Fig. 3: Existing guidelines on AI in medicine by research phase and level of consensus.

Preclinical guidelines regulate theoretical studies not involving clinical outcome data but potentially retrospectively involving patient data. Translational guidelines target retrospective or prospective observational trials involving patient data with a potential clinical implication. Clinical guidelines regulate interventional trials in a clinical setting. The breadth of guidelines is classified as general or subject-specific depending on target research areas mentioned in the guideline. In terms of the consensus process, comprehensive guidelines are based on a structured, consensus-based, methodical development approach involving multiple experts and relevant stakeholders with details on the exact protocol. Collaborative guidelines are (presumably) developed using a formal consensus procedure involving multiple experts, but provide no details on the exact protocol or methodological structure. Expert-led guidelines are not developed through a consensus-based procedure, do not involve relevant stakeholders, or do not clearly describe the development procedure.