Regulatory Approval Is Not Enough: Gaps in Trustworthy AI Reporting in FDA-Cleared Medical Devices
arXiv:2608.12360v1 Announce Type: new Abstract: Background: AI/ML-enabled medical devices are increasingly deployed in healthcare under evolving regulatory frameworks. As these systems become more integrated into clinical decision-making, there is growing expectation that they demonstrate key dimensions of trustworthy AI to support clinician, patient, and public trust. Whether publicly available regulatory documentation provides sufficient evidence to independently assess the trustworthiness of
Record details
Published: 14 August 2026
Source: arXiv cs.CY
Category: Research
Topics: Regulation · Healthcare
Retrieved: 14 August 2026
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ethics.ai (14 August 2026), “Regulatory Approval Is Not Enough: Gaps in Trustworthy AI Reporting in FDA-Cleared Medical Devices,” evidence record 19114, https://ethics.ai/record/19114 (originally published by arXiv cs.CY).
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