Medical Device Cybersecurity for Engineers and Manufacturers
Medical Device Cybersecurity for Engineers and Manufacturers

Author: Axel Wirth

Publisher: Artech House

Published: 2020-08-31

Total Pages: 270

ISBN-13: 163081816X

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Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed with urgency. In the end, this is about preventing patient harm and preserving patient trust. A comprehensive guide to medical device secure lifecycle management, this is a book for engineers, managers, and regulatory specialists. Readers gain insight into the security aspects of every phase of the product lifecycle, including concept, design, implementation, supply chain, manufacturing, postmarket surveillance, maintenance, updates, and end of life. Learn how to mitigate or completely avoid common cybersecurity vulnerabilities introduced during development and production. Grow your awareness of cybersecurity development topics ranging from high-level concepts to practical solutions and tools. Get insight into emerging regulatory and customer expectations. Uncover how to minimize schedule impacts and accelerate time-to-market while still accomplishing the main goal: reducing patient and business exposure to cybersecurity risks. Medical Device Cybersecurity for Engineers and Manufacturers is designed to help all stakeholders lead the charge to a better medical device security posture and improve the resilience of our medical device ecosystem.

Cybersecurity for Connected Medical Devices
Cybersecurity for Connected Medical Devices

Author: Arnab Ray

Publisher: Academic Press

Published: 2021-11-09

Total Pages: 334

ISBN-13: 0128182636

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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

Medical Device Cybersecurity
Medical Device Cybersecurity

Author: Axel Wirth

Publisher: Artech House Publishers

Published: 2020-08-31

Total Pages: 270

ISBN-13: 9781630818159

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This comprehensive book provides a complete guide for medical device manufacturers seeking to implement lifecycle processes that secure their premarket and postmarket activities. This step-by-step book educates manufacturers about the implementation of security best practices in accord with industry standards and expectations, advising the reader about everything from high-level concepts to real-world solutions and tools. It walks the reader through the security aspects of every lifecycle phase of the product, including concept; design; implementation; supply chain; manufacturing; postmarket; maintenance; and end of life. It details the practices, processes, and outputs necessary to create a secure medical device capable of gaining regulatory approval and meeting market entry requirements.This book equips medical device manufacturers with the knowledge and capability required to produce secure products that anticipate healthcare delivery organizations' (HDOs) and patients' needs and expectations, meet market-entry requirements set by regulators and standards organizations, and reduce patient, HDO, and manufacturer exposure to increasingly sophisticated cyber adversaries.It explores the differences between cybersecurity in an IT/MIS environment versus the application and management of cybersecurity during the development of an embedded product, as typically found in the medical device ecosystem. Designers and manufacturers learn how to mitigate or avoid common cybersecurity vulnerabilities frequently introduced during development and production. It details regulatory and customer expectations for documentation artifacts and deliverables that demonstrate cybersecurity compliance and features as well as regulator expectations for postmarket activities during device service life. Readers become aware of the growing sophistication of cyber adversaries disproportionate to industry understanding of cybersecurity exposure and potential impacts.

Cybersecurity for Industry 4.0
Cybersecurity for Industry 4.0

Author: Lane Thames

Publisher: Springer

Published: 2017-04-03

Total Pages: 273

ISBN-13: 3319506609

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This book introduces readers to cybersecurity and its impact on the realization of the Industry 4.0 vision. It covers the technological foundations of cybersecurity within the scope of the Industry 4.0 landscape and details the existing cybersecurity threats faced by Industry 4.0, as well as state-of-the-art solutions with regard to both academic research and practical implementations. Industry 4.0 and its associated technologies, such as the Industrial Internet of Things and cloud-based design and manufacturing systems are examined, along with their disruptive innovations. Further, the book analyzes how these phenomena capitalize on the economies of scale provided by the Internet. The book offers a valuable resource for practicing engineers and decision makers in industry, as well as researchers in the design and manufacturing communities and all those interested in Industry 4.0 and cybersecurity.

Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition
Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition

Author:

Publisher:

Published: 2024-10-31

Total Pages: 0

ISBN-13: 9781630819910

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Why Secure Medical Devices?, Establishing Cybersecurity Focus Within the MD, Global Regulations and Standards, Use Environments, Supply Chain Management, Secure Development and Production for Medical Device Manufacturers, Documentation and Artifacts, Postmarket Vulnerability Management, Incident Response & Communications, Device Security Lifecycle for Healthcare Delivery Organizations, Aspects of IT Security in Medical Device Systems, Applying Cryptography to Medical Device Systems, Cybersecurity Failures, Common Myths & Excuses

Diabetes Digital Health and Telehealth
Diabetes Digital Health and Telehealth

Author: David C. Klonoff

Publisher: Academic Press

Published: 2022-08-05

Total Pages: 340

ISBN-13: 0323906761

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Diabetes Digital Health and Telehealth explains, from technologic, economic and sociologic standpoints how digital health and telehealth have come to dominate the management of diabetes. The book also includes information on improved telemedicine tools and platforms for communicating with patients, reviewing medical records, and interpreting data from wearable devices. In addition, evolving wearable sensors such as continuous glucose monitors, closed loop automated insulin delivery systems, cuffless blood pressure monitors, exercise monitors and smart insulin pens are covered. - Covers advances in the fields of digital health and telehealth, including research methods, relevant types of evidence, and viable endpoints for assessing the clinical and economic benefits of digital health and telehealth for diabetes - Discusses improved telemedicine tools and platforms for communicating with patients, reviewing medical records and interpreting data from wearable devices - Analyzes information gaps, research methods, relevant types of evidence, and viable endpoints for assessing the clinical and economic benefits of digital health and telehealth for diabetes

Human resources for medical devices - the role of biomedical engineers
Human resources for medical devices - the role of biomedical engineers

Author: World Health Organization

Publisher: World Health Organization

Published: 2017-05-09

Total Pages: 0

ISBN-13: 9789241565479

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This publication addresses the role of the biomedical engineer in the development, regulation, management, training, and use of medical devices. The first part of the book looks at the biomedical engineering profession globally as part of the health workforce: global numbers and statistics, professional classification, general education and training, professional associations, and the certification process. The second part addresses all of the different roles that the biomedical engineer can have in the life cycle of the technology, from research and development, and innovation, mainly undertaken in academia; the regulation of devices entering the market; and the assessment or evaluation in selecting and prioritizing medical devices (usually at national level); to the role they play in the management of devices from selection and procurement to safe use in healthcare facilities. The annexes present comprehensive information on academic programs, professional societies, and relevant WHO and UN documents related to human resources for health as well as the reclassification proposal for ILO. This publication can be used to encourage the availability, recognition, and increased participation of biomedical engineers as part of the health workforce, particularly following the recent adoption of the recommendations of the UN High-Level Commission on Health Employment and Economic Growth, the WHO Global Strategy on Human Resources for Health, and the establishment of national health workforce accounts. The document also supports the aim of reclassification of the role of the biomedical engineer as a specific engineer that supports the development, access, and use of medical devices within the national, regional, and global occupation classification system.

The Ethics of Cybersecurity
The Ethics of Cybersecurity

Author: Markus Christen

Publisher: Springer Nature

Published: 2020-02-10

Total Pages: 388

ISBN-13: 3030290530

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This open access book provides the first comprehensive collection of papers that provide an integrative view on cybersecurity. It discusses theories, problems and solutions on the relevant ethical issues involved. This work is sorely needed in a world where cybersecurity has become indispensable to protect trust and confidence in the digital infrastructure whilst respecting fundamental values like equality, fairness, freedom, or privacy. The book has a strong practical focus as it includes case studies outlining ethical issues in cybersecurity and presenting guidelines and other measures to tackle those issues. It is thus not only relevant for academics but also for practitioners in cybersecurity such as providers of security software, governmental CERTs or Chief Security Officers in companies.

Introduction to Medical Software
Introduction to Medical Software

Author: Xenophon Papademetris

Publisher: Cambridge University Press

Published: 2022-05-05

Total Pages: 342

ISBN-13: 1009090143

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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.

Reinventing the Product
Reinventing the Product

Author: Eric Schaeffer

Publisher: Kogan Page Publishers

Published: 2019-03-03

Total Pages: 393

ISBN-13: 0749484659

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Create the personalized and compelling experiences that today's customers expect by harnessing AI and digital technologies to create smart connected products, with this cutting-edge guide from senior leaders at Accenture. Digital technology is both friend and foe: highly disruptive, yet it cannot be ignored. As traditional products transform into smart connected products faster than ever before, companies that fail to make use of it now put themselves in the firing line for disintermediation or even eradication. However, digital technology is also the biggest opportunity for product-making businesses to create the next generation of goods in the marketplace. In Reinventing the Product, Eric Schaeffer and David Sovie, both Senior Managing Directors at Accenture, show how this reinvention is made possible, to deliver truly intelligent, and often even autonomous, products. Reinventing the Product makes the case for companies to rethink their product strategy, innovation and engineering processes, including: - How to harness the opportunities of AI and digital technologies, such as IoT sensors, blockchain, advanced analytics, cloud and edge computing - Practical advice on transforming their entire culture to build the future of successful 'living products' - Features case studies from global organizations such as Faurecia, Signify, Symmons and Haier and interviews with thought leaders from top companies including Amazon, ABB, Tesla, Samsung and Google This book provides the only advice any product-making company needs as it embarks on, or accelerates, its digitization journey.