Article

Dynamic AI Risk Loop (DARL): A Continuous Risk Management Framework for AI-Enabled Health Information Systems in Medical Device Software

2026-05-25

Abstract excerpt

<title>Abstract</title> <p> The integration of artificial intelligence and machine learning (AI/ML) into health information systems, particularly AI-enabled Software as a Medical Device (SaMD) for radiological tumor detection, introduces dynamic risk profiles that existing health informatics governance frameworks are structurally inadequate to address. A critical and unresolved gap is the absence of any operatio...

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Literature Corpus work: 8bdfcd7d-31d8-535f-ac63-e88d1313d6e9
DOI: 10.21203/rs.3.rs-9444013/v1

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