{"id":3193,"date":"2018-03-15T15:30:20","date_gmt":"2018-03-15T14:30:20","guid":{"rendered":"https:\/\/mcamps.com\/?p=3193"},"modified":"2018-03-16T14:31:53","modified_gmt":"2018-03-16T13:31:53","slug":"mhealth-bcn-conference-apps-productos-sanitarios","status":"publish","type":"post","link":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/mhealth-bcn-conference-apps-productos-sanitarios\/","title":{"rendered":"mHealth BCN Conference: Apps and Medical Devices"},"content":{"rendered":"<p><strong>Joaqu\u00edn G\u00f3mez Abril<\/strong>, technical expert in <strong>CE marking<\/strong> of the Notified Body (NB) for Medical Devices (MDE) <strong>Kiwa<\/strong> and in collaboration with <strong>GTF M. Camps<\/strong>, participated on 22 February in the <strong>mHealth BCN Conference<\/strong>.<\/p>\n<p>The first edition of this congress, which has focused on mobile health applications, has been organised by the <a href=\"https:\/\/www.fundacionisys.org\/es\/\" target=\"_blank\" rel=\"noopener\">iSYS Foundation<\/a> -internet, health and society- and <a href=\"http:\/\/www.camfic.cat\/\" target=\"_blank\" rel=\"noopener\">CAMFiC<\/a> -Catalan Society of Family and Community Medicine.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-3195\" src=\"https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/Dise\u00f1o-sin-t\u00edtulo-55.png\" alt=\"Health BCN Conference : Apps y Productos Sanitarios CAMFiC iSYS\" width=\"500\" height=\"168\" title=\"\" srcset=\"https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/Dise\u00f1o-sin-t\u00edtulo-55.png 500w, https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/Dise\u00f1o-sin-t\u00edtulo-55-300x101.png 300w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/><\/p>\n<p>Joaqu\u00edn G\u00f3mez carries out his professional activity at Kiwa, a Notified Body (NB), which has the power to assess the regulatory compliance of medical devices. This assessment is necessary to be able to place a medical device on the market.<\/p>\n<h3><strong>\u00a0mHealth BCN Conference: the full conference programme<\/strong><\/h3>\n<p>Before starting with the lectures, the president of CAMFiC, Antoni Sis\u00f3 Almirall, and the president of the iSYS Foundation, Imma Grau Corral, presented the meeting to the attendees. After the presentation, the conferences were divided into 3 thematic blocks:<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-3196\" src=\"https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/isys.png\" alt=\"eHealth BCN Conference Joaquim G\u00f3mez GTF Kiwa\" width=\"360\" height=\"200\" title=\"\" srcset=\"https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/isys.png 360w, https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/isys-300x167.png 300w\" sizes=\"(max-width: 360px) 100vw, 360px\" \/><\/p>\n<h4 style=\"text-align: center;\"><strong>BLOCK I\u00a0<\/strong><\/h4>\n<p><strong>10:15 - 14:00 h EXPERT BLOCK<\/strong>The health app experts' block, which lasted almost 4 hours, was divided into three themes.  On the one hand, the <strong>App development constraints, <\/strong>moderated by Jes\u00fas Berd\u00fan, with the participation of 3 experts:<\/p>\n<ul>\n<li>Evaluation of digital health interventions.\u00a0<strong>Pablo Gasc\u00f3n<\/strong><\/li>\n<li>The App as a health product.\u00a0<strong>Joaquim G\u00f3mez Abril. GTF-Kiwa<\/strong><\/li>\n<li>Sustainability of projects\u00a0<strong>Gabriel Antoja<\/strong><\/li>\n<\/ul>\n<p>The second section of the first block, which has been entitled <strong>What you can't see: interoperability<\/strong>, was moderated by Felip Miralles, with the following interventions over the course of 1 hour:<\/p>\n<ul>\n<li>What is interoperability, levels and SNOMED CT. Toni Mas<\/li>\n<li>Information architecture and archetypes.\u00a0<strong>Raimundo Lozano<\/strong><\/li>\n<li>ICT SISCAT, and interoperability in mHealth.\u00a0<strong>Ariadna Rius<\/strong><\/li>\n<\/ul>\n<p>Y The last section of the first block, <strong>Of people and technology<\/strong>, moderated by Joan Escarrabill, had 4 participants:<\/p>\n<ul>\n<li>What we know about the relationship between technology and people.\u00a0<strong>Manuel Armayones<\/strong><\/li>\n<li>Patient experience.<strong>Joan Escarrabill<\/strong><\/li>\n<li>ICT and shared decision-making.\u00a0<strong>Montserrat Moharra<\/strong>.<\/li>\n<li>mHealth in the first person\u00a0<strong>Rafael Pardo<\/strong>.<\/li>\n<\/ul>\n<p><img decoding=\"async\" class=\"aligncenter wp-image-3197\" src=\"https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/checklist-3222079_960_720.jpg\" alt=\"eHealth BCN Conference Joaquim G\u00f3mez GTF Kiwa\" width=\"359\" height=\"225\" title=\"\" srcset=\"https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/checklist-3222079_960_720.jpg 960w, https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/checklist-3222079_960_720-300x188.jpg 300w, https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/checklist-3222079_960_720-768x482.jpg 768w\" sizes=\"(max-width: 359px) 100vw, 359px\" \/><\/p>\n<h3 style=\"text-align: center;\"><strong>BLOC II<\/strong><\/h3>\n<p><strong>15:30 - 17:30 h RESEARCH BLOCK<\/strong>In this block, moderated by <strong>Josep Basora<\/strong>, The panel discussed the evaluation processes of eHealth interventions. The roundtable, which was entitled <em>title Research in progress. Research experience in progress, <\/em>The following interventions were made:<\/p>\n<ul>\n<li>Intervention with SocialDiabetes in the NHS\u00a0<strong>M. Jes\u00fas Salido<\/strong>\u00a0y\u00a0<strong>Josep Vehi<\/strong><\/li>\n<li>InterSocial-\u00a0<strong>Ariadna Rius<\/strong><\/li>\n<li>eMPOC\u00a0<strong>Mireia Sans<\/strong><\/li>\n<li>Effectiveness of digital interventions in\u00a0<strong>Carme Carri\u00f3n<\/strong><\/li>\n<li>SIMPLe\u00a0<strong>Francesc Colom<\/strong><\/li>\n<\/ul>\n<p><img decoding=\"async\" class=\"aligncenter wp-image-3198\" src=\"https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/woman-1446557_960_720.jpg\" alt=\"18:00 - 18:45 h BLOQUE iSYScore: En el \u00faltimo bloque se ha presentado el \u201cInforme anual del estado de la cuesti\u00f3n: Apps de salud\u201d en catal\u00e1n y castellano, seg\u00fan el ISYScore. Adem\u00e1s, se ha publicado el 4\u00ba TOP 20 de Apps en salud 2017-2018. \" width=\"321\" height=\"214\" title=\"\" srcset=\"https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/woman-1446557_960_720.jpg 960w, https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/woman-1446557_960_720-300x200.jpg 300w, https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/woman-1446557_960_720-768x512.jpg 768w\" sizes=\"(max-width: 321px) 100vw, 321px\" \/><\/p>\n<h3 style=\"text-align: center;\"><strong>BLOC III<\/strong><\/h3>\n<p><strong>18:00 - 18:45 h iSYScore BLOCK: <\/strong>In the last block, the \u201c<strong>Annual State of Play Report: Health Apps<\/strong>\u201din Catalan and Spanish, according to the ISYScore. In addition, the 4th TOP 20 Apps in health for the 2017-2018 financial year has also been published.<\/p>\n<p>After the last block, diplomas were handed out to the participants and the day was brought to an end.<\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<p>But then... what has our collaborator Joaquim G\u00f3mez been talking about?<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-large wp-image-3200\" src=\"https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/40483750431_47f73748eb_o-1024x768.jpg\" alt=\"mHealth BCN Conference Joaquim Abril\" width=\"1024\" height=\"768\" title=\"\" srcset=\"https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/40483750431_47f73748eb_o-1024x768.jpg 1024w, https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/40483750431_47f73748eb_o-300x225.jpg 300w, https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/40483750431_47f73748eb_o-768x576.jpg 768w, https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/40483750431_47f73748eb_o-800x600.jpg 800w, https:\/\/mcamps.com\/wp-content\/uploads\/2018\/03\/40483750431_47f73748eb_o.jpg 1200w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/p>\n<h3><strong>What kind of mobile Apps fall under the category of Medical Devices? Some basic concepts<\/strong><\/h3>\n<p>After explaining the definition of medical devices, Joaquim G\u00f3mez explained that, for an app to be considered a medical device, it must improve health, even if only in a palliative way. After giving some examples of Apps that are Medical Devices, he defined for the audience the different categories of Medical Devices that exist, and defined the type of products that fall into these categories, and the key aspects for regulating these Medical Devices in the form of Apps before the health authorities.<\/p>\n<h3><strong>The regulatory framework: a reminder of existing legislation<\/strong><\/h3>\n<p>The <a href=\"http:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:es:PDF\" target=\"_blank\" rel=\"noopener\"><strong>Directive 93\/42\/EEC<\/strong><\/a> defines the essential requirements that the <strong>medical devices<\/strong> have to comply in order to obtain a CE marking. Once the CE marking is obtained, these products are legally allowed to enter the European market.<\/p>\n<p>The <strong><a href=\"http:\/\/eur-lex.europa.eu\/legal-content\/ES\/TXT\/?uri=CELEX%3A32017R0745\" target=\"_blank\" rel=\"noopener\">European Regulation EU 2017\/745<\/a>,<\/strong>\u00a0published in May 2017, will be fully operational in May 2020. Therefore, a period of 3 years is established for the adaptation of the Directive to the Regulation, and once completed, the application will be the same in all European countries.<\/p>\n<p>With the entry into force of the Regulation, much more rigorous aspects will be established than with the Directive - as a reference the Directive has 60 pages and the Regulation has more than 200. If you want to know the latest news about Medical Devices. CE Marking and Health Apps, <a href=\"https:\/\/mcamps.com\/contacto\/\" target=\"_blank\" rel=\"noopener\">do not hesitate to contact us<\/a>. Our proposal? Solutions!<\/p>","protected":false},"excerpt":{"rendered":"<p>Joaqu\u00edn G\u00f3mez Abril, t\u00e9cnico experto en Marcado CE de Productos Sanitarios del organismo notificado (ON) Kiwa y en colaboraci\u00f3n con GTF M. Camps, particip\u00f3 el pasado 22 de Febrero en mHealth BCN Conference. La primera edici\u00f3n de este congreso, que se ha centrado en las aplicaciones m\u00f3viles de salud,\u00a0 ha sido organizada por la Fundaci\u00f3n [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3194,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[199,301,50],"tags":[840,822,838,834,836,820,832,287],"class_list":["post-3193","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-productos-sanitarios","category-formacion","category-noticias","tag-app","tag-apps","tag-camfic","tag-gtf-m-camps","tag-isys","tag-mhealth-bcn-conference","tag-oaquin-gomez-abril","tag-productos-sanitarios"],"_links":{"self":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts\/3193","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/comments?post=3193"}],"version-history":[{"count":0,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts\/3193\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/media\/3194"}],"wp:attachment":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/media?parent=3193"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/categories?post=3193"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/tags?post=3193"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}