A lifecycle-oriented operational framework with nine measures was proposed to engineer transparency into AI-enabled medical devices to improve regulatory readiness and calibrated clinical trust.
Published August 2026, this peer-reviewed synthesis addresses transparency as a foundational condition for trustworthy AI in healthcare. It finds current methods to operationalize transparency across AI-enabled medical devices are fragmented, and proposes a SaMD lifecycle framework to map regulatory and standards requirements to concrete development and governance steps.
- Impact 30%
- 49
- Evidence 25%
- 95
- Scale 20%
- 35
- Confidence 15%
- 87
- Recency 10%
- 91
Updated Aug 25, 2026 · TRV-2026-0879
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