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</o:shapelayout></xml><![endif]--></head><body lang=EN-US link="#0563C1" vlink="#954F72" style='word-wrap:break-word'><div class=WordSection1><p class=MsoNormal><o:p> </o:p></p><p class=MsoBodyText><span style='font-size:10.0pt;font-family:"Calibri",sans-serif'><o:p> </o:p></span></p><h1><span style='font-size:22.0pt;font-family:"Arial",sans-serif'>Medical Device Nonvisual Accessibility <br>Act (H.R. 1328)<o:p></o:p></span></h1><h2><span style='font-size:12.0pt;font-family:"Arial",sans-serif'>Issue—Inaccessible digital interfaces prevent blind individuals from independently and safely operating medical devices that are essential to blind people’s daily healthcare needs.<o:p></o:p></span></h2><h2><span style='font-size:12.0pt;font-family:"Arial",sans-serif'> <o:p></o:p></span></h2><h2 align=left style='text-align:left'><span style='font-size:12.0pt;font-family:"Arial",sans-serif;color:red;font-style:normal'>Medical devices with a digital interface are becoming more prevalent and less accessible for blind Americans.<o:p></o:p></span></h2><p class=MsoBodyText>The rapid proliferation of advanced technology is undeniable. Most new models of medical devices, such as glucose, oxygen, and blood pressure monitors, along with the emergence of in-home devices that offer medical care options, such as chemotherapy treatments and dialysis, require consumers to interact with digital displays or other interfaces. This new technology <a name="_Hlk61018618">is constantly being </a>developed and deployed without nonvisual accessibility as an integral part of the design phase, which creates an accessibility barrier. The inaccessibility of these medical devices is not a mere inconvenience; when accessibility for blind consumers is omitted from the medical technology landscape, the health, safety, and independence of blind Americans are in imminent danger.<span style='color:red'><o:p></o:p></span></p><p class=MsoNormal style='margin-right:23.4pt;mso-add-space:auto'><span style='font-size:12.0pt'><o:p> </o:p></span></p><h2 align=left style='text-align:left'><a name="_Hlk61018851"><span style='font-size:12.0pt;font-family:"Arial",sans-serif;color:red;font-style:normal'>According to the Center for Connected Medicine, telehealth currently makes up 20 percent of all medical visits, and more healthcare providers are looking to expand telemedicine services.</span></a><span style='mso-bookmark:_Hlk61018851'></span><a style='mso-endnote-id:edn1' href="#_edn1" name="_ednref1" title=""><span style='mso-bookmark:_Hlk61018851'>[1]</span></a><span style='mso-bookmark:_Hlk61018851'><span style='font-size:12.0pt;font-family:"Arial",sans-serif;color:red;font-style:normal'> </span></span><span style='font-size:12.0pt;font-family:"Arial",sans-serif;color:red;font-style:normal'><o:p></o:p></span></h2><p class=MsoBodyText style='margin-right:15.85pt;mso-add-space:auto'> According to the Pew Research Center, Rural Americans live an average of 10.5 miles from the nearest hospital.<a style='mso-endnote-id:edn2' href="#_edn2" name="_ednref2" title=""><span class=MsoEndnoteReference>[2]</span></a> According to the Journal of the American Pharmacists Association, across the United States, 8.3 percent of counties had at least 50 percent of residents with a distance greater than ten miles from the closest pharmacy,<a style='mso-endnote-id:edn3' href="#_edn3" name="_ednref3" title=""><span class=MsoEndnoteReference>[3]</span></a> requiring many Americans to rely on telehealth services. Unfortunately, these visits assume that a person has easy access to accessible medical devices to take their own vital signs. As a result of inaccessibility, blind and low-vision Americans are at a distinct disadvantage when it comes to receiving the same virtual healthcare as our sighted counterparts. <o:p></o:p></p><p class=MsoBodyText style='margin-top:.55pt;mso-add-space:auto'><o:p> </o:p></p><h2 align=left style='text-align:left'><span style='font-size:12.0pt;font-family:"Arial",sans-serif;color:red;font-style:normal'>Nonvisual access is achievable, as demonstrated by several mainstream products. <o:p></o:p></span></h2><p class=MsoBodyText style='margin-right:8.05pt;mso-add-space:auto'><b><span style='color:#ED1C24'> </span></b>Apple has incorporated VoiceOver (a screen reading function) into all of its products, making iPhones, Macbooks and Mac desktops, and iPads fully accessible to blind people right out of the box. Virtually all ATMs manufactured in the United States are accessible, and every polling place is required to have a nonvisually accessible voting machine. Frequently, a simple audio output or tactile feature can make a product accessible at little to no additional cost for manufacturers.<o:p></o:p></p><p class=MsoBodyText style='margin-right:8.05pt;mso-add-space:auto'><b><span style='color:#ED1C24'><o:p> </o:p></span></b></p><h2 align=left style='text-align:left'><span style='font-size:12.0pt;font-family:"Arial",sans-serif;color:red;font-style:normal'>Current disability laws have not been able to keep up with advancements due to the rapid evolution of medical technology and its incorporation into medical devices.</span><span style='font-size:12.0pt;font-family:"Arial",sans-serif;color:#ED1C24;font-style:normal'> <o:p></o:p></span></h2><p class=MsoBodyText style='margin-right:8.05pt;mso-add-space:auto'><b><span style='color:#ED1C24'> </span></b>Although the Americans with Disabilities Act and other laws require physical accessibility for people with disabilities (e.g. wheelchair ramps, Braille in public buildings), no laws protect a blind consumer’s right to access medical devices. The National Council on Disability concluded that accessibility standards lag behind the rapid pace of technology, which can interfere with technology access.<a style='mso-endnote-id:edn4' href="#_edn4" name="_ednref4" title=""><span class=MsoEndnoteReference>[4]</span></a> This trend of inaccessibility will continue if accessibility solutions are ignored. Only a fraction of medical device manufacturers have incorporated nonvisual access standards into their product design, while others continue to resist these solutions.<b><span style='color:#ED1C24'><o:p></o:p></span></b></p><b><i><span style='font-size:12.0pt;font-family:"Calibri",sans-serif;mso-fareast-language:EN-US'><br clear=all style='page-break-before:always'></span></i></b><h2><span style='font-size:12.0pt;font-family:"Arial",sans-serif'>Solution—Medical Device Nonvisual Accessibility Act:<o:p></o:p></span></h2><p class=MsoBodyText style='margin-top:.5pt;mso-add-space:auto'><b><i><o:p> </o:p></i></b></p><h2 align=left style='text-align:left'><span style='font-size:12.0pt;font-family:"Arial",sans-serif;color:#2F5496;font-style:normal'>Calls on the Food and Drug Administration (FDA) to promulgate nonvisual accessibility regulations for Class II and Class III medical devices with digital interfaces. <a name="_Hlk61019190"><o:p></o:p></a></span></h2><p class=MsoBodyText style='mso-margin-top-alt:0in;margin-right:5.5pt;margin-bottom:0in;margin-left:6.0pt;margin-bottom:.0001pt;mso-add-space:auto'><span style='mso-bookmark:_Hlk61019190'>The FDA will consult with stakeholders with disabilities and manufacturers and issue a notice of proposed rulemaking no later than twelve months after the date of enactment of the act. No later than twenty-four months after the date of enactment of the act, the FDA will publish the final rule including the nonvisual accessibility requirements.<o:p></o:p></span></p><span style='mso-bookmark:_Hlk61019190'></span><p class=MsoBodyText style='mso-margin-top-alt:0in;margin-right:5.5pt;margin-bottom:0in;margin-left:6.0pt;margin-bottom:.0001pt;mso-add-space:auto'><o:p> </o:p></p><h2 align=left style='text-align:left'><span style='font-size:12.0pt;font-family:"Arial",sans-serif;color:#2F5496;font-style:normal'>Requires manufacturers of Class II and Class III medical devices with digital interfaces to make their products nonvisually accessible. <o:p></o:p></span></h2><p class=MsoBodyText style='margin-right:5.5pt;mso-add-space:auto'>Manufacturers will have twelve months following the publication of the final rule to ensure that all the Class II and Class III medical devices they produce with digital interfaces are nonvisually accessible.<o:p></o:p></p><p class=MsoBodyText><o:p> </o:p></p><h2 align=left style='text-align:left'><span style='font-size:12.0pt;font-family:"Arial",sans-serif;color:#2F5496;font-style:normal'>Authorizes the FDA to enforce the nonvisual access requirements for Class II and Class III medical devices with digital interfaces. <o:p></o:p></span></h2><p class=MsoNormal style='margin-right:6.8pt;mso-add-space:auto'><span style='font-size:12.0pt'>Any manufactured device found to be out of compliance, as a result of a public complaint to the FDA or by an independent FDA investigation, will be considered an adulterated product under the Federal Food, Drug, and Cosmetic Act. Manufacturers may file for an exemption for one of two reasons: clear and convincing evidence that making the medical device nonvisually accessible would fundamentally alter the product; or evidence that modifying the medical device would create an undue hardship for the company.</span><span style='font-size:12.0pt;font-family:"Calibri",sans-serif'><o:p></o:p></span></p><p class=MsoNormal style='mso-margin-top-alt:0in;margin-right:6.8pt;margin-bottom:0in;margin-left:5.95pt;margin-bottom:.0001pt;mso-add-space:auto'><span style='font-size:12.0pt;font-family:"Calibri",sans-serif'><o:p> </o:p></span></p><p class=MsoNormal style='mso-margin-top-alt:0in;margin-right:6.8pt;margin-bottom:0in;margin-left:5.95pt;margin-bottom:.0001pt;mso-add-space:auto'><span style='font-size:10.0pt;font-family:"Calibri",sans-serif'><o:p> </o:p></span></p><h2><span style='font-size:18.0pt;font-family:"Arial",sans-serif;color:#2F5496;font-style:normal'>GOAL—END UNEQUAL ACCESS TO MEDICAL DEVICES FOR BLIND AMERICANS.<o:p></o:p></span></h2><p class=MsoBodyText><o:p> </o:p></p><h2><span style='font-family:"Arial",sans-serif;font-style:normal'>Cosponsor the Medical Device Nonvisual Accessibility Act (H.R. 1328).<o:p></o:p></span></h2><p class=MsoNormal align=center style='text-align:center;text-autospace:ideograph-other'><b><span style='font-size:12.0pt'><o:p> </o:p></span></b></p><p class=MsoNormal align=center style='text-align:center;text-autospace:ideograph-other'><b><span style='font-size:12.0pt'>To cosponsor H.R. 1328 contact:<o:p></o:p></span></b></p><p class=MsoBodyText align=center style='text-align:center'>Michelle Paucar, Health Policy Counsel, Rep. Jan Schakowsky (D-IL-09), <o:p></o:p></p><p class=MsoBodyText align=center style='text-align:center'>Phone: 202-225-2111, Email: <a href="mailto:%20Michelle.Paucar@mail.house.gov"> Michelle.Paucar@mail.house.gov</a><b><span style='font-size:11.5pt'><o:p></o:p></span></b></p><p class=MsoBodyText style='margin-top:.5pt;mso-add-space:auto'><b><span style='font-size:11.5pt;font-family:"Calibri",sans-serif'><o:p> </o:p></span></b></p><p class=MsoNormal align=center style='mso-margin-top-alt:0in;margin-right:6.5pt;margin-bottom:0in;margin-left:8.5pt;margin-bottom:.0001pt;mso-add-space:auto;text-align:center'><b><span style='font-size:12.0pt'>For more information, contact:<o:p></o:p></span></b></p><p class=MsoBodyText align=center style='mso-margin-top-alt:0in;margin-right:28.0pt;margin-bottom:0in;margin-left:.25in;margin-bottom:.0001pt;mso-add-space:auto;text-align:center'>Justin Young, Government Affairs Specialist, National Federation of the Blind<o:p></o:p></p><p class=MsoBodyText align=center style='mso-margin-top-alt:0in;margin-right:28.0pt;margin-bottom:0in;margin-left:.25in;margin-bottom:.0001pt;mso-add-space:auto;text-align:center'>Phone: 410-659-9314, extension 2210, Email: <a href="mailto:jyoung@nfb.org">jyoung@nfb.org</a> or visit <a href="http://www.nfb.org">www.nfb.org</a><o:p></o:p></p><p class=MsoNormal><span style='font-family:"Calibri",sans-serif'><o:p> </o:p></span></p><div><p class=MsoNormal style='text-autospace:ideograph-numeric ideograph-other'><span style='font-family:"Calibri",sans-serif'><br clear=all><o:p></o:p></span></p><div class=MsoNormal style='text-autospace:ideograph-numeric ideograph-other'><span style='font-family:"Calibri",sans-serif'><hr size=1 width="33%" align=left></span></div></div></div><div style='mso-element:endnote-list'><br clear=all><hr align=left size=1 width="33%"><div style='mso-element:endnote' id=edn1><p class=MsoEndnoteText><a style='mso-endnote-id:edn1' href="#_ednref1" name="_edn1" title=""><span class=MsoEndnoteReference>[1]</span></a> <i>See </i>Center for Connected Medicine<i>, Telehealth utilization settles in at 20% or less of medical appointments</i>, available at<i> </i><a href="https://connectedmed.com/resources/post-pandemic-telehealth-utilization-settles-in-at-20-or-less-of-medical-appointments/">https://connectedmed.com/resources/post-pandemic-telehealth-utilization-settles-in-at-20-or-less-of-medical-appointments/</a></p></div><div style='mso-element:endnote' id=edn2><p class=MsoNormal><a style='mso-endnote-id:edn2' href="#_ednref2" name="_edn2" title=""><span class=MsoEndnoteReference>[2]</span></a> <i><span style='font-size:10.0pt'>See Pew Research Center, How far Americans live from the closest hospital differs by community type</span></i><span style='font-size:10.0pt'>, available at </span><a href="https://www.pewresearch.org/short-reads/2018/12/12/how-far-americans-live-from-the-closest-hospital-differs-by-community-type/"><span style='font-size:10.0pt'>https://www.pewresearch.org/short-reads/2018/12/12/how-far-americans-live-from-the-closest-hospital-differs-by-community-type/</span></a></p></div><div style='mso-element:endnote' id=edn3><p class=MsoNormal><a style='mso-endnote-id:edn3' href="#_ednref3" name="_edn3" title=""><span class=MsoEndnoteReference>[3]</span></a> <i><span style='font-size:10.0pt'>See </span></i><span style='font-size:10.0pt'>Journal of the American Pharmacists Association, Access to community pharmacies: A nationwide geographic information systems cross-sectional analysis available at </span><a href="https://www.japha.org/article/S1544-3191(22)00233-3/fulltext"><span style='font-size:10.0pt'>https://www.japha.org/article/S1544-3191(22)00233-3/fulltext</span></a></p></div><div style='mso-element:endnote' id=edn4><p class=MsoEndnoteText><a style='mso-endnote-id:edn4' href="#_ednref4" name="_edn4" title=""><span class=MsoEndnoteReference>[4]</span></a> <i>See </i>NATIONAL COUNCIL ON DISABILITIES, <i>National Disability Policy Progress Report: Technology that enables access to the full opportunities of citizenship under the Constitution is a right </i>at 19 (October 7, 2016), <i>available at </i><a name="_Hlk121475963"></a><a href="https://ncd.gov/progressreport/2016/progress-report-october-2016"><span style='mso-bookmark:_Hlk121475963'>https://ncd.gov/progressreport/2016/progress-report-october-2016</span><span style='mso-bookmark:_Hlk121475963'></span></a><span style='mso-bookmark:_Hlk121475963'></span></p></div></div></body></html>