A dual-layer context-based architecture for the detection of anomalous instructions sent to medical devices.

Complex medical devices are controlled by instructions sent from a host personal computer (PC) to the device. Anomalous instructions can introduce many potentially harmful threats to patients (e.g., radiation overexposure), to physical device components (e.g., manipulation of device motors), or to functionality (e.g., manipulation of medical images). Threats can occur due to cyber-attacks, human error (e.g., using the wrong protocol, or misconfiguring the protocol's parameters by a technician), or host PC software bugs. Thus, anomalous instructions might represent an intentional threat to the patient or to the device, a human error, or simply a non-optimal operation of the device. To protect medical devices, we propose a new dual-layer architecture. The architecture analyzes the instructions sent from the host PC to the physical components of the device, to detect anomalous instructions using two detection layers: (1) an unsupervised context-free (CF) layer that detects anomalies based solely on the instruction's content and inter-correlations; and (2) a supervised context-sensitive (CS) layer that detects anomalies in both the clinical objective and patient contexts using a set of supervised classifiers pre-trained for each specific context. The proposed dual-layer architecture was evaluated in the computed tomography (CT) domain, using 4842 CT instructions that we recorded, including two types of CF anomalous instructions, four types of clinical objective context instructions and four types of patient context instructions. The CF layer was evaluated using 14 unsupervised anomaly detection algorithms. The CS layer was evaluated using six supervised classification algorithms applied to each context (i.e., clinical objective or patient). Adding the second CS supervised layer to the architecture improved the overall anomaly detection performance (by improving the detection of CS anomalous instructions [when they were not also CF anomalous]) from an F1 score baseline of 72.6%, to an improved F1 score of 79.1% to 99.5% (depending on the clinical objective or patient context used). Adding, the semantics-oriented CS layer enables the detection of CS anomalies using the semantics of the device's procedure, which is not possible when using just the purely syntactic CF layer. However, adding the CS layer also introduced a somewhat increased false positive rate (FPR), and thus reduced somewhat the specificity of the overall process. We conclude that by using both the CF and CS layers, a dual-layer architecture can better detect anomalous instructions to medical devices. The increased FPR might be reduced, in the future, through the use of stronger models, and by training them on more data. The improved accuracy, and the potential capability of adding explanations to both layers, might be useful for creating decision support systems for medical device technicians.