{"id":10694,"date":"2022-10-28T10:44:00","date_gmt":"2022-10-28T08:44:00","guid":{"rendered":"https:\/\/www.uni.lu\/lcsb-en\/?post_type=news&#038;p=10694"},"modified":"2025-02-25T10:46:58","modified_gmt":"2025-02-25T09:46:58","slug":"toward-european-roadmap-for-the-evaluation-of-digital-medical-devices","status":"publish","type":"news","link":"https:\/\/www.uni.lu\/lcsb-en\/news\/toward-european-roadmap-for-the-evaluation-of-digital-medical-devices\/","title":{"rendered":"Toward European roadmap for the evaluation of digital medical devices"},"content":{"rendered":"\n<section class=\"wp-block-unilux-blocks-free-section section\"><div class=\"container xl:max-w-screen-xl\">\n\n<p>The World Health Organisation currently lists more than 2 million devices with a medical purpose. These innovative health technologies are transforming the medical landscape. They have the potential to improve healthcare for patients, providers and payers but are also disrupting the European regulatory landscape. Although the integration of these technologies is a strategic priority for Europe, there is currently no harmonised framework for their evaluation and use. There is now a clear need for a consistent quality labelling to help citizens identify digital medical devices fulfilling basic medical standards and privacy criteria. This is why a new European taskforce was recently launched to address the issue.\u00a0<\/p>\n\n\n<p>The objective of this taskforce is to define a common nomenclature for the different types of digital medical devices and to work on a harmonised process for their clinical evaluation as well as a proper regulatory framework at the European level. \u201cWe want to reach a consensus between competent agencies in several countries as it will facilitate the accessibility of these health technologies across Europe and should reduce barriers to market entry and reimbursement in the EU member states,\u201d details\u00a0<a href=\"https:\/\/wwwfr.uni.lu\/lcsb\/people\/jochen_klucken\" target=\"_self\" title=\"\" rel=\"noopener\">Prof. Jochen Klucken<\/a>, head of the\u00a0<a href=\"https:\/\/wwwfr.uni.lu\/lcsb\/research\/digital_medicine\" target=\"_self\" title=\"\" rel=\"noopener\">Digital Medicine group<\/a>\u00a0at the Luxembourg Centre for Systems Biomedicine (LCSB) of the University of Luxembourg and member of the taskforce.<\/p>\n\n\n<h3 class=\"has-text-align-left wp-block-unilux-blocks-heading\"        id=\"academics-national-agencies-and-eu-organisations-working-together\"\n    >\nAcademics, national agencies and EU organisations working together<\/h3>\n\n\n<p>The taskforce is chaired by the\u00a0<a href=\"https:\/\/gnius.esante.gouv.fr\/fr\/acteurs\/fiches-acteur\/delegation-ministerielle-au-numerique-en-sante-dns\" target=\"_blank\" title=\"\" rel=\"noopener\">Ministerial Delegation for Digital Health<\/a>\u00a0of the French Ministry of Health, co-chaired by the\u00a0<a href=\"https:\/\/www.eunethta.eu\" target=\"_blank\" title=\"\" rel=\"noopener\">European Network for Health Technology Assessment<\/a>\u00a0and coordinated by\u00a0<a href=\"https:\/\/eithealth.eu\/\" target=\"_blank\" title=\"\" rel=\"noopener\">EIT Health<\/a>. It brings together pan-European organisations, academic experts in the field of digital medicine and representatives of health technology assessment agencies from several European countries, including Germany, France, Luxembourg, Belgium, Finland, Austria, Denmark and Spain.<\/p>\n\n\n<p>The tasks are currently divided in three work packages focusing on:<\/p>\n\n\n<ul class=\"ulux-list\">\n\n<li class=\"ulux-list-item\">Harmonising the taxonomy for the different types of devices according to their application<\/li>\n\n\n<li class=\"ulux-list-item\">Identifying a common European method for assessing digital medical devices while respecting the mandates of national authorities<\/li>\n\n\n<li class=\"ulux-list-item\">Developing an evaluation framework to include the socio-economic dimension when integrating these devices into health systems<\/li>\n\n<\/ul>\n\n\n<h3 class=\"has-text-align-left wp-block-unilux-blocks-heading\"        id=\"key-expertise-from-luxembourg-and-neighbouring-countries\"\n    >\nKey expertise from Luxembourg and neighbouring countries<\/h3>\n\n\n<p><a href=\"https:\/\/gnius.esante.gouv.fr\/en\" target=\"_blank\" title=\"\" rel=\"noopener\">France<\/a>\u00a0and\u00a0<a href=\"https:\/\/www.bfarm.de\/EN\/Medical-devices\/Portals\/DiGA\/_node.html\" target=\"_blank\" title=\"\" rel=\"noopener\">Germany<\/a>\u00a0have newly established or upcoming fast track mechanisms for digital health applications. Their national procedures provide access to these devices for 73 million insured citizens in Germany and to 60 million citizens as part of the National Health Insurance Fund in France. As key members of the taskforce, they will share their experience regarding the implementation of a regulatory Health Technology Assessment framework.<\/p>\n\n\n<p>Luxembourg is bringing academic know-how to the table, with the participation of Prof. Klucken,\u00a0<a href=\"https:\/\/www.fnr.lu\/new-fnr-pearl-chair-healthcare-digitalisation\/\" target=\"_blank\" title=\"\" rel=\"noopener\">FNR PEARL Chair for Digital Medicine<\/a>\u00a0and head of a research group on the topic at the LCSB. He has a longstanding expertise in the development of wearable sensors for Parkinson\u2019s patients and is now leading an interdisciplinary team working on assessing medical benefit of digital healthcare services, as well as the structural and procedural changes needed and the degree of social acceptance. \u201cWe want to understand how patient-centred, personalised healthcare technologies can be tailored to patients needs and integrated into the existing healthcare procedures,\u201d explains Prof. Kluchen. \u201cThese devices have an enormous potential to improve healthcare but enabling digital medicine requires the development of new evaluation methods and a regulatory structure.\u201d Prof. Klucken represents the University of Luxembourg within the taskforce and acts as the rapporteur. He also recently organised the\u00a0<a href=\"https:\/\/digitalmedicineconference.uni.lu\/\" target=\"_blank\" title=\"\" rel=\"noopener\">Digital Medicine Conference in Luxembourg<\/a>\u00a0during which the first results of the work packages were presented.<\/p>\n\n<figure class=\"wp-block-dev4-reusable-blocks-image  object-fit--contain\">\n    \n<img decoding=\"async\" class=\"wp-block-image unilux-custom-image-block\"\n                alt=\"\"\n            src=\"https:\/\/www.uni.lu\/wp-content\/uploads\/sites\/22\/2023\/07\/digitalmedicineconference_webpics.png\"\n                    style=\"object-position: 50.00% 50.00%; font-family: &quot;object-fit: contain; object-position: 50.00% 50.00%;&quot;; aspect-ratio: 16\/9; object-fit: contain; width: 100%;\"\n        loading=\"lazy\"\n\/>    <\/figure>\n\n<p><\/p>\n\n\n<p>&#8212;<\/p>\n\n\n<p><strong><a href=\"https:\/\/www.has-sante.fr\/jcms\/p_3382241\/en\/towards-a-european-evaluation-framework-for-digital-medical-devices-dmds-in-the-european-union-launch-of-a-european-taskforce\" target=\"_blank\" title=\"\" rel=\"noopener\">Read the full press release from the French Ministry of Health &gt;&gt;<\/a><\/strong><\/p>\n\n\n<p><\/p>\n\n<sup>Images: Olivimages<\/sup><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"<p>The World Health Organisation currently lists more than 2 million devices with a medical purpose. These innovative health technologies are transforming the medical landscape. They have the potential to improve healthcare for patients, providers and payers but are also disrupting the European regulatory landscape. Although the integration of these technologies is a strategic priority for Europe, there is currently no harmonised framework for their evaluation and use. There is now a clear need for a consistent quality labelling to help citizens identify digital medical devices fulfilling basic medical standards and privacy criteria. This is why a new European taskforce was recently launched to address the issue.\u00a0<\/p>\n","protected":false},"author":335,"featured_media":10713,"template":"","format":"standard","meta":{"featured_image_focal_point":[],"show_featured_caption":false,"ulux_newsletter_groups":"","uluxPostTitle":"","uluxPrePostTitle":"","_trash_the_other_posts":false,"_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false},"news-category":[],"news-topic":[19],"organisation":[],"authorship":[335],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.3 (Yoast SEO v22.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Toward European roadmap for the evaluation of digital medical devices - LCSB I Uni.lu<\/title>\n<meta name=\"description\" content=\"The World Health Organisation currently lists more than 2 million devices with a medical purpose. 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Although the integration of these technologies is a strategic priority for Europe, there is currently no harmonised framework for their evaluation and use. There is now a clear need for a consistent quality labelling to help citizens identify digital medical devices fulfilling basic medical standards and privacy criteria. 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