‘Holes’ in federal AI healthcare regulation should be patched, Penn Med faculty say
‘Holes’ in federal AI healthcare regulation should be patched, Penn Med faculty say
Publish Date: 2026-03-23 23:46:00
Source Domain: www.thedp.com
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Regulatory Gaps in AI Approval: Experts at Penn Medicine argue that the current FDA approval pathways for traditional medical devices are inadequate for regulating AI-enabled devices.
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510(k) Pathway Concerns: 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.
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Lack of Post-Implementation Monitoring: Current regulatory processes fail to address changes in AI device performance over time and across different locations, known as “shift” or “drift.”
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Proposed Regulatory Framework: Experts support an expansive, robust regulatory framework with AI systems being monitored before receiving clearance, similar to a human’s approach to independent practice.
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Need for Institutional and Local Regulation: Institutions like Penn are encouraged to adopt their AI governance processes, and local regulation is needed to keep pace with technological advancements.
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Pennsylvania’s House Bill 1925: 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.
