{"id":10039,"date":"2020-10-09T09:52:37","date_gmt":"2020-10-09T14:52:37","guid":{"rendered":"https:\/\/saluddigital.com\/?p=10039"},"modified":"2025-10-19T23:38:26","modified_gmt":"2025-10-20T05:38:26","slug":"como-se-encuentran-reguladas-las-aplicaciones-de-salud-digital-en-alemania","status":"publish","type":"post","link":"https:\/\/saluddigital.com\/en\/plataformas-digitales\/como-se-encuentran-reguladas-las-aplicaciones-de-salud-digital-en-alemania\/","title":{"rendered":"How are digital health apps regulated in Germany?"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"10039\" class=\"elementor elementor-10039\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c9f7cd6 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no\" data-id=\"c9f7cd6\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-12415b6\" data-id=\"12415b6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-893c349 elementor-widget elementor-widget-heading\" data-id=\"893c349\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The Federal Institute for Drugs and Medical Devices (BfArM), Germany, is the body responsible for regulating digital mobile applications in that country.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-71d38de elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no\" data-id=\"71d38de\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d37aea2\" data-id=\"d37aea2\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4f004de elementor-widget elementor-widget-text-editor\" data-id=\"4f004de\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Germany has a directory of digital health applications (DiGA in German Digitale Gesundheitsanwendungen). The BfArM is the body that carries out the DiGA procedures for inclusion in this directory.<\/p><p>\u00a0<\/p><p>A DiGA is a medical device that must have the CE marking of European conformity, which considers the following points:<\/p><p>\u00a0<\/p><ul><li>Its functionality is based on digital technologies.<\/li><li>The medical purpose is achieved primarily through its digital function.<\/li><li>Supports the recognition, monitoring, treatment or alleviation of illness, or compensation for injury or disability.<\/li><li>It is used solely by the patient or is used in collaboration with the patient and the doctor.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-458df0d elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no\" data-id=\"458df0d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-a6a1f4f\" data-id=\"a6a1f4f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-82b519c elementor-widget elementor-widget-image\" data-id=\"82b519c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1200\" height=\"630\" src=\"https:\/\/saluddigital.com\/wp-content\/uploads\/2020\/10\/Aplicaciones-de-salud-digital-en-Alemania.jpg\" class=\"attachment-full size-full wp-image-10040\" alt=\"\" srcset=\"https:\/\/saluddigital.com\/wp-content\/uploads\/2020\/10\/Aplicaciones-de-salud-digital-en-Alemania.jpg 1200w, https:\/\/saluddigital.com\/wp-content\/uploads\/2020\/10\/Aplicaciones-de-salud-digital-en-Alemania-660x347.jpg 660w, https:\/\/saluddigital.com\/wp-content\/uploads\/2020\/10\/Aplicaciones-de-salud-digital-en-Alemania-768x403.jpg 768w, https:\/\/saluddigital.com\/wp-content\/uploads\/2020\/10\/Aplicaciones-de-salud-digital-en-Alemania-840x441.jpg 840w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-76fbb5c\" data-id=\"76fbb5c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-98f641f elementor-widget elementor-widget-text-editor\" data-id=\"98f641f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In addition, it has a legal basis in the Digital Healthcare Act and the DiGA Ordinance. The first one came into force in December 2019, and it included the issue of medical prescription, which implies that the more than 70 million people insured by German insurance can use a DiGA prescribed by doctors or psychotherapists and the expenses will be cutlery.<\/p><p>The procedures to validate a DiGA are for a maximum period of three months. The evaluation consists of the qualities of the product described by the manufacturer, examination of clinical evidence of a positive effect on medical care, and the protection of user data, as well as interoperability and ease of use.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-fa4d1e5 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no\" data-id=\"fa4d1e5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ace48ae\" data-id=\"ace48ae\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a3bb73f elementor-widget elementor-widget-text-editor\" data-id=\"a3bb73f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Manufacturers are provided with a guide on the requirements for the inclusion of innovations in the DiGA directory, in this way they promote comprehensive support to applicants and that the projects to be evaluated meet the requirements from that first instance.<\/p><p>In addition, from the beginning the BfArM provides the evaluation criteria and how the normative specifications will be interpreted according to the laws in force, in this way, they seek transparency in the process.<\/p><p>For Latin American countries, the case of Germany can be taken as one of the examples that exists in the European Union for the regulation and control of mobile medical applications and other devices.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ea1b89c elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no\" data-id=\"ea1b89c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-08309e5\" data-id=\"08309e5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-57b07f8 elementor-widget elementor-widget-toggle\" data-id=\"57b07f8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-9191\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-9191\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-caret-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-caret-up\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">BIBLIOGRAPHY<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-9191\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-9191\"><p><strong>FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES <\/strong><\/p><p><a href=\"https:\/\/www.bfarm.de\/EN\/MedicalDevices\/DiGA\/_node.html\">https:\/\/www.bfarm.de\/EN\/MedicalDevices\/DiGA\/_node.html<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>El Instituto Federal de Medicamentos y Dispositivos M\u00e9dicos (BfArM), de Alemania, es el organismo encargado de regular las aplicaciones m\u00f3viles digitales en dicho pa\u00eds. Alemania cuenta con un directorio de aplicaciones digitales en salud (DiGA en alem\u00e1n Digitale Gesundheitsanwendungen). El BfArM es el organismo que lleva los procedimientos de las DiGA para incluirlas en este directorio. Una DiGA es un dispositivo m\u00e9dico que debe contar con el marcado CE de conformidad europea, el cual considera los siguientes puntos: Su funcionalidad se basa en tecnolog\u00edas digitales. El prop\u00f3sito m\u00e9dico se logra principalmente a trav\u00e9s de su funci\u00f3n digital. Apoya el reconocimiento, seguimiento, tratamiento o alivio de enfermedades, o compensaci\u00f3n de lesiones o discapacidades. Es utilizado \u00fanicamente por el paciente o es utilizado en colaboraci\u00f3n con el paciente y el m\u00e9dico. Adem\u00e1s, cuenta con una base legal en la Ley de atenci\u00f3n medica digital y la Ordenanza sobre DiGA. La primera entro en vigor en diciembre de 2019, y en ella se incluy\u00f3 el tema de la prescripci\u00f3n m\u00e9dica, lo que implica que los m\u00e1s de 70 millones de asegurados por el seguro alem\u00e1n pueden utilizar una DiGA recetada por m\u00e9dicos o psicoterapeutas y los gastos estar\u00e1n cubiertos. Los procedimientos para validar una DiGA, son de un plazo m\u00e1ximo de tres meses. La evaluaci\u00f3n consiste en las cualidades del producto descritas por el fabricante, examen de evidencia cl\u00ednica de un efecto positivo en la atenci\u00f3n m\u00e9dica, y la protecci\u00f3n de datos del usuario, as\u00ed como la interoperabilidad y facilidad de uso. A los fabricantes se les proporciona una gu\u00eda sobre los requisitos para la inclusi\u00f3n de innovaciones al directorio DiGA, de esta forma promueven el apoyo integral a los solicitantes y que los proyectos a evaluar cumplan con los requisitos desde esa primera instancia. Adem\u00e1s, desde el inicio la BfArM proporciona los criterios de evaluaci\u00f3n y como se interpretar\u00e1n las especificaciones normativas de acuerdo a las leyes vigentes, de esta forma, buscan transparencia en el proceso. Para los pa\u00edses latinoamericanos, el caso de Alemania puede ser tomado como uno de los ejemplos que existe en la Uni\u00f3n Europea para la regulaci\u00f3n y el control de las aplicaciones m\u00f3viles m\u00e9dicas y otros dispositivos. BIBLIOGRAF\u00cdA FEDERAL INSTITUE FOR DRUGS AND MEDICAL DEVICES https:\/\/www.bfarm.de\/EN\/MedicalDevices\/DiGA\/_node.html<\/p>","protected":false},"author":1,"featured_media":10040,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[154,153],"tags":[145],"class_list":["post-10039","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-comunidades-conectadas","category-plataformas-digitales","tag-noticias"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/10039","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/comments?post=10039"}],"version-history":[{"count":0,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/10039\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media\/10040"}],"wp:attachment":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media?parent=10039"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/categories?post=10039"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/tags?post=10039"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}