{"id":217086,"date":"2026-05-20T06:00:00","date_gmt":"2026-05-20T10:00:00","guid":{"rendered":"https:\/\/testing.news-you-need.com\/index.php\/2026\/05\/20\/a-safety-proposal-for-ai-enabled-medical-devices\/"},"modified":"2026-05-20T06:05:19","modified_gmt":"2026-05-20T10:05:19","slug":"a-safety-proposal-for-ai-enabled-medical-devices","status":"publish","type":"post","link":"https:\/\/testing.news-you-need.com\/index.php\/2026\/05\/20\/a-safety-proposal-for-ai-enabled-medical-devices\/","title":{"rendered":"A Safety Proposal for AI-Enabled Medical Devices"},"content":{"rendered":"<p><a href=\"https:\/\/www.prnewswire.com\/news-releases\/a-safety-proposal-for-ai-enabled-medical-devices-302776850.html\">A Safety Proposal for AI-Enabled Medical Devices<\/a><\/p>\n<p><a href=\"https:\/\/www.prnewswire.com\/news-releases\/a-safety-proposal-for-ai-enabled-medical-devices-302776850.html\">https:\/\/www.prnewswire.com\/news-releases\/a-safety-proposal-for-ai-enabled-medical-devices-302776850.html<\/a><\/p>\n<p>Publish Date: <a href=\"publish_date]\">2026-05-20 06:00:00<\/a><\/p>\n<p>Source Domain: <a href=\"www.prnewswire.com\">www.prnewswire.com<\/a><\/p>\n<ul>\n<li>Paragon Health Institute has published a paper addressing the issue of generalization uncertainty involving AI-enabled medical devices in healthcare.<\/li>\n<li>AI medical devices must perform reliably in real-world scenarios, but issues in generalization can pose significant safety challenges.<\/li>\n<li>Current remedies for addressing generalization uncertainty are costly and do not adequately personalize risk assessments for individual patients.<\/li>\n<li>The paper proposes a voluntary framework called Digital Similarity Analysis (DSA) designed to compare individual patient data to the device&#8217;s training data.<\/li>\n<li>DSA aims to flag potential outliers, allowing physicians to decide how to proceed when such outliers are found, potentially enhancing the safety and personalization of AI medical devices.<\/li>\n<li>While DSA does not eliminate generalization uncertainty entirely, it provides useful guidance to clinicians and helps preserve device manufacturers&#8217; confidential training data.<\/li>\n<li>The DSA framework expands the discussion of algorithmic bias to individual patient characteristics, potentially improving safety and effectiveness across demographic segments.<\/li>\n<li>The paper is part of Paragon Health Institute\u2019s broader Health Care AI Initiative, focusing on the responsible innovation and use of AI in healthcare.<\/li>\n<\/ul>\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Safety Proposal for AI-Enabled Medical Devices https:\/\/www.prnewswire.com\/news-releases\/a-safety-proposal-for-ai-enabled-medical-devices-302776850.html Publish Date: 2026-05-20 06:00:00 Source Domain: www.prnewswire.com&#8230;<\/p>\n","protected":false},"author":1,"featured_media":217088,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/mma.prnewswire.com\/media\/2423462\/Paragon_Health_Institute_Logo.jpg?p=facebook","fifu_image_alt":"","footnotes":""},"categories":[14],"tags":[],"class_list":["post-217086","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-artificial-intelligence"],"_links":{"self":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts\/217086"}],"collection":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/comments?post=217086"}],"version-history":[{"count":1,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts\/217086\/revisions"}],"predecessor-version":[{"id":217089,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts\/217086\/revisions\/217089"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/media\/217088"}],"wp:attachment":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/media?parent=217086"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/categories?post=217086"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/tags?post=217086"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}