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AI and XAI Directives, Guidelines, Best Practices
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Dedicated GPT (4.2): Here
TRIPOD+AI statement: updated guidance for reporting clinical prediction models that use regression or machine learning methods
CLAIM – Checklist for Artificial Intelligence in Medical Imaging (2024 update)
URL: https://pubs.rsna.org/page/ai/claim
Summary of documents: https://www.equator-network.org/reporting-guidelines/checklist-for-artificial-intelligence-in-medical-imaging-claim-a-guide-for-authors-and-reviewers/
PROBAST+AI (Mar 2025) for risk-of-bias/applicability assessment of prediction model studies using AI
NISTIR 8312 – Four Principles of Explainable Artificial Intelligence
AI RMF 1.0 – Artificial Intelligence Risk Management Framework
Guidelines for clinical trial protocols for interventions involving
artificial intelligence: the SPIRIT-AI Extension
DECIDE-AI (2022) for early-stage clinical evaluation studies of AI decision support
STARD-AI (Sep 2025) for AI diagnostic accuracy studies
Good Machine Learning Practice for Medical Device Development: Guiding Principles -FDA
Document: PDF
Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles – FDA
Document: PDF
WHO guidance on Ethics & Governance of Artificial Intelligence for Health
Book: PDF
WHO guidance on Ethics & Governance of Artificial Intelligence for Health – Guidance on large multi-modal models
Book: PDF
WHO Regulatory considerations on artificial intelligence for health
File: PDF
