{"id":14255,"date":"2026-04-18T07:35:24","date_gmt":"2026-04-18T05:35:24","guid":{"rendered":"https:\/\/okomeds.com\/?p=14255"},"modified":"2026-03-27T07:38:29","modified_gmt":"2026-03-27T06:38:29","slug":"risk-ai-medical-translation","status":"publish","type":"post","link":"https:\/\/okomeds.com\/es\/risk-ai-medical-translation\/","title":{"rendered":"What legal risk do you face when using AI to translate medical documents?"},"content":{"rendered":"<p>Artificial intelligence has become a common tool in content translation, including in the healthcare sector. However, when it comes to medical documentation, the margin for error becomes a clinical and legal risk. And more and more regulatory bodies are focusing on this.<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><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><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/okomeds.com\/es\/risk-ai-medical-translation\/#The_false_sense_of_security_created_by_AI\" >The false sense of security created by AI<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/okomeds.com\/es\/risk-ai-medical-translation\/#When_language_directly_affects_patient_safety\" >When language directly affects patient safety<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/okomeds.com\/es\/risk-ai-medical-translation\/#Regulatory_and_compliance_risks\" >Regulatory and compliance risks<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/okomeds.com\/es\/risk-ai-medical-translation\/#AI_can_help_but_only_under_expert_control\" >AI can help, but only under expert control<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"The_false_sense_of_security_created_by_AI\"><\/span><strong>The false sense of security created by AI<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The rise of AI has led many companies to automate translation processes without reviewing their suitability. According to the European Medicines Agency, all documentation submitted in regulatory processes must be \u00abclear, precise and scientifically accurate\u00bb, especially for materials aimed at patients. This includes informed consent forms, technical information sheets and leaflets. A translation that does not respect these criteria may lead to rejection in authorisation processes.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"When_language_directly_affects_patient_safety\"><\/span><strong>When language directly affects patient safety<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The World Health Organization has pointed out in several reports on patient safety that communication errors are one of the most common causes of preventable clinical incidents.<\/p>\n<p>In the field of medical translation, this translates into problems such as:<\/p>\n<ul>\n<li>Incorrect interpretation of symptoms or side effects<\/li>\n<li>Ambiguous clinical instructions<\/li>\n<li>Loss of relevant nuances in the patient\u2019s medical history<\/li>\n<\/ul>\n<p>These errors can lead to inappropriate medical decisions or delays in treatment.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Regulatory_and_compliance_risks\"><\/span><strong>Regulatory and compliance risks<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>In Europe, regulations require medical information to be understandable to the patient. The EMA states that texts must be linguistically validated and adapted to the target audience.<\/p>\n<p>In addition, the use of automated tools raises data protection concerns. The General Data Protection Regulation (GDPR) requires specific guarantees when handling health data, considered especially sensitive.<\/p>\n<p>The use of uncontrolled AI platforms may involve data transfers outside a secure environment, which poses a significant legal risk.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"AI_can_help_but_only_under_expert_control\"><\/span><strong>AI can help, but only under expert control<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>AI can be useful as support in translation processes, but it does not replace specialised human validation. In environments such as pharmacovigilance or clinical trials, where terminology must conform to standards such as MedDRA, the involvement of experts is essential.<\/p>\n<p>The challenge is not to avoid technology, but to properly integrate it into controlled processes. Because in the medical field, a translation not only has to be correct: it has to be reliable, verifiable and safe.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Artificial intelligence has become a common tool in content translation, including in the healthcare sector. However, when it comes to medical documentation, the margin for error becomes a clinical and legal risk. And more and more regulatory bodies are focusing on this. The false sense&#8230;<\/p>\n","protected":false},"author":13,"featured_media":14256,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[6],"tags":[],"class_list":["post-14255","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-translations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>What legal risk do you face when using AI to translate medical documents? - Okomeds<\/title>\n<meta name=\"description\" content=\"Real risks of using AI in medical translation according to the EMA, WHO and European regulations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/okomeds.com\/risk-ai-medical-translation\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What legal risk do you face when using AI to translate medical documents? 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