Cybersecurity for Connected Medical Devices

Download or read online book entitled Cybersecurity for Connected Medical Devices written by Arnab Ray and published by Academic Press. This book was released on 15 November 2021 with total page 220 pages. Available in PDF, EPUB and Kindle. Get best books that you want by click Get Book Button and Read as many books as you like. Book Excerpt : Cybersecurity for Connected Medical Devices offers comprehensive coverage of all aspects of medical device cybersecurity, with a focus on technologies and processes. The author starts by explaining why medical device cybersecurity is important and how it's different from traditional IT security as well as traditional safety engineering. This is followed by an introduction to medical device and cybersecurity concepts which readers will need to understand for the rest of the book, namely cybersecurity professionals who want to understand the medical device domain and medical device/software/quality engineers who need a quick introduction to cybersecurity concepts. After laying the groundwork and creating a common language for the audience to collaborate, the author reviews the regulatory landscape, surveying different standards that impact cybersecurity for medical devices. Next comes a key chapter for all readers, introducing a method for integrating the elements of a cybersecurity program, as defined by NIST CCF, into a traditional medical device quality organization. The author further demonstrates how a cybersecurity development lifecycle can be integrated with a classical 'product development lifecycle management' process typically used in medical device companies. Next, he offers quality and systems engineers a deeper dive into CAPA, non-conforming product, and patching/ product maintenance. In conclusion, the author reviews the larger implications of insecure devices, healthcare data breaches in general, and offers important motives for why securing medical devices is a necessary condition for the security of health IT in general. Lays out clear guidelines on to how to build a medical device cybersecurity program and assess its maturity Explores the interplay between device safety and security and the creation of a cybersecurity assurance argument for regulatory submissions Includes an overview of incident-response, vulnerability intake, and customer outreach processes for medical device cybersecurity Presents an overview of design-time cybersecurity controls and a candidate secure development lifecycle process that is integrated with a CFR 21 820.30 Design Controls based development process