cs.CYFeb 24, 2026

A Governance and Evaluation Framework for Deterministic, Rule-Based Clinical Decision Support in Empiric Antibiotic Prescribing

Authors: Francisco José Gárate, Paloma Chausa, Diego Moreno, Judit López Luque, Vicens Díaz-Brito, Enrique Javier Gómez

Organizations: Grupo de Bioingeniería y Telemedicina, ETSI Telecomunicación, Centro de Tecnología Biomedica, Universidad Politécnica de Madrid, Avenida Complutense 30, 28040 Madrid, Spain · Instituto de Investigación Hospital 12 de Octubre (imas12), Hospital Universitario 12 de Octubre, 28041 Madrid, Spain · Innovation Unit, Parc Sanitari Sant Joan de Deu, Sant Boi de Llobregat, Spain; Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain · Infectious Diseases Department, Parc Sanitari Sant Joan de Deu, Sant Boi de Llobregat, Spain · 

Abstract

Empiric antibiotic prescribing in high-risk clinical contexts often requires decision making under conditions of incomplete information, where inappropriate coverage or unjustified escalation may compromise safety and antimicrobial stewardship. While clinical decision-support systems have been proposed to assist in this process, many approaches lack explicit governance and evaluation mechanisms defining scope, abstention conditions, recommendation permissibility, and expected system behavior. This work specifies a governance and evaluation framework for deterministic clinical decision-support systems operating under explicitly constrained scope. Deterministic behavior is adopted to ensure that identical inputs yield identical outputs, supporting transparency, auditability, and conservative decision support in high-risk prescribing contexts. The framework treats governance as a first-class design component, separating clinical decision logic from rule-based mechanisms that determine whether a recommendation may be issued. Explicit abstention, deterministic stewardship constraints, and exclusion rules are formalized as core constructs. The framework defines an evaluation methodology utilizing a fixed set of synthetic, mechanism-driven clinical cases with predefined expected behavior. This validation process focuses on behavioral alignment with specified rules rather than clinical effectiveness, predictive accuracy, or outcome optimization. Within this protocol, abstention is treated as a correct and intended outcome when governance conditions are not satisfied. The proposed framework provides a reproducible approach for specifying, governing, and inspecting deterministic clinical decision-support systems in empiric antibiotic prescribing contexts where transparency, auditability, and conservative behavior are prioritized.

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Apr 23, 2026

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

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. 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. 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. 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.
Apr 12, 2026

Governed Reasoning for Institutional AI

Institutional decisions -- regulatory compliance, clinical triage, prior authorization appeal -- require a different AI architecture than general-purpose agents provide. Agent frameworks infer authority conversationally, reconstruct accountability from logs, and produce silent errors: incorrect determinations that execute without any human review signal. We propose Cognitive Core: a governed decision substrate built from nine typed cognitive primitives (retrieve, classify, investigate, verify, challenge, reflect, deliberate, govern, generate), a four-tier governance model where human review is a condition of execution rather than a post-hoc check, a tamper-evident SHA-256 hash-chain audit ledger endogenous to computation, and a demand-driven delegation architecture supporting both declared and autonomously reasoned epistemic sequences. We benchmark three systems on an 11-case balanced prior authorization appeal evaluation set. Cognitive Core achieves 91% accuracy against 55% (ReAct) and 45% (Plan-and-Solve). The governance result is more significant: CC produced zero silent errors while both baselines produced 5-6. We introduce governability -- how reliably a system knows when it should not act autonomously -- as a primary evaluation axis for institutional AI alongside accuracy. The baselines are implemented as prompts, representing the realistic deployment alternative to a governed framework. A configuration-driven domain model means deploying a new institutional decision domain requires YAML configuration, not engineering capacity.
May 13, 2026

RISED: A Pre-Deployment Evaluation Framework for High-Stakes AI Decision-Support Systems, with Application to Healthcare

Clinical decision-support systems are expert systems whose recommendations clinicians act on directly, yet they are usually cleared on one aggregate accuracy number from a held-out test set. That number says nothing about input reliability under encoding shifts, subgroup gaps, threshold sensitivity, or operational feasibility. We present RISED, a pre-deployment evaluation framework operationalising five dimensions (Reliability, Inclusivity, Sensitivity, Equity, Deployability) through BCa bootstrap 95% confidence intervals, literature-grounded thresholds, and Holm-Bonferroni-corrected PASS / FAIL / INCONCLUSIVE verdicts; Equity is a proxy-dependence diagnostic rather than a gating test. Applied to seven cohorts spanning 35 years (n from 303 to 99,492), RISED surfaces failures invisible to AUROC: on Diabetes 130, Reliability passes by three orders of magnitude (PSS = 0.0004) while Inclusivity (AUC parity gap = 0.262) and Sensitivity (max threshold-flip rate 49.1%) fail decisively; both NHIS cohorts reproduce this. NHANES 2021-2023, with a complete feature profile, achieves INCONCLUSIVE verdicts; BRFSS 2024 produces the suite's most severe Sensitivity failure (max threshold-flip rate 64.2%) after instrument rotation removed hypertension and cholesterol. The pattern recurs on credit- and income-prediction cohorts, confirming domain-agnosticity; a multi-model check shows the failures are data-driven, not model-specific. RISED ships as an open-source Python package complementing TRIPOD+AI, FUTURE-AI, and Fairlearn with the structured numerical evidence those standards require but do not prescribe.