Introduction to Cybersecurity in Connected Medical Devices

The integration of Continuous Glucose Monitors (CGMs) into Automated Insulin Delivery (AID) systems has created a complex Internet of Medical Things (IoMT) environment, where cybersecurity flaws can have direct and severe consequences for patient safety [1]. This environment is characterized by the interconnectedness of various devices and systems, which increases the potential attack surface and vulnerability to cyber threats.

Technical Overview of Vulnerabilities

The primary communication standard used in these systems, Bluetooth Low Energy (BLE), presents several vulnerabilities, including eavesdropping, Man-in-the-Middle (MitM) attacks, and jamming [2]. These vulnerabilities can be exploited by attackers to compromise the security and integrity of CGM data, potentially leading to inaccurate insulin dosing and other adverse health consequences.

Critical Risks and Attack Vectors

Critical risks associated with these vulnerabilities include integrity attacks, where spoofed high glucose data can trigger insulin overdoses, and replay attacks using old data packets [3]. These attacks can have severe consequences for patient safety, highlighting the need for robust cybersecurity measures to protect against such threats. Furthermore, the potential for lateral movement within the IoMT environment increases the risk of compromised devices being used as a vector for attacks on other connected devices.

Regulatory Framework and Guidance

In response to these risks, regulatory bodies such as the FDA have issued guidance documents, including the 2023 guidance on cybersecurity in medical devices, which mandates the use of Software Bill of Materials (SBOM) and post-market management plans [4]. This guidance aims to ensure that manufacturers prioritize cybersecurity in the design and development of connected medical devices, thereby reducing the risk of cyber attacks and protecting patient safety.

Industry Response and Best Practices

Manufacturers are adopting various security measures to mitigate these risks, including application-layer encryption (AES-CCM) and Out-of-Band (OOB) pairing via NFC to secure connections beyond standard BLE protocols [5]. The shift toward a Zero Trust architecture for life-critical devices is crucial for mitigating cybersecurity risks and ensuring patient safety. Additionally, implementing regular security updates and penetration testing can help identify and address vulnerabilities before they can be exploited.

Conclusion

In conclusion, cybersecurity in connected medical devices is a critical concern that requires attention from manufacturers, regulators, and patients. By understanding the technical aspects of vulnerabilities and risks associated with CGMs and AID systems, we can work towards developing more secure and reliable solutions for diabetes management. It is essential to continue monitoring the evolving landscape of cybersecurity threats and adapting our strategies to address these challenges and ensure the safety and efficacy of connected medical devices.