Summary
Provides guiding principles for evaluating applications for interventional clinical trials involving AI-based tools. The guidance is intended for Institutional Review Boards, Helsinki Committees, researchers, and professional entities involved in AI-based research, and focuses on prospective interventional studies where an AI tool may influence clinical decision-making. It covers disclosure, informed consent, AI-system description, study design, performance assessment, error handling, data governance, privacy, cybersecurity, model updates, and clinical-system integration.
Healthcare Implications
Directly affects oversight of AI-based clinical research in Israel by giving review committees and research sponsors a structured framework for assessing safety, ethics, scientific validity, transparency, patient consent, data protection, bias, model performance, and change management before and during AI-based interventional studies. It may also inform broader health-system AI governance because the document treats these principles as relevant across the AI lifecycle.