{"id":25906,"date":"2020-03-12T12:41:18","date_gmt":"2020-03-12T12:41:18","guid":{"rendered":"https:\/\/bio-chem.co.il\/faq-digital-health\/"},"modified":"2021-09-09T05:20:32","modified_gmt":"2021-09-09T05:20:32","slug":"faq-digital-health","status":"publish","type":"page","link":"https:\/\/bio-chem.co.il\/en\/faq-digital-health\/","title":{"rendered":"Q&#038;A digital health"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 the100ptitle hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: #00959f;background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 4px;margin-top: 40px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:20px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-column-content-centered\"><div class=\"fusion-column-content\"><style type=\"text\/css\"><\/style><div class=\"fusion-title title fusion-title-1 fusion-title-center fusion-title-text fusion-title-size-two\" style=\"margin-top:10px;margin-right:0px;margin-bottom:0px;margin-left:0px;\"><div class=\"title-sep-container title-sep-container-left\"><div class=\"title-sep sep-\" style=\"border-color:rgba(255,255,255,0.15);\"><\/div><\/div><span class=\"awb-title-spacer\"><\/span><h2 class=\"title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:28;--minFontSize:28px;line-height:1.3;\"><span style=\"color: rgb(255, 255, 255);\">Questions and Answers<\/span><\/h2><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep-\" style=\"border-color:rgba(255,255,255,0.15);\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 faqs-part nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:20px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-no-small-visibility fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:60px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><style type=\"text\/css\">#accordian-1 .fusion-panel:hover,#accordian-1 .fusion-panel.hover{ background-color: #ffffff } #accordian-1 .fusion-panel { border-color:#2b2b2b; border-width:1px; background-color:rgba(255,255,255,0); }.fusion-accordian #accordian-1 .panel-title a .fa-fusion-box:before{ font-size: 13px;}.fusion-accordian #accordian-1 .panel-title a .fa-fusion-box{ color: #000000;}.fusion-accordian #accordian-1 .panel-title a{font-size:19px;}.fusion-accordian #accordian-1 .fa-fusion-box { background-color: #000000;border-color: #000000;}.fusion-accordian #accordian-1 .panel-title a:hover,.fusion-accordian #accordian-1 .panel-title a.hover { color: #8bc34a;}.fusion-faq-shortcode .fusion-accordian #accordian-1 .fusion-toggle-boxed-mode:hover .panel-title a { color: #8bc34a;}.fusion-accordian #accordian-1 .panel-title .active .fa-fusion-box,.fusion-accordian #accordian-1 .panel-title a:hover .fa-fusion-box,.fusion-accordian #accordian-1 .panel-title a.hover .fa-fusion-box { background-color: #8bc34a!important;border-color: #8bc34a!important;}<\/style><div class=\"fusion-faq-shortcode faqs-page\"><ul class=\"fusion-filters clearfix\"><\/ul><div class=\"fusion-faqs-wrapper\"><div class=\"accordian fusion-accordian\"><div class=\"panel-group \" id=\"accordian-1\"><div class=\"fusion-panel fusion-toggle-no-divider fusion-toggle-boxed-mode panel-default fusion-faq-post fusion-faq-post-26072 digitalhealth-en \"><span class=\"entry-title rich-snippet-hidden\">How will the field of digital health affect our health future?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/bio-chem.co.il\/en\/author\/niran\/\" title=\"Posts by Yaniv\" rel=\"author\">Yaniv<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2020-08-04T10:23:50+00:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-26072\" href=\"#collapse-1-26072\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">How will the field of digital health affect our health future?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-26072\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2-1 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-1\"><p style=\"text-align: left;\">The combination of these two different worlds, that of traditional medicine and that of technology and digital health, will enable better quality, customized and more efficient patient care, with improved accessibility and costs.<\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><div class=\"fusion-panel fusion-toggle-no-divider fusion-toggle-boxed-mode panel-default fusion-faq-post fusion-faq-post-26073 digitalhealth-en \"><span class=\"entry-title rich-snippet-hidden\">What is HIPAA?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/bio-chem.co.il\/en\/author\/niran\/\" title=\"Posts by Yaniv\" rel=\"author\">Yaniv<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2020-08-04T10:31:06+00:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-26073\" href=\"#collapse-1-26073\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">What is HIPAA?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-26073\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2-2 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-2\"><p style=\"text-align: left;\">HIPAA is the acronym for the US Health Insurance Portability and Accountability Act.of 1996. HIPAA defines the requirements for protecting sensitive data and patient information. This law applies to medical and digital healthcare companies dealing with patients&#8217; medical and\/or health information. Such companies have a duty to protect medical\/health information, and to take physical, technological and network security measures, as well as monitor the data, to ensure that this information is not leaked and is maintained in its entirety and with high reliability.<\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><div class=\"fusion-panel fusion-toggle-no-divider fusion-toggle-boxed-mode panel-default fusion-faq-post fusion-faq-post-26074 digitalhealth-en \"><span class=\"entry-title rich-snippet-hidden\">Which companies should work according to the HIPAA requirements?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/bio-chem.co.il\/en\/author\/niran\/\" title=\"Posts by Yaniv\" rel=\"author\">Yaniv<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2020-08-06T17:06:56+00:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-26074\" href=\"#collapse-1-26074\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">Which companies should work according to the HIPAA requirements?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-26074\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2-3 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-3\"><p style=\"text-align: left;\">Any body, company or other entity that provides treatment, information, data or personal information, whether directly or as part of working with such an entity, as a subcontractor or as a business partner, is also required to work in compliance with HIPAA requirements.<\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><div class=\"fusion-panel fusion-toggle-no-divider fusion-toggle-boxed-mode panel-default fusion-faq-post fusion-faq-post-26075 digitalhealth-en \"><span class=\"entry-title rich-snippet-hidden\">What is GDPR?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/bio-chem.co.il\/en\/author\/niran\/\" title=\"Posts by Yaniv\" rel=\"author\">Yaniv<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2020-08-06T17:09:05+00:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-26075\" href=\"#collapse-1-26075\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">What is GDPR?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-26075\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2-4 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-4\"><p style=\"text-align: left;\">GDPR is the acronym for the EU General Data Protection Regulation which came into force in 2018. It deals with confidentiality of information and privacy.<br \/>\nThe GDPR contains mandatory provisions to be applied by entities which, as part of their activities, collect personal information and\/or process information from\u00a0 the internet.<\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><div class=\"fusion-panel fusion-toggle-no-divider fusion-toggle-boxed-mode panel-default fusion-faq-post fusion-faq-post-26076 digitalhealth-en \"><span class=\"entry-title rich-snippet-hidden\">Why is there a need for HIPAA?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/bio-chem.co.il\/en\/author\/niran\/\" title=\"Posts by Yaniv\" rel=\"author\">Yaniv<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2020-08-04T10:44:49+00:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-26076\" href=\"#collapse-1-26076\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">Why is there a need for HIPAA?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-26076\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2-5 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-6 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-5\"><p style=\"text-align: left;\">HIPAA was created to protect sensitive data with two main purposes &#8211; to provide continuous health insurance coverage for workers who lose or change jobs, and to reduce the burden and health care costs provided to the insured, through standardization of\u00a0 how electronic means are used, medical information transmission and transmission of administrative and financial transactions, while improving the availability and accessibility of nursing and health insurance services to patients.<\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><div class=\"fusion-panel fusion-toggle-no-divider fusion-toggle-boxed-mode panel-default fusion-faq-post fusion-faq-post-26077 digitalhealth-en \"><span class=\"entry-title rich-snippet-hidden\">What medical information is protected under the HIPAA requirements?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/bio-chem.co.il\/en\/author\/niran\/\" title=\"Posts by Yaniv\" rel=\"author\">Yaniv<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2020-08-04T12:46:17+00:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-26077\" href=\"#collapse-1-26077\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">What medical information is protected under the HIPAA requirements?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-26077\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2-6 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-7 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-6\"><p style=\"text-align: left;\">The privacy rules and confidentiality of medical information contained in HIPAA apply to any health information being held or transferred that allows for the individual identification of a person. Health information can be stored in any form, including digitally.<\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><div class=\"fusion-panel fusion-toggle-no-divider fusion-toggle-boxed-mode panel-default fusion-faq-post fusion-faq-post-26078 digitalhealth-en \"><span class=\"entry-title rich-snippet-hidden\">What is digital health?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/bio-chem.co.il\/en\/author\/niran\/\" title=\"Posts by Yaniv\" rel=\"author\">Yaniv<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2020-08-06T17:12:02+00:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-26078\" href=\"#collapse-1-26078\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">What is digital health?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-26078\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2-7 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-8 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-7\"><p>The digital health field is an innovative technological field that connects the high-tech world to the healthcare world.<br \/>\nDigital health is also called digital technology, e-Health or health-tech.<br \/>\nThe digital health sector uses information, communication and technology (ICT) for the benefit of public health.<\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><div class=\"fusion-panel fusion-toggle-no-divider fusion-toggle-boxed-mode panel-default fusion-faq-post fusion-faq-post-26079 digitalhealth-en \"><span class=\"entry-title rich-snippet-hidden\">What is a CE Mark?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/bio-chem.co.il\/en\/author\/niran\/\" title=\"Posts by Yaniv\" rel=\"author\">Yaniv<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2020-08-04T10:58:40+00:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-26079\" href=\"#collapse-1-26079\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">What is a CE Mark?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-26079\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2-8 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-9 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-8\"><p>CE marking is a European system based on compliance of medical devices to regulatory requirements for maintenance of health, safety, effectiveness and performance, quality and the environment.<\/p>\n<p>The CE mark on a medical device allows the medical device to be sold on the European market and in other markets that have adopted compliance to the EU requirements. In most cases, a CE mark application will be submitted by the legal manufacturer of the medical device.<\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><div class=\"fusion-panel fusion-toggle-no-divider fusion-toggle-boxed-mode panel-default fusion-faq-post fusion-faq-post-26080 digitalhealth-en \"><span class=\"entry-title rich-snippet-hidden\">What is ISO 13485?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/bio-chem.co.il\/en\/author\/niran\/\" title=\"Posts by Yaniv\" rel=\"author\">Yaniv<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2020-08-06T17:14:36+00:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-26080\" href=\"#collapse-1-26080\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">What is ISO 13485?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-26080\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2-9 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-10 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-9\"><p style=\"text-align: left;\">ISO 13485 is an international standard relevant to quality management systems for medical devices. The latest version was published in 2016 and reconfirmed in 2020.<\/p>\n<p style=\"text-align: left;\">This standard specifies the requirements for quality management systems for medical device manufacturers to provide safe products for use and in accordance with the regulatory requirements of international bodies. It includes requirements for documentation, personnel qualification, risk management, change control and validation, among others, to ensure that medical devices are safe and effective, and that quality and compliance are maintained according to the applicable regulatory requirements.<\/p>\n<p>The standard is suitable for medical equipment organizations regardless of their size or specific type of \u200b\u200bmedical device or equipment.<\/p>\n<p>To the article <a href=\"https:\/\/bio-chem.co.il\/en\/articles-en\/cleaning-validation-for-bio-pharmaceutical-medical-device-2\/\">ISO 13485 in the medical industry<\/a><\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><div class=\"fusion-panel fusion-toggle-no-divider fusion-toggle-boxed-mode panel-default fusion-faq-post fusion-faq-post-26081 digitalhealth-en \"><span class=\"entry-title rich-snippet-hidden\">What is a medical device?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/bio-chem.co.il\/en\/author\/niran\/\" title=\"Posts by Yaniv\" rel=\"author\">Yaniv<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2020-08-04T11:46:46+00:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-26081\" href=\"#collapse-1-26081\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">What is a medical device?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-26081\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2-10 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-11 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-10\"><p>A harmonized, global definition of &#8220;medical device&#8221; (MD) does not yet exist.<\/p>\n<p>US law and regulations define a medical device as &#8220;instrument, apparatus, implement, machine, contrivance, implant, <em>in vitro<\/em> reagent\u2026intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or Intended to affect the structure or any function of the body\u2026and which does not achieve its primary intended purposes through chemical action \u2026and which is not dependent upon being metabolized for the achievement of its primary intended purposes\u2026&#8221;<\/p>\n<p>EU law and regulations define a medical device as any &#8220;instrument, apparatus, appliance, software, material or other article\u2026 for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease,\u2026injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means\u2026&#8221;<\/p>\n<p>The different heath authorities have rules for determining the risk class of a medical device, based on its potential for harm if misused, design complexity, and use characteristics. Risk classifications generally range from Class I through Class III or IV, where Class I is the lowest level of risk. Risk classification has an impact on the regulatory pathway to be followed for product registration applications and may also influence the quantity and quality of documentation required to support the applications in each target market.<\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><div class=\"fusion-panel fusion-toggle-no-divider fusion-toggle-boxed-mode panel-default fusion-faq-post fusion-faq-post-26090 digitalhealth-en \"><span class=\"entry-title rich-snippet-hidden\">What is data integrity?<\/span><span class=\"vcard rich-snippet-hidden\"><span class=\"fn\"><a href=\"https:\/\/bio-chem.co.il\/en\/author\/niran\/\" title=\"Posts by Yaniv\" rel=\"author\">Yaniv<\/a><\/span><\/span><span class=\"updated rich-snippet-hidden\">2020-08-04T12:38:52+00:00<\/span><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a data-toggle=\"collapse\" class=\"collapsed\" data-parent=\"#accordian-1\" data-target=\"#collapse-1-26090\" href=\"#collapse-1-26090\"><div class=\"fusion-toggle-icon-wrapper\"><div class=\"fusion-toggle-icon-wrapper-main\"><div class=\"fusion-toggle-icon-wrapper-sub\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/div><\/div><\/div><div class=\"fusion-toggle-heading\">What is data integrity?<\/div><\/a><\/h4><\/div><div id=\"collapse-1-26090\" class=\"panel-collapse collapse\"><div class=\"panel-body toggle-content post-content\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2-11 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-12 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-11\"><p style=\"text-align: left;\">Data integrity is a cornerstone of the quality management system in pharma and medical device companies.<br \/>\nIt is a\u00a0company&#8217;s ability to make absolutely certain that the data used by the company are complete, consistent, reliable and accurate throughout their life cycle.<\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-13 fusion_builder_column_1_6 1_6 fusion-one-sixth fusion-column-first\" style=\"width:16.666666666667%;width:calc(16.666666666667% - ( ( 4% + 4% ) * 0.16666666666667 ) );margin-right: 4%;margin-top:0px;margin-bottom:20px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-14 fusion_builder_column_2_3 2_3 fusion-two-third fusion-column-no-min-height\" style=\"width:66.666666666667%;width:calc(66.666666666667% - ( ( 4% + 4% ) * 0.66666666666667 ) );margin-right: 4%;margin-top:0px;margin-bottom:20px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-column-content-centered\"><div class=\"fusion-column-content\"><div class=\"fusion-flip-boxes flip-boxes row fusion-columns-3 flip-effect-classic hp-slip-boxes-services\"><div class=\"fusion-flip-box-wrapper fusion-column col-lg-4 col-md-4 col-sm-4\"><div class=\"fusion-flip-box flip-right\" tabindex=\"0\"><div class=\"flip-box-inner-wrapper\"><div class=\"flip-box-front\" style=\"background-color:#00959f;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#ffffff;transition-duration:0.8s;\"><div class=\"flip-box-front-inner\"><div class=\"flip-box-grafix flip-box-circle\" style=\"background-color:#000000;border-color:rgba(51,51,51,0);\"><i aria-hidden=\"true\" class=\"fa-apple fab\" style=\"color:#ffffff;\"><\/i><\/div><h2 class=\"flip-box-heading without-text\" style=\"color:#ffffff;\">Research and development<\/h2><\/div><\/div><div class=\"flip-box-back\" style=\"background-color:#000000;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#00959f;transition-duration:0.8s;\"><div class=\"flip-box-back-inner\">\n<p style=\"text-align: center;\">Consulting in a variety of areas, including design, research laboratories and clean rooms, development technologies, investor business presentations, regulatory strategies, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC and professional training.<\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/bio-chem.co.il\/en\/services-rnd\/\">read more<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-flip-box-wrapper fusion-column col-lg-4 col-md-4 col-sm-4\"><div class=\"fusion-flip-box flip-right\" tabindex=\"0\"><div class=\"flip-box-inner-wrapper\"><div class=\"flip-box-front\" style=\"background-color:#00959f;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#ffffff;transition-duration:0.8s;\"><div class=\"flip-box-front-inner\"><div class=\"flip-box-grafix flip-box-circle\" style=\"background-color:#000000;border-color:rgba(51,51,51,0);\"><i aria-hidden=\"true\" class=\"fa-landmark fas\" style=\"color:#ffffff;\"><\/i><\/div><h2 class=\"flip-box-heading without-text\" style=\"color:#ffffff;\">Design and engineering<\/h2><\/div><\/div><div class=\"flip-box-back\" style=\"background-color:#000000;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#00959f;transition-duration:0.8s;\"><div class=\"flip-box-back-inner\">\n<p style=\"text-align: center;\">Designing factories, clean rooms and laboratories, engineering documentation, certification, technology selection, process engineering, and validation, with a combination of theoretical knowledge, practical experience, and in-depth understanding of biomed regulations and in accordance with GxP principles.<\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/bio-chem.co.il\/en\/services-design-and-engineering\/\"> read more<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-flip-box-wrapper fusion-column col-lg-4 col-md-4 col-sm-4\"><div class=\"fusion-flip-box flip-right\" tabindex=\"0\"><div class=\"flip-box-inner-wrapper\"><div class=\"flip-box-front\" style=\"background-color:#00959f;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#ffffff;transition-duration:0.8s;\"><div class=\"flip-box-front-inner\"><div class=\"flip-box-grafix flip-box-circle\" style=\"background-color:#000000;border-color:rgba(51,51,51,0);\"><i aria-hidden=\"true\" class=\"fa-certificate fas\" style=\"color:#ffffff;\"><\/i><\/div><h2 class=\"flip-box-heading without-text\" style=\"color:#ffffff;\">Manufacture and packaging<\/h2><\/div><\/div><div class=\"flip-box-back\" style=\"background-color:#000000;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#00959f;transition-duration:0.8s;\"><div class=\"flip-box-back-inner\">\n<p style=\"text-align: center;\">Consulting on manufacturing plant design, manufacturing process development and engineering, selecting the most appropriate technology, process scale-up, technology transfer, GMP, process improvement, yield optimization and improvement, employee training, validation of equipment, systems, and production and cleaning processes.<\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/bio-chem.co.il\/en\/services-manufacture-and-packaging\/\">read more<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-flip-box-wrapper fusion-column col-lg-4 col-md-4 col-sm-4\"><div class=\"fusion-flip-box flip-right\" tabindex=\"0\"><div class=\"flip-box-inner-wrapper\"><div class=\"flip-box-front\" style=\"background-color:#00959f;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#ffffff;transition-duration:0.8s;\"><div class=\"flip-box-front-inner\"><div class=\"flip-box-grafix flip-box-circle\" style=\"background-color:#000000;border-color:rgba(51,51,51,0);\"><i aria-hidden=\"true\" class=\"fa-dharmachakra fas\" style=\"color:#ffffff;\"><\/i><\/div><h2 class=\"flip-box-heading without-text\" style=\"color:#ffffff;\">GxP, quality and validation<\/h2><\/div><\/div><div class=\"flip-box-back\" style=\"background-color:#000000;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#00959f;transition-duration:0.8s;\"><div class=\"flip-box-back-inner\">\n<p style=\"text-align: center;\">Advises, establishes, accompanies and upgrades various types of quality management systems, offers GMP training and courses, coordinates adoption of GxP principles, ISO 13485, quality assurance and preparation for global regulatory audits while conducting risk analysis and evaluation, and verification and validation of equipment, systems, software, test methods, manufacturing and cleaning processes, until\u00a0 a successful audit outcome is obtained.<\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/bio-chem.co.il\/en\/quality-validation-and-gxp-industries\/\">read more<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-flip-box-wrapper fusion-column col-lg-4 col-md-4 col-sm-4\"><div class=\"fusion-flip-box flip-right\" tabindex=\"0\"><div class=\"flip-box-inner-wrapper\"><div class=\"flip-box-front\" style=\"background-color:#00959f;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#ffffff;transition-duration:0.8s;\"><div class=\"flip-box-front-inner\"><div class=\"flip-box-grafix flip-box-circle\" style=\"background-color:#000000;border-color:rgba(51,51,51,0);\"><i aria-hidden=\"true\" class=\"fa-pills fas\" style=\"color:#ffffff;\"><\/i><\/div><h2 class=\"flip-box-heading without-text\" style=\"color:#ffffff;\">Regulation and registration<\/h2><\/div><\/div><div class=\"flip-box-back\" style=\"background-color:#000000;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#00959f;transition-duration:0.8s;\"><div class=\"flip-box-back-inner\">\n<p style=\"text-align: center;\">Regulatory consulting and drug registration,\u00a0 medical devices, CE mark, dietary\/nutritional supplements and cosmetics in Israel and worldwide, building a smart regulatory strategy, helping to prepare documents and meet requirements in a professional manner, in a short time, product labeling, shelf life and graphics, import licenses and meetings with regulatory bodies, until approval\u00a0 (marketing authorization) is received.<\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/bio-chem.co.il\/en\/services-regulation-and-registration\/\">read more<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-flip-box-wrapper fusion-column col-lg-4 col-md-4 col-sm-4\"><div class=\"fusion-flip-box flip-right\" tabindex=\"0\"><div class=\"flip-box-inner-wrapper\"><div class=\"flip-box-front\" style=\"background-color:#00959f;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#ffffff;transition-duration:0.8s;\"><div class=\"flip-box-front-inner\"><div class=\"flip-box-grafix flip-box-circle\" style=\"background-color:#000000;border-color:rgba(51,51,51,0);\"><i aria-hidden=\"true\" class=\"fa-book fas\" style=\"color:#ffffff;\"><\/i><\/div><h2 class=\"flip-box-heading without-text\" style=\"color:#ffffff;\">Software and systems<\/h2><\/div><\/div><div class=\"flip-box-back\" style=\"background-color:#000000;border-color:#000000;border-radius:4px;border-style:solid;border-width:1px;color:#00959f;transition-duration:0.8s;\"><div class=\"flip-box-back-inner\">\n<p style=\"text-align: center;\">Digital healthcare consulting, software development and medical applications in accordance with US\u00a0 FDA 21 CFR part 11 \/ EU Annex 11 \/ US HIPAA \/ EU GDPR requirements, ISO 13485\/ISO 27001\/ISO 27799, CE marking, risk assessment, verification and validation of software and control systems until marketing authorization (approval) is obtained.<\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/bio-chem.co.il\/en\/services-software-and-systems\/\">read more<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"clearfix\"><\/div><div class=\"fusion-aligncenter\"><style type=\"text\/css\">.fusion-button.button-1 .fusion-button-text, .fusion-button.button-1 i {color:#000000;}.fusion-button.button-1 .fusion-button-icon-divider{border-color:#000000;}.fusion-button.button-1:hover .fusion-button-text, .fusion-button.button-1:hover i,.fusion-button.button-1:focus .fusion-button-text, .fusion-button.button-1:focus i,.fusion-button.button-1:active .fusion-button-text, .fusion-button.button-1:active{color:#000000;}.fusion-button.button-1:hover .fusion-button-icon-divider, .fusion-button.button-1:hover .fusion-button-icon-divider, .fusion-button.button-1:active .fusion-button-icon-divider{border-color:#000000;}.fusion-button.button-1:hover, .fusion-button.button-1:focus, .fusion-button.button-1:active{border-color:#000000;}.fusion-button.button-1 {border-color:#000000;border-radius:2px;}.fusion-button.button-1{background: #8cc63f;}.fusion-button.button-1:hover,.button-1:focus,.fusion-button.button-1:active{background: #8cc63f;}.fusion-button.button-1 .fusion-button-text {text-transform:none;}<\/style><a class=\"fusion-button button-flat button-large button-custom button-1 fusion-button-default-span fusion-button-default-type hp-blog-rm\" target=\"_self\" href=\"https:\/\/bio-chem.co.il\/en\/methodology\/\"><span class=\"fusion-button-text\">Our work methodology<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-15 fusion_builder_column_1_6 1_6 fusion-one-sixth fusion-column-last\" style=\"width:16.666666666667%;width:calc(16.666666666667% - ( ( 4% + 4% ) * 0.16666666666667 ) );margin-top:0px;margin-bottom:20px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-4 the100ptitle hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: #00959f;background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-bottom: 20px;margin-top: 40px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-16 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:20px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-column-content-centered\"><div class=\"fusion-column-content\"><style type=\"text\/css\"><\/style><div class=\"fusion-title title fusion-title-2 fusion-title-center fusion-title-text fusion-title-size-two\" style=\"margin-top:10px;margin-right:0px;margin-bottom:0px;margin-left:0px;\"><div class=\"title-sep-container title-sep-container-left\"><div class=\"title-sep sep-\" style=\"border-color:rgba(255,255,255,0.15);\"><\/div><\/div><span class=\"awb-title-spacer\"><\/span><h2 class=\"title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:28;--minFontSize:28px;line-height:1.3;\"><span style=\"color: rgb(255, 255, 255);\">Bio-Chem articles for you<\/span><\/h2><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep-\" style=\"border-color:rgba(255,255,255,0.15);\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-5 theglobalblogsection nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: #ffffff;background-position: center center;background-repeat: no-repeat;padding-top:0px;padding-right:0px;padding-bottom:45px;padding-left:0px;margin-bottom: 0px;margin-top: 0px;border-width: 0px 0px 0px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-17 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"margin-top:0px;margin-bottom:20px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-column-content-centered\"><div class=\"fusion-column-content\"><div class=\"fusion-blog-shortcode fusion-blog-shortcode-1 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-layout-center hp-blog-posts\"><style type=\"text\/css\">.fusion-blog-shortcode-1 .fusion-blog-layout-grid .fusion-post-grid{padding:20px;}.fusion-blog-shortcode-1 .fusion-posts-container{margin-left: -20px !important; margin-right:-20px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-rollover fusion-blog-layout-grid fusion-blog-layout-grid-3 isotope fusion-blog-equal-heights\" data-pages=\"6\" data-grid-col-space=\"40\" style=\"margin: -20px -20px 0;min-height:500px;\"><article id=\"blog-1-post-35351\" class=\"fusion-post-grid post-35351 post type-post status-publish format-standard has-post-thumbnail hentry category-articles-en category-medical-en category-pharma-biotech-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(0,0,0,0);border:1px solid rgba(145,120,82,0.35);border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:rgba(145,120,82,0.35);\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t  <img width=\"1024\" height=\"1024\" src=\"https:\/\/bio-chem.co.il\/wp-content\/uploads\/2021\/08\/mRNA-based-drugs-platforms-for-cancer-treatment-article-by-bio-chem-experts.jpg\" class=\"attachment-full size-full wp-post-image\" alt=\"mRNA-based drugs platforms for cancer treatment - article by bio chem experts\" srcset=\"\/\/bio-chem.co.il\/wp-content\/uploads\/2021\/08\/mRNA-based-drugs-platforms-for-cancer-treatment-article-by-bio-chem-experts-200x200.jpg 200w, 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treatment<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t<h4 class=\"fusion-rollover-title\">\n\t\t\t\t\t<a class=\"fusion-rollover-title-link\" href=\"https:\/\/bio-chem.co.il\/en\/articles-en\/mrna-based-drugs-platforms-for-cancer-treatment\/\">\n\t\t\t\t\t\tmRNA-based drugs platforms for cancer treatment\t\t\t\t\t<\/a>\n\t\t\t\t<\/h4>\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t<div class=\"fusion-rollover-categories\"><a href=\"https:\/\/bio-chem.co.il\/en\/articles-en\/\" rel=\"tag\">Articles<\/a>, <a href=\"https:\/\/bio-chem.co.il\/en\/medical-en\/\" rel=\"tag\">Medical<\/a>, <a href=\"https:\/\/bio-chem.co.il\/en\/pharma-biotech-en\/\" rel=\"tag\">Pharma &amp; Biotech<\/a><\/div>\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<a class=\"fusion-link-wrapper\" href=\"https:\/\/bio-chem.co.il\/en\/articles-en\/mrna-based-drugs-platforms-for-cancer-treatment\/\" aria-label=\"mRNA-based drugs platforms for cancer treatment\"><\/a>\n\t<\/div>\n<\/div>\n<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/bio-chem.co.il\/en\/articles-en\/mrna-based-drugs-platforms-for-cancer-treatment\/\">mRNA-based drugs platforms for cancer treatment<\/a><\/h2><div class=\"fusion-post-content-container\"><p> New mRNA-based drugs platforms for cancer treatment The successful development of mRNA (messenger ribonucleic acid) based on anti-COVID 19 [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34806\" class=\"fusion-post-grid post-34806 post type-post status-publish format-standard has-post-thumbnail hentry category-articles-en category---gxp-en category---en category-286 category-287 category----en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(0,0,0,0);border:1px solid rgba(145,120,82,0.35);border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:rgba(145,120,82,0.35);\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t  <img width=\"1024\" height=\"1024\" src=\"https:\/\/bio-chem.co.il\/wp-content\/uploads\/2021\/07\/the-importance-of-data-integrity-in-pharmaceutical-companies-3.jpg\" class=\"attachment-full size-full wp-post-image\" alt=\"he-importance-of-data-integrity-in-pharmaceutical-companies\" srcset=\"\/\/bio-chem.co.il\/wp-content\/uploads\/2021\/07\/the-importance-of-data-integrity-in-pharmaceutical-companies-3-200x200.jpg 200w, 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it?\"><\/a>\n\t<\/div>\n<\/div>\n<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/bio-chem.co.il\/en\/articles-en\/validation-what-is-it\/\">Validation &#8211; What is it?<\/a><\/h2><div class=\"fusion-post-content-container\"><p> \u05d7\u05e9\u05d9\u05d1\u05d5\u05ea \u05d4- Data integrity \u05d1\u05d7\u05d1\u05e8\u05d5\u05ea \u05ea\u05e8\u05d5\u05e4\u05d5\u05ea \u05d0\u05de\u05d9\u05e0\u05d5\u05ea \u05d5\u05e9\u05dc\u05de\u05d5\u05ea \u05d4\u05e0\u05ea\u05d5\u05e0\u05d9\u05dd, \u05d0\u05d5 \u05d1\u05de\u05d5\u05e0\u05d7 \u05d4\u05dc\u05d5\u05e2\u05d6\u05d9 Data integrity \u05de\u05d0\u05e4\u05e9\u05e8\u05ea \u05d4\u05df \u05dc\u05d7\u05d1\u05e8\u05d4 \u05d5\u05d4\u05df \u05dc\u05d2\u05d5\u05e4\u05d9 [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34248\" class=\"fusion-post-grid post-34248 post type-post status-publish format-standard has-post-thumbnail hentry category-validation-qualification-en category-articles-en category-quality-gxp-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(0,0,0,0);border:1px solid rgba(145,120,82,0.35);border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:rgba(145,120,82,0.35);\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t  <img width=\"512\" height=\"512\" src=\"https:\/\/bio-chem.co.il\/wp-content\/uploads\/2021\/06\/GMP-Audit-article-by-bio-chem-experts.jpg\" class=\"attachment-full size-full wp-post-image\" alt=\"GMP Audit - article by bio chem experts\" srcset=\"\/\/bio-chem.co.il\/wp-content\/uploads\/2021\/06\/GMP-Audit-article-by-bio-chem-experts-200x200.jpg 200w, \/\/bio-chem.co.il\/wp-content\/uploads\/2021\/06\/GMP-Audit-article-by-bio-chem-experts-400x400.jpg 400w, \/\/bio-chem.co.il\/wp-content\/uploads\/2021\/06\/GMP-Audit-article-by-bio-chem-experts.jpg 512w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 784px) 373px, (min-width: 712px) 560px, (min-width: 640px) 712px, \" \/><div class=\"fusion-rollover\">\n\t<div class=\"fusion-rollover-content\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"fusion-rollover-link\" href=\"https:\/\/bio-chem.co.il\/en\/validation-qualification-en\/gmp-auditor\/\">GMP Auditor<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t<h4 class=\"fusion-rollover-title\">\n\t\t\t\t\t<a class=\"fusion-rollover-title-link\" href=\"https:\/\/bio-chem.co.il\/en\/validation-qualification-en\/gmp-auditor\/\">\n\t\t\t\t\t\tGMP 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href=\"https:\/\/bio-chem.co.il\/en\/validation-qualification-en\/gmp-auditor\/\">GMP Auditor<\/a><\/h2><div class=\"fusion-post-content-container\"><p> What is a GMP audit in Israel and abroad? A GMP audit in israel is an audit that covers [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-aligncenter\"><style type=\"text\/css\">.fusion-button.button-2 .fusion-button-text, .fusion-button.button-2 i {color:#000000;}.fusion-button.button-2 .fusion-button-icon-divider{border-color:#000000;}.fusion-button.button-2:hover .fusion-button-text, .fusion-button.button-2:hover i,.fusion-button.button-2:focus .fusion-button-text, .fusion-button.button-2:focus i,.fusion-button.button-2:active .fusion-button-text, .fusion-button.button-2:active{color:#000000;}.fusion-button.button-2:hover .fusion-button-icon-divider, .fusion-button.button-2:hover .fusion-button-icon-divider, .fusion-button.button-2:active .fusion-button-icon-divider{border-color:#000000;}.fusion-button.button-2:hover, .fusion-button.button-2:focus, .fusion-button.button-2:active{border-color:#000000;}.fusion-button.button-2 {border-color:#000000;border-radius:2px;}.fusion-button.button-2{background: #8cc63f;}.fusion-button.button-2:hover,.button-2:focus,.fusion-button.button-2:active{background: #8cc63f;}.fusion-button.button-2 .fusion-button-text {text-transform:none;}<\/style><a class=\"fusion-button button-flat button-large button-custom button-2 fusion-button-default-span fusion-button-default-type hp-blog-rm\" target=\"_self\" href=\"https:\/\/bio-chem.co.il\/en\/blog\/\"><span class=\"fusion-button-text\">More articles for you<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-6 lets-change-the-game nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: #00959f;background-position: center center;background-repeat: no-repeat;padding-top:25px;padding-right:0px;padding-bottom:15px;padding-left:0px;border-width: 1px 0px 1px 0px;border-color:#2b2b2b;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-18 fusion_builder_column_1_3 1_3 fusion-one-third fusion-column-first nslt-left fusion-column-no-min-height\" style=\"width:33.333333333333%;width:calc(33.333333333333% - ( ( 4% ) * 0.33333333333333 ) );margin-right: 4%;margin-top:-30px;margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 50px 0px 0px 0px;\"><div class=\"fusion-column-content-centered\"><div class=\"fusion-column-content\"><div class=\"fusion-text fusion-text-12\"><h2 style=\"text-align: center; 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