Digital Health


Book Description

Digital Health: Mobile and Wearable Devices for Participatory Health Applications is a key reference for engineering and clinical professionals considering the development or implementation of mobile and wearable solutions in the healthcare domain. The book presents a comprehensive overview of devices and appropriateness for the respective applications. It also explores the ethical, privacy, and cybersecurity aspects inherent in networked and mobile technologies. It offers expert perspectives on various approaches to the implementation and integration of these devices and applications across all areas of healthcare. The book is designed with a multidisciplinary audience in mind; from software developers and biomedical engineers who are designing these devices to clinical professionals working with patients and engineers on device testing, human factors design, and user engagement/compliance. - Presents an overview of important aspects of digital health, from patient privacy and data security to the development and implementation of networks, systems, and devices - Provides a toolbox for stakeholders involved in the decision-making regarding the design, development, and implementation of mHealth solutions - Offers case studies, key references, and insights from a wide range of global experts







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




Wearable and Implantable Medical Devices


Book Description

Wearable and Implantable Medical Devices: Applications and Challenges, Fourth Edition highlights the new aspects of wearable and implanted sensors technology in the healthcare sector and monitoring systems. The book's contributions include several interdisciplinary domains, such as wearable sensors, implanted sensors devices, Internet-of-Things (IoT), security, real-time medical healthcare monitoring, WIBSN design and data management, encryption, and decision-support systems. Contributions emphasize several topics, including real-world applications and the design and implementation of wearable devices. This book demonstrates that this new field has a brilliant future in applied healthcare research and in healthcare monitoring systems. - Includes comprehensive information on wearable and implanted device technology, wearable and implanted sensors design, WIBSN requirements, WIBSN in monitoring systems and security concepts - Highlights machine learning and computing in healthcare monitoring systems based on WIBSN - Includes a multidisciplinary approach to different healthcare applications and their associated challenges based on wearable and implanted technologies




Human resources for medical devices - the role of biomedical engineers


Book Description

This publication addresses the role of the biomedical engineer in the development, regulation, management, training, and use of medical devices. The first part of the book looks at the biomedical engineering profession globally as part of the health workforce: global numbers and statistics, professional classification, general education and training, professional associations, and the certification process. The second part addresses all of the different roles that the biomedical engineer can have in the life cycle of the technology, from research and development, and innovation, mainly undertaken in academia; the regulation of devices entering the market; and the assessment or evaluation in selecting and prioritizing medical devices (usually at national level); to the role they play in the management of devices from selection and procurement to safe use in healthcare facilities. The annexes present comprehensive information on academic programs, professional societies, and relevant WHO and UN documents related to human resources for health as well as the reclassification proposal for ILO. This publication can be used to encourage the availability, recognition, and increased participation of biomedical engineers as part of the health workforce, particularly following the recent adoption of the recommendations of the UN High-Level Commission on Health Employment and Economic Growth, the WHO Global Strategy on Human Resources for Health, and the establishment of national health workforce accounts. The document also supports the aim of reclassification of the role of the biomedical engineer as a specific engineer that supports the development, access, and use of medical devices within the national, regional, and global occupation classification system.




Usability Testing of Medical Devices


Book Description

Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h




Medical Technology Assessment Directory


Book Description

For the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.




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.




Plastics in Medical Devices


Book Description

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.




Flexible and Stretchable Medical Devices


Book Description

The book introduces flexible and stretchable wearable electronic systems and covers in detail the technologies and materials required for healthcare and medical applications. A team of excellent authors gives an overview of currently available flexible devices and thoroughly describes their physical mechanisms that enable sensing human conditions. In dedicated chapters, crucial components needed to realize flexible and wearable devices are discussed which include transistors and sensors and deal with memory, data handling and display. Additionally, suitable power sources based on photovoltaics, thermoelectric energy and supercapacitors are reviewed. A special chapter treats implantable flexible sensors for neural recording. The book editor concludes with a perspective on this rapidly developing field which is expected to have a great impact on healthcare in the 21st century.