The ethical and regulatory framework of medical artificial intelligence (AI) system’s behavioral performance for image-based diagnostics: An ethical evaluation of the International and European Union
Author summary The use of Artificial Intelligence (AI) in diagnostics based on medical images is increasing. AI can automatically analyze images, quickly detect patterns, and support physicians. However, using this technology in patient care raises ethical challenges and requires ethical and regulatory protection. In April and May 2025, we screened official documents to identify ethical challenges of the ethical and regulatory framework of the diagnostic technology’s behavior on the international and European Un…
Regulation and ethics guidance for image-based diagnostic AI mirrors that for general medical AI, and weak data security plus an attack-defense race threaten safety and every ethical principle examined.
The study analyzes official guidance documents at the international and EU level, so it assesses the content of the framework rather than measured clinical outcomes or other jurisdictions.
Evidence
- JournalismPLOS (Public Library of Science)2026-10-14
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Truvace Impact Record TRV-2026-1362, v1: “The ethical and regulatory framework of medical artificial intelligence (AI) system’s behavioral performance for image-based diagnostics: An ethical evaluation of the International and European Union.” Truvace, 2026-10-14. /record/TRV-2026-1362 (accessed at citation time). sha256 4a5a93d1d6b8260e…
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