CVE-2020-25183 is a high-severity authentication bypass vulnerability affecting the Medtronic MyCareLink Smart Model 25000 Patient Reader, a medical device used by patients to communicate with their implantable cardiac devices via Bluetooth. The vulnerability arises from an improper authentication mechanism (CWE-287) between the patient reader and the Medtronic MyCareLink Smart mobile application. Specifically, the authentication protocol can be bypassed by an attacker who is within Bluetooth range, allowing them to impersonate the legitimate mobile app. This enables the attacker to establish a connection with the patient reader without proper credentials or authorization. Since the device communicates sensitive health data and potentially controls critical cardiac device functions, unauthorized access could lead to severe confidentiality, integrity, and availability impacts. The vulnerability affects all versions of the Smart Model 25000 Patient Reader and requires no prior authentication but does require proximity due to Bluetooth communication constraints. The CVSS v3.1 base score is 8.0, reflecting high impact on confidentiality, integrity, and availability, with low attack complexity and no privileges required, but user interaction is needed (e.g., the attacker must be within Bluetooth range). No patches have been publicly released as of the publication date, and no known exploits are reported in the wild. This vulnerability highlights the risks inherent in medical device wireless communications and the critical need for robust authentication protocols in healthcare IoT devices.

For European organizations, especially healthcare providers and medical device manufacturers, this vulnerability poses significant risks. Hospitals and clinics using Medtronic cardiac devices and associated patient readers could face unauthorized access to patient health data, violating GDPR and other data protection regulations. The integrity of device data could be compromised, potentially leading to incorrect medical decisions or device malfunctions. Availability could also be impacted if attackers disrupt communication between the patient reader and the implantable device, risking patient safety. The vulnerability could undermine patient trust in remote monitoring technologies and complicate compliance with medical device cybersecurity standards such as the EU MDR (Medical Device Regulation). Additionally, healthcare providers may face legal and reputational consequences if patient safety is compromised due to exploitation of this flaw. The requirement for Bluetooth proximity limits remote exploitation but does not eliminate risk in clinical or home environments where attackers could be physically close.

Given the lack of publicly available patches, European healthcare organizations should implement compensating controls immediately. These include: (1) Enforcing strict physical security controls to limit unauthorized individuals' proximity to patients using the affected devices; (2) Educating patients and caregivers about the risks of unauthorized Bluetooth connections and advising them to keep their smartphones and patient readers in secure environments; (3) Monitoring Bluetooth communications for anomalous pairing attempts or unauthorized devices; (4) Coordinating with Medtronic for firmware updates or patches and prioritizing deployment once available; (5) Incorporating network segmentation and endpoint security controls to detect and block suspicious activity related to medical device communications; (6) Reviewing and updating incident response plans to address potential exploitation scenarios; (7) Engaging with regulatory bodies to ensure compliance with medical device cybersecurity requirements and reporting obligations; and (8) Considering alternative or additional authentication mechanisms where possible to strengthen device pairing security.