Soroush Saghafian

Mohammad Zhalechian, Soroush Saghafian, Omar Robles

The United States Food and Drug Administration's (FDA's) 510(k) pathway allows manufacturers to gain medical device approval by demonstrating substantial equivalence to a legally marketed device. However, the inherent ambiguity of this regulatory procedure has been associated with high recall among many devices cleared through this pathway, raising significant safety concerns. In this paper, we develop a combined human-algorithm approach to assist the FDA in improving its 510(k) medical device clearance process by reducing recall risk and regulatory workload. We first develop machine learning methods to estimate the risk of recall of 510(k) medical devices based on the information available at the time of submission. We then propose a data-driven clearance policy that recommends acceptance, rejection, or deferral to FDA's committees for in-depth evaluation. We conduct an empirical study using a unique dataset of over 31,000 submissions that we assembled based on data sources from the FDA and Centers for Medicare and Medicaid Service (CMS). Compared to the FDA's current practice, which has a recall rate of 10.3% and a normalized workload measure of 100%, a conservative evaluation of our policy shows a 32.9% improvement in the recall rate and a 40.5% reduction in the workload. Our analyses further suggest annual cost savings of approximately $1.7 billion for the healthcare system driven by avoided replacement costs, which is equivalent to 1.1% of the entire United States annual medical device expenditure. Our findings highlight the value of a holistic and data-driven approach to improve the FDA's current 510(k) pathway.

Minmin Zhang, Sina Aghaei, Soroush Saghafian

Large language models (LLMs) have shown remarkable in-context learning (ICL) capabilities, yet their potential for sequential decision-making remains underexplored. In this paper, we study the ICL capabilities of LLMs in sequential decision-making settings, including Markov Decision Processes (MDPs), Partially Observable MDPs (POMDPs), and Ambiguous POMDPs (APOMDPs). We fine-tune pretrained LLMs to perform few-shot decision-making directly from offline, oracle-labeled trajectories. Our framework enables flexible imitation of policies through supervised fine-tuning (SFT). Theoretically, we focus on linear MDPs and interpret a fine-tuned attention layer as implicitly estimating optimal Q-functions from in-context data. Building on this interpretation, we derive an end-to-end suboptimality bound for the induced policy that separates the in-context estimation error from the training-length bias. Empirically, across synthetic MDP, POMDP, and APOMDP settings, we find that fine-tuned LLMs achieve substantially smaller optimality gaps than in-context-only and random baselines, with especially large gains in longer-horizon, partially observed, and model-ambiguous environments. Together, these results show that supervised fine-tuning provides an effective route to endowing pretrained LLMs with sequential decision-making capabilities from offline data, which is an important advantage in domains such as healthcare where offline data are abundant.

Soroush Saghafian, Lihi Idan

Advanced analytics science methods have enabled combining the power of artificial and human intelligence, creating \textit{centaurs} that allow superior decision-making. Centaurs are hybrid human-algorithm models that combine both formal analytics and human intuition in a symbiotic manner within their learning and reasoning process. We argue that the future of AI development and use in many domains needs to focus more on centaurs as opposed to other AI approaches. This paradigm shift towards centaur-based AI methods raises some fundamental questions: How are centaurs different from other human-in-the-loop methods? What are the most effective methods for creating centaurs? When should centaurs be used, and when should the lead be given to pure AI models? Doesn't the incorporation of human intuition -- which at times can be misleading -- in centaurs' decision-making process degrade its performance compared to pure AI methods? This work aims to address these fundamental questions, focusing on recent advancements in generative AI, and especially in Large Language Models (LLMs), as a main case study to illustrate centaurs' critical essentiality to future AI endeavors.

Soroush Saghafian

A main research goal in various studies is to use an observational data set and provide a new set of counterfactual guidelines that can yield causal improvements. Dynamic Treatment Regimes (DTRs) are widely studied to formalize this process. However, available methods in finding optimal DTRs often rely on assumptions that are violated in real-world applications (e.g., medical decision-making or public policy), especially when (a) the existence of unobserved confounders cannot be ignored, and (b) the unobserved confounders are time-varying (e.g., affected by previous actions). When such assumptions are violated, one often faces ambiguity regarding the underlying causal model. This ambiguity is inevitable, since the dynamics of unobserved confounders and their causal impact on the observed part of the data cannot be understood from the observed data. Motivated by a case study of finding superior treatment regimes for patients who underwent transplantation in our partner hospital and faced a medical condition known as New Onset Diabetes After Transplantation (NODAT), we extend DTRs to a new class termed Ambiguous Dynamic Treatment Regimes (ADTRs), in which the causal impact of treatment regimes is evaluated based on a "cloud" of causal models. We then connect ADTRs to Ambiguous Partially Observable Mark Decision Processes (APOMDPs) and develop Reinforcement Learning methods, which enable using the observed data to efficiently learn an optimal treatment regime. We establish theoretical results for these learning methods, including (weak) consistency and asymptotic normality. We further evaluate the performance of these learning methods both in our case study and in simulation experiments.