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class="elementor-widget-container"> <form class="elementor-search-form" action="https://wirelesslifesciences.org" method="get" role="search"> <div class="elementor-search-form__container"> <label class="elementor-screen-only" for="elementor-search-form-f82b9ab">Search</label> <input id="elementor-search-form-f82b9ab" placeholder="Search..." class="elementor-search-form__input" type="search" name="s" value=""> <button class="elementor-search-form__submit" type="submit" aria-label="Search"> <i aria-hidden="true" class="fas fa-search"></i> <span class="elementor-screen-only">Search</span> </button> </div> </form> </div> </div> </div> </div> </div> </div> </div> </div> </div> <main id="content" class="site-main post-330 page type-page status-publish hentry"> <div class="page-content"> <div data-elementor-type="wp-page" data-elementor-id="330" class="elementor elementor-330" data-elementor-post-type="page"> <div class="elementor-element elementor-element-03dbec5 e-flex e-con-boxed e-con e-parent" data-id="03dbec5" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-2afca69 e-flex e-con-boxed e-con e-child" data-id="2afca69" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-6cf81cc elementor-widget elementor-widget-heading" data-id="6cf81cc" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">Open Outcomes Based Regulation (OOBR)</h1> </div> </div> <div class="elementor-element elementor-element-89b2792 elementor-widget elementor-widget-heading" data-id="89b2792" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Open Outcomes Based Regulation (OOBR)</h2> </div> </div> <div class="elementor-element elementor-element-c9e9374 e-flex e-con-boxed e-con e-child" data-id="c9e9374" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-93d6739 e-con-full e-flex e-con e-child" data-id="93d6739" data-element_type="container"> <div class="elementor-element elementor-element-4a6f0e7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor" data-id="4a6f0e7" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>WLSA is involved in all of these issues, but our primary effort addresses the root causes of the regulatory problem:</p><ul><li>The pace of regulation is slow while innovation that creates new products and improves existing products is fast.</li><li>When the status quo is unhealthy and getting worse, as with chronic diseases and the cost of health care, the failure to act may be more dangerous to more people than allowing the use of new products.</li><li>Pre-market certification is limited in that it cannot efficiently ascertain all the future risks associated with the use of a product, nor can it predict the future efficacy of a product relative to other interventions and changes in the environment of people鈥檚 lives.聽 Pre-market certification also creates an anti-competitive barrier to entry for better products.</li></ul><p>OOBR is based on a fundamental shift in thinking about the relationship of health and health care. 聽Health care has been at the center of policy activities for decades, leading to the conclusion that more health care would necessarily deliver more health to more people.聽 This assumption is too often wrong.聽 WLSA posits that the proper societal goal is聽<i>better health</i>聽not more health care.聽 Medical products and services are just one necessary tool in achieving the goal of better health.</p><p>A metaphor for this departure from conventional thinking is the relationship between productivity (factory output, room temperatures) and energy use.聽 The clear goal is to apply the least amount of energy input required to achieve the desired output.聽 Hence, the U.S. has tripled its domestic output over the last four decades while holding energy spending about 8% of GDP. 聽In contrast, health care costs have risen from 8% to 18% of GDP and health status is arguably worse than 40 years ago.聽 According to the Institutes of Medicine, about one-third of health care spending is wasted.</p><p>Open Outcomes Based Regulation would leverage patient engagement and the market to support quality assurance and the continuous evaluation and improvement of efficacy.聽 The three principal goals of medical product regulation are to ensure that products are high quality, safe and effective.聽 OOBR鈥檚 structure is as follows:</p> </div> </div> </div> <div class="elementor-element elementor-element-bb4b32c e-flex e-con-boxed e-con e-child" data-id="bb4b32c" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-ea6d5cb elementor-widget elementor-widget-text-editor" data-id="ea6d5cb" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2>Resources</h2><p><a title="WLSA Urges FDA" href="http://wirelesslifesciences.org/2011/11/wlsa-urges-fda-for-wireless-health-innovation-in-mobile-medical-applications-guidance/" target="_blank" rel="bookmark noopener">WLSA urges FDA for wireless health innovation in Mobile Medical Applications Guidance</a></p><hr /><p><a title="WLSA Comments with respect to the&nbsp;FCC/FDA Joint Meeting on Life Saving Wireless Medical Technology" href="http://wirelesslifesciences.org/2010/08/wlsa-comments-with-respect-to-the-fccfda-joint-meeting-on-life-saving-wireless-medical-technology/" target="_blank" rel="noopener">WLSA Comments with respect to the聽FCC/FDA Joint Meeting on Life Saving Wireless Medical Technology</a></p><hr /><p><a title="WLSA Comments on FDASIA Report" href="http://wirelesslifesciences.org/wp-content/uploads/2014/11/WLSA-Comments-on-FDASIA-Report-FINAL3.pdf" target="_blank" rel="noopener">WLSA Comments on FDASIA Report</a></p><hr /><p><a title="Multistakeholder Letter to House EC Health Subcommittee regarding AHRQ Lit Review" href="http://wirelesslifesciences.org/wp-content/uploads/2014/12/Multistakeholder-Letter-to-House-EC-Health-Subcom-re-AHRQ-Lit-Review-120514-1.pdf" target="_blank" rel="noopener">Multistakeholder Letter to House EC Health Subcommittee regarding AHRQ Lit Review</a></p> </div> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-cb32407 elementor-widget elementor-widget-image" data-id="cb32407" data-element_type="widget" data-widget_type="image.default"> <div class="elementor-widget-container"> <img fetchpriority="high" decoding="async" width="666" height="500" src="https://wirelesslifesciences.org/wp-content/uploads/2023/09/Initiatives-graphic.jpg" class="attachment-large size-large wp-image-332" alt="Open Outcomes Based Regulation (OOBR)" srcset="https://wirelesslifesciences.org/wp-content/uploads/2023/09/Initiatives-graphic.jpg 666w, https://wirelesslifesciences.org/wp-content/uploads/2023/09/Initiatives-graphic-300x225.jpg 300w" sizes="(max-width: 666px) 100vw, 666px" /> </div> </div> <div class="elementor-element elementor-element-4560f80 elementor-widget elementor-widget-text-editor" data-id="4560f80" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>The redesigned system would have the following effects:</p> </div> </div> <div class="elementor-element elementor-element-bc45f8a elementor-widget elementor-widget-image" data-id="bc45f8a" data-element_type="widget" data-widget_type="image.default"> <div class="elementor-widget-container"> <img decoding="async" width="666" height="500" src="https://wirelesslifesciences.org/wp-content/uploads/2023/09/Initiatives-graphic-2.jpg" class="attachment-large size-large wp-image-333" alt="Open Outcomes Based Regulation (OOBR)" srcset="https://wirelesslifesciences.org/wp-content/uploads/2023/09/Initiatives-graphic-2.jpg 666w, https://wirelesslifesciences.org/wp-content/uploads/2023/09/Initiatives-graphic-2-300x225.jpg 300w" sizes="(max-width: 666px) 100vw, 666px" /> </div> </div> <div class="elementor-element elementor-element-c7e32fc elementor-widget elementor-widget-text-editor" data-id="c7e32fc" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><b>OOBR adds patient input and the power of the research community to the evaluation of medical products:</b></p> </div> </div> <div class="elementor-element elementor-element-a966faa elementor-widget elementor-widget-image" data-id="a966faa" data-element_type="widget" data-widget_type="image.default"> <div class="elementor-widget-container"> <img decoding="async" width="666" height="500" src="https://wirelesslifesciences.org/wp-content/uploads/2023/09/OOBR-adds-voices.jpg" class="attachment-large size-large wp-image-334" alt="Open Outcomes Based Regulation (OOBR)" srcset="https://wirelesslifesciences.org/wp-content/uploads/2023/09/OOBR-adds-voices.jpg 666w, https://wirelesslifesciences.org/wp-content/uploads/2023/09/OOBR-adds-voices-300x225.jpg 300w" sizes="(max-width: 666px) 100vw, 666px" /> </div> </div> <div class="elementor-element elementor-element-96b7278 elementor-widget elementor-widget-text-editor" data-id="96b7278" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><b>OOBR changes the nature of medical products.</b></p> </div> </div> <div class="elementor-element elementor-element-323b85f elementor-widget elementor-widget-image" data-id="323b85f" data-element_type="widget" data-widget_type="image.default"> <div class="elementor-widget-container"> <img loading="lazy" decoding="async" width="666" height="500" src="https://wirelesslifesciences.org/wp-content/uploads/2023/09/OOBR-includes.jpg" class="attachment-large size-large wp-image-335" alt="Open Outcomes Based Regulation (OOBR)" srcset="https://wirelesslifesciences.org/wp-content/uploads/2023/09/OOBR-includes.jpg 666w, https://wirelesslifesciences.org/wp-content/uploads/2023/09/OOBR-includes-300x225.jpg 300w" sizes="(max-width: 666px) 100vw, 666px" /> </div> </div> <div class="elementor-element elementor-element-45fb1b6 elementor-widget elementor-widget-text-editor" data-id="45fb1b6" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><b>With this background,聽<a title="please review our proposal" href="http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0339-0047" target="_blank" rel="noopener">please review our proposal</a></b><b>. 聽</b></p><p>Some other WLSA position papers are linked below:</p><ul><li><a title="WLSA Urges FDA" href="http://wirelesslifesciences.org/2011/11/wlsa-urges-fda-for-wireless-health-innovation-in-mobile-medical-applications-guidance/" target="_blank" rel="noopener">WLSA urges FDA for wireless health innovation in Mobile Medical Applications Guidance</a></li><li><a title="WLSA Comments with respect to the&nbsp;FCC/FDA Joint Meeting on Life Saving Wireless Medical Technology" href="http://wirelesslifesciences.org/2010/08/wlsa-comments-with-respect-to-the-fccfda-joint-meeting-on-life-saving-wireless-medical-technology/" target="_blank" rel="noopener">WLSA Comments with respect to the聽FCC/FDA Joint Meeting on Life Saving Wireless Medical Technology</a></li></ul> </div> </div> </div> </div> </div> </div> </div> </div> </main> <div data-elementor-type="footer" data-elementor-id="71" class="elementor elementor-71 elementor-location-footer" data-elementor-post-type="elementor_library"> <div class="elementor-section-wrap"> <div 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