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Providing a concise and accessible overview of the design, implementation and management of medical software, this textbook will equip students with a solid understanding of critical considerations for both standalone medical software (software as a medical device/SaMD) and software that is integrated into hardware devices. It includes: practical discussion of key regulatory documents and industry standards, and how these translate into concrete considerations for medical software design; detailed coverage of the medical software lifecycle process ; accessible introduction to quality and risk management systems in the context of medical software; succinct coverage of essential topics in data science, machine learning, statistics, cybersecurity, software engineering and healthcare bring readers up-to-speed; six cautionary real-world case studies illustrate the dangers of improper or careless software processes. Accompanied by online resources for instructors, this is the ideal introduction for undergraduate students in biomedical engineering, electrical engineering and computer science, junior software engineers, and digital health entrepreneurs.
The latest edition of the definitive guide to the Ada language covers the full details of the core language Ada 2012 as updated by the 2016 ISO Corrigendum and introduces the key new features in Ada 2022. The book is in four parts. It begins by introducing the fundamental concepts for newcomers, before moving onto algorithmic aspects and then structural features such as OOP and multitasking. The fourth part gives details of the standard library and interaction with the external environment. Six complete executable programs illustrate the core features of the language in action. The book concludes with an appendix focussing on the new features in Ada 2022. These new features aid program proof and the efficient use of multicore architectures.
This vignette describes the Therac-25 radiation therapy machine, whose software bugs and lack of hardware safety interlocks led to six serious accidents between 1982 and 1987. Three lives were claimed due to overconfidence in software and loose design regulations. Ultimately, these events were a catalyst for the FDA to begin investigating and regulating medical software.
This vignette discusses the failed launch of the online marketplace for purchasing individual healthcare insurance that was created as part of the Affordable Care Act (ACA) in fall 2013. A key component of this effort was the website www.HealthCare.gov, through which individuals would be able to buy health insurance.
This chapter discusses the processes of identifying the needs of our users, which is the first step in the software life cycle. We begin with an overview of the structure of creating new projects. Next, we apply the “Brown Cow” model (Section 11.1) as a guide for how to go about understanding the user’s current situation and future needs.
In this short chapter, we discuss the final three steps in the software life cycle: (1) deployment (Section 16.1), (2) maintenance (Section 16.2), and (3) decommissioning (Section 16.3). These are complex topics in their own right.
In the case of the Boeing 737 MAX disaster, the manufacturer tried to address hardware problems with software fixes in order to avoid the costs of recertification of what would have been a new airplane (had the fixes been done in hardware). Overconfidence in the software and insufficient testing and pilot training led to two fatal crashes and 346 fatalities.