{"id":1833,"date":"2026-05-21T10:43:20","date_gmt":"2026-05-21T08:43:20","guid":{"rendered":"https:\/\/www.studiolegalesperti.it\/?p=1833"},"modified":"2026-05-21T10:54:01","modified_gmt":"2026-05-21T08:54:01","slug":"ia-sanita-e-responsabilita-aziendale-tra-regole-e-tecnica-nel-2026","status":"publish","type":"post","link":"https:\/\/www.studiolegalesperti.it\/en\/ia-sanita-e-responsabilita-aziendale-tra-regole-e-tecnica-nel-2026\/","title":{"rendered":"AI, Healthcare, and corporate responsibility: between regulation and technology in 2026"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_89 counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Article Index<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6ad956398b0bd\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6ad956398b0bd\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.studiolegalesperti.it\/en\/ia-sanita-e-responsabilita-aziendale-tra-regole-e-tecnica-nel-2026\/#Synoptic_table_of_the_jurisprudential_and_regulatory_framework\" >Synoptic table of the jurisprudential and regulatory framework<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.studiolegalesperti.it\/en\/ia-sanita-e-responsabilita-aziendale-tra-regole-e-tecnica-nel-2026\/#Impact_of_taxonomy_and_public_procurement_in_European_jurisprudence\" >Impact of taxonomy and public procurement in European jurisprudence<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.studiolegalesperti.it\/en\/ia-sanita-e-responsabilita-aziendale-tra-regole-e-tecnica-nel-2026\/#National_jurisdictional_applications\" >National jurisdictional applications<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.studiolegalesperti.it\/en\/ia-sanita-e-responsabilita-aziendale-tra-regole-e-tecnica-nel-2026\/#Evolution_of_the_regulatory_framework_and_reallocation_of_corporate_risk\" >Evolution of the regulatory framework and reallocation of corporate risk<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.studiolegalesperti.it\/en\/ia-sanita-e-responsabilita-aziendale-tra-regole-e-tecnica-nel-2026\/#Operational_strategies_for_managing_regulatory_risk\" >Operational strategies for managing regulatory risk<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<p class=\"wp-block-paragraph\">The demographic transition and population aging in nations such as Italy are accompanied by the <strong>need to implement healthcare models equipped with automation<\/strong>. The development of <strong>artificial intelligence and medical robotics<\/strong> responds to this need with evolutionary cycles that challenge the legislator&#8217;s timelines. The digital transition represents a <strong>clinical and managerial paradigm shift<\/strong> aimed at improving the effectiveness of care.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>regulatory framework of the European Union<\/strong> governs this scenario through a normative triad: the Medical Devices Regulation (EU Regulation 2017\/745, <strong>MDR<\/strong>), the Artificial Intelligence Act (EU Regulation 2024\/1689, <strong>AI Act<\/strong>), and the Directive on liability for defective products (EU Directive 2024\/2853, <strong>rPLD<\/strong>). This framework requires <strong>strategic reflection<\/strong> in the face of a transformation intertwined with patient rights.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The provisions place the protection of the individual at the center. In the digital healthcare market, regulatory deadlines and deferments outline a <strong>quantitative gradation for a qualitative approach to patient protection<\/strong>. This timeframe configures a <strong>strategic balance for healthcare management and manufacturing companies<\/strong>. Greater computing power corresponds to a <strong>redefinition of legal, strict, and contractual liability<\/strong>. Software companies choose to <strong>structure legal safeguards<\/strong> in harmony with the evolution of careful and rigorous jurisprudence.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Synoptic_table_of_the_jurisprudential_and_regulatory_framework\"><\/span><strong>Synoptic table of the jurisprudential and regulatory framework<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">The following table offers a map of the sources and disputes that outline risk management in the medical-technological sector.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Source or Jurisprudence<\/strong><\/td><td><strong>Subject of the Decision or Norm<\/strong><\/td><td><strong>Real Event Brought to Trial<\/strong><\/td><td><strong>Principle of Law and Regulatory Impact<\/strong><\/td><\/tr><tr><td><strong>Dir. EU 2024\/2853 (rPLD)<\/strong><\/td><td>Liability for defective products<\/td><td>Placing software and AI on the market (from December 2026)<\/td><td>Classifies software as a &#8220;product&#8221; and foresees the presumption of defectiveness in cases of algorithmic opacity.<\/td><\/tr><tr><td><strong>CJEU, C-568\/24 (Sof Medica)<\/strong><\/td><td>Public procurement and equivalence<\/td><td>Cluj-Napoca Hospital tender for robotic surgery systems<\/td><td>Requires the consideration of infrastructural limits and invites the inclusion of equivalence clauses between manufacturers.<\/td><\/tr><tr><td><strong>General Court EU, T-38\/21 (Inivos)<\/strong><\/td><td>Direct awards in urgency<\/td><td>Purchase of disinfection robots by the European Commission during the COVID-19 emergency<\/td><td>Sets the limits for procedures without a call for competition and confirms the obligation to ensure performance standards.<\/td><\/tr><tr><td><strong>CJEU, C-68\/21 (Iveco Orecchia)<\/strong><\/td><td>Competition and supply in procurement<\/td><td>Supply of spare components for bus fleets<\/td><td>Guides administrations to avoid closed ecosystems, requiring the acceptance of declarations of equivalence.<\/td><\/tr><tr><td><strong>CJEU, C-410\/19 (Software Incubator)<\/strong><\/td><td>Qualification of intangible assets<\/td><td>Supply of software with a perpetual license<\/td><td>Includes software in the notion of &#8220;goods&#8221; and &#8220;product&#8221;, outlining strict liability.<\/td><\/tr><tr><td><strong>Court of Siena, Judg. 49\/2026<\/strong><\/td><td>Classification and CE marking<\/td><td>Sanctions the sale in pharmacies of artisanal insoles classified as medical devices<\/td><td>Emphasizes the perceived intended use over the manufacturer&#8217;s intent and disclaimers.<\/td><\/tr><tr><td><strong>Court of Florence, Ord. 4329-1\/2025<\/strong><\/td><td>Regulatory obstacles in urgency<\/td><td>Development of ocular software on an infusion pump for a patient requesting assisted suicide<\/td><td>Distinguishes between a therapeutic device and hardware for self-determination, validating the tests of the auxiliary body (CNR).<\/td><\/tr><tr><td><strong>CJEU, C-203\/22 (Dun &amp; Bradstreet)<\/strong><\/td><td>Transparency versus trade secret<\/td><td>Denial of a contract based on an automated credit scoring algorithm<\/td><td>Requires the operator to balance trade secrets with the injured party&#8217;s right to know the algorithmic logic.<\/td><\/tr><tr><td><strong>CJEU, C-407\/19 (Katoen Natie)<\/strong><\/td><td>Equal treatment<\/td><td>System for recognizing and assigning work to Belgian dockers<\/td><td>Promotes the use of objective and impartial metrics in decision-making systems.<\/td><\/tr><tr><td><strong>CJEU, C-817\/19 (Ligue droits humains)<\/strong><\/td><td>Limitations on data usage<\/td><td>Processing and retention of air passenger data (PNR Directive)<\/td><td>Regulates massive processing and sets protection parameters applicable to AI training on medical records.<\/td><\/tr><tr><td><strong>CJEU, C-65\/20 (KRONE-Verlag)<\/strong><\/td><td>Delimitation of defective product<\/td><td>Injuries caused to a reader by medical advice (horseradish compress) published in a newspaper<\/td><td>Specifies that a professional opinion or informational content does not constitute a defective product.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Impact_of_taxonomy_and_public_procurement_in_European_jurisprudence\"><\/span><strong>Impact of taxonomy and public procurement in European jurisprudence<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">European jurisprudence is <strong>constantly engaged in resolving disputes related to formal classifications and public procurement procedures<\/strong>. These dynamics dictate the timelines for placing technologies on the market, <strong>regulating the innovation chain<\/strong> to protect safety standards. Attention is focused on the infrastructural integration of hospital software and emergency procedures.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In public procurement, tender specifications require to <strong>weigh the infrastructural limits<\/strong> of the contracting authorities. The Court of Justice (case C-568\/24, Sof Medica v. Cluj-Napoca Hospital) offers an exemplary case. On the issue of acquiring robotic surgery systems, the judges outlined the <strong>limit for administrations to formulate requirements capable of identifying a single manufacturer<\/strong>, suggesting the acceptance of offers based on <strong>functional equivalence<\/strong>. Manufacturers of AI platforms have the opportunity to <strong>design open architectures<\/strong>, ensuring interoperability to <strong>prevent practices of technological closure or lock-in<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regarding <strong>urgent negotiated procedures<\/strong>, the General Court of the European Union recalls the importance of performance standards. In the Inivos case (case T-38\/21) on the purchase of hospital disinfection robots, the ruling sets a clear principle: <strong>derogations dictated by pandemic necessities keep the safety thresholds unchanged<\/strong> for machinery.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">To protect competition, jurisprudence guides administrations to avoid drafting <strong>tenders likely to favor closed software ecosystems<\/strong> (Iveco Orecchia case, case C-68\/21). By analogy in the medical sector, <strong>healthcare organizations evaluate the acceptance of supplementary modules developed by third parties<\/strong>. The qualification of intangible assets completes the architecture. With case C-410\/19, the Court establishes that <strong>software falls within the legal concepts of goods and products<\/strong>, overcomes the figure of service provision, and <strong>initiates reflection on civil liability<\/strong>.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"National_jurisdictional_applications\"><\/span><strong>National jurisdictional applications<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Similar dynamics of adaptation emerge in the Italian jurisdictional context. The <strong>confrontation between innovation and regulatory precepts<\/strong> takes on concrete outlines. The application of the discipline highlights the boundaries of the certification framework. The Court of Siena (judgment no. 49\/2026) confirmed an administrative sanction against a merchant for the <strong>marketing of footwear insoles<\/strong>. The products, although accompanied by exculpatory disclaimers, exhibited commercial purposes related to foot ailments. The authority outlined the <strong>qualification of unregistered medical devices based on objective appearance<\/strong> and therapeutic promise. This ruling illustrates the <strong>sanctionary exposure linked to inaccurate self-assessments<\/strong>, with significant risk profiles for companies called upon to classify complex algorithmic triage systems.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regarding assisted suicide, the Court of Florence (order no. 4329-1\/2025) offers a precedent of balancing. Faced with the <strong>needs of an immobilized patient<\/strong>, private companies had <strong>declined to adapt the instruments in compliance with the MDR<\/strong>. The Court appointed the National Research Council (CNR) to <strong>engineer an ad hoc solution<\/strong>, integrating an infusion pump with ocular software. The Ministry of Health raised objections due to the <strong>impossibility of qualifying the new hardware as a medical device<\/strong>. The Court harmonized the requests and <strong>validated the functional tests carried out in a real environment<\/strong> at the patient&#8217;s home, in <strong>derogation of the timelines of ministerial laboratories<\/strong>. The case highlights the <strong>delicate balance between the patient&#8217;s biological needs and administrative timelines<\/strong>.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Evolution_of_the_regulatory_framework_and_reallocation_of_corporate_risk\"><\/span><strong>Evolution of the regulatory framework and reallocation of corporate risk<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">The entry into force of the Directive on liability for defective products (rPLD) in December 2026 introduces a <strong>reallocation of civil risk<\/strong>. The directive <strong>frames medical software and machine learning systems as products<\/strong>, including SaMD and SiMD, and grants injured parties the <strong>right to act under strict liability against the developing company<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Therefore, a <strong>legal presumption of system defectiveness is outlined if the manufacturer fails to disclose the design specifications<\/strong>. The <strong>protection of trade secrets finds a limit in favor of transparency<\/strong>. The Court of Justice (case C-203\/22, Dun &amp; Bradstreet) confirms the principle whereby <strong>the operator reconciles the protection of intellectual assets with the transparency of decision-making logic<\/strong> towards the injured party.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The directive expands the notion of manufacturer. <strong>Hospital structures that carry out the local retraining (fine-tuning) of a commercial predictive algorithm<\/strong> with internal datasets <strong>assume the subjective qualification of manufacturers, with the associated burden of strict liability<\/strong>. Algorithmic training requires new parameters. <strong>Decision-making processes require impartial metrics<\/strong> (Katoen Natie case, C-407\/19) and foresee <strong>limitations on the massive use of data<\/strong> (PNR ruling, C-817\/19), valuable rules for the <strong>management of medical records<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">To balance the framework, the Court (case C-65\/20, KRONE-Verlag) protects the medical profession: <strong>a professional opinion does not constitute a defective product<\/strong>. Consequently, <strong>liability for an inaccurate algorithmic output involves the manufacturing company<\/strong>, while the <strong>conduct of the healthcare professional remains guided by the parameters of professional negligence<\/strong>.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Operational_strategies_for_managing_regulatory_risk\"><\/span><strong>Operational strategies for managing regulatory risk<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">To promote business continuity and limit legal liabilities, companies and healthcare management must adopt clear strategic measures. An operational priority coincides with the <strong>revision of contracts<\/strong> coordinated with the <strong>functional organizational adaptation of personnel<\/strong>. Contracts require the <strong>definition of warranty and indemnity regimes<\/strong>. If the structure introduces calibration interventions, the agreements take care to <strong>demarcate the scope of liability, protecting the original supplier<\/strong> with respect to alterations beyond their control.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A technological prerequisite becomes the implementation of <strong>security and explainability right from the design phase (explainability by design)<\/strong>. The conception of the software aims to ensure the <strong>comprehensibility of decision-making logic by the physician<\/strong>. <strong>Overcoming the black box paradigm<\/strong> is the tool to <strong>prevent the application of the presumptions of defectiveness<\/strong> of the rPLD.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The strategy encourages <strong>joining regulated experimentation spaces (regulatory sandboxes)<\/strong>. Validation within these ecosystems allows developers to <strong>test algorithms under exemption from ordinary market procedures<\/strong>, structuring a <strong>documented risk management in the phases prior to commercial launch<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Adaptation, therefore, <strong>invites the healthcare, legal, and engineering departments to work in synergy, overcoming the silo approach<\/strong>. This evolution transforms regulatory compliance from a burden into a <strong>factor of stability<\/strong>, reliability, and competitiveness for digital healthcare.<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>La transizione demografica e l&#8217;invecchiamento della popolazione in nazioni quali l&#8217;Italia accompagnano la necessit\u00e0 di implementare modelli assistenziali provvisti di automazione. Lo sviluppo dell&#8217;intelligenza artificiale e della robotica medica risponde a tale fabbisogno con cicli evolutivi che sfidano le tempistiche del legislatore. La transizione digitale rappresenta un mutamento di paradigma clinico e gestionale orientato a [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":1835,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_themeisle_gutenberg_block_has_review":false,"footnotes":""},"categories":[14,24],"tags":[170,30,187],"class_list":["post-1833","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-civile","category-sanita","tag-samd","tag-sanita","tag-ssn"],"blocksy_meta":[],"_links":{"self":[{"href":"https:\/\/www.studiolegalesperti.it\/en\/wp-json\/wp\/v2\/posts\/1833","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.studiolegalesperti.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.studiolegalesperti.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.studiolegalesperti.it\/en\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.studiolegalesperti.it\/en\/wp-json\/wp\/v2\/comments?post=1833"}],"version-history":[{"count":4,"href":"https:\/\/www.studiolegalesperti.it\/en\/wp-json\/wp\/v2\/posts\/1833\/revisions"}],"predecessor-version":[{"id":1840,"href":"https:\/\/www.studiolegalesperti.it\/en\/wp-json\/wp\/v2\/posts\/1833\/revisions\/1840"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.studiolegalesperti.it\/en\/wp-json\/wp\/v2\/media\/1835"}],"wp:attachment":[{"href":"https:\/\/www.studiolegalesperti.it\/en\/wp-json\/wp\/v2\/media?parent=1833"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.studiolegalesperti.it\/en\/wp-json\/wp\/v2\/categories?post=1833"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.studiolegalesperti.it\/en\/wp-json\/wp\/v2\/tags?post=1833"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}