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Application Of Risk Management For It Networks Incorporating Medical Devices
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Book Synopsis Connected Medical Devices by : John Zaleski
Download or read book Connected Medical Devices written by John Zaleski and published by CRC Press. This book was released on 2015-03-27 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores how medical device integration (MDI) supports quality patient care and better clinical outcomes by reducing clinical documentation transcription errors, improving data accuracy and density within clinical records and ensuring the complete capture of medical device information on patients. It begins with a comprehensive overview of the types of medical devices in use and the ways in which those devices interact, then examines factors such as interoperability standards, patient identification, clinical alerts and regulatory and security considerations.
Book Synopsis Medical Device Cybersecurity for Engineers and Manufacturers by : Axel Wirth
Download or read book Medical Device Cybersecurity for Engineers and Manufacturers written by Axel Wirth and published by Artech House. This book was released on 2020-08-31 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis RISK MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY by : Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra
Download or read book RISK MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY written by Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra and published by Notion Press. This book was released on 2023-07-25 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Risk Management for the Medical Device Industry: A Guide based on ISO 14971" is an essential resource for professionals in the fast-paced medical device industry. Authored by Dr. Akash Sharma, Ms. Vriti Gamta, and Mr. Gaurav Luthra, experts in regulatory affairs and quality management systems, this practical guide offers comprehensive insights into risk management and compliance. Covering the entire risk management lifecycle, it includes case studies, best practices, and practical examples, along with discussions on integrating risk management with quality management systems and emerging technologies. Equip yourself with the knowledge and tools to ensure safety and effectiveness in the global market.
Book Synopsis Medical Device Regulatory Practices by : Val Theisz
Download or read book Medical Device Regulatory Practices written by Val Theisz and published by CRC Press. This book was released on 2015-08-03 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
Download or read book Federal Register written by and published by . This book was released on 2014 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Cybersecurity for Connected Medical Devices by : Arnab Ray
Download or read book Cybersecurity for Connected Medical Devices written by Arnab Ray and published by Academic Press. This book was released on 2021-11-09 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Handbook of Medical and Healthcare Technologies by : Borko Furht
Download or read book Handbook of Medical and Healthcare Technologies written by Borko Furht and published by Springer Science & Business Media. This book was released on 2013-11-20 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book equips readers to understand a complex range of healthcare products that are used to diagnose, monitor, and treat diseases or medical conditions affecting humans. The first part of the book presents medical technologies such as medical information retrieval, tissue engineering techniques, 3D medical imaging, nanotechnology innovations in medicine, medical wireless sensor networks, and knowledge mining techniques in medicine. The second half of the book focuses on healthcare technologies including prediction hospital readmission risk, modeling e-health framework, personal Web in healthcare, security issues for medical records, and personalized services in healthcare. The contributors are leading world researchers who share their innovations, making this handbook the definitive resource on these topics. Handbook of Medical and Healthcare Technologies is intended for a wide audience including academicians, designers, developers, researchers and advanced-level students. It is also valuable for business managers, entrepreneurs, and investors within the medical and healthcare industries.
Download or read book Medical Devices written by Carlo Boccato and published by Springer Nature. This book was released on 2022-02-24 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides caregivers and administrators with high-quality support for strategic decision making in the selection and use of medical devices so as to ensure value optimization. Medical treatment is increasingly complex, with wide application of medical devices and corresponding involvement of physics and engineering. A multidisciplinary methodology that brings together expertise from key disciplines in a holistic, system-oriented approach is essential in controlling this complexity and further improving health care. This book will help readers to understand the design, validation, and application of medical devices and the standards and regulations that apply to them across the world. In addition, it provides technical, operational, and economic perspectives on their use. The relevance of concepts such as expenditure optimization and sustainability to medical device technology is explained and healthcare reimbursement systems are discussed from different points of view. Readers will gain a clear appreciation of the managerial and economic implications of the use of medical devices and how to get the most out of them. Academic research, industrial experiences, and case studies are presented as appropriate.
Book Synopsis Healthcare Technology Management - A Systematic Approach by : Francis Hegarty
Download or read book Healthcare Technology Management - A Systematic Approach written by Francis Hegarty and published by CRC Press. This book was released on 2017-01-06 with total page 595 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and other care providers, as well as financial stakeholders. The authors propose a management model based on interlinked strategic and operational quality cycles which, when fully realized, delivers a comprehensive and transparent methodology for implementing a HTM programme throughout a healthcare organization. The approach proposes that HTM extends beyond managing the technology in isolation to include advancing patient care through supporting the application of the technology. The book shows how to cost effectively manage medical equipment through its full life cycle, from acquisition through operational use to disposal, and to advance care, adding value to the medical equipment assets for the benefit of patients and stakeholders. This book will be of interest to practicing clinical engineers and to students and lecturers, and includes self-directed learning questions and case studies. Clinicians, Chief Executive Officers, Directors of Finance and other hospital managers with responsibility for the governance of medical equipment will also find this book of interest and value. For more information about the book, please visit the website.
Book Synopsis Managing Medical Devices within a Regulatory Framework by : Beth Ann Fiedler
Download or read book Managing Medical Devices within a Regulatory Framework written by Beth Ann Fiedler and published by Elsevier. This book was released on 2016-09-10 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. - Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices - Provides operational and clinical practice recommendations in regard to regulatory changes for risk management - Discusses best practices for equipment procurement and maintenance - Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices
Book Synopsis Internet of Things Technology in Healthcare: Fundamentals, Principles and Cyber Security Issues by : V.Anand
Download or read book Internet of Things Technology in Healthcare: Fundamentals, Principles and Cyber Security Issues written by V.Anand and published by Anand Vemula. This book was released on with total page 43 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations by : Philip S. Cosgriff
Download or read book Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations written by Philip S. Cosgriff and published by CRC Press. This book was released on 2024-03-26 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Distributed Computing and Internet Technology by : Chittaranjan Hota
Download or read book Distributed Computing and Internet Technology written by Chittaranjan Hota and published by Springer. This book was released on 2013-01-11 with total page 586 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 9th International Conference on Distributed Computing and Internet Technology, ICDCIT 2013, held in Bhubaneswar, India, in February 2013. The 40 full papers presented together with 5 invited talks in this volume were carefully reviewed and selected from 164 submissions. The papers cover various research aspects in distributed computing, internet technology, computer networks, and machine learning.
Book Synopsis The Handbook of Information Security for Advanced Neuroprosthetics by : Matthew E. Gladden
Download or read book The Handbook of Information Security for Advanced Neuroprosthetics written by Matthew E. Gladden and published by Synthypnion Academic. This book was released on 2017-02-20 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: How does one ensure information security for a computer that is entangled with the structures and processes of a human brain – and for the human mind that is interconnected with such a device? The need to provide information security for neuroprosthetic devices grows more pressing as increasing numbers of people utilize therapeutic technologies such as cochlear implants, retinal prostheses, robotic prosthetic limbs, and deep brain stimulation devices. Moreover, emerging neuroprosthetic technologies for human enhancement are expected to increasingly transform their human users’ sensory, motor, and cognitive capacities in ways that generate new ‘posthumanized’ sociotechnological realities. In this context, it is essential not only to ensure the information security of such neuroprostheses themselves but – more importantly – to ensure the psychological and physical health, autonomy, and personal identity of the human beings whose cognitive processes are inextricably linked with such devices. InfoSec practitioners must not only guard against threats to the confidentiality and integrity of data stored within a neuroprosthetic device’s internal memory; they must also guard against threats to the confidentiality and integrity of thoughts, memories, and desires existing within the mind the of the device’s human host. This second edition of The Handbook of Information Security for Advanced Neuroprosthetics updates the previous edition’s comprehensive investigation of these issues from both theoretical and practical perspectives. It provides an introduction to the current state of neuroprosthetics and expected future trends in the field, along with an introduction to fundamental principles of information security and an analysis of how they must be re-envisioned to address the unique challenges posed by advanced neuroprosthetics. A two-dimensional cognitional security framework is presented whose security goals are designed to protect a device’s human host in his or her roles as a sapient metavolitional agent, embodied embedded organism, and social and economic actor. Practical consideration is given to information security responsibilities and roles within an organizational context and to the application of preventive, detective, and corrective or compensating security controls to neuroprosthetic devices, their host-device systems, and the larger supersystems in which they operate. Finally, it is shown that while implantable neuroprostheses create new kinds of security vulnerabilities and risks, they may also serve to enhance the information security of some types of human hosts (such as those experiencing certain neurological conditions).
Book Synopsis Medical Device Innovation Handbook by : William Durfee
Download or read book Medical Device Innovation Handbook written by William Durfee and published by Lulu.com. This book was released on 2014-03-23 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: A short handbook for the medical device innovator who wishes to understand the innovation process for new medical devices.
Book Synopsis Medical Device Data and Modeling for Clinical Decision Making by : John R. Zaleski
Download or read book Medical Device Data and Modeling for Clinical Decision Making written by John R. Zaleski and published by Artech House. This book was released on 2011 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: This cutting-edge volume is the first book that provides you with practical guidance on the use of medical device data for bioinformatics modeling purposes. You learn how to develop original methods for communicating with medical devices within healthcare enterprises and assisting with bedside clinical decision making. The book guides in the implementation and use of clinical decision support methods within the context of electronic health records in the hospital environment.This highly valuable reference also teaches budding biomedical engineers and bioinformaticists the practical benefits of using medical device data. Supported with over 100 illustrations, this all-in-one resource discusses key concepts in detail and then presents clear implementation examples to give you a complete understanding of how to use this knowledge in the field.
Book Synopsis Risk-Based Quality Management in Healthcare Organization by : Dr. Akash Sharma, Ms. Vriti Gamta, Mr.Gaurav Luthra
Download or read book Risk-Based Quality Management in Healthcare Organization written by Dr. Akash Sharma, Ms. Vriti Gamta, Mr.Gaurav Luthra and published by Notion Press. This book was released on 2023-08-09 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Risk-Based Quality Management in Healthcare Organization: A Guide based on ISO 13485 and EU MDR" is a comprehensive handbook that offers practical guidance for healthcare professionals to excel in risk-based quality management. It explores the regulatory landscape of the healthcare industry, emphasizing ISO 13485 and EU MDR as the foundation. The book provides a step-by-step approach to implementing effective risk assessment and mitigation strategies, ensuring compliance with international standards. It includes best practices to navigate risk management throughout the medical device lifecycle. The guide also addresses integrating risk management into existing quality management systems, conducting audits, and meeting EU MDR requirements. By mastering the principles in this guide, professionals can enhance patient safety, improve product quality, and achieve regulatory compliance. It is a valuable resource for healthcare professionals involved in device design, manufacturing, testing, and regulatory affairs.
