Digital Health

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class="navigation__icon icon-heart"></i> <span>HTA & Relative Efficacy Assessment</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/disease-specific-groups/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>Disease-specific groups</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/healthcare-systems/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>Healthcare Systems</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/value-of-medicines/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>Value of medicines</span> </div> </a> </li> </ul> </li> <li class="has-tertiary-nav"> <a href="https://efpia.eu/about-medicines/access-to-medicines/" class="navigation--link no-popup " 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</div> </a> </li> </ul> </div> </section> <section id="content" class="content__wrapper"> <header class=" site__header"> <div class="header__burger mobile"> <i class="icon-menu"></i> </div> <div class="header__logo"> <a href="https://efpia.eu/"> </a> </div> <div class="header__breadcrumb"> <div class="breadcrumb__link"> <a href="https://efpia.eu/about-medicines/"> About medicines</a> </div> <div class="breadcrumb__link"> <a href="https://efpia.eu/about-medicines/development-of-medicines/"> Development of medicines</a> </div>  <span class="truncated-breadcrumb"> Digital Health ... </span>  <span class="untruncated-breadcrumb"> Digital Health </span> </div> <div class="header__search"> <div class="search__container"> <form action="https://efpia.eu/search-results/"> <input type="text" name="query" id="header-search" class="search__input" placeholder="Search" /> <span class="fa fa-search desktop-search"></span> </form> </div> <div class="opensearch__mobile"> <span class="fa fa-search"></span> </div> </div> </header> <div class="searchbar__mobile"> <form action="https://efpia.eu/search-results/"> <i class="material-icons searchbar__close">close</i> <input type="text" placeholder="" name="query" /> <span class="fa fa-search submit-search-mob"></span> </form> </div> <div class="content__section"> <header role="banner" style="background-image: url(/media/547445/healthcare-data-presentation10-copy.png?width=1200&amp;height=490); background-position: 50% 50%; " class=" " id="banner-image"> <div class="text__wrapper"> <div class="header__blurb"> <h2>Digital Health </h2> <p>The tools and technologies that will reshape healthcare are rapidly becoming available in hospitals and homes across Europe. The digital transformation is already here.</p> </div> </div> </header>  <div class="video__modal"> <div class="video__modal-cell"> <div class="video__close"> <a href="#" class="icon-close"></a> </div> <div class="videoWrapper">  <iframe id="player" width="420" height="315" frameborder="0" allowfullscreen="allowfullscreen" mozallowfullscreen="mozallowfullscreen" msallowfullscreen="msallowfullscreen" oallowfullscreen="oallowfullscreen" webkitallowfullscreen="webkitallowfullscreen"></iframe> </div> </div> </div> <nav class="section-navigation"> <div class="container">  <div class="section-navigation__nav-items social"> <div class="section-navigation__nav-items__links"> <a href="#" onclick="window.print()" class="print-button"> <i class="material-icons">print</i> <span>Print</span> </a> <a href="http://www.facebook.com/sharer/sharer.php?u=https://efpia.eu/about-medicines/development-of-medicines/digital-health/" class="section-navigation__nav-items__links--social" title="Share on Facebook" target="_blank"> <i class="fa fa-facebook-square"></i> </a> <a href="http://twitter.com/share?url=https://efpia.eu/about-medicines/development-of-medicines/digital-health/&text=Digital Health&via=Efpia" class="section-navigation__nav-items__links--social" title="Share on Twitter" target="_blank"> <i class="fa fa-twitter-square"></i> </a> <a href="http://www.linkedin.com/shareArticle?url=https://efpia.eu/about-medicines/development-of-medicines/digital-health/&title=Digital Health&source=https://efpia.eu/about-medicines/development-of-medicines/digital-health/" class="section-navigation__nav-items__links--social" title="Share on LinkedIn" target="_blank"> <i class="fa fa-linkedin-square"></i> </a> </div> </div> </div> </nav> <section class="content__container content__container--no-padding-m"> <div class="umb-grid"> <div class="grid-section"> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <div style="text-align: left;"> <p><span class="rte-paragraph">Digital technologies have transformed our lives. From entertainment and communication to travel and banking, digital disruption has delivered efficiency, transparency and convenience. Now the data-driven revolution is beginning to transform healthcare. By realising the potential of digital health, we can accelerate the shift towards patient-centred, outcomes-focused access, sustainable healthcare in Europe.<br /><br /></span><span class="rte-paragraph">The world’s response to the pandemic has highlighted the importance of reliable data exchange between parts of the healthcare system and between countries. This has accelerated a greater reliance on telemedicine, a need to analyse large sets of data to define research and testing and to accelerate healthcare solutions.<br /><br /></span><span class="rte-paragraph">We are focused on delivering access to new treatments and technologies today. To ensure development of further medical innovation and a sustainable global healthcare system in a globally competitive Europe, we must all work together now to make this a reality.</span></p> </div> <div style="text-align: left;"><span class="rte-paragraph rte-heading"><strong>So, what <em>is</em> digital health? </strong></span></div> <div style="text-align: left;"> <p><span class="rte-paragraph">Digital health is a broad term that encompasses a variety of terms including e-health, m-health and telehealth and captures everything from electronic patient records, remote monitoring, connected devices, digital therapeutics and more. It means embracing information technology, big data, AI and machine learning to collect, share, analyse and use data on patient outcomes to help healthcare professionals make informed decisions and to improve care. Taken together, this patient-centred disruption is rapidly changing how industry operates and how services are developed and delivered, rebuilding relationships between key actors such as the research-based industry, patients, healthcare professionals, health institutions, and regulators.<br /><br /><img id="__mcenew" src="/media/636770/efpia_infographic_211104_final-_1920x1080.png?width=972&height=547" alt="" width="972" height="547" rel="16269" data-id="16269" /><br /></span></p> </div> <div style="text-align: left;"><span class="rte-paragraph rte-heading"><strong>The future is here</strong></span></div> <div style="text-align: left;"> <p><span class="rte-paragraph">This is not science-fiction. The tools and technologies that will reshape healthcare are rapidly becoming available in hospitals and homes across Europe. The digital transformation is already here.<br /></span></p> <ul> <li><span class="rte-paragraph"><strong>Optimised Diagnosis:</strong>Radiology departments are using artificial intelligence (AI) to optimise diagnosis</span></li> <li><span class="rte-paragraph"><strong>Enhanced Monitoring:</strong>‘Smart’ inhalers are monitoring asthma patients’ use of medication</span></li> <li><span class="rte-paragraph"><strong>Remote Engagement</strong>: Medical specialists are offering advice to patients and training colleagues remotely</span></li> <li><span class="rte-paragraph"><strong>Connected Data:</strong>Clinics are securely sharing vital patient information to enhance individuals’ care</span></li> <li><span class="rte-paragraph"><strong>Ongoing Feedback:</strong>Outcomes data is being pooled to extract real-world insights on how interventions add value</span></li> <li><span class="rte-paragraph"><strong>Tech enabled Delivery: </strong>Drone technology is being used to deliver medicine in remote areas in times of crisis</span></li> <li><span class="rte-paragraph"><strong>Improved Efficiency:</strong>Blockchain technologies are being looked at to increase efficiencies across global supply chains to speed up time of manufacturing and delivering medicinal products to patients</span></li> <li><span class="rte-paragraph"><strong>Breakthrough Research:</strong> Clinical trial data from around the world is shared across borders to more quickly develop new medicines that are safe and effective</span></li> </ul> <p><span class="rte-paragraph">There is more to come. Researchers are exploring how blockchain technology could enhance information security, how remote monitoring can improve patients’ experience and make services more efficient, and how citizens can enjoy real control over their own health data. </span><span class="rte-paragraph"> </span></p> <p><span class="rte-paragraph rte-heading"><strong>A changing health system ecosystem</strong></span></p> <p><span class="rte-paragraph">The digital revolution challenges the status quo. It demands fresh thinking from all actors and partnerships between established players and newcomers. By working together, the pharma sector and tech companies can help improve health outcomes, personalize therapies, enable coordination of care, and shift services from inpatient to outpatient settings, even home care, and this for an extended number of disease conditions. This can deliver on our shared goal of increased patient satisfaction and supporting data-driven clinical decisions, while keeping at heart our mission of ensuring patient safety.<br /><br /></span><span class="rte-paragraph">The ambitious agenda of the new President Von der Leyen focuses on a “<em>Europe to strive for more by grasping the opportunities from the digital age within safe and ethical boundaries</em>.” EFPIA applauds the Commission’s effort to create an EU policy environment that unlocks the value of the data economy and we support the European Strategy for Data which encompasses the creation of a European Health Data Space and the Commission’s effort to develop a European approach for AI that promotes Europe’s innovation capacity in AI while supporting the development and uptake of ethical and trustworthy AI. As this important work proceeds, all stakeholders will benefit from a framework that is grounded in evidence and developed in consultation with them.<br /><br /></span><span class="rte-paragraph rte-heading">Why is health data access important to R&D?</span></p> <p>Health data is the fuel driving the research and innovation engine of healthcare. There is significant scope for the EHDS to improve data sharing in the EU. By doing this, the EU could strengthen public health, deliver better health outcomes for citizens and promote their well-being. </p> </div> <img src="/media/agqdszbd/screenshot-2023-07-05-at-151832.png" alt=""> <div class="download-list__container"> <h2 class="section__header">Download the infographic</h2> <ul class="download-list__list"> <li class="download-list__item"> <a href="/media/vexp4lxs/why-is-data-access-important.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">Why Is Data Access Important</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> </ul> </div> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <p><span class="rte-heading"><strong>Our vision</strong></span></p> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-4 column"> <div > <p><span class="rte-paragraph">EFPIA is committed to actively supporting the digital revolution in healthcare, partnering with all healthcare players to define new ways of working and solutions to the most pressing needs that will ultimately improve population health. <br /><br />We need to ensure that all aspects of the system are ‘digital enabled’. This means working with policymakers, regulatory agencies and healthcare providers to ensure we have the infrastructure, the data security framework, and the mindset required to capitalise on the opportunities that lie before us.</span></p> </div> </div> <div class="col-md-8 column"> <div > <img src="/media/554470/screenshot-2020-06-22-at-173630.png" alt=""> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <p><span class="rte-paragraph">Our vision for the digital health transformation:</span></p> <ul> <li><span class="rte-paragraph"><strong>Enable Innovation :</strong> Ensure Europe’s digital agenda supports pharmaceutical innovation</span></li> <li><span class="rte-paragraph"><strong>Ensure Stakeholder Acceptance:</strong> Support regulatory acceptance of data/digital opportunities</span></li> <li><span class="rte-paragraph"><strong>Enhanced Effectiveness:</strong> Optimize and increase effectiveness of the current business model</span></li> <li><span class="rte-paragraph"><strong>Expect Disruption:</strong> Prepare for the impact of digital disruption on business models and relationships between patients, clinicians and other actors</span></li> <li><span class="rte-paragraph"><strong>Remain Patient focused:</strong> Deliver patient benefits through digital solutions</span></li> <li><span class="rte-paragraph"><strong>Accelerate Healthcare</strong>: Accelerate drug development using digital technologies</span></li> <li><span class="rte-paragraph"><strong>Drive collaboration:</strong> Encourage public-private partnerships to find solutions to blockages (interoperability), address legitimate concerns (privacy) and ensure that digital transformation is geared towards better care for all (patient outcomes).</span></li> </ul> <p><span class="rte-paragraph rte-heading"><strong><br />What are we doing?<br /></strong></span><span class="rte-paragraph">EFPIA’s strategic aim in the digital health space is to support transformation of European healthcare for the benefit of patients and that digital evolution enables a move towards effective data-driven healthcare systems, ensuring the continued competitiveness of Europe. </span></p> <div><img id="__mcenew" style="display: block; margin-left: auto; margin-right: auto;" src="/media/554471/digital-health-vision.jpg?width=663&height=287" alt="" width="663" height="287" rel="14080" data-id="14080" /></div> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <br /><span class="rte-paragraph"><br />To enable this transformation, EFPIA proposes to complement the European Commission’s digital health agenda and address the following drivers of change:<br /><br /></span> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-4 column"> <div > <img src="/media/547437/screenshot-2020-05-25-at-130843.png" alt=""> </div> </div> <div class="col-md-8 column"> <div > <span class="rte-paragraph"><strong>Societal trust in health data sharing:</strong> Europe needs a health data coalition to build public understanding of the value of health data, and enhance confidence in how data is collected and used. The European Patients Forum are taking the lead in a vital initiative called <strong><a href="https://datasaveslives.eu/" target="_blank">Data Saves Lives</a>.</strong> This Platform would enable dialogue between key stakeholders to promote responsible use of health data and to facilitate societal understanding and would contribute to a change in attitudes to data-sharing.<br /><br /></span> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-4 column"> <div > <img src="/media/547439/screenshot-2020-05-25-at-131633.png" alt=""> </div> </div> <div class="col-md-8 column"> <div > <span class="rte-paragraph"><strong>Using data to give patients feedback on benefit/risk and value of their care: </strong>The one fundamental prerequisite for allowing new technologies to deliver the full potential of possible benefits for the society is access to health data. Health care systems recognize the value of data but need to address several challenges in order to create a frictionless health data flow built on trust. The future will see a connected data network that builds on the IMI European Health and Evidence Data Network (<a href="http://ehden.eu">EHDEN</a>) project. It promises to harmonise around 100 million Electronic Health Records unlocking the power of real-world data.<br /><br /></span> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-4 column"> <div > <img src="/media/554858/screenshot-2020-10-23-at-122545.png" alt=""> </div> </div> <div class="col-md-8 column"> <div > <div style="text-align: left;"><span class="rte-paragraph"><span class="rte-paragraph"><strong>Empowering patients to own their data: </strong>Healthcare system information, particularly patient-generated outcomes data, must be better connected. This will allow stakeholders to use this data for good. <a href="https://health-outcomes-observatory.eu/" target="_blank">H20</a>, an IMI project on Health Outcomes Observatories will work with patient organizations to collect and standardize patient reported outcomes data in a sustainable way and to create transparency of health outcomes (to be initiated in 2020) building on outcomes standards defined by <a href="https://www.ichom.org/portfolio/diabetes/">ICHOM</a> and <a href="https://www.imi.europa.eu/projects-results/project-factsheets/bd4bo">IMI BD4BO</a>. </span>The objectives are to enable real time data access for patients/physicians, enable Value Based Healthcare through data and to drive research agendas and investments. Patient empowerment goes hand in hand with increased digital literacy.</span><br /><span class="rte-paragraph"><br /></span></div> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-4 column"> <div > <img src="/media/547453/ai.jpg" alt=""> </div> </div> <div class="col-md-8 column"> <div > <span class="rte-paragraph"><strong>Digital Technologies</strong> - <strong>Leverage Digital Innovation: </strong>The potential of AI is opening new possibilities in transforming health and care in the future, improving the delivery of health and care and driving greater efficiencies and thereby contributing to the reducing the cost of healthcare. Leveraging the potential of AI has the benefit of improving the delivery of health and care, benefiting both patients and society. However, as an emerging field in health and care it also bring with its uncertainties and poses a number of challenges, including access to data, data governance, regulation of its uses, transparency, accountability and ethical considerations.<br /><br /><br /></span> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <div style="text-align: left;"><span class="rte-paragraph rte-heading"><strong>What’s next? Enabling a digital ecosystem</strong></span></div> <div style="text-align: left;"><span class="rte-paragraph"></span></div> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-6 column"> <div > <div style="text-align: left;"><span class="rte-paragraph">EFPIA and individual companies are piloting digital tools to explore their potential and foster acceptance among users. In the process, we are working with others on standardizing the quality of data and reimagining how digital technologies can empower patients to act on health, product and disease information.</span></div> <div style="text-align: left;"><span class="rte-paragraph"> </span></div> <div style="text-align: left;"><span class="rte-paragraph">We view digital health as a catalyst that will accelerate the changes necessary to creating an efficient, patient-centred health system. Now is the time for EU level intervention to make digital healthcare a reality! There is still much to be done – but we are ready for the challenge.<br /><br /><br /></span></div> </div> </div> <div class="col-md-6 column"> <div > <img src="/media/554465/screenshot-2020-06-22-at-155344.png" alt=""> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <a href="https://www.ifpma.org/wp-content/uploads/2021/11/Biopharmaceutical_Industry_Digital_Health_Principles_Nov2021-1.pdf" target="_blank"><img id="__mcenew" src="/media/636505/screenshot-2021-12-01-at-152230.png" alt="" rel="15998" data-id="15998" /></a> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <div class="download-list__container"> <h2 class="section__header"></h2> <ul class="download-list__list"> <li class="download-list__item"> <a href="/media/mswnu1zy/efpia-position-on-opt-out-in-the-ehds-regulation.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">EFPIA position on opt out in the EHDS Regulation</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/2t2dem05/efpia-position-on-ehds.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">EFPIA Position On EHDS</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/676468/efpia-response-to-the-consultation-on-legislative-proposal-for-a-european-health-data-space.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">EFPIA response to the consultation on legislative proposal for a European Health Data Space</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/636888/efpia-recommendations-on-a-connected-data-system-in-europe_final.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">EFPIA Recommendations on a Connected Data System in Europe</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/554841/efpia-ehds-position_final.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">Position on a European Health Data Space</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/589625/efpia-reply-to-the-consultation-for-the-inception-impact-assessment-on-the-intended-initiative-in-a-european-health-data-space.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">EFPIA reply to the consultation for the inception impact assessment on the intended initiative in a European Health Data Space.pdf</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/602895/efpia-response-to-consultation-on-ehds.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">EFPIA Response to the consultation on the European health data space</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/676660/efpia-digital-endpoints-reference-documents.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">Current references on clinical endpoints derived from Digital Health Technologies</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> </ul> </div> <p><span class="rte-paragraph"><span class="rte-paragraph"><strong><span class="rte-heading">Related resources:<br /></span></strong><a rel="noopener" href="/umbraco/media/413646/eu-industrial-and-pharmaceutical-strategy-an-opportunity-to-drive-europe-s-health-and-growth.pdf" target="_blank"></a></span></span></p> <p><span class="rte-paragraph"><a rel="noopener" href="https://youtu.be/bovSv1bt4WM" target="_blank">Video on "Wearables and Insideables"<br /></a><br />Commission <strong>package on shaping Europe's digital future</strong>:</span></p> <ul> <li><span class="rte-paragraph"><a href="https://ec.europa.eu/info/strategy/priorities-2019-2024/europe-fit-digital-age/shaping-europe-digital-future_en">Shaping Europe's digital future</a></span></li> <li><span class="rte-paragraph"><a href="https://ec.europa.eu/info/strategy/priorities-2019-2024/europe-fit-digital-age/european-data-strategy_en">European Data strategy</a></span></li> <li><span class="rte-paragraph"><a href="https://ec.europa.eu/info/files/white-paper-artificial-intelligence-european-approach-excellence-and-trust_en">White paper on Artificial Intelligence</a></span></li> <li style="text-align: left;"><span class="rte-paragraph"><a href="https://ec.europa.eu/info/files/commission-report-safety-and-liability-implications-ai-internet-things-and-robotics_en">Liability issues relating to AI and robotics</a></span></li> </ul> <p><span class="rte-paragraph"><a rel="noopener" href="https://ec.europa.eu/info/strategy/priorities-2019-2024/europe-fit-digital-age/european-industrial-strategy_en" target="_blank">European industrial strategy</a></span></p> <ul> <li style="text-align: left;"><span class="rte-paragraph"><a rel="noopener" href="/media/413646/eu-industrial-and-pharmaceutical-strategy-an-opportunity-to-drive-europe-s-health-and-growth.pdf" target="_blank">EU Industrial and Pharmaceutical Strategy: An Opportunity to Drive Europe’s Health and Growth</a></span></li> <li style="text-align: left;"><span class="rte-paragraph"><a rel="noopener" data-id="14076" href="/media/554467/efpia_europeandatastrategy-briefing.pdf" target="_blank" title="EFPIA_EuropeanDataStrategy briefing.pdf">EFPIA briefing – submission to the Commission Data Strategy 2020</a></span></li> <li style="text-align: left;"><span class="rte-paragraph"><a rel="noopener" data-id="14075" href="/media/554466/efpia_europeanartificialintelligence-briefing.pdf" target="_blank" title="EFPIA_EuropeanArtificialIntelligence briefing.pdf">EFPIA briefing – Submission to the Commission AI white paper 2020</a></span></li> </ul> <p><span class="rte-paragraph"><a href="https://www.youtube.com/watch?v=msnKN-bKn_U&feature=youtu.be">EFPIA virtual event “Diabetes and COVID-19: when two pandemics meet” June 2020</a></span></p> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > </div> </div> </div> </div> </div> </div> </div> </section> </div> 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