Regulatory Approval Is Not Enough: Gaps in Trustworthy AI Reporting in FDA-Cleared Medical Devices
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 cleared AI systems remains unclear. Methods: We analysed FDA AI/ML-enabled medical device summary reports published between 2021 and 2025. Reports underwent automated keyword screening followed by multi-stage manual consensus review to identify ...
| Authors | Ahmed M Salih, Oliver Díaz, Alejandro Guzman et al. |
|---|---|
| Primary category | cs.CY |
| Published | 4 July 2026 |
| Last updated at source | 4 July 2026 |
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