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Automated medical report generation (MRG) holds great promise for reducing the heavy workload of radiologists. However, its clinical deployment is hindered by three major sources of uncertainty. First, visual uncertainty, caused by noisy or…

Implementing software security practices is a critical concern in modern software development. Industry practitioners, security tool providers, and researchers have provided standard security guidelines and sophisticated security…

Autonomous systems must sustain justified confidence in their correctness and safety across their operational lifecycle-from design and deployment through post-deployment evolution. Traditional assurance methods often separate…

The efficiency and service quality in a medical environment can be improved by using electronic documents (or e-docs) and digital signatures to speed up both doctors' activity and to provide in the same time easy retrieval and use of needed…

Medication errors continue to be the leading cause of avoidable patient harm in hospitals. This paper sets out a framework to assure medication safety that combines machine learning and safety engineering methods. It uses safety analysis to…

Safety analysis is used to identify hazards and build knowledge during the design phase of safety-relevant functions. This is especially true for complex AI-enabled and software intensive systems such as Autonomous Drive (AD).…

One of the major impediments in deployment of Autonomous Driving Systems (ADS) is their safety and reliability. The primary reason for the complexity of testing ADS is that it operates in an open world characterized by its…

As autonomous driving technology continues to advance, end-to-end models have attracted considerable attention owing to their superior generalisation capability. Nevertheless, such learning-based systems entail numerous safety risks…

Formal verification techniques have been playing an important role in pre-silicon validation processes. One of the most important points considered in performing formal verification is to define good verification scopes; we should define…

The potential presented by Artificial Intelligence (AI) for healthcare has long been recognised by the technical community. More recently, this potential has been recognised by policymakers, resulting in considerable public and private…

Formal verification of software is a bit of a niche activity: it is only applied to the most safety-critical or security-critical software and it is typically only performed by specialized verification engineers. This paper considers…

Purpose: The introduction of artificial intelligence / machine learning (AI/ML) products to the regulated fields of pharmaceutical research and development (R&D) and drug manufacture, and medical devices (MD) and in-vitro diagnostics (IVD),…

Standards play the key role in safety-critical systems. Errors in standards could mislead system developer's understanding and introduce bugs into system implementations. In this paper, we present an Event-B formalization and verification…

Autonomous robots are projected to significantly augment the manual workforce, especially in repetitive and hazardous tasks. For a successful deployment of such robots in human environments, it is crucial to guarantee human safety.…

Automated Driving Systems (ADS) have made great achievements in recent years thanks to the efforts from both academia and industry. A typical ADS is composed of multiple modules, including sensing, perception, planning, and control, which…

Online and AI-based symptom checkers are applications that assist medical laypeople in diagnosing their symptoms and determining which course of action to take. When evaluating these tools, previous studies primarily used an approach…

Medicine is rife with high-stakes uncertainty. Doctors routinely make clinical judgments and decisions that juggle many fundamental unknowns, like predictions about what might be causing a patients' symptoms or decisions about what…

Safety in the automotive domain is a well-known topic, which has been in constant development in the past years. The complexity of new systems that add more advanced components in each function has opened new trends that have to be covered…

With the rise of increasingly complex autonomous systems powered by black box AI models, there is a growing need for Run Time Assurance (RTA) systems that provide online safety filtering to untrusted primary controller output. Currently,…

In this paper, a new hierarchical software architecture is proposed to improve the safety and reliability of a safety-critical drone system from the perspective of its source code. The proposed architecture uses formal verification methods…