Towards cyber-biosecurity by design: an experimental approach to Internet-of-Medical-Things design and development

Abstract

The introduction of the internet and the proliferation of internet-connected devices (IoT) enabled knowledge sharing, connectivity and global communications. At the same time, these technologies generated a crime harvest as security was overlooked. The Internet-of-Medical-Things (IoMT) generates biological information and is transforming healthcare through the introduction of internet-connected medical-grade devices that are integrated with wider-scale health networks to improve patients’ health. Many innovative ideas arise from academia; however, there is a lack of support in medical device regulation. The implementation of the current regulatory framework is limited to security risk assessment and guidance. Unfortunately, premarket risk-management requirements of current regulation do not include crime risks and a more predictive approach could help fill this gap. Crime science, or the perspective of crime as an event that can be influenced directly by its immediate environment, may encourage the biotechnology industry to design-in security and crime out. In this article, I provide a point of view of an early career researcher and medical device developer navigating the medical device regulatory pathway for the first time. I narrow the focus of this article to an assessment that is specific to current UK provisions and acknowledge the limited scope. In response to the ongoing changes in the current regulatory framework of the UK, I propose a new secure by design mechanism that can be employed by early career developers earlier in the development process of a product. Such a model can be used to systematically consider security design in devices and to understand and address potential crime risks ahead of their widespread use.

Organoids, Biocybersecurity, and Cyberbiosecurity—A Light Exploration

“…The ongoing advancements in this area challenge our understanding of the boundaries between biological and computational systems, paving the way for future discoveries and applications. Considering possible futures that corporate technology behemoths will influence through IoT and synthetic biotechnology stacks, much work is required on the policy side to ensure the adequate protection of users [166,167].…”

Risk Evaluation and Attack Detection in Heterogeneous IoMT Devices Using Hybrid Fuzzy Logic Analytical Approach

“…Hence, to keep risks under control, continuous risk assessment and management are becoming increasingly important [4]. According to Data Bridge Market Research [5], it is estimated that the IoMT market will surge from USD 48.69 billion in 2021 to USD 270.4 billion in 2029 [6].…”