{"id":198606,"date":"2026-03-23T23:46:00","date_gmt":"2026-03-24T03:46:00","guid":{"rendered":"https:\/\/testing.news-you-need.com\/index.php\/2026\/03\/23\/holes-in-federal-ai-healthcare-regulation-should-be-patched-penn-med-faculty-say\/"},"modified":"2026-03-24T00:50:13","modified_gmt":"2026-03-24T04:50:13","slug":"holes-in-federal-ai-healthcare-regulation-should-be-patched-penn-med-faculty-say","status":"publish","type":"post","link":"https:\/\/testing.news-you-need.com\/index.php\/2026\/03\/23\/holes-in-federal-ai-healthcare-regulation-should-be-patched-penn-med-faculty-say\/","title":{"rendered":"\u2018Holes\u2019 in federal AI healthcare regulation should be patched, Penn Med faculty say"},"content":{"rendered":"<p><a href=\"https:\/\/www.thedp.com\/article\/2026\/03\/penn-medicine-artificial-intelligence-regulatory-framework-healthcare\">\u2018Holes\u2019 in federal AI healthcare regulation should be patched, Penn Med faculty say<\/a><\/p>\n<p><a href=\"https:\/\/www.thedp.com\/article\/2026\/03\/penn-medicine-artificial-intelligence-regulatory-framework-healthcare\">https:\/\/www.thedp.com\/article\/2026\/03\/penn-medicine-artificial-intelligence-regulatory-framework-healthcare<\/a><\/p>\n<p>Publish Date: <a href=\"publish_date]\">2026-03-23 23:46:00<\/a><\/p>\n<p>Source Domain: <a href=\"www.thedp.com\">www.thedp.com<\/a><\/p>\n<ul>\n<li>\n<p><strong>Regulatory Gaps in AI Approval<\/strong>: Experts at Penn Medicine argue that the current FDA approval pathways for traditional medical devices are inadequate for regulating AI-enabled devices.<\/p>\n<\/li>\n<li>\n<p><strong>510(k) Pathway Concerns<\/strong>: The 510(k) pathway, intended for devices similar to existing options, grants clearance to nearly all AI-based devices with insufficient robust evidence of safety and efficacy.<\/p>\n<\/li>\n<li>\n<p><strong>Lack of Post-Implementation Monitoring<\/strong>: Current regulatory processes fail to address changes in AI device performance over time and across different locations, known as &#8220;shift&#8221; or &#8220;drift.&#8221;<\/p>\n<\/li>\n<li>\n<p><strong>Proposed Regulatory Framework<\/strong>: Experts support an expansive, robust regulatory framework with AI systems being monitored before receiving clearance, similar to a human&#8217;s approach to independent practice.<\/p>\n<\/li>\n<li>\n<p><strong>Need for Institutional and Local Regulation<\/strong>: Institutions like Penn are encouraged to adopt their AI governance processes, and local regulation is needed to keep pace with technological advancements.<\/p>\n<\/li>\n<li>\n<p><strong>Pennsylvania&#8217;s House Bill 1925<\/strong>: Introduced legislation aims to ensure transparency and human involvement in AI use, while minimizing bias and discrimination, which Penn Medicine experts view as steps in the right direction.<\/p>\n<\/li>\n<\/ul>\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u2018Holes\u2019 in federal AI healthcare regulation should be patched, Penn Med faculty say https:\/\/www.thedp.com\/article\/2026\/03\/penn-medicine-artificial-intelligence-regulatory-framework-healthcare Publish&#8230;<\/p>\n","protected":false},"author":1,"featured_media":198607,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/snworksceo.imgix.net\/dpn\/7a9b0a83-cc7d-481e-ba0b-704f4d6c8159.sized-1000x1000.jpg?w=800&h=600","fifu_image_alt":"","footnotes":""},"categories":[14],"tags":[],"class_list":["post-198606","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\/198606"}],"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=198606"}],"version-history":[{"count":1,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts\/198606\/revisions"}],"predecessor-version":[{"id":198608,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts\/198606\/revisions\/198608"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/media\/198607"}],"wp:attachment":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/media?parent=198606"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/categories?post=198606"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/tags?post=198606"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}