A concise and accessible overview of the design, implementation and management of medical software.

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.

This complete medical informatics textbook begins by reviewing the IT aspects of informatics, including systems architecture, electronic health records, interoperability, privacy and security, cloud computing, mobile healthcare, imaging, capturing data, and design issues. Next, it provides case studies that illustrate the roll out of EHRs in hospitals. The third section incorporates four anatomy and physiology lectures that focus on the physiological basis behind data captured in EHR medical records. The book includes links to documents and standards sources so students can explore each idea discussed in more detail.

This newest book from Watts Humphrey is a hands-on introduction to basic disciplines of software engineering. Designed as a workbook companion to any introductory programming or software-engineering text, Humphrey provides here the practical means to integrate his highly regarded Personal Software Process (PSP) into college and university curricula. The book may also be adapted for use in industrial training or for self-improvement by practicing software engineers. Applying the book's exercises to their course assignments, students learn both to manage their time effectively and to monitor the quality of their work, good practices they will need to be successful in their future careers. The book is supported by its own electronic supplement, which includes spreadsheets for data entry and analysis. A complete instructor's package is also available. By mastering PSP techniques early in their studies, students can avoid--or overcome--the popular "hacker" ethic that leads to so many bad habits. Employers will appreciate new hires prepared to do competent professional work without, as now is common, expensive retraining and years of experience.

Introduction to Clinical Engineering focuses on the application of engineering practice within the healthcare delivery system, often defined as clinical engineering. Readers will explore the fundamental concepts integral to the support of healthcare technology to advance medical care. The primary mission of clinical engineers is the utilization of medical devices, software, and systems to deliver safe and effective patient care throughout technology's lifecycle. This unique and interdisciplinary workforce is part of the healthcare team and serves as the intersection between engineering and medicine. This book is aimed at practitioners, managers, students, and educators to serve as a resource that offers a broad perspective of the applications of engineering principles, regulatory compliance, lifecycle planning, systems thinking, risk analysis, and resource management in healthcare. This book is an invaluable tool for healthcare technology management (HTM) professionals and can serve as a guide for students to explore the profession in depth. - Offers readers an in-depth look into the support and implementation of existing medical technology used for patient care in a clinical setting - Provides insights into the clinical engineering profession, focusing on engineering principles as applied to the US healthcare system - Explores healthcare technology, hospital and systems safety, information technology and interoperability with medical devices, clinical facilities management, as well as human resource management

The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program. Lays out clear guidelines for how to build a medical device cybersecurity program through the development of capabilities Discusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management System Provides a candidate method for system and software threat modelling Provides an overview of cybersecurity risk management for medical devices Presents technical cybersecurity controls for secure design of medical devices Provides an overview of cybersecurity verification and validation for medical devices Presents an approach to logically structure cybersecurity regulatory submissions

Extensively class-tested, this textbook takes an innovative approach to software testing: it defines testing as the process of applying a few well-defined, general-purpose test criteria to a structure or model of the software. It incorporates the latest innovations in testing, including techniques to test modern types of software such as OO, web applications, and embedded software. The book contains numerous examples throughout. An instructor's solution manual, PowerPoint slides, sample syllabi, additional examples and updates, testing tools for students, and example software programs in Java are available on an extensive website.