{"id":132630,"date":"2022-07-18T14:35:00","date_gmt":"2022-07-18T18:25:00","guid":{"rendered":"https:\/\/hispanicprwire.com\/english-national-alliance-for-hispanic-health-cautions-fda-on-2022-report-on-the-risks-and-health-benefits-of-non-device-software\/"},"modified":"2022-07-18T14:40:02","modified_gmt":"2022-07-18T18:40:02","slug":"la-alianza-nacional-para-la-salud-hispana-advierte-a-la-fda-sobre-el-informe-del-2022-sobre-los-riesgos-y-beneficios-para-la-salud-del-software-que-no-es-de-dispositivo","status":"publish","type":"post","link":"https:\/\/hispanicprwire.com\/en\/la-alianza-nacional-para-la-salud-hispana-advierte-a-la-fda-sobre-el-informe-del-2022-sobre-los-riesgos-y-beneficios-para-la-salud-del-software-que-no-es-de-dispositivo\/","title":{"rendered":"National Alliance for Hispanic Health Cautions FDA on 2022 Report on the Risks and Health Benefits of Non-device Software"},"content":{"rendered":"<p><\/p>\n<style type=\"text\/css\"><![CDATA[\n\/* Style Definitions *\/\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n]]><\/style>\n<div class=\"xn-content\">\n<p><span class=\"xn-location\">WASHINGTON<\/span>, <span class=\"xn-chron\">July 18, 2022<\/span> \/PRNewswire-HISPANIC PR WIRE\/ &#8212; &#8220;The COVID pandemic has changed the acceptance of mHealth throughout the Nation. There is an urgency in FDA&#8217;s upcoming Congressionally mandated 2022 Report on the risks and health benefits of non-device software to consider the multitude of mHealth software in the new landscape of health and implications of an ongoing lack of adequate data by race, ethnicity, and gender.&#8221; said <span class=\"xn-person\">Jane L. Delgado<\/span>, PhD, MS, President and CEO of the <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3596975-1&amp;h=2225595768&amp;u=http%3A%2F%2Fwww.healthyamericas.org%2F&amp;a=National+Alliance+for+Hispanic+Health\" target=\"_blank\" rel=\"nofollow\">National Alliance for Hispanic Health<\/a>, the Nation&#8217;s leading Hispanic health advocacy group. In submitting comments for FDA&#8217;s proposed 2022 report, the Alliance commended FDA for using in the 2020 report the WHO definition of health, i.e.,<b> &#8220;<\/b>a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity,&#8221; and urges them to take that definition fully into account as they develop the 2022 Report.<\/p>\n<p>The Alliance called for the 2022 FDA report to recognize the patient safety risk as a result of the lack of inclusion of known differences in drug response by race, ethnicity, and gender[i] and the risk of reliance on clinical decision systems (CDS) that lack adequate race, ethnicity, and gender data from clinical trials. Dr. Delgado added, &#8220;Over the past 20 years less than half of clinical trials (43%) in the U.S. reported any race or ethnic data.&#8221;[ii]<\/p>\n<div class=\"wcag-arialevel-3\" style=\"display: block; font-size: 1.17em; margin-block-start: 1em; margin-block-end: 1em; margin-inline-start: 0px; margin-inline-end: 0px; font-weight: bold; text-align: left;\" role=\"heading\" aria-level=\"3\"><b>About the National Alliance for Hispanic Health<\/b>\u00a0(The Alliance)<\/div>\n<p>The Alliance is the nation&#8217;s foremost science-based source of information and trusted advocate for the health of Hispanics in <span class=\"xn-location\">the United States<\/span> with a mission to achieve the best health for all. For more information visit us at\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3596975-1&amp;h=1365522281&amp;u=http%3A%2F%2Fwww.healthyamericas.org%2F&amp;a=www.healthyamericas.org\" target=\"_blank\" rel=\"nofollow\">www.healthyamericas.org<\/a><\/p>\n<p\/>\n<hr\/>\n<p>[i]\u00a0National Alliance for Hispanic Health. Genes, Culture, and Health: Ensuring the Best Health Outcomes for All. <span class=\"xn-location\">Washington, DC<\/span>: 20015. <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3596975-1&amp;h=1704035679&amp;u=https%3A%2F%2Fbit.ly%2F3ckfWfe&amp;a=https%3A%2F%2Fbit.ly%2F3ckfWfe\" target=\"_blank\" rel=\"nofollow\">https:\/\/bit.ly\/3ckfWfe<\/a><\/p>\n<p>[ii]\u00a0Turner, Brandon, <span class=\"xn-person\">Jecca R. Steinberg<\/span>, <span class=\"xn-person\">Brannon T. Weeks<\/span>, <span class=\"xn-person\">Fatima Rodriguez<\/span>, <span class=\"xn-person\">Mark R. Cullen<\/span>. &#8220;Race\/ethnicity reporting and representation in US clinical trials: A cohort study.&#8221; <i>The Lancet Regional Health \u2013 Americas<\/i>. Volume 11, <span class=\"xn-chron\">July 2022<\/span>, 100252. <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3596975-1&amp;h=1133480481&amp;u=https%3A%2F%2Fdoi.org%2F10.1016%2Fj.lana.2022.100252&amp;a=https%3A%2F%2Fdoi.org%2F10.1016%2Fj.lana.2022.100252\" target=\"_blank\" rel=\"nofollow\">https:\/\/doi.org\/10.1016\/j.lana.2022.100252<\/a><\/p>\n<p>SOURCE  National Alliance for Hispanic Health<\/p>\n<\/div>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<div class=\"xn-content\">\n<p><span class=\"xn-location\">WASHINGTON<\/span>, <span class=\"xn-chron\">July 18, 2022<\/span> \/PRNewswire-HISPANIC PR WIRE\/ &#8212; &#8220;The COVID pandemic has changed the acceptance of mHealth throughout the Nation. There is an urgency in FDA&#8217;s upcoming Congressionally mandated 2022 Report on the risks and health benefits of non-device software to consider the multitude of mHealth software in the new landscape of health and implications of an ongoing lack of adequate data by race, ethnicity, and gender.&#8221; said <span class=\"xn-person\">Jane L. Delgado<\/span>, PhD, MS, President&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[13],"tags":[],"class_list":["post-132630","post","type-post","status-publish","format-standard","hentry","category-salud"],"acf":[],"_links":{"self":[{"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/posts\/132630","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/comments?post=132630"}],"version-history":[{"count":"1","href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/posts\/132630\/revisions"}],"predecessor-version":[{"id":132631,"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/posts\/132630\/revisions\/132631"}],"wp:attachment":[{"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/media?parent=132630"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/categories?post=132630"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/tags?post=132630"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}