Objective: Fluoropyrimidines are widely prescribed for colorectal and breast cancers, but are associated with toxicities such as hand-foot syndrome and cardiotoxicity. Since toxicity documentation is often embedded in clinical notes, we aimed to develop and evaluate natural language processing (NLP) methods to extract treatment and toxicity information. Materials and Methods: We constructed a gold-standard dataset of 236 clinical notes from 204,165 adult oncology patients. Domain experts annotated categories related to treatment regimens and toxicities. We developed rule-based, machine learning-based (Random Forest, Support Vector Machine [SVM], Logistic Regression [LR]), deep learning-based (BERT, ClinicalBERT), and large language models (LLM)-based NLP approaches (zero-shot and error-analysis prompting). Models used an 80:20 train-test split. Results: Sufficient data existed to train and evaluate 5 annotated categories. Error-analysis prompting achieved optimal precision, recall, and F1 scores (F1=1.000) for treatment and toxicities extraction, whereas zero-shot prompting reached F1=1.000 for treatment and F1=0.876 for toxicities extraction.LR and SVM ranked second for toxicities (F1=0.937). Deep learning underperformed, with BERT (F1=0.873 treatment; F1= 0.839 toxicities) and ClinicalBERT (F1=0.873 treatment; F1 = 0.886 toxicities). Rule-based methods served as our baseline with F1 scores of 0.857 in treatment and 0.858 in toxicities. Discussion: LMM-based approaches outperformed all others, followed by machine learning methods. Machine and deep learning approaches were limited by small training data and showed limited generalizability, particularly for rare categories. Conclusion: LLM-based NLP most effectively extracted fluoropyrimidine treatment and toxicity information from clinical notes, and has strong potential to support oncology research and pharmacovigilance.

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We study the automated derivation of safety requirements in a self-driving vehicle use case, leveraging LLMs in combination with agent-based retrieval-augmented generation. Conventional approaches that utilise pre-trained LLMs to assist in safety analyses typically lack domain-specific knowledge. Existing RAG approaches address this issue, yet their performance deteriorates when handling complex queries and it becomes increasingly harder to retrieve the most relevant information. This is particularly relevant for safety-relevant applications. In this paper, we propose the use of agent-based RAG to derive safety requirements and show that the retrieved information is more relevant to the queries. We implement an agent-based approach on a document pool of automotive standards and the Apollo case study, as a representative example of an automated driving perception system. Our solution is tested on a data set of safety requirement questions and answers, extracted from the Apollo data. Evaluating a set of selected RAG metrics, we present and discuss advantages of a agent-based approach compared to default RAG methods.

In the automobile industry, ensuring the safety of automated vehicles equipped with the Automated Driving System (ADS) is becoming a significant focus due to the increasing development and deployment of automated driving. Automated driving depends on sensing both the external and internal environments of a vehicle, utilizing perception sensors and algorithms, and Electrical/Electronic (E/E) systems for situational awareness and response. ISO 21448 is the standard for Safety of the Intended Functionality (SOTIF) that aims to ensure that the ADS operate safely within their intended functionality. SOTIF focuses on preventing or mitigating potential hazards that may arise from the limitations or failures of the ADS, including hazards due to insufficiencies of specification, or performance insufficiencies, as well as foreseeable misuse of the intended functionality. However, the challenge lies in ensuring the safety of vehicles despite the limited availability of extensive and systematic literature on SOTIF. To address this challenge, a Systematic Literature Review (SLR) on SOTIF for the ADS is performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The objective is to methodically gather and analyze the existing literature on SOTIF. The major contributions of this paper are: (i) presenting a summary of the literature by synthesizing and organizing the collective findings, methodologies, and insights into distinct thematic groups, and (ii) summarizing and categorizing the acknowledged limitations based on data extracted from an SLR of 51 research papers published between 2018 and 2023. Furthermore, research gaps are determined, and future research directions are proposed.

Emergent effects can arise in multi-agent systems (MAS) where execution is decentralized and reliant on local information. These effects may range from minor deviations in behavior to catastrophic system failures. To formally define these effects, we identify misalignments between the global inherent specification (the true specification) and its local approximation (such as the configuration of different reward components or observations). Using established safety terminology, we develop a framework to understand these emergent effects. To showcase the resulting implications, we use two broadly configurable exemplary gridworld scenarios, where insufficient specification leads to unintended behavior deviations when derived independently. Recognizing that a global adaptation might not always be feasible, we propose adjusting the underlying parameterizations to mitigate these issues, thereby improving the system's alignment and reducing the risk of emergent failures.

Existing definitions and associated conceptual frameworks for computer-based system safety should be revisited in light of real-world experiences from deploying autonomous vehicles. Current terminology used by industry safety standards emphasizes mitigation of risk from specifically identified hazards, and carries assumptions based on human-supervised vehicle operation. Operation without a human driver dramatically increases the scope of safety concerns, especially due to operation in an open world environment, a requirement to self-enforce operational limits, participation in an ad hoc sociotechnical system of systems, and a requirement to conform to both legal and ethical constraints. Existing standards and terminology only partially address these new challenges. We propose updated definitions for core system safety concepts that encompass these additional considerations as a starting point for evolving safe-ty approaches to address these additional safety challenges. These results might additionally inform framing safety terminology for other autonomous system applications.

Automated Driving (AD) systems have the potential to increase safety, comfort and energy efficiency. Recently, major automotive companies have started testing and validating AD systems (ADS) on public roads. Nevertheless, the commercial deployment and wide adoption of ADS have been moderate, partially due to system functional insufficiencies (FI) that undermine passenger safety and lead to hazardous situations on the road. FIs are defined in ISO 21448 Safety Of The Intended Functionality (SOTIF). FIs are insufficiencies in sensors, actuators and algorithm implementations, including neural networks and probabilistic calculations. Examples of FIs in ADS include inaccurate ego-vehicle localization on the road, incorrect prediction of a cyclist maneuver, unreliable detection of a pedestrian, etc. The main goal of our study is to formulate a generic architectural design pattern, which is compatible with existing methods and ADS, to improve FI mitigation and enable faster commercial deployment of ADS. First, we studied the 2021 autonomous vehicles disengagement reports published by the California Department of Motor Vehicles (DMV). The data clearly show that disengagements are five times more often caused by FIs rather than by system faults. We then made a comprehensive list of insufficiencies and their characteristics by analyzing over 10 hours of publicly available road test videos. In particular, we identified insufficiency types in four major categories: world model, motion plan, traffic rule, and operational design domain. The insufficiency characterization helps making the SOTIF analyses of triggering conditions more systematic and comprehensive. Based on our FI characterization, simulation experiments and literature survey, we define a novel generic architectural design pattern Daruma to dynamically select the channel that is least likely to have a FI at the moment.

Driving Automation Systems (DAS) are subject to complex road environments and vehicle behaviors and increasingly rely on sophisticated sensors and Artificial Intelligence (AI). These properties give rise to unique safety faults stemming from specification insufficiencies and technological performance limitations, where sensors and AI introduce errors that vary in magnitude and temporal patterns, posing potential safety risks. The Safety of the Intended Functionality (SOTIF) standard emerges as a promising framework for addressing these concerns, focusing on scenario-based analysis to identify hazardous behaviors and their causes. Although the current standard provides a basic cause-and-effect model and high-level process guidance, it lacks concepts required to identify and evaluate hazardous errors, especially within the context of AI. This paper introduces two key contributions to bridge this gap. First, it defines the SOTIF Temporal Error and Failure Model (STEAM) as a refinement of the SOTIF cause-and-effect model, offering a comprehensive system-design perspective. STEAM refines error definitions, introduces error sequences, and classifies them as error sequence patterns, providing particular relevance to systems employing advanced sensors and AI. Second, this paper proposes the Model-based SOTIF Analysis of Failures and Errors (MoSAFE) method, which allows instantiating STEAM based on system-design models by deriving hazardous error sequence patterns at module level from hazardous behaviors at vehicle level via weakest precondition reasoning. Finally, the paper presents a case study centered on an automated speed-control feature, illustrating the practical applicability of the refined model and the MoSAFE method in addressing complex safety challenges in DAS.

Recent advances in the field of deep learning and impressive performance of deep neural networks (DNNs) for perception have resulted in an increased demand for their use in automated driving (AD) systems. The safety of such systems is of utmost importance and thus requires to consider the unique properties of DNNs. In order to achieve safety of AD systems with DNN-based perception components in a systematic and comprehensive approach, so-called safety concerns have been introduced as a suitable structuring element. On the one hand, the concept of safety concerns is -- by design -- well aligned to existing standards relevant for safety of AD systems such as ISO 21448 (SOTIF). On the other hand, it has already inspired several academic publications and upcoming standards on AI safety such as ISO PAS 8800. While the concept of safety concerns has been previously introduced, this paper extends and refines it, leveraging feedback from various domain and safety experts in the field. In particular, this paper introduces an additional categorization for a better understanding as well as enabling cross-functional teams to jointly address the concerns.

The hype around ChatGPT has brought the topic of artificial intelligence and its impressive potential to the fore. At the same time, ensuring the quality and maintaining control of AI systems are becoming increasingly important--especially when these systems take on responsible tasks. After all, the chat-bot's results are based on huge amounts of text data from the internet. That said, systems like ChatGPT only compute the most likely answer to a question and output it as a fact. Researchers from the Fraunhofer Institute for Intelligent Analysis and Information Systems IAIS will be showcasing various assessment tools and processes that can be used to systematically examine AI systems for weaknesses throughout their life cycle and safeguard against AI risks at the Hannover Messe 2023 from April 17 to 21 (at the joint Fraunhofer booth A12 in Hall 16).