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Connected Medical Devices (CMDs) have a large impact on patients as they allow them to lead a more normal life. Any malfunction could not only remove the health benefits the CMDs provide, they could also cause further harm to the patient.…
Automated Driving Systems (ADSs) have seen rapid progress in recent years. To ensure the safety and reliability of these systems, extensive testings are being conducted before their future mass deployment. Testing the system on the road is…
Autonomous driving functions (ADFs) in public traffic have to comply with complex system requirements that are based on knowledge of experts from different disciplines, e.g., lawyers, safety experts, psychologists. In this paper, we present…
Run Time Assurance (RTA) Systems are online verification mechanisms that filter an unverified primary controller output to ensure system safety. The primary control may come from a human operator, an advanced control approach, or an…
We are concerned with systems, particularly safety-critical systems, that involve interaction between users and devices, such as the user interface of medical devices. We therefore developed a MISRA C code generator for formal models…
Improving effectiveness and safety of patient care is an ultimate objective for medical cyber-physical systems. A recent study shows that the patients' death rate can be reduced by computerizing medical guidelines. Most existing medical…
Artificial Intelligence (AI) systems are now an integral part of multiple industries. In clinical research, AI supports automated adverse event detection in clinical trials, patient eligibility screening for protocol enrollment, and data…
Autonomous systems such as self-driving cars rely on sensors to perceive the surrounding world. Measures must be taken against attacks on sensors, which have been a hot topic in the last few years. For that goal one must first evaluate how…
The automotive domain is shifting to software-centric development to meet regulation, market pressure, and feature velocity. This shift increases embedded systems' complexity and strains testing capacity. Despite relevant standards, a…
Autonomous driving systems (ADS) are increasingly deployed in real traffic, yet testing remains fundamentally challenging due to open environments, complex scenarios, and the lack of established processes and metrics. Despite extensive…
Background: Artificial Intelligence (AI) clinical decision support (CDS) systems have the potential to augment surgical risk assessments, but successful adoption depends on an understanding of end-user needs and current workflows. This…
Context: Ensuring safety for any sophisticated system is getting more complex due to the rising number of features and functionalities. This calls for formal methods to entrust confidence in such systems. Nevertheless, using formal methods…
Using probabilities in the formal-methods-based development of safety-critical software has quickened interests in academia and industry. We address this area by our model-driven engineering method for reactive systems SPACE and its…
The increasing use of deep neural networks for safety-critical applications, such as autonomous driving and flight control, raises concerns about their safety and reliability. Formal verification can address these concerns by guaranteeing…
Prognostic and diagnostic AI-based medical devices hold immense promise for advancing healthcare, yet their rapid development has outpaced the establishment of appropriate validation methods. Existing approaches often fall short in…
Hybrid systems verification is quite important for developing correct controllers for physical systems, but is also challenging. Verification engineers, thus, need to be empowered with ways of guiding hybrid systems verification while…
Asthma is a common, usually long-term respiratory disease with negative impact on global society and economy. Treatment involves using medical devices (inhalers) that distribute medication to the airways and its efficiency depends on the…
Safety architectures play a crucial role in the safety assurance of automated driving vehicles (ADVs). They can be used as safety envelopes of black-box ADV controllers, and for graceful degradation from one ODD to another. Building on our…
Formal methods and testing are two important approaches that assist in the development of high quality software. For long time these approaches have been seen as competitors and there was very little interaction between the two communities.…
There is a growing demand for the use of Artificial Intelligence (AI) and Machine Learning (ML) in healthcare, particularly as clinical decision support systems to assist medical professionals. However, the complexity of many of these…