{"id":14269,"date":"2020-01-28T14:30:00","date_gmt":"2020-01-28T13:30:00","guid":{"rendered":"https:\/\/www.viafirma.com\/blog-xnoccio\/que-es-consentimiento-informado-y-como-se-firma\/"},"modified":"2026-07-24T10:27:22","modified_gmt":"2026-07-24T08:27:22","slug":"what-are-informed-consents-and-how-can-they-be-esigned","status":"publish","type":"post","link":"https:\/\/www.viafirma.com\/en\/what-are-informed-consents-and-how-can-they-be-esigned\/","title":{"rendered":"What are informed consents and how can they be eSigned?"},"content":{"rendered":"\r\n<p class=\"wp-block-paragraph\">At present, every sector is transforming its document management system through the use of electronic signatures, and the healthcare sector is no exception. Informed consent forms, medical records and the signing of contracts for medical staff are just some of the documents that are now signed digitally to optimise efficiency without compromising legal certainty.<\/p>\r\n<p>Among these, the informed consent form is the document that ensures respect for the patient\u2019s autonomy in medical decision-making, but having it signed by hand results in countless hours wasted, high storage costs and an unmanageable volume of paper. Hence the need to make the switch to digital tools.<\/p>\r\n<p>In this guide, we detail the regulatory requirements this document must meet under Spanish law, when its use in written form is mandatory, and how Viafirma\u2019s digital signature solutions enable these documents to be secured with full legal guarantees and zero paper.<\/p>\r\n<h2>What is informed consent?<\/h2>\r\n<p>Informed consent is a medical procedure that guarantees respect for the patient\u2019s autonomy, allowing them to make decisions about their medical care. It is a legal right of the patient and an obligation for healthcare professionals (doctors, nurses, anaesthetists, etc.).<\/p>\r\n<h3>When is informed consent required?<\/h3>\r\n<p>Informed consent is not always required. For simple procedures, such as a physical examination of the patient, consent may be implied and tacit. However, for <strong>invasive procedures<\/strong>, those involving <strong>significant risk<\/strong>, or<strong> those where alternatives are available<\/strong>, written consent must be obtained.<\/p>\r\n<p>This document is an <strong>obligation for healthcare providers<\/strong> (doctors, nurses, anaesthetists, etc.) and a <strong>legal right of the patient<\/strong>, ensuring they understand the risks and options before making a decision. Therefore, informed consent<strong> requires at least two signatures<\/strong>: that of the patient and that of the healthcare professional (depending on the number of professionals involved, one or more people must sign).<\/p>\r\n<h3>What requirements must informed consent meet?<\/h3>\r\n<p>In accordance with the General Data Protection Regulation (GDPR), for informed consent to be considered as such, it must meet <strong>four requirements<\/strong>:<\/p>\r\n<ul>\r\n<li><strong>Free<\/strong>: The person giving consent must do so freely. In other words, they must be able to accept or refuse to give consent; if they choose the latter, it must be guaranteed that there will be no negative consequences for that person.<\/li>\r\n<li><strong>Specific<\/strong>: The information provided must be used solely and exclusively for the purposes for which consent has been given. These conditions must not be altered or extended once the document has been signed.<\/li>\r\n<li><strong>Granular<\/strong>: There must be an option to give or withhold consent for each specific purpose for which the data is provided. Furthermore, an informed consent form must include certain sections: necessity, duration, purpose, rights and details of the data controllers.<\/li>\r\n<li><strong>Verifiable<\/strong>: The entire content of the consent must be verifiable and cross-checkable at any time as required. This provides all the necessary legal safeguards, as the details of the consent can be consulted; these details will remain unchanged once the document has been signed.<\/li>\r\n<\/ul>\r\n<h3>What aspects must the informed consent include?<\/h3>\r\n<p>Law 41\/2002 sets out the minimum <strong>elements that informed consent must contain<\/strong>:<\/p>\r\n<ul>\r\n<li>The relevant or significant consequences that the procedure is certain to entail.<\/li>\r\n<li>The risks related to the patient\u2019s personal or professional circumstances.<\/li>\r\n<li>Risks that are likely to occur under normal conditions, based on experience and the current state of scientific knowledge, or those directly related to the type of procedure.<\/li>\r\n<li>Contraindications.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" class=\"wp-image-12470\" src=\"https:\/\/www.viafirma.com\/wp-content\/uploads\/2019\/10\/Firma-digital-en-el-sector-sanitario.jpg\" alt=\"Firma consentimiento informado\" \/><\/figure>\r\n\r\n\r\n\r\n<p class=\"wp-block-paragraph\">&nbsp;<\/p>\r\n<h2>Spanish legislation on informed consent<\/h2>\r\n<p>As we have seen, everything relating to what informed consent must contain is duly regulated at both Spanish and European level; the two sets of regulations are fully compatible.<\/p>\r\n<p>In Spain, informed consent is governed by <a href=\"https:\/\/www.boe.es\/buscar\/act.php?id=BOE-A-2002-22188\" target=\"_blank\" rel=\"noopener\">Law 41\/2002<\/a> and <a href=\"https:\/\/www.boe.es\/buscar\/doc.php?id=BOE-A-2007-12945\" target=\"_blank\" rel=\"noopener\">Law 14\/2007 on Biomedical Research<\/a>, which establish that it is mandatory in various areas and healthcare processes. Through informed consent, the patient confirms that they have received and understood all the information provided by the healthcare professional regarding the proposed treatment. However, there may be certain situations in which it is not the patient who signs the consent form, but rather a legal representative:<\/p>\r\n<ul>\r\n<li>If the patient is declared<strong> legally incapable<\/strong> by a judge.<\/li>\r\n<li><span style=\"font-size: 16px;\">If the patient is <strong>under 16 years of age<\/strong> and is not intellectually or emotionally incapacitated.<\/span>\r\n<ul>\r\n<li><span style=\"font-size: 16px;\">If the minor <strong>has reached the age of 12<\/strong>, consent shall be given by the minor\u2019s legal representative after hearing the minor\u2019s opinion.<\/span><\/li>\r\n<\/ul>\r\n<\/li>\r\n<li><span style=\"font-size: 16px;\">If the minor <strong>is over 16 years of age or has been emancipated<\/strong> and the situation involves a <strong>serious risk<\/strong>, the views of the parents or legal representatives will be taken into account.<\/span><\/li>\r\n<li><span style=\"font-size: 16px;\">If the patient is <strong>unable to make decisions<\/strong>, whether due to their physical or mental condition.<\/span><\/li>\r\n<\/ul>\r\n<p>It is very common for this consent to be given verbally; however, in certain specific cases, Law 41\/2002 requires it to be given in writing in situations such as:<\/p>\r\n<ul>\r\n<li><strong>Surgical<\/strong> procedures.<\/li>\r\n<li><strong>Diagnostic techniques and invasive treatments.<\/strong><\/li>\r\n<li>Where there is a <strong>significant and foreseeable risk<\/strong> to the patient or where the outcome of the procedure is uncertain.<\/li>\r\n<\/ul>\r\n<p>There are also situations in which <strong>the requirement to sign an informed consent form is waived<\/strong>:<\/p>\r\n<ul>\r\n<li>Where the patient expresses in writing <strong>their wish not to receive the information<\/strong>.<\/li>\r\n<li>Where <strong>there is a risk to public health<\/strong> for health reasons established by law.<\/li>\r\n<li>Where there is a <strong>serious and immediate risk<\/strong> to the patient\u2019s physical or mental well-being and it is not possible to obtain their authorisation, consulting, where circumstances permit, their family members or those with whom they have a de facto relationship.<\/li>\r\n<\/ul>\r\n<h2>Digital signatures for informed consent forms<\/h2>\r\n<p>Informed consent forms are usually several pages long and cover information and risks; given the large number of consent forms generated every day, this is undoubtedly a good starting point for <strong>going paperless<\/strong>.<\/p>\r\n<p>Healthcare professionals can easily sign using a <strong>digital certificate<\/strong>. However, for patients, who may not have a certificate or know how to use one, a digitalised signature is used, which biometrically captures the patient\u2019s handwritten signature and inserts it into the electronic document, storing legal evidence that guarantees the document\u2019s legal validity.<\/p>\r\n<p>Signing these documents provides the signatory with <strong>evidence of informed decision-making regarding their care<\/strong>, thereby respecting their freedom of choice. These documents also <strong>protect healthcare professionals<\/strong>, <strong>as they guarantee transparency, honesty and respect for the signatory\u2019s dignity and rights<\/strong>.<\/p>\r\n<h2>Sign your informed consent documents with Viafirma<\/h2>\r\n<p>If you work in the <a href=\"https:\/\/www.viafirma.com\/en\/category\/blog-en\/health-sector-en\/\">healthcare sector<\/a> or with medical staff and need to sign informed consent documents on technology platforms or using your own software and templates, Viafirma\u2019s solution is for you. We offer in-house <strong>digital solutions that streamline the digital signing of informed consent forms,<\/strong> whether on-site or remotely, using other types of electronic signatures available through our tools.<\/p>\r\n<p>Would you like to find out more? Our consultancy team can help you implement these documents digitally. <a href=\"https:\/\/www.viafirma.com\/en\/contact\/\">Contact us<\/a> and we\u2019ll provide you with detailed information.<\/p>\r\n<p><span style=\"font-weight: 400;\"><div class=\"vf_related_posts_wrapper\"><h2 class=\"vf_related_posts_title\">Informaci\u00f3n relacionada<\/h2><div class=\"vf_related_posts\"><article class=\"vc_gitem-post-data-source-post\"><a href=\"https:\/\/www.viafirma.com\/en\/doctors\/\"><div class=\"vc_gitem-post-image\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"476\" src=\"https:\/\/www.viafirma.com\/wp-content\/uploads\/2024\/01\/blog_salud-1024x634-1-768x476.webp\" class=\"attachment-medium_large size-medium_large wp-post-image\" alt=\"blog_salud-1024x634\" srcset=\"https:\/\/www.viafirma.com\/wp-content\/uploads\/2024\/01\/blog_salud-1024x634-1-768x476.webp 768w, https:\/\/www.viafirma.com\/wp-content\/uploads\/2024\/01\/blog_salud-1024x634-1-300x186.webp 300w, https:\/\/www.viafirma.com\/wp-content\/uploads\/2024\/01\/blog_salud-1024x634-1.webp 1024w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/div><\/a><div class=\"vc_gitem-post-data\"><h3 class=\"vc_gitem-post-data-source-post_title\"><a href=\"https:\/\/www.viafirma.com\/en\/doctors\/\">Electronic signature for doctors<\/a><\/h3><p>Do you work as administrative staff in a medical center<\/p><\/div><\/article><article class=\"vc_gitem-post-data-source-post\"><a href=\"https:\/\/www.viafirma.com\/en\/electronic-prescription\/\"><div class=\"vc_gitem-post-image\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"512\" src=\"https:\/\/www.viafirma.com\/wp-content\/uploads\/2021\/08\/Medico-trabajando-768x512.webp\" class=\"attachment-medium_large size-medium_large wp-post-image\" alt=\"medico-trabajando\" srcset=\"https:\/\/www.viafirma.com\/wp-content\/uploads\/2021\/08\/Medico-trabajando-768x512.webp 768w, https:\/\/www.viafirma.com\/wp-content\/uploads\/2021\/08\/Medico-trabajando-300x200.webp 300w, https:\/\/www.viafirma.com\/wp-content\/uploads\/2021\/08\/Medico-trabajando-1024x683.webp 1024w, https:\/\/www.viafirma.com\/wp-content\/uploads\/2021\/08\/Medico-trabajando.webp 1350w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/div><\/a><div class=\"vc_gitem-post-data\"><h3 class=\"vc_gitem-post-data-source-post_title\"><a href=\"https:\/\/www.viafirma.com\/en\/electronic-prescription\/\">Electronic prescription<\/a><\/h3><p>Are you wondering how the electronic prescription works? This project was a pioneer in terms of electronic identity and signature,&hellip;<\/p><\/div><\/article><article class=\"vc_gitem-post-data-source-post\"><a href=\"https:\/\/www.viafirma.com\/en\/patient-intake-forms\/\"><div class=\"vc_gitem-post-image\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"475\" src=\"https:\/\/www.viafirma.com\/wp-content\/uploads\/2025\/01\/140125_blog_formulario-1-768x475.webp\" class=\"attachment-medium_large size-medium_large wp-post-image\" alt=\"Healthcare professional reviewing digitized patient intake forms to optimize their care\" srcset=\"https:\/\/www.viafirma.com\/wp-content\/uploads\/2025\/01\/140125_blog_formulario-1-768x475.webp 768w, https:\/\/www.viafirma.com\/wp-content\/uploads\/2025\/01\/140125_blog_formulario-1-300x186.webp 300w, https:\/\/www.viafirma.com\/wp-content\/uploads\/2025\/01\/140125_blog_formulario-1-1024x634.webp 1024w, https:\/\/www.viafirma.com\/wp-content\/uploads\/2025\/01\/140125_blog_formulario-1.webp 1228w\" sizes=\"auto, (max-width: 768px) 100vw, 768px\" \/><\/div><\/a><div class=\"vc_gitem-post-data\"><h3 class=\"vc_gitem-post-data-source-post_title\"><a href=\"https:\/\/www.viafirma.com\/en\/patient-intake-forms\/\">Patient Intake Forms<\/a><\/h3><p>Everything you need to know about patient intake forms<\/p><\/div><\/article><\/div><\/div><\/span><\/p>\r\n\r\n\r\n","protected":false},"excerpt":{"rendered":"At present, every sector is transforming its document management system...","protected":false},"author":1,"featured_media":55682,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[172],"class_list":["post-14269","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-sector-en"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.viafirma.com\/en\/wp-json\/wp\/v2\/posts\/14269","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.viafirma.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.viafirma.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.viafirma.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.viafirma.com\/en\/wp-json\/wp\/v2\/comments?post=14269"}],"version-history":[{"count":2,"href":"https:\/\/www.viafirma.com\/en\/wp-json\/wp\/v2\/posts\/14269\/revisions"}],"predecessor-version":[{"id":102891,"href":"https:\/\/www.viafirma.com\/en\/wp-json\/wp\/v2\/posts\/14269\/revisions\/102891"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.viafirma.com\/en\/wp-json\/wp\/v2\/media\/55682"}],"wp:attachment":[{"href":"https:\/\/www.viafirma.com\/en\/wp-json\/wp\/v2\/media?parent=14269"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.viafirma.com\/en\/wp-json\/wp\/v2\/categories?post=14269"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}