BIOTRONIK Statement on the Medical Advisory and Safety Communication Regarding Medtronic’s Conexus Radio Frequency Telemetry Protocol Executive Summary:
The Department of Homeland Security and the US FDA have issued a Medical Advisory and Safety Communication respectively describing two types of cybersecurity vulnerabilities affecting multiple Medtronic devices that utilize the Conexus telemetry protocol. BIOTRONIK utilizes substantially different protocols for both the clinical and the home environment. Moreover, by design, the remote communication system via BIOTRONIK Home Monitoring® does not have the functionality to transmit or alter therapeutic commands to the implant.
Full Statement
On March 21, 2019, the Department of Homeland Security issued a Medical Advisory describing two types of cybersecurity vulnerabilities affecting multiple Medtronic devices that utilize the Conexus telemetry protocol. Correspondingly, the US Food and Drug Administration (FDA) issued a Safety Communication, similarly describing how the Conexus wireless telemetry protocol has cybersecurity vulnerabilities. The FDA has confirmed that if these vulnerabilities were to be exploited, they could allow an unauthorized individual (such as somebody other than the patient’s physician) to access and potentially manipulate an implantable device.
Both the Medical Advisory and the Safety Communication refer to vulnerabilities that affect Medtronic devices in the clinical environment and the home environment.
BIOTRONIK utilizes substantially different protocols for both, (1) the wireless communication used in a clinical environment for programming implantable devices by a physician’s programmer, and (2) the Home Monitoring communication used in a home environment for remote patient monitoring.
By design, the remote communication system via BIOTRONIK Home Monitoring® does not have the functionality to alter the therapeutic behavior of the implant.
It is only possible to program the implant wirelessly once a radio frequency (RF) connection has been activated using a specific bidirectional, near-field communication protocol. Technical implementation and the laws of physics limit the range of this communication to only a few meters. To activate an RF connection, the programmer wand must be placed on the patient’s chest a few centimeters above the implant. By design, commands cannot be transmitted to the implant without prior activation of the RF connection in this way.
Safety is paramount to the design and production of all BIOTRONIK devices and is at the center of everything we do. As part of its established cybersecurity processes, BIOTRONIK continuously analyzes external reports and assesses device security. BIOTRONIK takes these additional steps to ensure the safety and efficacy of all of its systems.
About BIOTRONIK:
At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases as well as chronic pain. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular, endovascular and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.
More Statements
-
Image
StatementBIOTRONIK Statement on CardioMessenger II Cybersecurity
CardioMessenger devices form an essential part of BIOTRONIK’s remote monitoring system, enabling the secure transmission of critical patient and device data to the treating physician. As the company that pioneered remote monitoring, we have taken cybersecurity design seriously since 2001. It is integrated into our quality management system, all relevant business processes and prioritized at every step of the product life cycle. Our cardiac implants do not accept programming modifications or commands via any form of long-distance communication. By design, it is technically impossible to
-
Image
StatementStatement on the Cybersecurity of BIOTRONIK Solutions Following WIRED Magazine’s Article on Vulnerabilities in Pacemaker Programmer Systems
On August 9, WIRED magazine reported that researchers discovered cybersecurity vulnerabilities in the way pacemaker programmers connected to the software delivery network of a specified manufacturer. The researchers claim that “digital code signing”—the cryptographic validation of the legitimacy and integrity of software—is lacking in the manufacturer’s infrastructure, allowing an attacker to potentially take control of device programmers through malicious updates that can subsequently be spread to implanted pacemakers. 1 None of BIOTRONIK’s devices, programmers or networks are affected by
-
Image
StatementBIOTRONIK Statement on the Publication ‘Security Testing of the Pacemaker Ecosystem’
The work ‘Security Testing of the Pacemaker Ecosystem’ was recently published as a master’s thesis, authored by Mr. Anders Been Wilhelmsen and Mr. Eivind Skjelmo Kristiansen. This publication investigates the state of cybersecurity of BIOTRONIK’s ICS 3000 – a programmer for BIOTRONIK implantable cardiac pacemakers, defibrillators and monitors that is used by healthcare professionals during the implantation procedure and follow-ups. ICS 3000 programmers were distributed between 2001 and 2012. In the publication, the authors report about several cybersecurity weaknesses such as: The central
-
Image
StatementBIOTRONIK Statement on “SweynTooth” Cybersecurity Vulnerabilities
The US Food and Drug Administration has issued a Safety Communication regarding a family of cybersecurity vulnerabilities known as SweynTooth, which may introduce risks for certain medical devices that use Bluetooth Low Energy (BLE) wireless communication technology. If exploited, these vulnerabilities can allow unauthorized users to potentially cause a device to stop working, stop it from working correctly and/or bypass security to access certain device functions. The FDA has said it is not aware of any confirmed adverse events related to these vulnerabilities although software to exploit
-
Image
StatementBIOTRONIK Statement on the Log4Shell Vulnerability
The discovery of a high-severity vulnerability known as Log4Shell was disclosed publicly on December 9, 2021, while a related lower-severity vulnerability was disclosed on December 14, 2021. These vulnerabilities are present in a software library used by many servers worldwide (see Background for details). In light of this recent discovery, BIOTRONIK has carefully analyzed all of its provided services. The analysis concluded that the conditions for exploitation of the Log4Shell vulnerability and the related CVE-2021-45046 and CVE-2021-45105 vulnerabilities do not exist in any of BIOTRONIK’s
-
Image
StatementBIOTRONIK Statement on the Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers
On October 11, the US Food and Drug Administration (FDA) issued a Safety Communication regarding cybersecurity updates affecting Medtronic implantable cardiac device programmers, based on an NCCIC Advisory. 1 According to the FDA’s communication, Medtronic is issuing a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the internet connection in two models of programmers used to download software from the manufacturer’s software distribution network (SDN). Successful exploitation of these vulnerabilities would allow an adversary to influence this
-
Image
BIOTRONIK Statement on the FDA’s Safety Communication “URGENT/11”
On October 1, the US Food and Drug Administration (FDA) issued a Safety Communication regarding a set of cybersecurity vulnerabilities, referred to as “Urgent/11” that — if exploited by a remote attacker — may introduce risks for medical devices and hospital networks. According to the communication: “These vulnerabilities may allow anyone to remotely take control of the medical device and change its function, cause denial of service, or cause information leaks or logical flaws, which may prevent device function.” These vulnerabilities exist in a third-party software component known as IPnet