Cybersecurity for Connected Medical Devices


Book Description

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




Do No Harm


Book Description

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.




Medical Device Cybersecurity for Engineers and Manufacturers


Book Description

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.




Connected Medical Devices


Book Description

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.




Medical Devices


Book Description

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9




Hearing Health Care for Adults


Book Description

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.




Medical Devices and the Public's Health


Book Description

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.




Internet of Medical Things


Book Description

This book looks at the growing segment of Internet of Things technology (IoT) known as Internet of Medical Things (IoMT), an automated system that aids in bridging the gap between isolated and rural communities and the critical healthcare services that are available in more populated and urban areas. Many technological aspects of IoMT are still being researched and developed, with the objective of minimizing the cost and improving the performance of the overall healthcare system. This book focuses on innovative IoMT methods and solutions being developed for use in the application of healthcare services, including post-surgery care, virtual home assistance, smart real-time patient monitoring, implantable sensors and cameras, and diagnosis and treatment planning. It also examines critical issues around the technology, such as security vulnerabilities, IoMT machine learning approaches, and medical data compression for lossless data transmission and archiving. Internet of Medical Things is a valuable reference for researchers, students, and postgraduates working in biomedical, electronics, and communications engineering, as well as practicing healthcare professionals.




The Internet of Medical Things (IoMT)


Book Description

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.




Innovation and Protection


Book Description

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.