Forensic Analysis of Compromised Medical Devices

Introduction to Forensic Analysis of Compromised Medical Devices

The forensic analysis of compromised medical devices, such as Continuous Glucose Monitors (CGMs), is a critical aspect of ensuring the safety and efficacy of these devices. This analysis involves a multidisciplinary approach, incorporating digital forensics, material forensics, and data forensics to identify and address potential vulnerabilities.

Digital Forensics in CGMs

Digital forensics plays a vital role in investigating cybersecurity breaches, particularly those related to Bluetooth Low Energy (BLE) vulnerabilities in CGMs. Research has shown that these vulnerabilities can lead to risks such as eavesdropping, signal spoofing, and replay attacks, where false glucose data is injected into the system [1]. To identify such attacks, analysts examine sequence number anomalies and timestamp errors to distinguish between legitimate sensor noise and malicious activity. For instance, a study by Li and Chen (2020) highlighted the importance of digital forensics in detecting BLE vulnerabilities in CGMs [1].

Material Forensics for Device Failure Analysis

Material forensics involves the use of Scanning Electron Microscopy (SEM) to examine explanted sensors and determine the cause of device failures [2]. This approach can help distinguish between failures resulting from patient error (e.g., tensile overload) and those caused by manufacturing defects (e.g., fatigue failure). A study by Kim and Lee (2019) demonstrated the effectiveness of SEM in analyzing the failure of CGM sensors [2].

Data Forensics for Identifying Hardware Instability

Data forensics compares raw sensor current (nA) against smoothed algorithmic output to identify potential software masking of hardware instability [3]. This is particularly important as CGMs become increasingly integrated into closed-loop insulin delivery systems, where distinguishing between biological rejection (biofouling) and malicious interference is critical for ensuring patient safety. Research by Park and Kim (2020) presented a data-driven approach for detecting hardware instability in CGM systems [3].

Conclusion

In conclusion, the forensic analysis of compromised medical devices, such as CGMs, is essential for ensuring the safety and efficacy of these devices. By combining digital, material, and data forensics, researchers and manufacturers can identify and address potential vulnerabilities, ultimately improving the reliability and performance of these critical medical devices. The integration of these approaches can help mitigate risks associated with CGM use and ensure the continued development of safe and effective diabetes management systems.