Before the Clinic: Transparent and Operable Design Principles for Healthcare AI
This work addresses the problem of translating AI into clinical practice for development teams, clinicians, and regulators, but it is incremental as it builds on existing XAI frameworks and clinician needs.
The paper tackles the gap in practical guidance for preparing AI systems for clinical evaluation by proposing Transparent Design and Operable Design principles to operationalize pre-clinical technical requirements, aiming to accelerate clinical translation and reduce friction.
The translation of artificial intelligence (AI) systems into clinical practice requires bridging fundamental gaps between explainable AI theory, clinician expectations, and governance requirements. While conceptual frameworks define what constitutes explainable AI (XAI) and qualitative studies identify clinician needs, little practical guidance exists for development teams to prepare AI systems prior to clinical evaluation. We propose two foundational design principles, Transparent Design and Operable Design, that operationalize pre-clinical technical requirements for healthcare AI. Transparent Design encompasses interpretability and understandability artifacts that enable case-level reasoning and system traceability. Operable Design encompasses calibration, uncertainty, and robustness to ensure reliable, predictable system behavior under real-world conditions. We ground these principles in established XAI frameworks, map them to documented clinician needs, and demonstrate their alignment with emerging governance requirements. This pre-clinical playbook provides actionable guidance for development teams, accelerates the path to clinical evaluation, and establishes a shared vocabulary bridging AI researchers, healthcare practitioners, and regulatory stakeholders. By explicitly scoping what can be built and verified before clinical deployment, we aim to reduce friction in clinical AI translation while remaining cautious about what constitutes validated, deployed explainability.