Medical Device Cybersecurity For Engineers And Manufacturers

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Medical Device Cybersecurity

Axel Wirth,Christopher Gates,Jason Smith
Medical Device Cybersecurity Book PDF

Author : Axel Wirth,Christopher Gates,Jason Smith
Publisher : Artech House Publishers
Page : 270 pages
File Size : 51,6 Mb
Release : 2020-08-31
Category : Electronic
ISBN : 1630818151

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Medical Device Cybersecurity by Axel Wirth,Christopher Gates,Jason Smith Pdf

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

Axel Wirth,Christopher Gates,Jason Smith
Medical Device Cybersecurity for Engineers and Manufacturers Book PDF

Author : Axel Wirth,Christopher Gates,Jason Smith
Publisher : Artech House
Page : 270 pages
File Size : 53,9 Mb
Release : 2020-08-31
Category : Computers
ISBN : 9781630818166

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Medical Device Cybersecurity for Engineers and Manufacturers by Axel Wirth,Christopher Gates,Jason Smith Pdf

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

Axel Wirth,Jason Smith,Christopher Gates
Medical Device Cybersecurity for Engineers and Manufacturers Book PDF

Author : Axel Wirth,Jason Smith,Christopher Gates
Publisher : Unknown
Page : 0 pages
File Size : 40,9 Mb
Release : 2020
Category : Computer security
ISBN : 1523145986

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Medical Device Cybersecurity for Engineers and Manufacturers by Axel Wirth,Jason Smith,Christopher Gates Pdf

" 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

Arnab Ray
Cybersecurity for Connected Medical Devices Book PDF

Author : Arnab Ray
Publisher : Academic Press
Page : 334 pages
File Size : 40,7 Mb
Release : 2021-11-09
Category : Computers
ISBN : 9780128182635

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Cybersecurity for Connected Medical Devices by Arnab Ray Pdf

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

David C. Klonoff,David Kerr,Elissa R. Weitzman
Diabetes Digital Health and Telehealth Book PDF

Author : David C. Klonoff,David Kerr,Elissa R. Weitzman
Publisher : Academic Press
Page : 340 pages
File Size : 52,6 Mb
Release : 2022-08-05
Category : Medical
ISBN : 9780323906760

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Diabetes Digital Health and Telehealth by David C. Klonoff,David Kerr,Elissa R. Weitzman Pdf

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

Xenophon Papademetris,Ayesha N. Quraishi,Gregory P. Licholai
Introduction to Medical Software Book PDF

Author : Xenophon Papademetris,Ayesha N. Quraishi,Gregory P. Licholai
Publisher : Cambridge University Press
Page : 341 pages
File Size : 44,8 Mb
Release : 2022-05-05
Category : Business & Economics
ISBN : 9781316514993

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Introduction to Medical Software by Xenophon Papademetris,Ayesha N. Quraishi,Gregory P. Licholai Pdf

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

Women Securing the Future with TIPPSS for Connected Healthcare

Florence D. Hudson
Women Securing the Future with TIPPSS for Connected Healthcare Book PDF

Author : Florence D. Hudson
Publisher : Springer Nature
Page : 272 pages
File Size : 43,6 Mb
Release : 2022-05-30
Category : Technology & Engineering
ISBN : 9783030935924

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Women Securing the Future with TIPPSS for Connected Healthcare by Florence D. Hudson Pdf

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.

Careers in Biomedical Engineering

Michael Levin-Epstein
Careers in Biomedical Engineering Book PDF

Author : Michael Levin-Epstein
Publisher : Academic Press
Page : 150 pages
File Size : 47,6 Mb
Release : 2019-02-15
Category : Computers
ISBN : 9780128148167

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Careers in Biomedical Engineering by Michael Levin-Epstein Pdf

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

Security and Privacy for Implantable Medical Devices

Wayne Burleson,Sandro Carrara
Security and Privacy for Implantable Medical Devices Book PDF

Author : Wayne Burleson,Sandro Carrara
Publisher : Springer Science & Business Media
Page : 205 pages
File Size : 54,6 Mb
Release : 2013-12-03
Category : Technology & Engineering
ISBN : 9781461416746

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Security and Privacy for Implantable Medical Devices by Wayne Burleson,Sandro Carrara Pdf

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.

Medical Device Regulation

Elijah Wreh
Medical Device Regulation Book PDF

Author : Elijah Wreh
Publisher : Elsevier
Page : 680 pages
File Size : 55,6 Mb
Release : 2023-02-22
Category : Technology & Engineering
ISBN : 9780323953535

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Medical Device Regulation by Elijah Wreh Pdf

Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations

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

V.Anand
Internet of Things Technology in Healthcare Fundamentals Principles and Cyber Security Issues Book PDF

Author : V.Anand
Publisher : Anand Vemula
Page : 43 pages
File Size : 42,7 Mb
Release : 2024-05-07
Category : Computers
ISBN : 8210379456XXX

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Internet of Things Technology in Healthcare: Fundamentals, Principles and Cyber Security Issues by V.Anand Pdf

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.

28 Days to Save the World

Dan Purvis
28 Days to Save the World Book PDF

Author : Dan Purvis
Publisher : BenBella Books
Page : 289 pages
File Size : 53,5 Mb
Release : 2022-12-06
Category : Business & Economics
ISBN : 9781637741900

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28 Days to Save the World by Dan Purvis Pdf

In 2020, engineering firm Velentium faced an unprecedented ask: partner with a small medical device company and a very large vehicle manufacturer to increase emergency ventilator production from hundreds per month to thousands per week—in just 28 days. Serving on the frontlines of pandemic response is enough pressure to cause any size business to buckle, but the small firm thrived and even doubled in size to complete their manufacturing scale-up known as Project V: seven months of work in six weeks. Velentium’s cofounder Dan Purvis attributes their extraordinary success to their decade-in-the-making company culture, which buoyed them in the face of an unforeseeable crisis. In 28 Days to Save the World, he lays out how to harness the power of organizational culture to prepare your small business to weather any challenges ahead. Every quarter, more than 30 million small-business entrepreneurs face innumerable familiar crises—of management, strategic direction, cashflow and credit, staff, and customers—that can spell their doom. Drawing from his twenty-five years of experience as a small-business leader, and with gripping stories from Project V, Purvis reveals crisis-tested methods for turning challenges into opportunities. He shows how a well-crafted culture: Reveals the right path in a crisis Taps into team members’ inner motivation Unites leaders and followers Compels action in “made for you” moments Enables you to step up to global challenges Catalyzes deep connections between people inside and outside your organization When a defining moment arrives for your organization, will your team be ready? 28 Days to Save the World is an essential resource for ensuring that you are.

Do No Harm

Matthew Webster
Do No Harm Book PDF

Author : Matthew Webster
Publisher : John Wiley & Sons
Page : 260 pages
File Size : 51,5 Mb
Release : 2021-06-10
Category : Technology & Engineering
ISBN : 9781119794035

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Do No Harm by Matthew Webster Pdf

Discover the security risks that accompany the widespread adoption of new medical devices and how to mitigate them In Do No Harm: Protecting Connected Medical Devices, Healthcare, and Data from Hackers and Adversarial Nation States, cybersecurity expert Matthew Webster delivers an insightful synthesis of the health benefits of the Internet of Medical Things (IoMT), the evolution of security risks that have accompanied the growth of those devices, and practical steps we can take to protect ourselves, our data, and our hospitals from harm. You'll learn how the high barriers to entry for innovation in the field of healthcare are impeding necessary change and how innovation accessibility must be balanced against regulatory compliance and privacy to ensure safety. In this important book, the author describes: The increasing expansion of medical devices and the dark side of the high demand for medical devices The medical device regulatory landscape and the dilemmas hospitals find themselves in with respect medical devices Practical steps that individuals and businesses can take to encourage the adoption of safe and helpful medical devices or mitigate the risk of having insecure medical devices How to help individuals determine the difference between protected health information and the information from health devices—and protecting your data How to protect your health information from cell phones and applications that may push the boundaries of personal privacy Why cybercriminals can act with relative impunity against hospitals and other organizations Perfect for healthcare professionals, system administrators, and medical device researchers and developers, Do No Harm is an indispensable resource for anyone interested in the intersection of patient privacy, cybersecurity, and the world of Internet of Medical Things.

Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations

Philip S. Cosgriff,Matthew J. Memmott
Writing In House Medical Device Software in Compliance with EU UK and US Regulations Book PDF

Author : Philip S. Cosgriff,Matthew J. Memmott
Publisher : CRC Press
Page : 223 pages
File Size : 40,6 Mb
Release : 2024-03-26
Category : Science
ISBN : 9781040002353

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Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations by Philip S. Cosgriff,Matthew J. Memmott Pdf

This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house. It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations. This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice. Key Features: Up to date with the latest regulations in the UK, the EU, and the US Useful for those producing medical software for routine clinical use Contains best practice

Medical Device Essentials and Cybersecurity Quality Audit Management

Nimmo Chatterjee Dragomelo
Medical Device Essentials and Cybersecurity Quality Audit Management Book PDF

Author : Nimmo Chatterjee Dragomelo
Publisher : Grosvenor House Publishing Limited
Page : 134 pages
File Size : 42,5 Mb
Release : 2020-09-25
Category : Business & Economics
ISBN : 1839752424

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Medical Device Essentials and Cybersecurity Quality Audit Management by Nimmo Chatterjee Dragomelo Pdf

The author has conducted many hundreds of independent audits in the oil and gas/offshore industries over the last 35 years for national and international companies worldwide to their various standards requirements. However, many existing clients (Oil and Gas as well as Healthcare enterprises, Hospitals) are now moving heavily towards cyber security based network vulnerability audits. To address the issue ISO 27001, ISO13485, ISO14971 and related standards were integrated with the existing ISO9001, 14001 and 18001 model to create a multipurpose audit plan. This short book, however, mainly focuses on the quality aspects of remote controlled electronic medical devices using BSC (Balance Score Card) system. It is the first of a series of books the author plans to publish in integrated cyber security audit management.