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This book review is about the Elsevier Academic Press 
newly published Cybersecurity for Connected Medical 
Devices by author Arnab Ray, Ph.D.  In addition to the 
Preface, the book contains nine chapters, an Afterword, 
and an Index for a total of 332 pages. This book contains 
a bevy of information that could overwhelm on first 
reading, but helpfully, from Chapter 2 onwards, every 
chapter serves up a summary and key takeaways that 
consolidate the key messages. Arnab Ray is a computer 
scientist with a background in critical software devel-
opment and cybersecurity design of medical devices 
that provides a cybersecurity developer’s perspective 
throughout this book.

Whilst the key audience is manufacturers of medi-
cal devices who are responsible for designing a cyber 
secure product, clinical engineers with an interest in 
cybersecurity should find this book a handy supplement 
to make sense of the fast-evolving landscape. They will 
gain a broad understanding of basic cybersecurity prin-
ciples, which can help influence integration choices in a 
healthcare delivery organization (HDO). Often medical 
device manufacturers (MDM) have not given enough 
consideration to the challenges of incorporating and 
maintaining a medical device in an HDO IT network. 
Importantly, Arnab recognizes that cybersecurity is a 
shared responsibility between the manufacturers and 
healthcare providers, but does not propose an effective 
mechanism for defining and sharing such responsibility. 

The introduction provides context to support the 
assertion that the cybersecurity of medical devices is a 
growing concern. It cites some high-profile examples of 
cyber-attacks on medical devices in a controlled envi-
ronment to provide proof of concept. While there are no 
reports of cybersecurity incidents in a real-life context it 
warns, that since most devices do not log cyber-related 
issues, a cyber incident could be incorrectly diagnosed 
as equipment malfunction. It would have been useful 
to highlight tools available to HDOs such as intrusion 
detection, dynamic network segmentation, and malware 
prevention systems and to examine how they impact 
medical devices’ performance. 

With the increasing integration of connected medi-
cal devices, with varying levels of endpoint security, to 
information systems, there are more opportunities for 
cybercriminals to gain illegal access to confidential infor-
mation and disrupt wider operations within a healthcare 

Book Review
By Lloyd M. C. Lilley
Medical Devices IT Lead, Clinical Engineering, Nottingham University Hospitals NHS Trust, UK

Cybersecurity for Connected Medical Devices

Arnab Ray

ISBN: 978-0-12-818262-8 

Academic Press: Elsevier

First edition: Published November 2021

Book price: US$84.95

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J Global Clinical Engineering Vol.5 Issue 1, 2022  6

delivery organization. This chapter helpfully discusses 
the development of national cybersecurity policies in the 
U.S. with some acknowledgment of similar policies in the 
E.U. Acknowledgement of the widely accepted challenge 
of designing a cyber secure product without introducing 
unintended negative consequences on usability and pa-
tient safety, highlights the limitations in designing a cyber 
secure product. Medical device manufacturers (MDM) 
are encouraged to consider risk-based controls, which 
conflicts with the recommendation of a controls-based 
approach, mentioned in Chapter 4. The introduction 
concludes with cybersecurity lifecycle challenges, and 
a suggestion for the development of a manufacturer’s 
business model, that makes cybersecurity a distinct 
structural part of the business.

A helpful analogy of a home, bank vault, and a pre-
cious asset is referred to throughout Chapter 2, Basic 
Cybersecurity Concepts, which effectively convey the 
fundamental concepts and challenges of cybersecurity 
and risk management. The key concepts of vulnerability 
and threats are articulated in simple, easy-to-understand 
terms. As the cybersecurity landscape evolves around 
the globe, terminology develops meanings that can 
seem rather vague, and often mean different things to 
different people, which might be a little disconcerting 
to a novice. The author approaches this conundrum by 
adopting certain definitions from authoritative sources 
and using them consistently throughout the book. As a 
result, the reader has a stable foundation from which to 
explore and understand the core principles. 

The medical device’s information security objectives 
are described as availability, integrity, and confidentiality 
in order of priority. However, one could argue that integ-
rity has a higher priority since an altered record is more 
likely to go unnoticed, potentially causing widespread 
harm before it is detected, whereas the unavailability 
of information is obvious and should result in the im-
plementation of contingency plans. This chapter clearly 
describes five categories of controls used to reduce 
the likelihood of an attack being successful. One of the 

categories, cryptography, is explored in detail with a 
study of the major cryptographic techniques used to 
establish secure communications between the sender 
and the intended receiver. The level of detail given is 
appropriate for one who is new to this discipline and is 
informative enough to help a designer make decisions 
about the most appropriate method to implement.

Standards and regulations, which aim to ensure man-
ufacturers build safe medical devices, are developing 
to include cybersecurity requirements. The increasing 
focus on cybersecurity is the subject of Chapter 3, 
Regulatory Overview and includes a summary of the 
current US and EU regulatory frameworks. It is recog-
nized that a robust quality management system (QMS) 
is necessary for manufacturers if they are to meet the 
standards expected by the regulatory authorities.  This 
chapter discusses key manufacturing quality standards, 
suggesting cybersecurity is not yet fully formed in them, 
and in fact lags behind some standards that HDOs have 
had access to for some time. Manufacturers struggling 
to adapt are offered useful guidance on how to achieve 
a cyber aware QMS with a suggested 5 step process for 
introducing regulatory requirements into an existing 
system. 

In Chapter 4, The Product Cybersecurity Organisa-
tion, the author suggests that with few tools available 
to quantify cybersecurity impact it is difficult for MDM’s 
decision-makers to be convinced of the benefits of invest-
ing. One could argue that making the case for investing 
is not difficult because of many well-known instances 
where damage has occurred from cyber-attacks on IT 
systems – the connected medical device is another type 
of IT system prone to the same attacks therefore, much 
is already known about exploitable system weaknesses. 
The author prefers a controls-based framework as op-
posed to a risk-based framework for building a cyber 
secure product. I believe that both frameworks have a 
place in design and there will always be an element of 
risk-based design due to the costs in terms of build and 
device performance. Recommendations for addressing 

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7 J Global Clinical Engineering Vol.5 Issue 1, 2022

Copyright © 2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY): Creative Commons - 
Attribution 4.0 International - CC BY 4.0. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright 
owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction 
is permitted which does not comply with these terms.

organizational shortfalls are made by offering key building 
blocks to achieving a product cybersecurity organization. 

Cybersecurity risk management is a complex field and 
the author clearly wanted to give more attention to this 
area therefore it occupies Chapters 5 and 6. Chapter 5 
predominantly addresses risk assessment and looks at 
threat modeling from system and subsystem levels. To 
help demonstrate a systemic threat and vulnerability 
modeling approach, an infusion pump with network 
connectivity is specified, and used as an example. This 
provides a convenient vehicle to explain the transferra-
ble process for assessing cybersecurity risk. There is a 
lack of threat modeling tools specific to medical devices 
but there are modeling tools for IT systems that can be 
adapted. The author demonstrates this by using Micro-
soft’s STRIDE framework to identify system threats and 
complete a threat model.

Chapter 6, Cybersecurity Risk Management-II, 
builds on the previous chapter with an illustration of 
a complete system cybersecurity risk model. The main 
theme of this chapter is the response to an identified 
risk. The infusion pump example specified in Chapter 
5, again proves useful but this time to explore system 
threats and the corresponding responses or controls. 
The MDM cybersecurity designer is walked through 
high-level examples of threat articulation, responses, 
and undertaking a risk-benefit analysis.

It is recommended that technical controls are trace-
able to regulations and standards. Chapter 7, Cyberse-
curity Design Engineering, takes a look at these controls 
identifying them as master controls, and with examples, 

key factors for building cyber-secure medical devices 
are considered. A brief look at the limiting factors in 
the hardware and battery-operated devices clearly 
demonstrates the challenge of incorporating effective 
cybersecurity controls without degrading performance. It 
would have been useful to provide examples from other 
safety-conscious industries such as aviation or nuclear 
power, which are at an advanced stage of maturity.

 Chapter 8 delves deeper into five more capabilities of 
an MDM that were defined in Chapter 4. Each capability 
is clearly described, providing industry insights with 
recommended best practices. 

The final chapter, Chapter 9, Product Security Gov-
ernance and Regulatory Compliance explores two more 
capabilities that an MDM should demonstrate. This 
chapter describes the governance elements required 
to satisfy regulations, which are fundamentally sup-
ported by a QMS. The advice given here is simple and 
clear - MDM’s need to continually refresh their resources 
and processes, and be transparent about the product’s 
cybersecurity posture.

Although this book is aimed at medical device man-
ufacturers (MDM), I feel it is suited to anyone with an 
interest in medical device cybersecurity, including those 
working in healthcare delivery organizations. A lot of 
ground is covered mostly from a regulatory and com-
pliance challenges angle; as a result, it only provides an 
overview, which the author concedes. However, the reader 
will find this book a useful springboard, from which to 
develop a greater understanding of a fast-evolving do-
main. This book successfully provides a framework for 
MDMs to design a cybersecurity-focused organization. 

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