AEGIS: An Operational Infrastructure for Post-Market Governance of Adaptive Medical AI Under US and EU Regulations
This addresses the need for safe continuous learning in medical AI devices for healthcare providers and regulators, though it appears incremental as it builds on existing regulatory frameworks.
The paper tackles the problem of governing adaptive medical AI systems under US and EU regulations by presenting AEGIS, a framework that operationalizes regulatory mechanisms like FDA PCCP and EU AI Act provisions. The results show that in simulated iterations on a sepsis prediction example, AEGIS yielded decisions across all four categories (8 APPROVE, 1 CONDITIONAL APPROVAL, 1 CLINICAL REVIEW, 1 REJECT) and detected drift before performance degradation.
Machine learning systems deployed in medical devices require governance frameworks that ensure safety while enabling continuous improvement. Regulatory bodies including the FDA and European Union have introduced mechanisms such as the Predetermined Change Control Plan (PCCP) and Post-Market Surveillance (PMS) to manage iterative model updates without repeated submissions. This paper presents AI/ML Evaluation and Governance Infrastructure for Safety (AEGIS), a governance framework applicable to any healthcare AI system. AEGIS comprises three modules, i.e., dataset assimilation and retraining, model monitoring, and conditional decision, that operationalize FDA PCCP and EU AI Act Article 43(4) provisions. We implement a four-category deployment decision taxonomy (APPROVE, CONDITIONAL APPROVAL, CLINICAL REVIEW, REJECT) with an independent PMS ALARM signal, enabling detection of the critical state in which no deployable model exists while the released model is simultaneously at risk. To illustrate how AEGIS can be instantiated across heterogeneous clinical contexts, we provide two examples: sepsis prediction from electronic health records and brain tumor segmentation from medical imaging. Both cases use identical governance architecture, differing only in configuration. Across 11 simulated iterations on the sepsis example, AEGIS yielded 8 APPROVE, 1 CONDITIONAL APPROVAL, 1 CLINICAL REVIEW, and 1 REJECT decision, exercising all four categories. ALARM signals were co-issued at iterations 8 and 10, including the critical state where no deployable model exists and the released model is simultaneously failing. AEGIS detected drift before observable performance degradation. These results demonstrate that AEGIS translates regulatory change-control concepts into executable governance procedures, supporting safe continuous learning for adaptive medical AI across diverse clinical applications.