{"id":442,"date":"2026-06-30T20:47:48","date_gmt":"2026-06-30T18:47:48","guid":{"rendered":"https:\/\/lauragarcialaguna.com\/?p=442"},"modified":"2026-08-25T21:29:29","modified_gmt":"2026-08-25T19:29:29","slug":"sistemas-de-ia-de-alto-riesgo","status":"publish","type":"post","link":"https:\/\/lauragarcialaguna.com\/en\/sistemas-de-ia-de-alto-riesgo\/","title":{"rendered":"High-risk AI systems: how to tell if yours is one"},"content":{"rendered":"<p class=\"lgl-indent wp-block-paragraph\">The AI Regulation doesn't prohibit artificial intelligence. It does something more subtle and more demanding: it <strong>categorizes it by risk levels<\/strong>. And there's a category, <strong>high-risk AI systems<\/strong>, where almost all<strong> the fine print<\/strong>, almost all the obligations, and almost all the headaches are concentrated. The problem is that many companies use systems that could be in that category\u2026 without even knowing it.<\/p>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">If you advise companies that use AI\u2014or if you use it yourself\u2014the first question isn't \"Do I comply with the Regulation?\" but a more basic one: \"<strong>Is my system high-risk?<\/strong>\" Almost everything else depends on the answer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What does \"high risk\" mean (and what doesn't)?<\/h2>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\"><strong>High risk doesn't mean prohibited.<\/strong> Prohibited practices are a separate category (manipulation, social scoring, certain biometrics). High risk is the level immediately below: systems that can be used, yes, but which, due to their <strong>potential impact on health, safety, or fundamental human rights,<\/strong> come with a serious set of obligations.<\/p>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">Imagine an AI that decides<strong> who gets hired<\/strong>, who <strong>gets a loan<\/strong> or how a <strong>medical emergency is prioritized<\/strong>. They aren't banned; they're monitored.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">The Two Entry Points<\/h2>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">A system enters the high-risk category through one of two paths:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>By product.<\/strong> When the AI <strong>is a product<\/strong> \u2014or a product's safety component\u2014already regulated by the EU and requires a third-party conformity assessment: machinery, medical devices, toys, elevators, vehicles, etc. This is what the Regulation groups in <strong>Annex I<\/strong>.<\/li>\n\n\n\n<li><strong>By use.<\/strong> When <strong>the system is intended<\/strong> for any of the sensitive areas that the Regulation lists in <strong>Annex III<\/strong>, regardless of the product it's used in.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">The List You Really Need to Look At<\/h2>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">The second path is the one most systems enter through. The Regulation identifies as high-risk, among others, AI systems used for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Biometrics<\/strong>: identification or categorization of people.<\/li>\n\n\n\n<li><strong>Critical infrastructure<\/strong>: water, energy, traffic.<\/li>\n\n\n\n<li><strong>Education and training<\/strong>: admissions, exam evaluation.<\/li>\n\n\n\n<li><strong>Employment<\/strong>: personnel selection, resume screening, promotion or dismissal decisions.<\/li>\n\n\n\n<li><strong>Access to essential services<\/strong>: credit scoring, health and life insurance, public assistance, emergency prioritization.<\/li>\n\n\n\n<li><strong>Security and law enforcement.<\/strong><\/li>\n\n\n\n<li><strong>Migration, asylum, and border control.<\/strong><\/li>\n\n\n\n<li><strong>Administration of justice and democratic processes.<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">If your system\u2014or your client's\u2014does anything similar to this, it should raise a red flag.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">The nuance that could save you<\/h2>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">Being on Annex III doesn't automatically condemn you. The Regulation adds a safety valve: a system on that list <strong>won't be considered high-risk if it doesn't pose a significant risk<\/strong> to health, safety, or rights. For example, if it only performs a<strong> very specific procedural task<\/strong>, if it merely <strong>improves the outcome<\/strong> of a completed human activity, or if it <strong>detects deviations<\/strong> without replacing human judgment.<\/p>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">However, beware of the exception to the exception: if the system <strong>creates profiles of individuals<\/strong>, it is always considered high-risk. No exceptions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What it means to be involved<\/h2>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">If your system is high-risk, it's not enough for it to \"work well\": <strong>you have to demonstrate and document it<\/strong>. Risk management system, data quality control, technical documentation, activity logs, transparency towards users, <strong>human oversight<\/strong> that is real, and adequate levels of accuracy, robustness, and cybersecurity. Added to this is conformity assessment, CE marking, and registration in the European database.<\/p>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">And the obligations are divided: it's not the same to be the <strong>supplier<\/strong> who develops the system as it is to be the <strong>one responsible for the deployment<\/strong> that uses it. It's important to know where you stand.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to know in practice<\/h2>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">To clear up any doubts, ask yourself\u2014or your client\u2014these questions:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Is the AI in, or integrated into, <strong>an already regulated product<\/strong> (healthcare, machine, vehicle, etc.)?<\/li>\n\n\n\n<li>Is it used in any of the areas in <strong>Annex III <\/strong>(employment, credit, education, biometrics, etc.)?<\/li>\n\n\n\n<li>Does it make or influence decisions that<strong> affect people's rights<\/strong>?<\/li>\n\n\n\n<li><strong>Does it create profiles?<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">If you answer \"yes\" to several, be prepared: you're most likely at high risk.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">You have less time than it seems<\/h2>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">These obligations aren't science fiction or a \"someday\" problem. For the systems in <strong>Annex III<\/strong>, the bulk of the requirements apply from <strong>August 2, 2026<\/strong>; for those embedded in regulated products, from <strong>August 2, 2027<\/strong>. It seems far off, but<strong> adapting a high-risk system\u2014documenting it, auditing it, redesigning its oversight\u2014takes months, not weeks<\/strong>.<\/p>\n\n\n\n<p class=\"lgl-indent wp-block-paragraph\">Knowing whether your system is high-risk isn't a technicality: it's the question that determines how much of the Regulation applies to you. And like almost everything at the intersection of law and technology, the sooner you ask yourself this question, the cheaper the answer will be.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity lgl-sep\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">Sources<\/h3>\n\n\n\n<ul class=\"wp-block-list lgl-fuentes\">\n<li>Regulation (EU) 2024\/1689 \u2014 official text (EUR-Lex): <a target=\"_blank\" rel=\"noopener\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/ES\/TXT\/?uri=CELEX:32024R1689\">eur-lex.europa.eu<\/a><\/li>\n\n\n\n<li>Official summary \"Rules for trustworthy AI in the EU\" (EUR-Lex): <a target=\"_blank\" rel=\"noopener\" href=\"https:\/\/eur-lex.europa.eu\/ES\/legal-content\/summary\/rules-for-trustworthy-artificial-intelligence-in-the-eu.html\">eur-lex.europa.eu\/summary<\/a><\/li>\n<\/ul>\n\n\n\n<style>.lgl-indent{text-indent:2em;}.lgl-fuentes a{color:#1155cc;text-decoration:underline;}.lgl-sep{margin-top:3rem !important;}<\/style>","protected":false},"excerpt":{"rendered":"<p>El Reglamento de IA no proh\u00edbe la inteligencia artificial. Hace algo m\u00e1s sutil y m\u00e1s exigente: la ordena por niveles de riesgo. Y hay un caj\u00f3n, el de los sistemas de IA de alto riesgo, donde se concentra casi toda la letra peque\u00f1a, casi todas las obligaciones y casi todos los dolores de cabeza. El [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":443,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[30],"tags":[],"class_list":["post-442","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-reglamento-ia"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Sistemas de IA de alto riesgo: c\u00f3mo saber si el tuyo lo es<\/title>\n<meta name=\"description\" content=\"\u00bfTu sistema de IA es de alto riesgo seg\u00fan el Reglamento de IA? 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