{"id":3109,"date":"2024-06-07T07:12:47","date_gmt":"2024-06-07T07:12:47","guid":{"rendered":"https:\/\/healthlab.nrw\/ai-in-healthcare\/"},"modified":"2025-04-09T14:43:10","modified_gmt":"2025-04-09T14:43:10","slug":"ai-in-healthcare","status":"publish","type":"page","link":"https:\/\/healthlab.nrw\/en\/ai-in-healthcare\/","title":{"rendered":"AI in Healthcare"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;2&#8243; back_color=&#8221;color-428319&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;185530&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;mobile-full&#8221;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-121267&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;141725&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column_text text_color=&#8221;color-173812&#8243; uncode_shortcode_id=&#8221;174821&#8243; text_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;kruimelpad&#8221;]<a href=\"https:\/\/healthlab.nrw\/en\/academy\/companies\/\">back to the course overview<\/a>[\/vc_column_text][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;496879&#8243;]<\/p>\n<h2>AI in Healthcare<\/h2>\n<p><strong>Specific Requirements for Software as Medical Device Using AI<\/strong><\/p>\n<p>If a (digital) medical device uses artificial intelligence (AI) in performance- or safety-relevant parts, additional AI-specific requirements apply to the Quality Management System (QMS) and Technical Documentation (TD). Although the MDR does not explicitly mention AI, such requirements can already be derived from the current state of the art. In the near future, explicit regulatory requirements will be introduced through the EU AI Act. This course outlines current QMS and TD requirements, presents the expectations of Notified Bodies, and looks ahead to what the EU AI Act will bring and how to prepare.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_single_image media=&#8221;2679&#8243; media_width_use_pixel=&#8221;yes&#8221; alignment=&#8221;center&#8221; uncode_shortcode_id=&#8221;325128&#8243; media_width_pixel=&#8221;500&#8243;][\/vc_column_inner][\/vc_row_inner][vc_raw_html]PGgzIGNsYXNzPSJpbmxpbmUtaDMiPkNvdXJzZSBDb250ZW50PC9oMz48c3BhbiBjbGFzcz0ia3Vyc21vZHVsZSI+NCBDb3Vyc2UgTW9kdWxlczwvc3Bhbj4KPHA+U2VsZi1wYWNlZCBkaWdpdGFsIG1vZHVsZXMgd2l0aCBhIGZpbmFsIFEmYW1wO0Egc2Vzc2lvbiBsZWQgYnkgaW5kdXN0cnkgZXhwZXJ0cy48L3A+[\/vc_raw_html][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;115281&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs01&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;239732&#8243;]<strong>Requirements for Medical Devices Using AI<br \/>\n<\/strong>This module explains how AI is defined, when AI usage triggers additional requirements, what these are, and where they originate\u2014from Notified Bodies\u2019 expectations and the upcoming EU AI Act.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;612150&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs02&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;520392&#8243;]<strong>Requirements in the Early Development Phase<br \/>\n<\/strong>Covers requirements to consider early in development, such as human oversight of AI, setting clinically relevant performance parameters, proof planning, and AI-specific risk management.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;129606&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs03&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;726569&#8243;]<strong>The Path to Conformity Assessment<br \/>\n<\/strong>Describes how QMS and TD must be expanded to include AI-specific content: data management, AI training, and validation activities. These are then reviewed by a Notified Body.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;757952&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs04&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;645177&#8243;]<strong>Deployment and Maintenance<br \/>\n<\/strong>AI-specific requirements don\u2019t stop after product launch. Post-market surveillance and ongoing maintenance\u2014especially for continuously learning AI\u2014are also regulated. This includes additional duties for manufacturers who also operate the devices.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;109788&#8243; el_class=&#8221;border-kurse&#8221;][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;483731&#8243;]<\/p>\n<h3 class=\"h4\">Q&amp;A Session<\/h3>\n<p>Interactive session to discuss questions with instructors.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;208887&#8243;]<\/p>\n<h3 class=\"h4\">Methods<\/h3>\n<ul class=\"plus-orange\">\n<li>Web lectures<\/li>\n<li>Practical tutorials<\/li>\n<li>Supporting literature and course script<\/li>\n<li>Templates and real-life examples<\/li>\n<li>Live Q&amp;A with industry experts<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;109788&#8243; el_class=&#8221;border-kurse&#8221;][vc_column_inner width=&#8221;1\/1&#8243;][vc_column_text uncode_shortcode_id=&#8221;137445&#8243;]<\/p>\n<h3 class=\"h4\">Target Audience<\/h3>\n<p>This course is designed for everyone involved in the development and commercialization of digital health solutions, including:<\/p>\n<ul class=\"plus-orange\">\n<li>Founders<\/li>\n<li>Software developers and architects<\/li>\n<li>Project managers<\/li>\n<li>Regulatory affairs and quality management professionals<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;207849&#8243; el_class=&#8221;border-kurse&#8221;][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;269530&#8243;]<\/p>\n<h3 class=\"h4\">Instructor<\/h3>\n<p>[\/vc_column_text][vc_column_text uncode_shortcode_id=&#8221;105247&#8243;]<\/p>\n<div class=\"image-caption-container\"><img decoding=\"async\" class=\"alignnone size-full wp-image-2661\" src=\"https:\/\/healthlab.nrw\/wp-content\/uploads\/2024\/06\/achim-mayer.png\"><span class=\"caption\"><strong>Dr. Achim Mayer<\/strong><br \/>\nCE plus | regenold GmbH, Badenweiler<\/span><\/div>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_visibility=&#8221;yes&#8221; medium_width=&#8221;0&#8243; mobile_visibility=&#8221;yes&#8221; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;168987&#8243;][\/vc_column_inner][\/vc_row_inner][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;661073&#8243; el_class=&#8221;max-560&#8243;][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;298994&#8243;]<\/p>\n<h3 class=\"h4\">Investment<\/h3>\n<p>\u20ac299 excl. VAT[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_button button_color=&#8221;color-173812&#8243; size=&#8221;btn-lg&#8221; hover_fx=&#8221;full-colored&#8221; border_width=&#8221;0&#8243; scale_mobile=&#8221;no&#8221; button_color_type=&#8221;uncode-palette&#8221; uncode_shortcode_id=&#8221;845250&#8243; link=&#8221;url:mailto%3Aacademy%40healthlab.nrw%3Fsubject%3DMeine%2520Anmeldung%2520zum%2520Onlinekurs%2520KI%2520im%2520Gesundheitswesen%26amp%3Bbody%3DBitte%2520Namen%2C%2520Telefonnummer%2520und%2520Rechnungsadresse%2520angeben.%2520Die%2520Investition%2520pro%2520Person%2520ist%2520299%2520Euro.|&#8221;]Sign up now[\/vc_button][\/vc_column_inner][\/vc_row_inner][vc_column_text text_lead=&#8221;small&#8221; el_class=&#8221;buttoninfo&#8221; uncode_shortcode_id=&#8221;160209&#8243;]<\/p>\n<p style=\"text-align: center;\"><strong>Enrollment possible at any time<\/strong><\/p>\n<p>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;2&#8243; back_color=&#8221;color-428319&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;185530&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;mobile-full&#8221;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-121267&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":138,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3109","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>AI in Healthcare<\/title>\n<meta name=\"description\" content=\"If a (digital) medical device uses artificial intelligence (AI) in performance- or safety-relevant parts, additional AI-specific requirements...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/healthlab.nrw\/en\/ai-in-healthcare\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AI in Healthcare\" 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