SMART: structured, meaningful, auditable, responsible, and transparent documentation for clinical AI.

objectiveClinical AI systems and models increasingly need traceable documentation that makes intended use, performance evidence, transparency, and lifecycle status explicit, yet existing model cards, datasheets, reporting guidelines, and other documentation approaches do not consistently bring together structured clinical fields, vocabulary-linked cohort descriptions, structured performance reporting, and governed documentation history. We introduce Structured, Meaningful, Auditable, Responsible, and Transparent (SMART), a framework that adapts the model card concept into structured, lifecycle-aware documentation with OMOP integration, role-based lifecycle governance, and a blockchain-backed audit trail for verifying documentation integrity and lifecycle history. MATERIALS AND

methodsFollowing a design-science-informed approach, we analyzed documentation requirements, reviewed existing approaches, implemented SMART through open-source packages and smart contracts, and evaluated it using example SMART model cards, an illustrative COPD exacerbation risk-prediction documentation case study, and blockchain-governed lifecycle experiments.

resultsThe design process resulted in the SMART framework in which documentation provisions are reflected across Schema, Lifecycle, and Chain (ie, Blockchain) components. Evaluation showed that, in multi-party settings, documentation history remains independently verifiable because lifecycle actions are role-attributed and linked to content hashes; median testnet gas use ranged from 352 722 to 852 399 gas across the evaluated lifecycle operations. DISCUSSION: SMART positions clinical AI documentation as a shared infrastructure for preliminary model assessment, making role attribution, lifecycle state, and documentation changes more transparent and traceable over time.

conclusionBy providing an implementable framework, SMART illustrates how clinical AI documentation can be structured, clinically contextualized, auditable, responsible, transparent, and lifecycle-aware.