CVE-2019-10964 is a high-severity vulnerability affecting all versions of the Medtronic MiniMed 508 insulin pump. These pumps communicate wirelessly via RF with other devices such as blood glucose meters, glucose sensor transmitters, and CareLink USB devices. The core issue lies in the wireless communication protocol, which lacks proper authentication and authorization mechanisms. This deficiency allows an attacker with adjacent physical proximity to the pump to intercept, inject, replay, or modify the data transmitted between the pump and its associated devices. Exploiting this vulnerability could enable an attacker to alter pump settings and control insulin delivery, potentially causing serious harm to the patient. The vulnerability is classified under CWE-284 (Improper Access Control), indicating insufficient enforcement of access restrictions. The CVSS 3.1 base score is 7.1, reflecting a high severity due to the potential for high impact on integrity and availability, although the attack vector is adjacent network and requires high attack complexity with no privileges or user interaction needed. No patches are currently listed, and there are no known exploits in the wild, but the risk remains significant given the critical nature of insulin pump operation and patient safety implications.

For European organizations, particularly healthcare providers and medical device suppliers, this vulnerability poses a significant patient safety risk. Successful exploitation could lead to unauthorized manipulation of insulin delivery, potentially causing hypoglycemia or hyperglycemia, which can be life-threatening. Healthcare institutions using these devices may face operational disruptions, legal liabilities, and reputational damage. Additionally, the vulnerability could undermine trust in medical device cybersecurity, prompting regulatory scrutiny under EU medical device regulations and GDPR if patient data integrity or availability is compromised. The need for physical proximity limits large-scale remote exploitation but does not eliminate risk in clinical or home care environments where attackers could gain adjacent access. The impact extends beyond individual patients to healthcare infrastructure resilience and compliance with European health and safety standards.

Given the absence of official patches, European healthcare providers should implement strict physical security controls to prevent unauthorized access to patients using MiniMed 508 pumps. This includes monitoring and restricting access in clinical settings and educating patients and caregivers about the risks of nearby malicious devices. Network segmentation and RF monitoring could help detect anomalous wireless activity around these devices. Healthcare organizations should coordinate with Medtronic for firmware updates or device replacements and consider transitioning to newer insulin pump models with improved security features. Incident response plans should include procedures for suspected device tampering. Additionally, regulatory bodies should be engaged to enforce reporting and remediation requirements. Regular risk assessments and cybersecurity training for medical staff are critical to mitigate exploitation risks.