The Open-Box Fallacy: Why AI Deployment Needs a Calibrated Verification Regime
Authors: Phongsakon Mark Konrad, Tim Lukas Adam, Ane Cathrine Holst Merrild, Riccardo Terrenzi, Rebecca De Rosa, Toygar Tanyel, Serkan Ayvaz
Organizations: Centre for Industrial Software, University of Southern Denmark, Alsion 2, Sønderborg, 6400, Denmark · ProMake, Newark, DE, USA
Abstract
AI deployment in sensitive domains such as health care, credit, employment, and criminal justice is often treated as unsafe to authorize until model internals can be explained. This often leads to an excessive reliance on mechanistic interpretability to address a deployment challenge beyond its intended scope. We argue that the gate should instead be calibrated verification: authorization should be domain-scoped, independently checkable, monitored after release, accountable, contestable, and revocable. The reason is twofold. First, model capability is uneven across nearby tasks, so authorization must attach to a specific use rather than to a model in general. Second, societies have long governed opaque expertise through credentials, monitoring, liability, appeal, and revocation rather than mechanism-level explanation. Recent evidence reinforces this distinction between mechanistic understanding and deployment authority: a 53-percentage-point gap between internal representations and output correction shows that understanding may not translate into action, while one scoping review found that only 9.0% of FDA-approved AI/ML device documents contained a prospective post-market surveillance study. We propose Verification Coverage, a six-component reportable standard with a minimum-composition rule, as the metric that should sit beside capability scores in model cards, leaderboards, and regulatory disclosures.
Artificial intelligence now decides who receives a loan, who is flagged for criminal investigation, and whether an autonomous vehicle brakes in time. Governments have responded: the EU AI Act, the NIST Risk Management Framework, and the Council of Europe Convention all demand that high-risk systems demonstrate safety before deployment. Yet beneath this regulatory consensus lies a critical vacuum: none specifies what ``acceptable risk'' means in quantitative terms, and none provides a technical method for verifying that a deployed system actually meets such a threshold. The regulatory architecture is in place; the verification instrument is not. This gap is not theoretical. As the EU AI Act moves into full enforcement, developers face mandatory conformity assessments without established methodologies for producing quantitative safety evidence - and the systems most in need of oversight are opaque statistical inference engines that resist white-box scrutiny. This paper provides the missing instrument. Drawing on the aviation certification paradigm, we propose a two-stage framework that transforms AI risk regulation into engineering practice. In Stage One, a competent authority formally fixes an acceptable failure probability δ and an operational input domain ε - a normative act with direct civil liability implications. In Stage Two, the RoMA and gRoMA statistical verification tools compute a definitive, auditable upper bound on the system's true failure rate, requiring no access to model internals and scaling to arbitrary architectures. We demonstrate how this certificate satisfies existing regulatory obligations, shifts accountability upstream to developers, and integrates with the legal frameworks that exist today.
Pre-deployment verification of enterprise artificial intelligence (AI) agents remains a critical gap between large language model (LLM) capability benchmarking and production deployment. Post-deployment monitoring, human-in-the-loop controls, and prompt-level guardrails offer limited assurance once an agent is operating in production. We present an ontology-grounded verification framework -- to our knowledge the first to combine three components: an Agent Operational Envelope formalizing the certification space across permissions, domain constraints, safety properties, governance rules, and autonomy levels; an ontology-to-scenario generation pipeline that derives regulatory, operational, and adversarial test scenarios automatically; and a machine-verifiable Trust Certificate with graduated deployment verdicts. A controlled pilot across four regulated industries (Fintech, Banking, Insurance, Healthcare), instantiated as five industry-by-regulatory-regime cells across the United States and Vietnam (where Vietnam's 2025 AI Law makes such verification legally mandated for financial services), generated 1,800 scenarios evaluated against 125 primary-source regulatory requirements and 25 injected faults. Ontology-grounded generation significantly outperformed the dominant persona-based baseline on regulatory coverage (48.3% versus 33.1%; corrected p_c = .0006) and attained the highest domain specificity (4.77/5.0; p = 2e-6); transparently, its advantage over plain and retrieval-augmented prompting did not survive Bonferroni correction. Cross-validation across three LLM families (Claude Sonnet 4, Qwen 2.5 72B, Gemma 4 26B; 5,400 total scenarios) replicated the persona-versus-ontology pattern. The framework offers a reproducible, regulation-grounded route to pre-deployment assurance for enterprise AI agents, complementing runtime governance with an auditable deployment gate.
Compute governance today is a governance of training: the thresholds, reporting requirements, and frontier-AI regimes now in force attach to training compute and treat the trained model as the regulatory unit. That picture is incomplete: capability increasingly migrates to the deployment stage through inference-time scaling, agentic scaffolding, and compression onto consumer hardware. This paper asks which mechanisms are available once the regulatory object shifts from the training run to the inference call. We develop a feasibility taxonomy of twenty inference-time mechanisms across monitoring, verification, and enforcement, each rated on a four-point readiness scale against a documented four-vendor evidence base. We then stress the taxonomy against a two-dimensional adversary model (three capability tiers crossed with four adversary roles) and map each mechanism to four governance scenarios (domestic regulation, bilateral or multilateral coordination, industry self-regulation, and compute-marketplace governance). Fifteen of the twenty mechanisms have commercial technical substrates in production today, although governance-grade assurance and adversarial robustness vary substantially. The adversary analysis shows that this readiness holds only against a cooperative deployer and a low-to-medium-capability user: no mechanism rates adequate against a high-capability state-level deployer, and fine-tuning removes the model-internal components of the enforcement cluster, although platform-external controls can persist. A substitution analysis connects the taxonomy to a companion hardware paper as a conditional substitution principle describing when inference-stage and hardware-stage mechanisms provide comparable regulatory coverage under stated conditions. A second-rater reliability check on a random subset of the readiness ratings returned a quadratic-weighted Cohen's kappa of 0.74.