arXiv:2604.21263cs.AIcs.PL2026-04

用元谓词约束医疗决策证据,确保可审计性

Trustworthy Clinical Decision Support Using Meta-Predicates and Domain-Specific Languages

  • 引入元谓词约束临床规则的证据类型,保证逻辑合理
  • 在560万基因变异上实现每例可追溯决策路径
  • 适合需合规审计的医疗AI系统开发者

医疗AI监管要求临床决策支持不仅准确,还需可审计。现有形式语言仅验证语法正确性,无法判断规则是否使用恰当的证据。本文提出元谓词——对谓词的约束——结合领域特定语言(DSL),通过四维分类(目的、知识领域、规模、获取方式)建立证据类型体系,限定规则中允许使用的证据类型。该框架在AnFiSA平台实现,以布里格姆基因组医学协议处理基因组瓶基准数据中的560万变异。结果表明,变异解读的决策树可重构成单调级联,实现每个变异的可追溯审计日志;元谓词验证可在部署前发现人类或AI生成规则中的认知错误。该方法与事后解释工具如LIME、SHAP互补:前者限制决策前可使用的证据,后者揭示决策后依据。结论表明,元谓词验证使决策既准确又基于可审计的合理证据。虽在基因组学验证,但适用于所有需可审计决策逻辑的领域。

原文摘要 · Abstract (English)

\textbf{Background:} Regulatory frameworks for AI in healthcare, including the EU AI Act and FDA guidance on AI/ML-based medical devices, require clinical decision support to demonstrate not only accuracy but auditability. Existing formal languages for clinical logic validate syntactic and structural correctness but not whether decision rules use epistemologically appropriate evidence. \textbf{Methods:} Drawing on design-by-contract principles, we introduce meta-predicates -- predicates about predicates -- for asserting epistemological constraints on clinical decision rules expressed in a DSL. An epistemological type system classifies annotations along four dimensions: purpose, knowledge domain, scale, and method of acquisition. Meta-predicates assert which evidence types are permissible in any given rule. The framework is instantiated in AnFiSA, an open-source platform for genetic variant curation, and demonstrated using the Brigham Genomics Medicine protocol on 5.6 million variants from the Genome in a Bottle benchmark. \textbf{Results:} Decision trees used in variant interpretation can be reformulated as unate cascades, enabling per-variant audit trails that identify which rule classified each variant and why. Meta-predicate validation catches epistemological errors before deployment, whether rules are human-written or AI-generated. The approach complements post-hoc methods such as LIME and SHAP: where explanation reveals what evidence was used after the fact, meta-predicates constrain what evidence may be used before deployment, while preserving human readability. \textbf{Conclusions:} Meta-predicate validation is a step toward demonstrating not only that decisions are accurate but that they rest on appropriate evidence in ways that can be independently audited. While demonstrated in genomics, the approach generalises to any domain requiring auditable decision logic.

医疗AI可解释性审计基因组学

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