (EU) 2022/2555</span>, the <span style="background-color:rgb(234, 234, 4);">Network and Information Security directive</span> issued by the European Parliament and the European Council, which is knowns also as the «<span style="font-weight:bold;">NIS 2</span>».</span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span><br></span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span>The NIS 2 Directive is focused on measures for a high common level of cybersecurity across the Union, and especially:<br></span></span></div><div style="color:inherit;text-align:left;"><ul><li style="text-align:left;"><span style="color:inherit;"><span><span style="background-color:rgb(4, 234, 119);">amending the Regulation (EU) No. 910/2014</span></span></span><span style="color:inherit;"> on e<span style="font-weight:bold;">lectronic identification and trust services for electronic transactions in the internal market</span> and repealing Directive 1999/93/EC;</span></li><li style="text-align:left;"><span style="color:inherit;background-color:rgb(4, 234, 119);">amending the </span><span style="color:inherit;"><span style="background-color:rgb(4, 234, 119);">Directive (EU) 2018/1972</span> of the European Parliament and of the Council of 11 December 2018 establishing the <span style="font-weight:bold;">European Electronic Communications Code (Recast)Text with EEA relevance</span>;</span></li><li style="text-align:left;"><span style="color:inherit;"><span style="background-color:rgb(4, 234, 119);">repealing the Directive (EU) 2016/1148</span></span><span style="color:inherit;"><span> of the European Parliament and of the Council of 6 July 2016 concerning measures for a <span style="font-weight:bold;">high common level of security of network and information systems across the Union</span>.</span></span></li></ul></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><br></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"></span><span style="color:inherit;"><span>We remember that this <span style="font-weight:bold;">NIS 2 Direct</span> (date 14 December 2022) <span style="font-weight:bold;">entered into force on 13th January 2023</span> and its <span style="background-color:rgb(234, 234, 4);">implementation in national regulation</span> must be done on <span style="background-color:rgb(234, 234, 4);">17th October 2024 at the latest.</span></span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span><br></span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span>As an European Directive, it lays down the results or goals that each Member State must achieve, however it is up to the single country to devise their own laws on how to reach these results or goals.</span></span></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
</div></div></div><p><span></span></p></div></div></div></div><span style="font-size:18px;"><span style="color:inherit;"><span style="font-size:11pt;"></span></span></span></div>
</div></div><div data-element-id="elm_wzAvgkL-VAqKMkrpmOE2rA" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_wzAvgkL-VAqKMkrpmOE2rA"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">Where does the EU Network &amp; Information Security 2 Directive (NIS 2) apply? <br></h2></div>
<div data-element-id="elm_ekP4jKQdUJxC3VCyF1FaFw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_ekP4jKQdUJxC3VCyF1FaFw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="line-height:2;"><div style="line-height:2;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><div style="color:inherit;"><span style="font-size:16px;">The <span style="font-weight:bold;">NIS2</span> applies to <span style="background-color:rgb(244, 244, 78);">all the sectores that the law defines «critical»</span>, such as:</span></div><div style="color:inherit;"><span style="font-size:16px;"><span style="color:inherit;"><span>📘 </span></span><span style="color:inherit;"><span>energy;</span></span></span></div><div style="color:inherit;"><span style="font-size:16px;"><span style="color:inherit;"><span>📘 </span></span><span style="color:inherit;"><span>public services;</span></span></span></div><div style="color:inherit;"><span style="font-size:16px;"><span style="color:inherit;"><span>📘 </span></span><span style="color:inherit;"><span>financial services;</span></span></span></div><div style="color:inherit;"><span style="font-size:16px;"><span style="color:inherit;"><span>📘 </span></span><span style="color:inherit;"><span>health services;</span></span></span></div><div style="color:inherit;"><span style="font-size:16px;"><span style="color:inherit;"><span>📘 </span></span><span style="color:inherit;"><span>telecommunications;</span></span></span></div><div style="color:inherit;"><span style="font-size:16px;"><span style="color:inherit;"><span>📘 </span></span><span style="color:inherit;"><span>space;</span></span></span></div><div style="color:inherit;"><span style="font-size:16px;"><span style="color:inherit;"><span>📘 </span></span><span style="color:inherit;"><span>public administration;</span></span></span></div><div style="color:inherit;"><div style="color:inherit;line-height:2;"><span style="color:inherit;font-size:16px;"><span>📘 </span></span><span style="color:inherit;"><span><span style="font-size:16px;">ect.</span><br></span></span></div></div></div></div></div></div></div><div style="color:inherit;"><p style="text-align:left;"><span style="font-size:16px;"></span></p><p style="text-align:left;"></p></div>
</div></div></div></div><div data-element-id="elm_L-8Ak19AFmgNUielZdXr8g" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_L-8Ak19AFmgNUielZdXr8g"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">The EU Network &amp; Information Security 2 Directive (NIS 2) structure<br></h2></div>
<div data-element-id="elm_8Q2q2zyRcF4wA8xrFDXLNw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_8Q2q2zyRcF4wA8xrFDXLNw"].zpelem-text { border-radius:1px; margin-block-start:14px; } </style><div class="zptext zptext-align-left " data-editor="true"><div><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1.5;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><span style="color:inherit;"><span></span></span>The Directive (EU) 2022/2555 on Network &amp; Information Security (NIS 2) is <span style="font-weight:bold;">divided in the following chapters</span>:</div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
</div></div></div><p style="text-align:left;"></p><p><span></span><span></span></p><div><div style="line-height:2;"></div>
</div></div></div></div></div><span style="font-size:18px;"><span style="color:inherit;"><span style="font-size:11pt;"><span style="color:inherit;"><span style="font-size:11pt;"></span></span></span></span></span></div>
<p></p><p></p><p></p></div></div><div data-element-id="elm_NqnJEmqoWtwd205HKISa9w" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_NqnJEmqoWtwd205HKISa9w"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="line-height:2;"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><span style="font-size:16px;"><span style="color:inherit;">🔖</span><span></span><span style="color:inherit;"><span>Whereas (144)</span></span></span></div></div><div style="color:inherit;"><div style="color:inherit;line-height:2;"><span style="font-size:16px;"><span style="color:inherit;"></span><span style="color:inherit;">🔖 </span><span style="color:inherit;"><span>Chapter I: general provisions</span></span></span></div></div><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><span style="font-size:16px;"><span></span><span style="color:inherit;"></span><span style="color:inherit;">🔖</span><span></span><span style="color:inherit;"><span>Chapter II: coordinated cybersecurity frameworks</span></span></span><p style="text-align:left;line-height:2;"><span style="color:inherit;"></span><span style="color:inherit;">🔖</span><span style="color:inherit;"><span>Chapter III: cooperation at union and international level</span></span></p><span style="font-size:16px;"><p style="text-align:left;"></p></span><p style="text-align:left;line-height:2;"><span style="color:inherit;"></span><span style="color:inherit;">🔖</span><span></span><span style="color:inherit;"><span>Chapter IV: cybersecurity risk-management measures and reporting obligations</span></span></p><span style="font-size:16px;"><p style="text-align:left;"></p></span><p style="text-align:left;line-height:2;"><span style="color:inherit;"></span><span style="color:inherit;">🔖</span><span></span><span style="color:inherit;"><span>Chapter V: jurisdiction and registration</span></span></p><p style="text-align:left;"></p><span style="font-size:16px;"><p style="text-align:left;"></p></span><p style="text-align:left;line-height:2;"><span style="color:inherit;"><span>🔖</span></span><span style="color:inherit;"><span>Chapter VI: information sharing</span></span></p><span style="font-size:16px;"><p style="text-align:left;"></p></span><p style="text-align:left;line-height:2;"><span style="color:inherit;"><span>🔖</span></span><span style="color:inherit;"><span>Chapter VII: supervision and enforcement</span></span></p><span style="font-size:16px;"><p style="text-align:left;"></p></span><p style="text-align:left;line-height:2;"><span style="color:inherit;"><span>🔖</span></span><span style="color:inherit;"><span>Chapter VIII<span>: </span>delegated and implementing acts</span></span></p><span style="font-size:16px;"><p style="text-align:left;"></p><div style="color:inherit;"><div><div><div style="line-height:2;"><span>🔖</span><span style="color:inherit;"><span>Annex I: sectors of high criticality </span></span><br><span style="color:inherit;"><span>🔖</span></span><span style="color:inherit;"><span>Annex II: other critical sectors</span></span></div></div></div></div></span><p style="text-align:left;"></p><p style="text-align:left;"><span style="color:inherit;"></span><span style="color:inherit;"><br></span></p><p style="text-align:left;line-height:2;"><span style="font-size:12pt;">How can we manage the compliance with all the <span style="font-weight:bold;">requirements</span> set by <span style="font-weight:bold;">NIS 2</span>? Our solution is <span style="background-color:rgb(234, 234, 4);">a GRC Approach</span>: let's take a closer look in the chapter below.<br></span></p></div></div></div></div></div></div>
</div><div data-element-id="elm_JjD8tlosrYxfDmn2ItzCcA" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_JjD8tlosrYxfDmn2ItzCcA"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">How to apply the NIS 2 EU Directive?<br></h2></div>
<div data-element-id="elm_KiIuPQ4kfJBwqS4N9F3DIA" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_KiIuPQ4kfJBwqS4N9F3DIA"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div><div><div style="line-height:2;"><p style="text-align:left;line-height:2;"><span style="font-size:12pt;">We can choose a <span style="font-weight:bold;">GRC approach</span> to apply the Directive (EU) 2022/2555 that can be based on the main <span style="font-weight:bold;">ISO standards</span> in relationship with the law.</span></p><p style="text-align:left;"></p><p style="text-align:left;"><span style="font-size:12pt;">Lets check them out:</span></p></div></div></div>
</div></div><div data-element-id="elm_twpyx-3F0wbqCO7RQ90xAA" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_twpyx-3F0wbqCO7RQ90xAA"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="line-height:2;"><div style="line-height:2;"><div style="color:inherit;"><div style="color:inherit;"><p style="text-align:left;"><span style="font-size:16px;">✅ <span style="font-weight:bold;">ISO 20000-1</span> on IT services;<br></span></p><p style="text-align:left;"><span style="font-size:16px;">✅ <span style="font-weight:bold;">ISO 27001</span> on Information Security; on Risk Management;<br></span></p><p style="text-align:left;"><span style="font-size:16px;">✅ <span style="font-weight:bold;">ISO 22301</span> on Business Continuity;</span></p><p style="text-align:left;"><span style="color:inherit;"><span style="font-size:16px;">✅ <span style="font-weight:bold;">ISO 31000</span> on Risk Management;</span></span></p><p style="text-align:left;"><span style="color:inherit;"><span style="font-size:16px;">✅ <span style="font-weight:bold;">ISO 27035</span> on Incident Management.</span></span><span style="font-size:16px;"><br></span></p></div></div><div style="color:inherit;"><p style="text-align:left;"><span style="font-size:16px;"></span></p><p style="text-align:left;"></p></div>
</div></div></div></div><div data-element-id="elm_8FQI4Cjro0v8pKUlqtyp6g" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_8FQI4Cjro0v8pKUlqtyp6g"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">Our infographic on the NIS2 Directive application with our GRC approach (and the main ISO standards)<br></h2></div>
<div data-element-id="elm_YL0X5frm4hbkkpkeEY5h1w" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_YL0X5frm4hbkkpkeEY5h1w"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true">To better figure out&nbsp; the «<span style="font-weight:bold;">big picture</span>», take a look at our infographic:<br></div>
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                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/UE-directive-Network-and-information-security-nis-2-cybersecurity-main-related-standards.jpg" width="415" height="311.25" loading="lazy" size="fit" data-lightbox="true"/></picture></span><figcaption class="zpimage-caption zpimage-caption-align-center"><span class="zpimage-caption-content">By Andrea Leonardi (VP @ Minerva Group Service, MP @ Alpemi Consulting &amp; itSMF Swizerland board member).</span></figcaption></figure></div>
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</div></div></div></div></div></div> ]]></content:encoded><pubDate>Wed, 22 May 2024 18:08:00 +0200</pubDate></item><item><title><![CDATA[The EU Regulation on Digital Operational Resilience Act (DORA): GRC approach and main related standards]]></title><link>https://www.itsmf.ch/blogs/post/eu-digital-operational-resilience-act-grc-approach-related-standards</link><description><![CDATA[<img align="left" hspace="5" src="https://www.itsmf.ch/eu-regulation-digital-operational-resilience-act-grc-approach-iso-standards.png"/>The Digital Operational Resilience ACT (EU Regulation 2022/2554) entered into force con January 2023: let's check out all its novelties.]]></description><content:encoded><![CDATA[<div class="zpcontent-container blogpost-container "><div data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA" data-element-type="section" class="zpsection "><style type="text/css"> [data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA"].zpsection{ border-radius:1px; } </style><div class="zpcontainer-fluid zpcontainer"><div data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw" data-element-type="row" class="zprow zprow-container zpalign-items- zpjustify-content- " data-equal-column=""><style type="text/css"> [data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw"].zprow{ border-radius:1px; } </style><div data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g" data-element-type="column" class="zpelem-col zpcol-12 zpcol-md-8 zpcol-sm-12 zpalign-self- "><style type="text/css"> [data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g"].zpelem-col{ border-radius:1px; } </style><div data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p><span style="font-style:italic;">Reading time: ~ 2 min.</span><br></p></div>
</div><div data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width: 703px ; height: 527.25px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width:723px ; height:542.25px ; } } @media (max-width: 767px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width:415px ; height:311.25px ; } } [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/european-regulation-digital-operational-resilience-act-and-iso-standards-grc-implementation.jpg" width="415" height="311.25" loading="lazy" size="fit" alt="direttiva sulla responsabilità da intelligenza artificiale itsmf blog" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">The EU Digital Operational Resilience Act (DORA)<br></h2></div>
<div data-element-id="elm_MA7yDYFPfnWBQlmFKNXRhQ" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_MA7yDYFPfnWBQlmFKNXRhQ"].zpelem-text { border-radius:1px; margin-block-start:14px; } </style><div class="zptext zptext-align-left " data-editor="true"><div><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1.5;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span>In our post, we're going to take a closer look to the <span style="font-weight:bold;">EU Regulation 2022/2554</span>, the <span style="background-color:rgb(244, 244, 78);">Digital Operational Resilience Act for the financial sector</span> issued by the European Parliament and the European Council (known as well as «<span style="font-weight:bold;">DORA</span>»).</span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span><br></span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span>First of all, we should remember that the EU Regulation (date 14 December 2022) entered into force on 16 January 2023 and it applies to the <span style="font-weight:bold;">EU financial service providers</span>.</span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span><br></span></span></div><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span>We have to know that the Digital Operational Resilience Act amended also these <span style="font-weight:bold;">regulations</span>:<br></span></span></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
</div></div></div><p style="text-align:left;"></p><p><span></span><span></span></p><div><div style="line-height:2;"></div>
</div></div></div></div></div><span style="font-size:18px;"><span style="color:inherit;"><span style="font-size:11pt;"><span style="color:inherit;"><span style="font-size:11pt;"></span></span></span></span></span></div>
<p></p><p></p><p></p></div></div><div data-element-id="elm_gFfImNwrCZ7pL_iXTej8HA" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_gFfImNwrCZ7pL_iXTej8HA"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="line-height:2;"><div style="line-height:2;"><div style="color:inherit;"><div style="color:inherit;"><p style="text-align:justify;"><span style="color:inherit;font-size:16px;"><span>📘 Regulation (EC) No. 1060/2009;<br></span></span></p><p style="text-align:justify;"><span style="color:inherit;font-size:16px;"><span>📘 Regulation (EU) No. 648/2012;<br></span></span></p><p style="text-align:justify;"><span style="color:inherit;font-size:16px;"><span>📘 Regulation (EU) No. 600/2014;<br></span></span></p><p style="text-align:justify;"><span style="color:inherit;font-size:16px;"><span>📘 Regulation (EU) No. 909/2014;<br></span></span></p><p style="text-align:justify;"><span style="color:inherit;"><span style="font-size:12pt;"><span style="font-size:16px;">📘 Regulation (EU) No. 2016/1011.</span><br></span></span></p></div></div><div style="color:inherit;"><br></div><div style="color:inherit;">Let's check out in the next lines which <span style="font-weight:bold;">requirements</span> have been set by the lawmakers on the new «<span style="font-weight:bold;">DORA</span>».<br></div><div style="color:inherit;"><p style="text-align:left;"><span style="font-size:16px;"></span></p><p style="text-align:left;"></p></div>
</div></div></div></div><div data-element-id="elm_L-8Ak19AFmgNUielZdXr8g" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_L-8Ak19AFmgNUielZdXr8g"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">The Digital Operational Resilience Act: the main requirements<br></h2></div>
<div data-element-id="elm_8Q2q2zyRcF4wA8xrFDXLNw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_8Q2q2zyRcF4wA8xrFDXLNw"].zpelem-text { border-radius:1px; margin-block-start:14px; } </style><div class="zptext zptext-align-left " data-editor="true"><div><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1.5;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:1;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><div style="color:inherit;text-align:left;line-height:2;"><div style="color:inherit;text-align:left;"><span style="color:inherit;"><span></span></span>The EU Regulation 2022/2554 defines in particular a <span style="font-weight:bold;">set of requirements</span> which are meant to <span style="background-color:rgb(4, 234, 119);">ensure digital resilience and security</span>.</div><div style="color:inherit;text-align:left;"><br></div><div style="color:inherit;text-align:left;">The <span style="font-weight:bold;">main parts</span> of the Digital Operational Resilience Act on these matters are in the following chapters:<br></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
</div></div></div><p style="text-align:left;"></p><p><span></span><span></span></p><div><div style="line-height:2;"></div>
</div></div></div></div></div><span style="font-size:18px;"><span style="color:inherit;"><span style="font-size:11pt;"><span style="color:inherit;"><span style="font-size:11pt;"></span></span></span></span></span></div>
<p></p><p></p><p></p></div></div><div data-element-id="elm_NqnJEmqoWtwd205HKISa9w" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_NqnJEmqoWtwd205HKISa9w"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><span style="color:inherit;">🔖</span><span style="font-size:12pt;"> 1. General Provisions<br></span></div><div style="color:inherit;"><span style="color:inherit;"></span><span style="color:inherit;">🔖 2. ICT Risk Management<br></span></div><div style="color:inherit;"><span style="font-size:12pt;"></span><span style="color:inherit;"></span><span style="color:inherit;">🔖</span><span style="font-size:12pt;"> 3. ICT Related Incident Management Process </span><br><p style="text-align:left;"><span style="color:inherit;"></span><span style="color:inherit;">🔖</span><span style="font-size:12pt;"> 4. Digital Operational Resilience test</span></p><p style="text-align:left;"><span style="color:inherit;"></span><span style="color:inherit;">🔖</span><span style="font-size:12pt;"> 5. Managing of ICT Third Party Risk<br></span></p><p style="text-align:left;"><span style="color:inherit;"></span><span style="color:inherit;">🔖</span><span style="font-size:12pt;"> 6. Information Sharing Arrangement<br></span></p><p style="text-align:left;"><span style="color:inherit;"></span><span style="color:inherit;"><br></span></p><p style="text-align:left;"><span style="font-size:12pt;">How can we manage the compliance with all the <span style="font-weight:bold;">requirements</span> set by <span style="font-weight:bold;">DORA</span>? Our solution is <span style="background-color:rgb(234, 234, 4);">a GRC Approach</span>: let's take a closer look in the chapter below.<br></span></p></div><p></p></div>
</div><div data-element-id="elm_JjD8tlosrYxfDmn2ItzCcA" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_JjD8tlosrYxfDmn2ItzCcA"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">How to manage the compliance with DORA requirements?<br></h2></div>
<div data-element-id="elm_KiIuPQ4kfJBwqS4N9F3DIA" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_KiIuPQ4kfJBwqS4N9F3DIA"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="line-height:2;"><p style="text-align:left;"><span style="font-size:12pt;">We can support the management – in an integrated way – of the <span style="font-weight:bold;">requirements set by the Digital Operational Resilience Act </span>with the GRC approach based in particular on these ISO standards:<br></span></p><p style="text-align:left;"></p></div>
</div></div><div data-element-id="elm_twpyx-3F0wbqCO7RQ90xAA" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_twpyx-3F0wbqCO7RQ90xAA"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="line-height:2;"><div style="line-height:2;"><div style="color:inherit;"><div style="color:inherit;"><p style="text-align:left;"><span style="font-size:16px;">✅ ISO 38500 on Governance;<br></span></p><p style="text-align:left;"><span style="font-size:16px;">✅ ISO 31000 on Risk Management;<br></span></p><p style="text-align:left;"><span style="font-size:16px;">✅ ISO 37301 on Compliance Management.<br></span></p></div></div><div style="color:inherit;"><p style="text-align:left;"><span style="font-size:16px;"></span></p><p style="text-align:left;"></p></div>
</div></div></div></div><div data-element-id="elm_PKgONOGVRJ08pUscsa_x1g" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_PKgONOGVRJ08pUscsa_x1g"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><p style="text-align:left;"><span style="font-size:16px;"><span style="font-size:16px;">This GRC approach provides a useful basis for addressing and integrating too the main aspects of these reference standards:</span><br></span></p><p style="text-align:left;"></p><span style="font-size:16px;"></span></div><p></p></div>
</div><div data-element-id="elm_iBVJP7GkYBO5hKRdzKQ6Qg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_iBVJP7GkYBO5hKRdzKQ6Qg"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><p style="text-align:left;"><span style="color:inherit;"><span style="font-size:12pt;">📘 </span></span><span style="font-size:12pt;">Resilience and Business Continuity (<span style="font-weight:bold;">ISO 22301</span>);<br></span></p><p style="text-align:left;"><span style="color:inherit;"><span style="font-size:12pt;">📘 Information Security (<span style="font-weight:bold;">ISO 27001</span>);</span></span></p><p style="text-align:left;"><span style="color:inherit;"><span style="font-size:12pt;">📘 ICT Services (<span style="font-weight:bold;">ISO 20000-1</span>).</span></span></p></div><p></p></div>
</div><div data-element-id="elm_8FQI4Cjro0v8pKUlqtyp6g" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_8FQI4Cjro0v8pKUlqtyp6g"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">Our infographic on DORA requirements and the related ISO standards<br></h2></div>
<div data-element-id="elm_YL0X5frm4hbkkpkeEY5h1w" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_YL0X5frm4hbkkpkeEY5h1w"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true">To better figure out&nbsp; the «<span style="font-weight:bold;">big picture</span>», take a look at our infographic:<br></div>
</div><div data-element-id="elm_GJ3NT9jCQU0ivFXDnpKrvQ" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_GJ3NT9jCQU0ivFXDnpKrvQ"] .zpimage-container figure img { width: 703px ; height: 527.25px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_GJ3NT9jCQU0ivFXDnpKrvQ"] .zpimage-container figure img { width:723px ; height:542.25px ; } } @media (max-width: 767px) { [data-element-id="elm_GJ3NT9jCQU0ivFXDnpKrvQ"] .zpimage-container figure img { width:415px ; height:311.25px ; } } [data-element-id="elm_GJ3NT9jCQU0ivFXDnpKrvQ"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/DORA-requirements-grc-approach-iso-standards.jpg" width="415" height="311.25" loading="lazy" size="fit" data-lightbox="true"/></picture></span><figcaption class="zpimage-caption zpimage-caption-align-center"><span class="zpimage-caption-content">By Andrea Leonardi (VP @ Minerva Group Service, MP @ Alpemi Consulting &amp; itSMF Swizerland board member).</span></figcaption></figure></div>
</div><div data-element-id="elm_hHpQNoDx88mvUsX2WAKThg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_hHpQNoDx88mvUsX2WAKThg"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;line-height:1.5;"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><div style="color:inherit;line-height:2;"><div style="color:inherit;line-height:2;"><div style="color:inherit;line-height:2;"><div><span style="font-size:16px;"><span><span></span></span></span><span style="font-size:16px;"><span>If you want to keep you up-to-date with the most recent news on this topic, don't forget to follow our social media or subscribe on our newsletter.<br></span></span></div>
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</div></div></div></div></div></div> ]]></content:encoded><pubDate>Wed, 24 Apr 2024 07:00:00 +0200</pubDate></item><item><title><![CDATA[La direttiva sulla responsabilità da intelligenza artificiale]]></title><link>https://www.itsmf.ch/blogs/post/direttiva-sulla-responsabilità-da-intelligenza-artificiale</link><description><![CDATA[<img align="left" hspace="5" src="https://www.itsmf.ch/la-direttiva-sulla-responsabilità-da-intelligenza-artificiale-ue-itsmf-blog-anna-capoluongo.jpg"/>La proposta di direttiva sulla responsabilità da intelligenza artificiale della Commissione Europea mira ad adeguare le norme di responsabilità civile extracontrattuale ai sistemi AI.]]></description><content:encoded><![CDATA[<div class="zpcontent-container blogpost-container "><div data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA" data-element-type="section" class="zpsection "><style type="text/css"></style><div class="zpcontainer-fluid zpcontainer"><div data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw" data-element-type="row" class="zprow zprow-container zpalign-items- zpjustify-content- " data-equal-column=""><style type="text/css"> [data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw"].zprow{ border-radius:1px; } </style><div data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g" data-element-type="column" class="zpelem-col zpcol-12 zpcol-md-8 zpcol-sm-12 zpalign-self- "><style type="text/css"> [data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g"].zpelem-col{ border-radius:1px; } </style><div data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p><span style="font-style:italic;">Tempo di lettura: ~ 5 min.</span><br></p></div>
</div><div data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width: 703px ; height: 468.99px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width:723px ; height:482.33px ; } } @media (max-width: 767px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width:415px ; height:276.86px ; } } [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/la-direttiva-sulla-responsabilit%C3%A0-da-intelligenza-artificiale-ue-itsmf-blog-1.jpg" width="415" height="276.86" loading="lazy" size="fit" alt="direttiva sulla responsabilità da intelligenza artificiale itsmf blog" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true"><span style="color:inherit;">La proposta di direttiva sulla responsabilità da intelligenza artificiale della Commissione Europea<br></span></h2></div>
<div data-element-id="elm_8ISiIdzAT0Dstu_ezLc5gg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_8ISiIdzAT0Dstu_ezLc5gg"].zpelem-text { border-radius:1px; margin-block-start:33px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="line-height:1.2;"><div><div><div style="line-height:2;"><div style="line-height:2;"><div style="line-height:2;"><div style="line-height:2;"><div style="line-height:2;"><span style="font-size:14px;"><span style="color:inherit;"><span>A Settembre 2022 la <span style="font-weight:bold;">Commissione Europea</span> ha pubblicato una proposta di <span style="background-color:rgb(4, 234, 119);">Direttiva</span> per adeguare le norme di <span style="font-weight:bold;">responsabilità civile&nbsp;extracontrattuale</span> ai sistemi di <span style="background-color:rgb(4, 234, 119);">intelligenza artificiale</span> (cd. </span></span>«<span style="color:inherit;">Artificial intelligence liability Directive</span>» <span style="color:inherit;"><span><span style="background-color:rgb(234, 119, 4);"><span style="font-weight:bold;">1</span></span>),</span></span><span style="color:inherit;"><span> nel tentativo di integrare e modernizzare il&nbsp;quadro normativo dell'UE in tali ambiti, introducendo anche nuove norme specifiche per i danni causati da sistemi di&nbsp;AI.</span></span></span></div></div></div></div></div></div></div></div></div>
</div><div data-element-id="elm_fe_IZx1FA1gyqbnqSgcCCg" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_fe_IZx1FA1gyqbnqSgcCCg"].zpelem-heading { border-radius:1px; margin-block-start:11px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true"><div style="color:inherit;"><h2></h2><h2><span>Alcuni dettagli in più sulla </span>«<span>com (2022) 496</span>»</h2></div></h2></div>
<div data-element-id="elm_MA7yDYFPfnWBQlmFKNXRhQ" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_MA7yDYFPfnWBQlmFKNXRhQ"].zpelem-text { border-radius:1px; margin-block-start:14px; } </style><div class="zptext zptext-align-left " data-editor="true"><div><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><p style="text-align:left;"><span style="font-size:14px;"><span>In tal senso, gli <i>users </i><span style="background-color:rgb(4, 234, 119);">danneggiati da sistemi di intelligenza artificiale</span> potrebbero godere dello&nbsp;stesso livello di protezione di quelli danneggiati da altre tecnologie, alleggerendo, al contempo, l'onere della prova che nel campo dei sistemi intelligenti risulta particolarmente complesso, anche a causa del cd. effetto </span>«<span style="font-weight:bold;">black box</span>»<span>. <br></span></span></p><p style="text-align:left;"><span style="font-size:14px;"><br></span></p><p style="text-align:left;"><span style="font-size:14px;">Quest’ultimo incide proprio sulla <span style="background-color:rgb(234, 234, 4);">trasparenza e sulla spiegabilità dell’algoritmo</span>, ossia sulla comprensibilità di <span style="font-weight:bold;">input, output e del funzionamento</span> vero e proprio dell’AI.</span></p><p style="text-align:left;"><span style="font-size:14px;"><br></span></p><p style="text-align:left;"><span style="font-size:10.5pt;"><span style="font-size:14px;">In questo senso, il problema è che l’<span style="font-weight:bold;">intelligenza artificiale</span> è capace<i></i></span></span>«<span style="font-size:10.5pt;"><span style="font-size:14px;"><i>di</i></span></span><span style="font-size:10.5pt;"><span style="font-size:14px;"><i><span style="background-color:rgb(4, 234, 119);">produrre dei risultati</span>, ma il processo attraverso cui produce questi risultati, la <span style="font-weight:bold;">ragione</span> per cui l’algoritmo compie specifiche decisioni, <span style="background-color:rgb(234, 234, 4);">non sono totalmente comprensibili e spiegabili dal punto di vista dell’utente finale</span>. È evidente che la trasparenza è particolarmente importante per assicurare la correttezza nell’uso degli algoritmi e per identificare possibili distorsioni</i></span></span>»<span style="font-size:10.5pt;"><span style="font-size:14px;"><span><span style="font-weight:bold;background-color:rgb(234, 119, 4);">2</span></span>.</span><br></span></p><p style="text-align:left;"></p><p><span></span><span></span></p><div><div style="line-height:2;"></div></div></div></div></div></div><span style="font-size:18px;"><span style="color:inherit;"><span style="font-size:11pt;"><span style="color:inherit;"><span style="font-size:11pt;"></span></span></span></span></span></div><p></p><p></p><p></p></div>
</div><div data-element-id="elm_kkQQUZ_1vZEA229hNcY2yA" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_kkQQUZ_1vZEA229hNcY2yA"].zpelem-text { background-color:rgba(234,119,4,0.18); background-image:unset; border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><div style="text-align:left;"><div style="text-align:left;"><div style="text-align:left;"><p><span style="font-size:12px;"><span style="background-color:rgb(234, 119, 4);">1</span> Si veda <a href="https://commission.europa.eu/business-economy-euro/doing-business-eu/contract-rules/digital-contracts/liability-rules-artificial-intelligence_en"><span>https://commission.europa.eu/business-economy-euro/doing-business-eu/contract-rules/digital-contracts/liability-rules-artificial-intelligence_en</span></a><br></span></p><p><span style="font-size:12px;"><span><span style="background-color:rgb(234, 119, 4);">2</span></span><a href="https://www.europarl.europa.eu/RegData/etudes/STUD/2020/654179/EPRS_STU%282020%29654179_EN.pdf"><span>https://www.europarl.europa.eu/RegData/etudes/STUD/2020/654179/EPRS_STU(2020)654179_EN.pdf</span></a>. </span></p></div></div></div></div><p></p></div>
</div><div data-element-id="elm_whpLkLjj3x11HYk804sMEA" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_whpLkLjj3x11HYk804sMEA"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true"><div style="color:inherit;"><h2></h2><h2>L<span>a direttiva sui prodotti difettosi e la proposta AiLD<br></span></h2></div></h2></div>
<div data-element-id="elm_hHpQNoDx88mvUsX2WAKThg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_hHpQNoDx88mvUsX2WAKThg"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><p style="text-align:left;"><span style="font-size:14px;"><span>Ad oggi, per chiarezza, il quadro normativo applicabile in materia di responsabilità </span><span style="color:inherit;"><span>–</span></span><span> su territorio europeo </span><span style="color:inherit;"><span>–</span></span><span> è costituito dalla <span style="font-weight:bold;">Direttiva 85/374/CEE</span> (cd. </span>«<span>Direttiva PLD</span>»<span>, Product Liability Directive), per i danni da&nbsp;prodotti difettosi, oltre che dalle norme nazionali applicabili nei singoli Stati membri.</span></span></p><p style="text-align:left;"><span style="font-size:14px;"><br></span></p><p style="text-align:left;"><span style="font-size:14px;">Da un lato, dunque, le<span style="font-weight:bold;"> norme nazionali</span> in materia di responsabilità offrono <span style="background-color:rgb(234, 234, 4);">diverse possibilità di risarcimento per responsabilità per colpa o responsabilità oggettiva</span> (indipendente dalla colpa).</span></p><p style="text-align:left;"><span style="font-size:14px;"><br></span></p><p style="text-align:left;"><span style="font-size:14px;">Nel primo caso, sarà richiesta la dimostrazione dell'esistenza di un danno, di una colpa del responsabile e di un nesso di&nbsp;causalità tra colpa e danno, mentre nel perimetro della <span style="font-weight:bold;">responsabilità oggettiva</span> il <i>focus</i> verterà sulla <span style="background-color:rgb(4, 234, 119);">concretizzazione del rischio&nbsp;derivante/generato dal responsabile</span>, di volta in volta individuato dalla legge.</span></p><p style="text-align:left;"><span style="font-size:14px;"><br></span></p><p style="text-align:left;"><span style="font-size:14px;">Dall’altro si pone la <span style="font-weight:bold;">direttiva PLD</span>, che ha come obiettivo quello di <span style="background-color:rgb(4, 234, 119);">armonizzare a livello europeo i regimi di responsabilità oggettiva</span> per le richieste di risarcimento dei danni causati al&nbsp;consumatore a causa della difettosità di una vasta gamma di prodotti (dalle materie prime ai dispositivi&nbsp;di intelligenza artificiale), stabilendo regole comuni in base alle quali il produttore (e in alcuni casi il fornitore/venditore) potrà essere ritenuto&nbsp;responsabile dei danni causati da un difetto del proprio prodotto, a condizione che la parte lesa dimostri il danno, il difetto e il nesso causale.</span></p><p style="text-align:left;"><span style="font-size:14px;"><br></span></p><p style="text-align:left;"><span style="font-size:14px;">In base alla PLD, potrà essere richiesto un risarcimento per danni alla persona o ai beni di consumo derivanti da un prodotto difettoso&nbsp;fino a 10 anni dopo la messa in circolazione del prodotto stesso.</span></p></div></div></div><p></p></div>
</div><div data-element-id="elm_F_Ia0uCU2hcmvx-yXG0f2Q" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_F_Ia0uCU2hcmvx-yXG0f2Q"].zpelem-heading { border-radius:1px; } </style><h3
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">L'approccio della proposta della direttiva sulla responsabilità da IA<br></h3></div>
<div data-element-id="elm_IA_F9jKvlMYIWYBdIbMefQ" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_IA_F9jKvlMYIWYBdIbMefQ"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><p style="text-align:left;"><span style="font-size:10.5pt;">Diverso, invece, l’approccio della proposta di Direttiva sulla responsabilità per l'IA (di seguito per comodità anche “<span style="font-weight:bold;">AiLD</span>”), che mira ad <span style="background-color:rgb(4, 234, 119);">armonizzare le norme sulla responsabilità civile extracontrattuale per i danni&nbsp;causati da sistemi intelligenti (IA)</span>.</span></p><p style="text-align:left;"><span style="font-size:10.5pt;"><br></span></p><p style="text-align:left;"><span style="font-size:10.5pt;">L’<span style="background-color:rgb(234, 234, 4);">articolo 1</span>, infatti, recita così:</span></p><p style="text-align:left;">«<span style="font-size:10.5pt;"><i>1. <b>La presente direttiva stabilisce norme comuni su:</b></i></span></p><p style="text-align:left;"><b><i><span style="font-size:10.5pt;">(a) la divulgazione di prove relative a sistemi di intelligenza artificiale (IA) ad alto rischio per consentire a un attore di fondare una richiesta di risarcimento danni di diritto civile per colpa extracontrattuale;</span></i></b></p><p style="text-align:left;"><b><i><span style="font-size:10.5pt;">b) l'onere della prova in caso di azioni civili extracontrattuali fondate su colpa intentate dinanzi ai giudici nazionali per danni causati da un sistema di IA</span></i></b><i><span style="font-size:10.5pt;">.</span></i></p><p style="text-align:left;"><i><span style="font-size:10.5pt;"><br></span></i></p><p style="text-align:left;"><i><span style="font-size:10.5pt;">2. <b>La presente direttiva si applica alle azioni di diritto civile extracontrattuale per risarcimento danni</b>, nei casi in cui il danno causato da un sistema di IA si verifichi dopo [la fine del periodo di recepimento].</span></i></p><p style="text-align:left;"><i><span style="font-size:10.5pt;">L<span style="background-color:rgb(4, 234, 119);">a presente direttiva non si applica alla responsabilità penale</span>.</span></i></p><p style="text-align:left;"><i><span style="font-size:10.5pt;"><br></span></i></p><p style="text-align:left;"><i><span style="font-size:10.5pt;">3. La presente direttiva non pregiudica:</span></i></p><p style="text-align:left;"><i><span style="font-size:10.5pt;">a) le norme del diritto dell'Unione che disciplinano le condizioni di responsabilità nel settore dei trasporti;</span></i></p><p style="text-align:left;"><i><span style="font-size:10.5pt;">b) eventuali diritti che una persona lesa può avere ai sensi delle norme nazionali di attuazione della direttiva 85/374/CEE;</span></i></p><p style="text-align:left;"><i><span style="font-size:10.5pt;">(c) le esenzioni dalla responsabilità e gli obblighi di dovuta diligenza di cui alla [legge sui servizi digitali] e</span></i></p><p style="text-align:left;"><i><span style="font-size:10.5pt;">d) le norme nazionali che determinano quale parte ha l'onere della prova, quale grado di certezza è richiesto per quanto riguarda il livello della prova o come viene definita la colpa, diverse da quanto previsto dagli articoli 3 e 4.</span></i></p><p style="text-align:left;"><i><span style="font-size:10.5pt;"><br></span></i></p><p style="text-align:left;"><i><span style="font-size:10.5pt;">4. <span style="background-color:rgb(4, 234, 119);">Gli Stati membri possono adottare o mantenere norme nazionali più favorevoli ai ricorrenti </span>per motivare una domanda di diritto civile extracontrattuale per danni causati da un sistema di IA, a condizione che tali norme siano compatibili con il diritto dell'Unione</span></i>»<span style="font-size:10.5pt;">.</span></p></div></div><p></p></div>
</div><div data-element-id="elm_zOR-pLRu4QIGIPxzxBxQIA" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_zOR-pLRu4QIGIPxzxBxQIA"].zpelem-heading { border-radius:1px; margin-block-start:18px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true"><span>Che cos'è per </span>«<span>la legge</span>»<span> l'intelligenza artificiale?</span></h2></div>
<div data-element-id="elm_GZlJJyMxJYmmQtNe5dt29w" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_GZlJJyMxJYmmQtNe5dt29w"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><p style="text-align:left;"><span style="font-size:10.5pt;">Per garantire la coerenza, la Direttiva sulla responsabilità per l'IA fa riferimento a una serie di <span style="font-weight:bold;">nozioni chiave</span> quali </span>«<span style="font-size:10.5pt;">sistema di IA</span>»<span style="font-size:10.5pt;">, </span>«<span style="font-size:10.5pt;">sistema di IA ad alto rischio</span>»<span style="font-size:10.5pt;">, </span>«<span style="font-size:10.5pt;">fornitore</span>»<span style="font-size:10.5pt;"> e </span>«<span style="font-size:10.5pt;">utente</span>»<span style="font-size:10.5pt;"> contenute nel progetto di legge sull'IA, senza dare una definizione di tali concetti.</span></p><p style="text-align:left;"><span style="font-size:10.5pt;"><br></span></p><p style="text-align:left;"><span style="font-size:10.5pt;">La AiLD, ad esempio, si rifà direttamente al concetto generale di </span>«<span style="font-size:10.5pt;font-weight:bold;">Sistema di IA</span>»<span style="font-size:10.5pt;"> come previsto dall<span style="background-color:rgb(234, 234, 4);">’AI Act</span>, ossia </span>«<i><span style="font-size:10.5pt;">software developed with certain techniques and approaches (machine learning, logic- and knowledge-based approaches, statistical approaches etc.) that can, for a given set of human-defined objectives, generate outputs such as content, predictions, recommendations, or decisions influencing the environments with which these systems interact</span></i>»<span style="font-size:10.5pt;">.</span></p><p style="text-align:left;"><span style="font-size:10.5pt;"><br></span></p><p style="text-align:left;"><span style="font-size:10.5pt;">È giusto il caso di evidenziare come da ultimo, il <span style="font-weight:bold;">Parlamento Europeo</span> abbia accettato di <span style="background-color:rgb(4, 234, 119);">adottare la definizione di AI</span> proposta dall'Organizzazione per la Cooperazione e lo Sviluppo Economico (<span style="font-weight:bold;">OCSE</span>) nell’AI Act, segnando una svolta significativa e aprendo ai principi di omogeneità e certezza (quanto meno definitoria) a livello comunitario.</span></p><p style="text-align:left;"><span style="font-size:10.5pt;"><br></span></p><p style="text-align:left;">«<span style="font-size:10.5pt;"><i>Artificial intelligence system (ai system) means a machine-based system that is designed to operate with varying levels of autonomy and that can, for explicit or implicit objectives, generate output such as predictions, recommendations, or decisions influencing physical or virtual environments</i></span>»<span style="font-size:10.5pt;"><i>. </i></span></p><p style="text-align:left;"><span style="font-size:10.5pt;"><br></span></p><p style="text-align:left;"><span style="font-size:10.5pt;">Le nuove&nbsp;norme della <span style="font-weight:bold;">AiLD</span> si applicherebbero, quindi, ai <span style="background-color:rgb(244, 244, 78);">danni causati dai sistemi di IA</span>, indipendentemente dal fatto che siano definiti <span style="font-weight:bold;">ad alto rischio o meno</span> ai sensi&nbsp;dell’IA act<span><span style="font-size:10.5pt;"><span style="font-weight:bold;background-color:rgb(234, 119, 4);">3</span></span></span>, e a <span style="background-color:rgb(4, 234, 119);">prescindere da un legame contrattuale tra “vittima” e responsabile</span>. </span></p><p style="text-align:left;"><span style="font-size:10.5pt;"><br></span></p><p style="text-align:left;"><span style="font-size:10.5pt;">Si andrebbe così a garantire che<span style="font-weight:bold;">&nbsp;chiunque (persona fisica o giuridica) possa essere risarcito</span> in caso di <span style="background-color:rgb(234, 234, 4);">danno subito da parte di un fornitore,&nbsp;sviluppatore o user di IA</span>.</span></p></div></div><p></p></div>
</div><div data-element-id="elm_oHdpXbzjmZ8UbBfpme4z7w" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_oHdpXbzjmZ8UbBfpme4z7w"].zpelem-text { background-color:rgba(234,119,4,0.18); background-image:unset; border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><div style="text-align:left;"><div style="text-align:left;"><div style="text-align:left;"><p><span style="font-size:12px;font-family:&quot;open sans&quot;;"><span><span style="background-color:rgb(234, 119, 4);font-weight:bold;">3</span></span></span><span style="color:inherit;font-size:12px;font-family:&quot;open sans&quot;;">Commissione Europea, Questions &amp; Answers: AI Liability Directive, 28 September 2022, https://ec.europa.eu/commission/presscorner/detail/en/QANDA_22_5793. Rilevante per il suo danno, e che è ragionevolmente probabile un nesso causale con la prestazione dell'IA, si potrà presumere che tale inadempienza abbia causato il danno. Ricordando, però, che: “Since this Directive introduces a rebuttable presumption, the defendant should be able to rebut it, in particular by showing that its fault could not have caused the damage” (Considerando 30).</span></p><p></p></div></div></div></div><p></p></div>
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                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/liability-regimes-in-the-EU-AI.png" width="472" height="557" loading="lazy" size="original" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_UTPWn_eHvaQk8trduyGvgA" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_UTPWn_eHvaQk8trduyGvgA"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><p style="text-align:left;"><span style="font-size:14px;"><span>Diversamente da altri concetti, nel caso di </span>«<span>richiesta di risarcimento danni</span>»<span> la Direttiva ne definisce la portata nel senso di richiesta di diritto civile non contrattuale, basata sulla colpa, per il risarcimento dei danni causati da un risultato di un sistema di IA o dall'incapacità di tale sistema di produrre un risultato che avrebbe dovuto essere prodotto.</span></span></p><p style="text-align:left;"><span style="font-size:14px;"><br></span></p><p style="text-align:left;"><span style="font-size:14px;"><span>Si tratta, dunque, della creazione di una presunzione di causalità che <span style="background-color:rgb(4, 234, 119);"> renderebbe l’onere della prova ricadente sui richiedenti il risarcimento molto più ragionevole e </span></span><span style="background-color:rgb(4, 234, 119);">«<span>semplificato</span>»<span>.</span></span></span></p><p style="text-align:left;"><span style="font-size:14px;"><br></span></p><p style="text-align:left;"><span style="font-size:14px;">L'articolo 4, infatti, stabilisce una presunzione di causalità confutabile che stabilisce un nesso di causalità tra l'inosservanza di un obbligo di diligenza ai sensi del diritto dell'Unione o nazionale (ossia la colpa) e l'output prodotto dal sistema di intelligenza artificiale o l'incapacità del sistema di intelligenza artificiale di produrre un output che ha dato origine al danno in questione.</span></p><p style="text-align:left;"><span style="font-size:14px;"><br></span></p><p style="text-align:left;"><span style="font-size:14px;"><span>In pratica, se una vittima può dimostrare che qualcuno è stato colpevole di non aver rispettato un determinato obbligo rilevante per il suo danno, e che è ragionevolmente probabile un nesso causale con la prestazione dell'IA, si potrà presumere che tale inadempienza abbia causato il danno. Ricordando, però, che: </span>«<span><i>Since this Directive introduces a rebuttable presumption, the defendant should be able to rebut it, in particular by showing that its fault could not have caused the damage</i></span>»<span> (Considerando 30).</span></span></p></div></div></div></div><p></p></div>
</div><div data-element-id="elm_IkPuS9IVhs3uScR-pG9CSg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_IkPuS9IVhs3uScR-pG9CSg"].zpelem-text { background-color:rgba(234,119,4,0.15); background-image:unset; border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="line-height:2;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;line-height:2;"><p style="text-align:left;"><b><span style="font-size:14px;">Contenuto realizzato da Anna Capoluongo</span></b></p><div style="color:inherit;text-align:left;"><p><span style="font-size:14px;">Avvocato, DPO, Vicepresidente I.R.L.E.S.S., membro del GdL sull’intelligenza artificiale (ANORC) e di D&amp;L Network.</span></p></div></div></div></div><span style="color:inherit;font-size:18px;"><span></span></span></div><span style="color:inherit;"><span style="font-size:16px;"><span></span></span></span></div></div>
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</div></div></div></div></div></div> ]]></content:encoded><pubDate>Tue, 18 Apr 2023 09:15:08 +0200</pubDate></item><item><title><![CDATA[GRC and personal data transfer from Switzerland: the standard contractual clauses]]></title><link>https://www.itsmf.ch/blogs/post/grc-and-personal-data-transfer-from-switzerland-scc</link><description><![CDATA[<img align="left" hspace="5" src="https://www.itsmf.ch/grc-personal-data-transfer-from-switzerland-to-cou1647854187151.jpeg"/>The transfer of personal data to a country with an inadequate level of data protection from Switzerland and the role of Standard Contractual Clauses.]]></description><content:encoded><![CDATA[<div class="zpcontent-container blogpost-container "><div data-element-id="elm_K-uLfw-aTb2JUW5S-CoGCQ" data-element-type="section" class="zpsection "><style type="text/css"></style><div class="zpcontainer-fluid zpcontainer"><div data-element-id="elm_3w4yu0FRRBudzzmNaZc9ZA" data-element-type="row" class="zprow zprow-container zpalign-items- zpjustify-content- " data-equal-column=""><style type="text/css"> [data-element-id="elm_3w4yu0FRRBudzzmNaZc9ZA"].zprow{ border-radius:1px; } </style><div data-element-id="elm_cCjPg4vgRK-RSo8vwd5B_A" data-element-type="column" class="zpelem-col zpcol-12 zpcol-md-8 zpcol-sm-12 zpalign-self- "><style type="text/css"> [data-element-id="elm_cCjPg4vgRK-RSo8vwd5B_A"].zpelem-col{ border-radius:1px; } </style><div data-element-id="elm_aAqyS99LaoJkccGYRU8mVg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_aAqyS99LaoJkccGYRU8mVg"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p><span style="font-style:italic;">Reading time: ~ 2 min.</span><br></p></div>
</div><div data-element-id="elm_XYNK5gAmPvISTHemrXJLFA" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_XYNK5gAmPvISTHemrXJLFA"] .zpimage-container figure img { width: 703px ; height: 338.30px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_XYNK5gAmPvISTHemrXJLFA"] .zpimage-container figure img { width:723px ; height:347.92px ; } } @media (max-width: 767px) { [data-element-id="elm_XYNK5gAmPvISTHemrXJLFA"] .zpimage-container figure img { width:415px ; height:199.71px ; } } [data-element-id="elm_XYNK5gAmPvISTHemrXJLFA"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/grc-personal-data-transfer-switzerland-scc.jpg" width="415" height="199.71" loading="lazy" size="fit" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_cScrzOvKIyUuevMXGGTBxw" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_cScrzOvKIyUuevMXGGTBxw"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">The transfer of personal data to a country with an inadequate level of data protection: the role of standard contractual clauses (SCC)<br></h2></div>
<div data-element-id="elm_1tt905tdmL-wZ-diimDdRw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_1tt905tdmL-wZ-diimDdRw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><h2 style="text-align:justify;"><div style="line-height:1.2;"><div><div><span style="font-size:16px;color:rgba(0, 0, 0, 0.71);">During the past months, we had an overview on&nbsp;<strong>personal data protection</strong>&nbsp;and&nbsp;<strong>privacy</strong>&nbsp;topics several times.</span></div><div><span style="font-size:16px;color:rgba(0, 0, 0, 0.71);"><br></span></div></div><div><div><span style="font-size:16px;color:rgba(0, 0, 0, 0.71);">We had a focus indeed on&nbsp;<strong>Swiss FADP</strong>&nbsp;(LPD-DSG) and&nbsp;<strong>EU GDPR</strong>&nbsp;requirements.&nbsp;</span></div></div><div><div><span style="font-size:16px;color:rgba(0, 0, 0, 0.71);"><br></span></div><div><span style="font-size:16px;color:rgba(0, 0, 0, 0.71);">Today we are going to take a closer look to a big threat, taken so seriously by the Swiss lawmaker. The transfer of personal data to a country without an adequate level of data protection on its laws.&nbsp;</span></div></div><div><div><span style="font-size:16px;color:rgba(0, 0, 0, 0.71);"><br></span></div><div><span style="font-size:16px;color:rgba(0, 0, 0, 0.71);">In particular we will show you the relevance of the role of&nbsp;<strong>standard contractual clauses</strong>&nbsp;(SCC) on this matter.&nbsp;</span></div></div></div></h2></div>
</div><div data-element-id="elm_Pphr8PiA0wRIHoUEEhQrGA" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_Pphr8PiA0wRIHoUEEhQrGA"] .zpimage-container figure img { width: 1070px ; height: 802.50px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_Pphr8PiA0wRIHoUEEhQrGA"] .zpimage-container figure img { width:723px ; height:542.25px ; } } @media (max-width: 767px) { [data-element-id="elm_Pphr8PiA0wRIHoUEEhQrGA"] .zpimage-container figure img { width:415px ; height:311.25px ; } } [data-element-id="elm_Pphr8PiA0wRIHoUEEhQrGA"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/FADP-LPD-DSG-SCC-transfer-personal-data-country-without-adequate-standards-protection.jpg" width="415" height="311.25" loading="lazy" size="fit" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_gWPLA48GcHTu1yt8lN-LaA" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_gWPLA48GcHTu1yt8lN-LaA"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">The Federal Data Protection and Information Commissioner provisions<br></h2></div>
<div data-element-id="elm_ttv3Q3M4TyWWxvW2hwgsLA" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_ttv3Q3M4TyWWxvW2hwgsLA"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-center " data-editor="true"><h3 style="text-align:justify;"><div style="line-height:1.2;"><div style="text-align:left;"><div><div style="line-height:1.2;"><div><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);text-align:justify;">As is known, on August 27th, 2021 the </span><strong style="color:rgba(0, 0, 0, 0.71);font-size:14px;text-align:justify;">Federal Data Protection and Information Commissioner of Switzerland (FDPIC) </strong><span style="color:rgba(0, 0, 0, 0.71);text-align:justify;">has released provisions concerning the </span><strong style="color:rgba(0, 0, 0, 0.71);font-size:14px;text-align:justify;">transfer of personal data </strong><span style="color:rgba(0, 0, 0, 0.71);text-align:justify;">to a country with an </span><strong style="color:rgba(0, 0, 0, 0.71);font-size:14px;text-align:justify;">inadequate level of data protection</strong><span style="color:rgba(0, 0, 0, 0.71);text-align:justify;">, based on recognised </span><strong style="color:rgba(0, 0, 0, 0.71);font-size:14px;text-align:justify;">standard contractual clauses (SCC) </strong><span style="color:rgba(0, 0, 0, 0.71);text-align:justify;">and model contracts.</span></span></div><div><span style="font-size:16px;"><br></span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">The FDPIC (the Swiss Data Protection Authority) commented on the issue of non-EU transfers, focusing more specifically on the <strong>SCCs approved by the European Commission</strong>.</span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><br></span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">In fact, the FDPIC has officially recognised the standard contractual clauses <strong>as a legitimate condition for the transfer of personal data</strong> to those <strong>countries that do not have an adequate level of data protection</strong>, albeit with due care and modification.</span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><br></span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">More precisely, the FDPIC - in its ruling - distinguishes the hypothesis of the transfer to <strong>which only the Swiss law on data protection applies </strong>(and which, therefore, has no connection with the GDPR), from the hypothesis in <strong>which the GDPR applies </strong>to the processing pursuant to Article 3(2), but the exporter is a Data Controller or Manager located in Switzerland (and therefore subject to Swiss law).</span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><br></span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">In this case - according to the FDPIC - <strong>the parties may choose whether to draw up two separate agreements (one under GDPR and the other under Swiss data protection law) or to refer</strong><strong> to a single regime</strong>, subjecting all transfers to GDPR standards, but providing for the appropriate adjustments.&nbsp; &nbsp;</span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><br></span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><a href="https://www.linkedin.com/in/leonardi-andrea/">Andrea Leonardi</a> (Vice President of MGS)&nbsp;</span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><a href="https://www.linkedin.com/in/anna-capoluongo-59351a17/">Anna Capoluongo</a> (Lawyer)</span></div></div></div></div></div></h3></div>
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</div></div></div></div></div></div> ]]></content:encoded><pubDate>Thu, 14 Oct 2021 07:00:22 +0200</pubDate></item><item><title><![CDATA[GRC and Data Protection: the GRC approch in EU and Swiss contexts]]></title><link>https://www.itsmf.ch/blogs/post/grc-and-data-protection-the-grc-approch-in-eu-and-swiss-contexts</link><description><![CDATA[<img align="left" hspace="5" src="https://www.itsmf.ch/grc-data-protection-approach-lpd-gdpr-switzerland-eu.jpg"/>Data protection between EU and Switzerland and the GRC Data Protection approach on GDPR and LPD-DSG-LPD (FDA): let's take a closer look at these laws together.]]></description><content:encoded><![CDATA[<div class="zpcontent-container blogpost-container "><div data-element-id="elm_N6iikHLyS7O0zrZ79oklww" data-element-type="section" class="zpsection "><style type="text/css"></style><div class="zpcontainer-fluid zpcontainer"><div data-element-id="elm_Iu5Iy11DSwmYgy5rWvD6Vg" data-element-type="row" class="zprow zprow-container zpalign-items- zpjustify-content- " data-equal-column=""><style type="text/css"> [data-element-id="elm_Iu5Iy11DSwmYgy5rWvD6Vg"].zprow{ border-radius:1px; } </style><div data-element-id="elm_zHhY5K0-S8q5MCIRlFXRGg" data-element-type="column" class="zpelem-col zpcol-12 zpcol-md-8 zpcol-sm-12 zpalign-self- "><style type="text/css"></style><div data-element-id="elm_UFslJv4rgh2wXyT5Aed8RQ" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_UFslJv4rgh2wXyT5Aed8RQ"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p><span style="font-style:italic;">Reading time: ~ 2 min.</span><br></p></div>
</div><div data-element-id="elm_QbEIEBQv4-5h9-5okJlciw" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_QbEIEBQv4-5h9-5okJlciw"] .zpimage-container figure img { width: 703px ; height: 421.80px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_QbEIEBQv4-5h9-5okJlciw"] .zpimage-container figure img { width:723px ; height:433.80px ; } } @media (max-width: 767px) { [data-element-id="elm_QbEIEBQv4-5h9-5okJlciw"] .zpimage-container figure img { width:415px ; height:249.00px ; } } [data-element-id="elm_QbEIEBQv4-5h9-5okJlciw"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/data-protection-between-ue-and-switzerland-grc-data-protection-approach-on-gdpr-lpd.jpg" width="415" height="249.00" loading="lazy" size="fit" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_nH1RCmg3s3_XYvKyTaYMjw" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_nH1RCmg3s3_XYvKyTaYMjw"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">Data protection between EU and Switzerland: the GRC Data Protection approach on GDPR and LPD-DSG-LPD (FDA)<br></h2></div>
<div data-element-id="elm_5YHF-TeKS8ifX2o5LA0k6Q" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_5YHF-TeKS8ifX2o5LA0k6Q"].zpelem-text { border-radius:1px; margin-block-start:1px; } </style><div class="zptext zptext-align-center " data-editor="true"><h2 style="text-align:justify;line-height:1.2;"><div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">GRC and Data Protection: what about the approach in Switzerland?</span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">&nbsp;</span></div></div><div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><span>We already told you about the new <strong>Federal Data Protection Act</strong></span><span> (also known as LPD) that was enacted in Switzerland in our previous post</span>. <span>Today we are getting back on this topic considering </span><strong><span>one big challenge for the Swiss companies</span></strong><span>: the GRC and data protection between European Union and Switzerland.</span></span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><span><br></span></span></div></div><div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">Many organizations in Switzerland will face a double challenge. They have to <strong>manage compliance</strong> with the requirements of the LPD and, at the same time, with GDPR too. This one - as known - applies also to the EU citizens personal data processing carried out outside of the EU.</span></div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><br></span></div></div><div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">Many Swiss companies have to find <strong>a solution</strong> that could be suitable for both the contexts.&nbsp;</span></div></div><div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">How to <strong>manage compliance</strong> with the requirements of the LPD and the GDPR in an integrated way?&nbsp;</span></div></div></h2></div>
</div><div data-element-id="elm_Vh-8icMH0ajsGstWWYmVQA" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_Vh-8icMH0ajsGstWWYmVQA"] .zpimage-container figure img { width: 1070px ; height: 802.50px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_Vh-8icMH0ajsGstWWYmVQA"] .zpimage-container figure img { width:723px ; height:542.25px ; } } @media (max-width: 767px) { [data-element-id="elm_Vh-8icMH0ajsGstWWYmVQA"] .zpimage-container figure img { width:415px ; height:311.25px ; } } [data-element-id="elm_Vh-8icMH0ajsGstWWYmVQA"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/grc-and-data-protection-lpd-gdpr-integration-privacy-switzerland-eu.jpg" width="415" height="311.25" loading="lazy" size="fit" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_Zjel_SAQyd9GYW7OjhMmhw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_Zjel_SAQyd9GYW7OjhMmhw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div><div style="text-align:justify;"><div style="line-height:1.2;"><div><div><span style="color:rgba(0, 0, 0, 0.71);">The&nbsp;<strong>adoption of a common GRC approach</strong>&nbsp;(Governance, Risk Management, Compliance) based on the main ISO standards can be of great help.&nbsp;</span></div></div><div><div><span style="color:rgba(0, 0, 0, 0.71);">This can be the right choice with particular reference to the following standards:</span></div></div><ul><li style="text-align:justify;"><span><span style="color:rgba(0, 0, 0, 0.71);">Risk management according to ISO 31000</span><br></span></li><li style="text-align:justify;"><span><span style="color:rgba(0, 0, 0, 0.71);">Privacy Impact Assesment on ISO 29134</span><br></span></li><li style="text-align:justify;"><span><span style="color:rgba(0, 0, 0, 0.71);">Compliance management (ISO 37301)</span><br></span></li><li style="text-align:justify;"><span><span style="color:rgba(0, 0, 0, 0.71);">Information security management system (ISO 27001)</span><br></span></li><li style="text-align:justify;"><span><span style="color:rgba(0, 0, 0, 0.71);">Business continuity management system (ISO 22301)</span><br></span></li><li style="text-align:justify;"><span><span style="color:rgba(0, 0, 0, 0.71);">IT Service Management System (ISO 20000-1).</span><br></span></li></ul><div><span style="color:rgba(0, 0, 0, 0.71);"><br></span></div><div><div><span style="color:rgba(0, 0, 0, 0.71);">Due to this high relevance for a lot of companies, we will have a special focus on topic with a dedicated class.&nbsp;</span></div></div><div><span style="color:rgba(0, 0, 0, 0.71);"><br></span></div><div><div><span style="color:rgba(0, 0, 0, 0.71);">ITSMF and MGS will have a partnership on the next class about GRC and Data protection between EU and Switzerland.&nbsp;</span></div></div><div><span style="color:rgba(0, 0, 0, 0.71);"><br></span></div><div><div><span style="color:rgba(0, 0, 0, 0.71);">We will held this class on&nbsp;<strong>6th and 7th October</strong>: but you will get more info about during the next weeks.</span></div></div></div></div></div></div>
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</div></div></div></div></div></div> ]]></content:encoded><pubDate>Wed, 04 Aug 2021 05:00:41 +0200</pubDate></item><item><title><![CDATA[GRC and data protection in Switzerland: structure and main requirements of the LPD]]></title><link>https://www.itsmf.ch/blogs/post/grc-and-data-protection-in-switzerland-structure-and-main-requirements-of-the-lpd</link><description><![CDATA[<img align="left" hspace="5" src="https://www.itsmf.ch/swiss-data-protection-law-lpd-gdpr-privacy-1536x973.jpg"/>Data protection in Switzerland is regulated by the Swiss Federal Data Protection Act (DPA): the new law will enter into force on September 2023.]]></description><content:encoded><![CDATA[<div class="zpcontent-container blogpost-container "><div data-element-id="elm_cV5v2uGLSoiOXxz-oQdc8Q" data-element-type="section" class="zpsection "><style type="text/css"></style><div class="zpcontainer-fluid zpcontainer"><div data-element-id="elm_GjrpJyqjRKytv4gzL2eeug" data-element-type="row" class="zprow zprow-container zpalign-items- zpjustify-content- " data-equal-column=""><style type="text/css"> [data-element-id="elm_GjrpJyqjRKytv4gzL2eeug"].zprow{ border-radius:1px; } </style><div data-element-id="elm_t3LdkZXnQnqeavjQyBxZEQ" data-element-type="column" class="zpelem-col zpcol-12 zpcol-md-8 zpcol-sm-12 zpalign-self- "><style type="text/css"></style><div data-element-id="elm_j1Xuyft3ZuW4us3MgP1Chw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_j1Xuyft3ZuW4us3MgP1Chw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p><span style="font-style:italic;">Reading time: ~ 2 min.</span><br></p></div>
</div><div data-element-id="elm_ZhLIcBH0ptbkTvyMQulu9Q" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_ZhLIcBH0ptbkTvyMQulu9Q"] .zpimage-container figure img { width: 703px ; height: 468.48px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_ZhLIcBH0ptbkTvyMQulu9Q"] .zpimage-container figure img { width:723px ; height:481.81px ; } } @media (max-width: 767px) { [data-element-id="elm_ZhLIcBH0ptbkTvyMQulu9Q"] .zpimage-container figure img { width:415px ; height:276.56px ; } } [data-element-id="elm_ZhLIcBH0ptbkTvyMQulu9Q"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/data-protection-in-switzerland-the-swiss-federal-data-protection-act.jpg" width="415" height="276.56" loading="lazy" size="fit" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_InM6eqYyrTbOA6fcIh5wzg" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_InM6eqYyrTbOA6fcIh5wzg"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">Data protection in Switzerland: the Swiss Federal Data Protection Act (DPA)<br></h2></div>
<div data-element-id="elm_I7duHo9QRWyYwhO39PadfA" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_I7duHo9QRWyYwhO39PadfA"].zpelem-text { border-radius:1px; margin-block-start:-1px; } </style><div class="zptext zptext-align-center " data-editor="true"><h2 style="text-align:justify;line-height:1.2;"><div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">As is known, on September 25th, 2020, <b>the Federal Data Protection Act (LPD) of Switzerland was enacted</b>.&nbsp;</span></div></div><div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">The LPD - similarly to the GDPR - has <b>a three levels structure</b>: you can find on it chapters, sections and single articles.&nbsp;</span></div></div><div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">There are <b>many clear correlations between the requirements of the Swiss LPD and the requirements of the European GDPR</b>. These are:</span></div></div><ul><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The purpose and field of application.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The definition of personal data and processing.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The figures involved (data subject, data controller and data processor).</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The applicable principles to the processing.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The rights of the data subject.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The privacy by design and by default.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The obligations of data controllers and processors.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The personal data protection.</span><br></span></li><li style="text-align:justify;"><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">The role of the data protection consultant.</span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The purpose and field of application.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The definition of personal data and processing.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The figures involved (data subject, data controller and data processor).</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The applicable principles to the processing.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The rights of the data subject.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The privacy by design and by default.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The obligations of data controllers and processors.</span><br></span></li><li style="text-align:justify;"><span style="font-size:16px;"><span style="color:rgba(0, 0, 0, 0.71);">The personal data protection.</span><br></span></li><li style="text-align:justify;"><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">The role of the data protection consultant.</span></li></ul><div><div><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">How to <b>manage the compliance </b>with the requirements of the Swiss LPD? What is the right answer? Remember, <strong>every company</strong> has to pay attention to and comply with this act!&nbsp;</span></div></div></h2></div>
</div><div data-element-id="elm_BFr7LG70yPHbAKksbtaXng" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_BFr7LG70yPHbAKksbtaXng"] .zpimage-container figure img { width: 1070px ; height: 799.94px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_BFr7LG70yPHbAKksbtaXng"] .zpimage-container figure img { width:723px ; height:540.52px ; } } @media (max-width: 767px) { [data-element-id="elm_BFr7LG70yPHbAKksbtaXng"] .zpimage-container figure img { width:415px ; height:310.26px ; } } [data-element-id="elm_BFr7LG70yPHbAKksbtaXng"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/lpd-data-protection-swiss-law-privacy.png" width="415" height="310.26" loading="lazy" size="fit" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_AwlgafvliH87x_ObN7rVDQ" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_AwlgafvliH87x_ObN7rVDQ"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;">The&nbsp;<b>adoption of a GRC (Governance, Risk Management and Compliance) approach&nbsp;</b><span style="text-align:justify;">based on the main ISO standards can be particularly useful, so we will check it on our next blog posts.</span></span></p><p><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><span style="text-align:justify;"><br></span></span></p><p><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><span style="text-align:justify;">We are going to see how it is possible to execute everything in the right way in the next weeks: so please stay tuned!&nbsp;</span></span></p><p><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><span style="text-align:justify;"><br></span></span></p><p><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><span style="text-align:justify;">Keep in mind also that we are going to&nbsp;</span><strong style="text-align:justify;">take a deeper and closer look</strong><span style="text-align:justify;">&nbsp;at this crucial topic on our&nbsp;</span><strong style="text-align:justify;">next class by itSMF</strong><span style="text-align:justify;">&nbsp;with the partnership of&nbsp;</span><strong style="text-align:justify;">MGS</strong><span style="text-align:justify;">.&nbsp;</span></span></p><p><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><span style="text-align:justify;"><br></span></span></p><p><span style="color:rgba(0, 0, 0, 0.71);font-size:16px;"><span style="text-align:justify;">This class is going to be scheduled on&nbsp;</span><strong style="text-align:justify;">6th and 7th October</strong><span style="text-align:justify;">. We will keep you in touch shortly with some details and of course the enrollment.</span></span><br></p></div>
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</div></div></div></div></div></div> ]]></content:encoded><pubDate>Thu, 22 Jul 2021 05:00:08 +0200</pubDate></item></channel></rss>