aceOvercoming the opaque side of AI in healthcare: a lifecycle based approach
Introduction Transparency has emerged as a foundational condition for trustworthy Artificial Intelligence (AI) in healthcare. Despite its centrality, practical approaches to systematically operationalize transparency across the entire lifecycle of AI-enabled medical devices remain fragmented and insufficiently structured. This work addresses this gap by proposing a lifecycle-oriented operational approach to guide the consistent implementation and evaluation of transparency in AI-based medical technologies. Areas…
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.
Existing practical approaches for implementing and evaluating transparency across the full lifecycle of AI-enabled medical devices are fragmented and lack systematic structure.
Evidence
- Peer-reviewedExpert Review of Medical Devices2026-08-24
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Truvace Impact Record TRV-2026-0879, v1: “Overcoming the opaque side of AI in healthcare: a lifecycle based approach.” Truvace, 2026-08-25. /record/TRV-2026-0879 (accessed at citation time). sha256 843a8ba0d8d50c98…
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