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Medical Device Cybersecurity

Author: Axel Wirth

Publisher: Artech House Publishers

Published: 2020-08-31

Total Pages: 270

ISBN-13: 9781630818159

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.

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.

Medical Device Cybersecurity for Engineers and Manufacturers

Author: Axel Wirth

Publisher:

Published: 2020

Total Pages: 0

ISBN-13: 9781523145980

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" Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussiońŒ 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

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

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

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.

Careers in Biomedical Engineering

Author: Michael Levin-Epstein

Publisher: Academic Press

Published: 2019-02-15

Total Pages: 150

ISBN-13: 0128148160

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Careers in Biomedical Engineering offers readers a comprehensive overview of new career opportunities in the field of biomedical engineering. The book begins with a discussion of the extensive changes which the biomedical engineering profession has undergone in the last 10 years. Subsequent sections explore educational, training and certification options for a range of subspecialty areas and diverse workplace settings. As research organizations are looking to biomedical engineers to provide project-based assistance on new medical devices and/or help on how to comply with FDA guidelines and best practices, this book will be useful for undergraduate and graduate biomedical students, practitioners, academic institutions, and placement services. Explores various positions in the field of biomedical engineering, including highly interdisciplinary fields, such as CE/IT, rehabilitation engineering and neural engineering Offers readers informative case studies written by the industry's top professionals, researchers and educators Provides insights into how educational, training and retraining programs are changing to meet the needs of quickly evolving professions

Internet of Things Technology in Healthcare: Fundamentals, Principles and Cyber Security Issues

Author: V.Anand

Publisher: Anand Vemula

Published:

Total Pages: 43

ISBN-13:

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This book aims at providing details of security foundation and implementation for connected healthcare. The key tenets of the cyber security – Inventory, of hardware and software, prioritization of the critical data and applications, monitoring, advanced defense with secure SDLC and testing. The various components including, risk mitigation strategies and the long-term roadmap for the implementation of the security within the healthcare space. It also gives a deep dive on the various regulations pertaining the healthcare devices and other components of the healthcare value chain. The book also focuses on the incident reporting, the total product lifecycle framework, and how innovation can help achieve the maturity through some of the tools stack.

Women Securing the Future with TIPPSS for Connected Healthcare

Author: Florence D. Hudson

Publisher: Springer Nature

Published: 2022-05-30

Total Pages: 272

ISBN-13: 3030935922

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The second in the Women Securing the Future with TIPPSS series, this book provides insight and expert advice from seventeen women leaders in technology, healthcare and policy to address the challenges of Trust, Identity, Privacy, Protection, Safety and Security (TIPPSS) for connected healthcare, and the growing Internet of Medical Things (IoMT) ecosystem. The ten chapters in this book delve into trust, security and privacy risks in connected healthcare for patients, medical devices, personal and clinical data, healthcare providers and institutions, and provide practical approaches to manage and protect the data, devices, and humans. Cybersecurity, technology and legal experts discuss risks, from data and device hacks to ransomware, and propose approaches to address the challenges including new frameworks for architecting and evaluating medical device and connected hospital cybersecurity. We all need to be aware of the TIPPSS challenges in connected healthcare, and we call upon engineers, device manufacturers, system developers and healthcare providers to ensure trust and manage the risk. Featuring contributions from prominent female experts and role models in technology, cybersecurity, engineering, computer science, data science, business, healthcare, accessibility, research, law, privacy and policy, this book sets the stage to improve security and safety in our increasingly connected world.

Security and Privacy for Implantable Medical Devices

Author: Wayne Burleson

Publisher: Springer Science & Business Media

Published: 2013-12-03

Total Pages: 204

ISBN-13: 1461416744

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This book presents a systematic approach to analyzing the challenging engineering problems posed by the need for security and privacy in implantable medical devices (IMD). It describes in detail new issues termed as lightweight security, due to the associated constraints on metrics such as available power, energy, computing ability, area, execution time, and memory requirements. Coverage includes vulnerabilities and defense across multiple levels, with basic abstractions of cryptographic services and primitives such as public key cryptography, block ciphers and digital signatures. Experts from Computer Security and Cryptography present new research which shows vulnerabilities in existing IMDs and proposes solutions. Experts from Privacy Technology and Policy will discuss the societal, legal and ethical challenges surrounding IMD security as well as technological solutions that build on the latest in Computer Science privacy research, as well as lightweight solutions appropriate for implementation in IMDs.