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Software safety (sometimes called software system safety) is an engineering discipline that aims to ensure that software, which is used in safety-related systems (i.e. safety-related software), does not contribute to any hazards such a system might pose. There are numerous standards that govern the way how safety-related software should be ...
The SOFTWARE SYSTEM is software safety class A if: the SOFTWARE SYSTEM cannot contribute to a HAZARDOUS SITUATION; or; the SOFTWARE SYSTEM can contribute to a HAZARDOUS SITUATION which does not result in unacceptable RISK after consideration of RISK CONTROL measures external to the SOFTWARE SYSTEM. The SOFTWARE SYSTEM is software safety class B if:
IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.
[7] [8] Medical software became more prominent in medical devices in fields such as nuclear medicine, cardiology, and medical robotics by the early 1990s, prompting additional scrutiny of the "safety-critical" nature of medical software in the research and legislative communities, in part fueled by the Therac-25 radiation therapy device scandal.
A root cause analysis identifies the set of multiple causes that together might create a potential accident. Root cause techniques have been successfully borrowed from other disciplines and adapted to meet the needs of the system safety concept, most notably the tree structure from fault tree analysis, which was originally an engineering technique. [7]
Health information technology (HIT) is "the application of information processing involving both computer hardware and software that deals with the storage, retrieval, sharing, and use of health care information, health data, and knowledge for communication and decision making". [8]
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Software assurance initiatives are programs and activities designed to ensure the quality, reliability, and security of software systems. These initiatives are important because software is used in a wide range of applications, from business operations to critical infrastructure, and defects or vulnerabilities in software can have serious consequences.