Application Of Risk Management For It Networks Incorporating Medical Devices Application Guidance Guidance On Standards For Establishing The Security Capabilities Identified In Iec Tr 80001 2 2
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Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition
Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition removes the mystery from cybersecurity engineering and regulatory processes and practices, showing medical device manufacturers how to produce and maintain devices that meet evolving regulatory expectations and reduce cybersecurity risks to business and patients. It represents a complete guide for medical device manufacturers seeking to implement lifecycle processes that secure their premarket and postmarket activities. This step-by-step guide educates manufacturers about the implementation of security best practices in accordance with industry standards and expectations, advising the reader about everything from high-level concepts to real-world solutions and tools. It focuses on 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. Reflecting rapid industry developments, regulatory changes, and technology advances, this new edition equips manufacturers with the knowledge to produce secure products that meet regulatory and market requirements while anticipating threats from sophisticated cyber adversaries. It's an indispensable resource for a wide range of professionals involved in medical device manufacturing, including engineering management, software/firmware engineers, business managers, regulatory professionals, contract manufacturers, FDA regulators, product/project managers, sales and marketing teams, and healthcare delivery organizations.
Internet of Things Technology in Healthcare: Fundamentals, Principles and Cyber Security Issues
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.
Cybersecurity for Connected Medical Devices
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