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Connected Medical Devices
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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
Download or read book Do No Harm written by Matthew Webster and published by John Wiley & Sons. This book was released on 2021-06-10 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 270 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 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 The Role of Human Factors in Home Health Care by : National Research Council
Download or read book The Role of Human Factors in Home Health Care written by National Research Council and published by National Academies Press. This book was released on 2010-11-14 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.
Book Synopsis The Internet of Medical Things (IoMT) by : R. J. Hemalatha
Download or read book The Internet of Medical Things (IoMT) written by R. J. Hemalatha and published by John Wiley & Sons. This book was released on 2022-03-29 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: INTERNET OF MEDICAL THINGS (IOMT) Providing an essential addition to the reference material available in the field of IoMT, this timely publication covers a range of applied research on healthcare, biomedical data mining, and the security and privacy of health records. With their ability to collect, analyze and transmit health data, IoMT tools are rapidly changing healthcare delivery. For patients and clinicians, these applications are playing a central part in tracking and preventing chronic illnesses — and they are poised to evolve the future of care. In this book, the authors explore the potential applications of a wave of sensor-based tools—including wearables and stand-alone devices for remote patient monitoring—and the marriage of internet-connected medical devices with patient information that ultimately sets the IoMT ecosystem apart. This book demonstrates the connectivity between medical devices and sensors is streamlining clinical workflow management and leading to an overall improvement in patient care, both inside care facilities and in remote locations.
Book Synopsis Biomaterials and Medical Device - Associated Infections by : L Barnes
Download or read book Biomaterials and Medical Device - Associated Infections written by L Barnes and published by Elsevier. This book was released on 2014-11-21 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite advances in materials and sterilisation, patients who receive biomaterials of medical device implants are still at risk of developing an infection around the implantation site. This book reviews the fundamentals of biomaterials and medical device related infections and methods and materials for the treatment and prevention of infection. The first part of the book provides readers with an introduction to the topic including analyses of biofilms, diagnosis and treatment of infection, pathology and topography. The second part of the book discusses a range of established and novel technologies and materials which have been designed to prevent infection. Provides analysis of biofilms and their relevance to implant associated infections. Assesses technologies for controlling biofilms. Considers advantages and disadvantages of in vivo infection studies.
Book Synopsis Medical Device Reliability and Associated Areas by : B.S. Dhillon
Download or read book Medical Device Reliability and Associated Areas written by B.S. Dhillon and published by CRC Press. This book was released on 2000-03-29 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing,
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Book Synopsis Innovation and Protection by : I. Glenn Cohen
Download or read book Innovation and Protection written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Book Synopsis Safe Medical Devices for Children by : Institute of Medicine
Download or read book Safe Medical Devices for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2006-01-20 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Book Synopsis Procuring Interoperability by : National Academy of Medicine
Download or read book Procuring Interoperability written by National Academy of Medicine and published by . This book was released on 2023-09-03 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Realizing the promise of digital technology will depend on the ability to share information across time and space from multiple devices, sources, systems, and organizations. The major barrier to progress is not technical; rather, it is in the failure of organizational demand and purchasing requirements. In contrast to many other industries, the purchasers of health care technologies have not marshaled their purchasing power to drive interoperability as a key requirement. Better procurement practices, supported by compatible interoperability platforms and architecture, will allow for better, safer patient care; reduced administrative workload for clinicians; protection from cybersecurity attacks; and significant financial savings across multiple markets. With funding support from the Gordon and Betty Moore Foundation, this National Academy of Medicine Special Publication represents a multi-stakeholder exploration of the path toward achieving large-scale interoperability through strategic acquisition of health information technology solutions and devices. In this publication, data exchanges over three environments are identified as critical to achieving interoperability: facility-to-facility (macro-tier); intra-facility (meso-tier); and at point-of-care (micro-tier). The publication further identifies the key characteristics of information exchange involved in health and health care, the nature of the requirements for functional interoperability in care processes, the mapping of those requirements into prevailing contracting practices, the specification of the steps necessary to achieve system-wide interoperability, and the proposal of a roadmap for using procurement specifications to engage those steps. The publication concludes with a series of checklists to be used by health care organizations and other stakeholders to accelerate progress in achieving system-wide interoperability.
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309439264 Total Pages :325 pages Book Rating :4.3/5 (94 download)
Book Synopsis Hearing Health Care for Adults by : National Academies of Sciences, Engineering, and Medicine
Download or read book Hearing Health Care for Adults written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-10-06 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: The loss of hearing - be it gradual or acute, mild or severe, present since birth or acquired in older age - can have significant effects on one's communication abilities, quality of life, social participation, and health. Despite this, many people with hearing loss do not seek or receive hearing health care. The reasons are numerous, complex, and often interconnected. For some, hearing health care is not affordable. For others, the appropriate services are difficult to access, or individuals do not know how or where to access them. Others may not want to deal with the stigma that they and society may associate with needing hearing health care and obtaining that care. Still others do not recognize they need hearing health care, as hearing loss is an invisible health condition that often worsens gradually over time. In the United States, an estimated 30 million individuals (12.7 percent of Americans ages 12 years or older) have hearing loss. Globally, hearing loss has been identified as the fifth leading cause of years lived with disability. Successful hearing health care enables individuals with hearing loss to have the freedom to communicate in their environments in ways that are culturally appropriate and that preserve their dignity and function. Hearing Health Care for Adults focuses on improving the accessibility and affordability of hearing health care for adults of all ages. This study examines the hearing health care system, with a focus on non-surgical technologies and services, and offers recommendations for improving access to, the affordability of, and the quality of hearing health care for adults of all ages.
Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Book Synopsis Data Modelling and Analytics for the Internet of Medical Things by : Rajiv Pandey
Download or read book Data Modelling and Analytics for the Internet of Medical Things written by Rajiv Pandey and published by CRC Press. This book was released on 2023-12-22 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: The emergence of the Internet of Medical Things (IoMT) is transforming the management of diseases, improving diseases diagnosis and treatment methods, and reducing healthcare costs and errors. This book covers all the essential aspects of IoMT in one place, providing readers with a comprehensive grasp of IoMT and related technologies. Data Modelling and Analytics for the Internet of Medical Things integrates the architectural, conceptual, and technological aspects of IoMT, discussing in detail the IoMT, connected smart medical devices, and their applications to improve health outcomes. It explores various methodologies and solutions for medical data analytics in healthcare systems using machine learning and deep learning approaches, as well as exploring how technologies such as blockchain and cloud computing can further enhance data analytics in the e-health domain. Prevalent IoMT case studies and applications are also discussed. This book is suitable for scientists, design engineers, system integrators, and researchers in the field of IoMT. It will also be of interest to postgraduate students in computer science focusing on healthcare applications and a supplementary reading for IoMT courses.
Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2011-06-10 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.
