Notice-and-comment rulemaking gives any affected party the same formal right to influence federal regulation, but formal access is not substantive capacity to shape rule text. Existing strategies operate at the rule or aggregate-corpus level, too coarse to capture the discrete regulatory obligations where commenters seek change. We introduce obligation-level responsiveness auditing, an auditable, AI-assisted framework for measuring whether public-comment engagement co-occurs with changes to specific regulatory duties. The framework extracts proposed and final-rule obligations, matches comments to the obligations they address, and classifies proposed-final outcomes; each load-bearing component is evaluated against blind human judgment. We apply the framework to 70,075 comments across 36 EPA anchor rulemakings, drawn from a corpus of 786,197 comments across 6,145 dockets from 2010-2022. Three descriptive findings emerge. First, engagement is associated with revision at a modest within-docket magnitude. Second, support-versus-opposition direction does not clearly differentiate outcomes, an informative null inconsistent with simple preference-aggregation. Third, under a permissive reconstruction of commenter type, organizational-majority engagement concentrates in editorial-refinement rather than substantive-modification outcomes at the cross-docket level. A blind human audit of the load-bearing outcome contrast preserves this third finding under corrected labels and reveals that text-similarity methods are insufficient for distinguishing editorial from substantive regulatory change, a measurement-validity lesson we treat as a supporting methodological contribution. Together, these findings locate the equity asymmetry upstream of agency response: in differential capacity across commenter populations to identify, interpret, and contest specific legal obligations.
Ahmed M Salih, Oliver Díaz, Alejandro Guzman +6cs.CY cs.LG
Background: AI/ML-enabled medical devices are increasingly deployed in healthcare under evolving regulatory frameworks. As these systems become more integrated into clinical decision-making, there is growing expectation that they demonstrate key dimensions of trustworthy AI to support clinician, patient, and public trust. Whether publicly available regulatory documentation provides sufficient evidence to independently assess the trustworthiness of cleared AI systems remains unclear. Methods: We analysed FDA AI/ML-enabled medical device summary reports published between 2021 and 2025. Reports underwent automated keyword screening followed by multi-stage manual consensus review to identify documented evidence for the six FUTURE-AI principles: Fairness, Universality, Traceability, Usability, Robustness, and Explainability. Descriptive, temporal, and clinical-domain analyses were performed. Multivariable logistic regression assessed whether year of clearance or clinical domain predicted higher reporting transparency, defined as evidence reported for three or more principles. Results: Of 1,105 FDA summary reports screened, 519 were included. Trustworthy AI reporting was limited and uneven. Nearly one quarter (24.7%) provided no evidence for any principle, and none documented evidence across all six. Robustness was most frequently reported (57.6%), while Traceability (8.3%) and Explainability (3.5%) were the most pronounced gaps. Neither year of clearance (OR 1.02, 95% CI 0.88-1.19) nor clinical domain (OR 0.73, 95% CI 0.46-1.15) predicted higher reporting transparency. Interpretation: Substantial, persistent trustworthy AI reporting gaps exist in FDA documentation. Regulatory approval alone should not be considered a proxy for trustworthiness. Standardised, audit-ready reporting across the AI lifecycle is needed to support independent assessment and responsible adoption of healthcare AI.
Agent-based models are widely used to evaluate policy interventions in complex socio-technical systems, yet many policy-oriented ABMs represent regulation as a fixed scenario parameter. This limits their ability to distinguish whether regulatory conclusions depend on agent adaptation, policy adaptation, or the interaction between both. Building on a previously proposed four-regime architecture, this paper contributes a controlled simulation benchmark rather than a new general framework. Using a single configurable emissions-regulation ABM, we compare constant policy/constant agents, constant policy/adaptive agents, adaptive policy/constant agents, and adaptive policy/adaptive agents under matched simulation conditions. We evaluate naive fixed policies, tracking-aware calibrated fixed policies, and three adaptive controllers: setpoint, safety-margin, and one-sided control. The benchmark recovers expected controller archetypes: setpoint control tracks the cap but produces frequent boundary crossings, safety-margin control reduces violations through conservatism, and one-sided control can limit violations but may ratchet toward over-conservatism when combined with adaptive agents. The contribution is methodological: scalar indicators, cap-relative symbolic diagnostics, trajectory motifs, and visual inspection jointly reveal how regulatory conclusions can differ even when average outcomes appear similar. Adaptive policy-oriented ABMs should therefore be evaluated through regime distinguishability, not only through average performance.