An empirical evaluation of the risks of AI model updates using clinical data: stability, arbitrariness, and fairness

Artificial Intelligence and Machine Learning (AI/ML) models used in clinical settings are increasingly deployed to support clinical decision-making. However, when training data become stale due to changes in demographics, environment, or patient behaviors, model performance can degrade substantially. While updating models with new training data is necessary, such updates may also introduce new risks. We evaluated the proposed monitoring framework on four publicly available U.S.-based Type 1 Diabetes datasets containing high-resolution continuous glucose monitoring (CGM) data, comprising approximately 11,300 weekly observations from 496 participants under 20 years of age. All datasets included structured sociodemographic information. Using the prediction of severe hyperglycemia events in children with type 1 diabetes as a case study, we examine how different model update strategies can adversely affect model stability (e.g., by causing predictions to "flip" for a large number of cases after an update), increase arbitrariness in predictions, or worsen accuracy equity and the balance of error rates across subpopulations. We propose multiple dimensions for continuous monitoring to detect these issues and argue that such monitoring is essential for the development of trustworthy clinical decision support systems.

Impact of Age Specialized Models for Hypoglycemia Classification

Disease progression varies with age and is influenced by underlying genetic, biochemical, and hormonal etiologies, suggesting the need for tailored monitoring, care, and medication beyond standard clinical guidelines. Specifically, in autoimmune diseases like type 1 diabetes (T1D), where patients depend on exogenous insulin to compensate for insulin deficiency, medication dosing and the physiological response reflected in vital signs can differ. Insulin therapy can lead to hypoglycemia, a dangerous condition characterized by decreased blood glucose levels ($\leq$70). This risk can be mitigated through improved diabetes management supported by data analytics. Notably, leveraging data from continuous glucose monitoring (CGM) devices, hypoglycemia onset can be predicted. However, while glucose variability, auto-antibody levels, and hypoglycemia occurrence differ across age groups, hypoglycemia classification most often only relies on population-based models specialized in specific age ranges. In this work, we classify hypoglycemia 0, 5-15, 20-45, and 50-120 minutes before onset using DiaData, a large CGM dataset of patients with T1D ranging from children to seniors. In particular, we investigate: 1) the generalizability of a population-based model including all age groups, 2) the impact of age-segmented models trained separately per age group, and 3) the effect of model individualization through transfer learning. The results show that a global population-based model yields similar or superior performance compared to age-segmented models. These findings suggest that data from children, teenagers, and adults can be combined for training models on hypoglycemia classification. While glucose variation differs across age groups, short-term hypoglycemic patterns are similar. However, data of children obtain their best recall with age specialized model.

Retinal Cyst Detection from Optical Coherence Tomography Images

Retinal Cysts are formed by leakage and accumulation of fluid in the retina due to the incompetence of retinal vasculature. These cystic spaces have significance in several ocular diseases such as age-related macular degeneration, diabetic macular edema, etc. Optical coherence tomography is one of the predominant diagnosing techniques for imaging retinal pathologies. Segmenting and quantification of intraretinal cysts plays the vital role in predicting visual acuity. In literature, several methods have been proposed for automatic segmentation of intraretinal cysts. As cystoid macular edema becomes a major problem to humankind, we need to quantify it accurately and operate it out, else it might cause many problems later on. Though research is being carried out in this area, not much of progress has been made and accuracy achieved so far is 68\% which is very less. Also, the methods depend on the quality of the image and give very low results for high noise images like topcon. This work uses ResNet CNN (Convolutional Neural Network) approach of segmentation by the way of patchwise classification for training on image set from cyst segmentation challenge dataset and testing on test data set given by 2 different graders for all 4 vendors in the challenge. It also compares these methods using first publicly available novel cyst segmentation challenge dataset. The methods were evaluated using quantitative measures to assess their robustness against the challenges of intraretinal cyst segmentation. The results are found to be better than the previous state of the art approaches giving more than 70\% dice coefficient on all vendors irrespective of their quality.

Ontology-Aware Design Patterns for Clinical AI Systems: Translating Reification Theory into Software Architecture

Clinical AI systems routinely train on health data structurally distorted by documentation workflows, billing incentives, and terminology fragmentation. Prior work has characterised the mechanisms of this distortion: the three-forces model of documentary enactment, the reification feedback loop through which AI may amplify coding artefacts, and terminology governance failures that allow semantic drift to accumulate. Yet translating these insights into implementable software architecture remains an open problem. This paper proposes seven ontology-aware design patterns in Gang-of-Four pattern language for building clinical AI pipelines resilient to ontological distortion. The patterns address data ingestion validation (Ontological Checkpoint), low-frequency signal preservation (Dormancy-Aware Pipeline), continuous drift monitoring (Drift Sentinel), parallel representation maintenance (Dual-Ontology Layer), feedback loop interruption (Reification Circuit Breaker), terminology evolution management (Terminology Version Gate), and pluggable regulatory compliance (Regulatory Compliance Adapter). Each pattern is specified with Problem, Forces, Solution, Consequences, Known Uses, and Related Patterns. We illustrate their composition in a reference architecture for a primary care AI system and provide a walkthrough tracing all seven patterns through a diabetes risk prediction scenario. This paper does not report empirical validation; it offers a design vocabulary grounded in theoretical analysis, subject to future evaluation in production systems. Three patterns have partial precedent in existing systems; the remaining four have not been formally described. Limitations include the absence of runtime benchmarks and restriction to the German and EU regulatory context.

Predicting Trajectories of Long COVID in Adult Women: The Critical Role of Causal Disentanglement

Early prediction of Post-Acute Sequelae of SARS-CoV-2 severity is a critical challenge for women's health, particularly given the diagnostic overlap between PASC and common hormonal transitions such as menopause. Identifying and accounting for these confounding factors is essential for accurate long-term trajectory prediction. We conducted a retrospective study of 1,155 women (mean age 61) from the NIH RECOVER dataset. By integrating static clinical profiles with four weeks of longitudinal wearable data (monitoring cardiac activity and sleep), we developed a causal network based on a Large Language Model to predict future PASC scores. Our framework achieved a precision of 86.7\% in clinical severity prediction. Our causal attribution analysis demonstrate the model's ability to differentiate between active pathology and baseline noise: direct indicators such as breathlessness and malaise reached maximum saliency (1.00), while confounding factors like menopause and diabetes were successfully suppressed with saliency scores below 0.27.

Survival Meets Classification: A Novel Framework for Early Risk Prediction Models of Chronic Diseases

Chronic diseases are long-lasting conditions that require lifelong medical attention. Using big EMR data, we have developed early disease risk prediction models for five common chronic diseases: diabetes, hypertension, CKD, COPD, and chronic ischemic heart disease. In this study, we present a novel approach for disease risk models by integrating survival analysis with classification techniques. Traditional models for predicting the risk of chronic diseases predominantly focus on either survival analysis or classification independently. In this paper, we show survival analysis methods can be re-engineered to enable them to do classification efficiently and effectively, thereby making them a comprehensive tool for developing disease risk surveillance models. The results of our experiments on real-world big EMR data show that the performance of survival models in terms of accuracy, F1 score, and AUROC is comparable to or better than that of prior state-of-the-art models like LightGBM and XGBoost. Lastly, the proposed survival models use a novel methodology to generate explanations, which have been clinically validated by a panel of three expert physicians.

SNPgen: Phenotype-Supervised Genotype Representation and Synthetic Data Generation via Latent Diffusion

Polygenic risk scores and other genomic analyses require large individual-level genotype datasets, yet strict data access restrictions impede sharing. Synthetic genotype generation offers a privacy-preserving alternative, but most existing methods operate unconditionally, producing samples without phenotype alignment, or rely on unsupervised compression, creating a gap between statistical fidelity and downstream task utility. We present SNPgen, a two-stage conditional latent diffusion framework for generating phenotype-supervised synthetic genotypes. SNPgen combines GWAS-guided variant selection (1,024-2,048 trait-associated SNPs) with a variational autoencoder for genotype compression and a latent diffusion model conditioned on binary disease labels via classifier-free guidance. Evaluated on 458,724 UK Biobank individuals across four complex diseases (coronary artery disease, breast cancer, type 1 and type 2 diabetes), models trained on synthetic data matched real-data predictive performance in a train-on-synthetic, test-on-real protocol, approaching genome-wide PRS methods that use $2$-$6\times$ more variants. Privacy analysis confirmed zero identical matches, near-random membership inference (AUC $\approx 0.50$), preserved linkage disequilibrium structure, and high allele frequency correlation ($r \geq 0.95$) with source data. A controlled simulation with known causal effects verified faithful recovery of the imposed genetic association structure.

Uncertainty-aware Blood Glucose Prediction from Continuous Glucose Monitoring Data

In this work, we investigate uncertainty-aware neural network models for blood glucose prediction and adverse glycemic event identification in Type 1 diabetes. We consider three families of sequence models based on LSTM, GRU, and Transformer architectures, with uncertainty quantification enabled by either Monte Carlo dropout or through evidential output layers compatible with Deep Evidential Regression. Using the HUPA-UCM diabetes dataset for validation, we find that Transformer-based models equipped with evidential output heads provide the most effective uncertainty-aware framework, achieving consistently higher predictive accuracies and better-calibrated uncertainty estimates whose magnitudes significantly correlate with prediction errors. We further evaluate the clinical risk of each model using the recently proposed Diabetes Technology Society error grid, with risk categories defined by international expert consensus. Our results demonstrate the value of integrating principled uncertainty quantification into real-time machine-learning-based blood glucose prediction systems.

Bootstrapped Physically-Primed Neural Networks for Robust T2 Distribution Estimation in Low-SNR Pancreatic MRI

Estimating multi-component T2 relaxation distributions from Multi-Echo Spin Echo (MESE) MRI is a severely ill-posed inverse problem, traditionally solved using regularized non-negative least squares (NNLS). In abdominal imaging, particularly the pancreas, low SNR and residual uncorrelated noise challenge classical solvers and deterministic deep learning models. We introduce a bootstrap-based inference framework for robust distributional T2 estimation that performs stochastic resampling of the echo train and aggregates predictions across multiple subsets. This treats the acquisition as a distribution rather than a fixed input, yielding variance-reduced, physically consistent estimates and converting deterministic relaxometry networks into probabilistic ensemble predictors. Applied to the P2T2 architecture, our method uses inference-time bootstrapping to smooth noise artifacts and enhance fidelity to the underlying relaxation distribution. Noninvasive pancreatic evaluation is limited by location and biopsy risks, highlighting the need for biomarkers capable of capturing early pathophysiological changes. In type 1 diabetes (T1DM), progressive beta-cell destruction begins years before overt hyperglycemia, yet current imaging cannot assess early islet decline. We evaluate clinical utility via a test-retest reproducibility study (N=7) and a T1DM versus healthy differentiation task (N=8). Our approach achieves the lowest Wasserstein distances across repeated scans and superior sensitivity to physiology-driven shifts in the relaxation-time distribution, outperforming NNLS and deterministic deep learning baselines. These results establish inference-time bootstrapping as an effective enhancement for quantitative T2 relaxometry in low-SNR abdominal imaging.

Not Just How Much, But Where: Decomposing Epistemic Uncertainty into Per-Class Contributions

In safety-critical classification, the cost of failure is often asymmetric, yet Bayesian deep learning summarises epistemic uncertainty with a single scalar, mutual information (MI), that cannot distinguish whether a model's ignorance involves a benign or safety-critical class. We decompose MI into a per-class vector $C_k(x)=σ_k^{2}/(2μ_k)$, with $μ_k{=}\mathbb{E}[p_k]$ and $σ_k^2{=}\mathrm{Var}[p_k]$ across posterior samples. The decomposition follows from a second-order Taylor expansion of the entropy; the $1/μ_k$ weighting corrects boundary suppression and makes $C_k$ comparable across rare and common classes. By construction $\sum_k C_k \approx \mathrm{MI}$, and a companion skewness diagnostic flags inputs where the approximation degrades. After characterising the axiomatic properties of $C_k$, we validate it on three tasks: (i) selective prediction for diabetic retinopathy, where critical-class $C_k$ reduces selective risk by 34.7\% over MI and 56.2\% over variance baselines; (ii) out-of-distribution detection on clinical and image benchmarks, where $\sum_k C_k$ achieves the highest AUROC and the per-class view exposes asymmetric shifts invisible to MI; and (iii) a controlled label-noise study in which $\sum_k C_k$ shows less sensitivity to injected aleatoric noise than MI under end-to-end Bayesian training, while both metrics degrade under transfer learning. Across all tasks, the quality of the posterior approximation shapes uncertainty at least as strongly as the choice of metric, suggesting that how uncertainty is propagated through the network matters as much as how it is measured.