Safety-critical software systems are those whose failure or malfunction could result in casualty and/or serious financial loss. In such systems, safety assurance cases (SACs) are an emerging approach that adopts a proactive strategy to produce structuralized safety justifications and arguments. While SACs are recommended in many software-intensive safety-critical domains, the lack of knowledge ...

BackgroundFor using of complementary and alternative medicine methods (CAM) in the leukemia pediatrics than other types of cancer, we have two great challenges; first challenge is their safety and risks and second challenge is study gaps in this field. Regarding to these challenges, this study is a narrative review of some CAM methods in the leukemia pediatrics from the perspective of their saf...

For type 2 diabetes mellitus treatment and clinical development, proper evaluation of cardiovascular risk has been required by regulatory agencies (eg, the US Food and Drug Administration) since cardiovascular safety is very important in this patient population. The US Food and Drug Administration issued general guidelines for cardiovascular safety evaluation that outlined the requirements cons...

Risk assessment plays a key role in Safety Management Systems. For more than forty years, likelihood and consequence have been used to guide the allocation of finite resources. Standards, such as IEC61508 and the DO-178 series, extended these concepts to support the development of software related systems. Human reliability analysis developed risk assessment techniques to represent and reason a...

In January 2005 the UK Ministry of Defence released Issue 3 of Defence Standard 00-56 (MOD 2004). This standard provides a comprehensive structure for safety management and for engineering safety into defence equipment and services. The standard moves away from mandating specific processes and instead takes a goalbased approach that requires suppliers to justify their systems by means of safety...

354 INTRODUCTION The delivery of safe and high-quality health care has reached a crisis in the United States in terms of personal loss due to preventable errors, as well as economic loss. Estimates of the economic costs in the intensive care unit (ICU), which represents just a portion of the health care system at large, approach nearly 1% of the gross domestic product.1 A natural impulse to add...

In presenting a framework for tackling these issues, the paper examines current safety practices. In particular it challenges, from a theoretical perspective, and by reference to recent research, two common misconceptions that safety is largely a matter of equipment reliability and that process-based assurance can provide adequate evidence of system safety. It argues that failure to address the...

The emerging network-enabled medical devices impose new challenges for the safety assurance of medical cyber-physical systems (MCPS). In this paper, we present a case study of building a high-level safety argument for a patient-controlled analgesia (PCA) closed-loop system, with the purpose of exploring potential methodologies for assuring the safety of MCPS. 1998 ACM Subject Classification D.2...

This report documents the program and the outcomes of Dagstuhl Seminar 15162 on “Software and Systems Traceability for Safety-Critical Projects”. The event brought together researchers and industrial practitioners working in the field of safety critical software to explore the needs, challenges, and solutions for Software and Systems Traceability in this domain. The goal was to explore the gap ...