Threat Modeling and Risk Analysis for Miniaturized Wireless Biomedical Devices

The landscape of miniaturized wireless biomedical devices (MWBDs), including various injectables, ingestibles, implantables, and wearables, is rapidly expanding as proactive mobile healthcare proliferates. While the growth of MWBDs increases the flexibility of medical services, the adoption of these technologies poses privacy and security risks to their users. As a result, while being restricted in resources (size, power, processing, and storage), these devices require trust and must be at least minimally secure in the face of evolving threats. Making MWBDs secure begins with threat modeling. Therefore, this research reviews and summarizes the information on threat modeling applicable to MWBDs. Then, we propose a domain-specific qualitative-quantitative threat model that aims to help the designers and manufacturers of MWBDs to identify threats and embed security in their designs in the premarket phase of the lifecycle of an MWBD. This model is tailored to a wide range of MWBDs. Among the different stakeholders, this model focuses on the user. It also prioritizes noninvasive direct attacks against telemetry interfaces. To discuss the advantages and disadvantages of the proposed model, it is compared to some other threat models. To illustrate how the model can be adopted by a threat-modeling team, it is then applied to representative case studies from each category of MWBDs. The outcomes of the performed risk analysis reveal that the model is easy to apply and sufficient to disclose threats.