Incident: Pacemaker Vulnerabilities: Remote Control Threat to Patient Safety

Published Date: 2018-08-09

Postmortem Analysis
Timeline 1. The software failure incident involving vulnerabilities in Medtronic's pacemaker programmers and infrastructure happened approximately two years before the article was published on August 9, 2018 [74617]. Therefore, the incident likely occurred around August 2016.
System 1. Medtronic's Carelink 2090 pacemaker programmers and other relevant equipment 2. Medtronic's software delivery network 3. Medtronic's pacemaker programmers 4. Medtronic's insulin pump 5. Windows XP operating system [74617]
Responsible Organization 1. Researchers Billy Rios and Jonathan Butts of Whitescope and QED Secure Solutions discovered vulnerabilities in Medtronic's infrastructure that could be exploited to control implanted pacemakers remotely [74617]. 2. Medtronic, the pacemaker manufacturer, was responsible for the software failure incident due to the vulnerabilities in their software delivery network and pacemaker programmers [74617].
Impacted Organization 1. Pacemaker patients were impacted by the software failure incident reported in the article [74617].
Software Causes 1. Vulnerabilities in Medtronic's software delivery network, allowing for potential remote control of implanted pacemakers [74617]. 2. Lack of digital code signing in Medtronic's software updates, enabling the installation of tainted updates that could compromise pacemakers [74617]. 3. Exploitable vulnerabilities in Medtronic's pacemaker programmers, which connect to the software delivery network, leading to potential control by attackers [74617].
Non-software Causes 1. Lack of timely action by Medtronic in addressing vulnerabilities reported by researchers [74617]. 2. Insufficient assessment and response by Medtronic to potential safety risks [74617]. 3. Delay in evaluating and resolving reported vulnerabilities by Medtronic [74617].
Impacts 1. The software failure incident involving vulnerabilities in Medtronic's pacemaker programmers could potentially allow attackers to remotely control implanted pacemakers, deliver unnecessary shocks, or withhold necessary shocks, posing a significant risk to pacemaker patients [74617]. 2. The incident highlighted the lack of digital code signing in Medtronic's software delivery network, which could enable the installation of tainted updates and compromise the integrity of the system [74617]. 3. Researchers also discovered a cloud vulnerability in Medtronic's system that could allow attackers to remotely access and modify patients' pacemaker data, further emphasizing the security risks associated with the software failure incident [74617]. 4. The incident raised concerns about the potential exploitation of vulnerabilities in medical devices, including insulin pumps, which could lead to serious consequences such as remotely dosing patients with extra insulin [74617].
Preventions 1. Implementing robust authentication and integrity checks in the software delivery network to prevent unauthorized access and tampering [74617]. 2. Utilizing digital code signing to validate the legitimacy and integrity of software updates, thereby preventing the installation of tainted updates that could lead to control of the programmers and pacemakers [74617]. 3. Updating outdated operating systems like Windows XP to more secure and supported versions to reduce vulnerabilities [74617].
Fixes 1. Implementing digital code signing to validate the legitimacy and integrity of software updates [74617]. 2. Timely addressing and remediation of vulnerabilities identified by security researchers [74617]. 3. Enhancing authentication processes and integrity checks in the software delivery network [74617].
References 1. Researchers Billy Rios and Jonathan Butts of Whitescope and QED Secure Solutions [74617] 2. Department of Homeland Security [74617] 3. Food and Drug Administration [74617] 4. Medtronic [74617] 5. Minnesota Star Tribune [74617] 6. Medical supply distributors and third-party resellers [74617]

Software Taxonomy of Faults

Category Option Rationale
Recurring one_organization, multiple_organization (a) The software failure incident related to vulnerabilities in pacemaker programmers and implanted pacemakers has happened again within the same organization, Medtronic. Researchers Billy Rios and Jonathan Butts discovered a chain of vulnerabilities in Medtronic's infrastructure that could allow an attacker to control implanted pacemakers remotely, deliver unnecessary shocks, or withhold necessary shocks [74617]. (b) The incident involving vulnerabilities in medical devices has also occurred at other organizations. The researchers identified a separate vulnerability in a Medtronic insulin pump that could enable an attacker to remotely administer extra insulin to a patient [74617].
Phase (Design/Operation) design, operation (a) The software failure incident related to the design phase is evident in the vulnerabilities discovered by researchers in Medtronic's infrastructure that could allow an attacker to control implanted pacemakers remotely, deliver unnecessary shocks, or withhold necessary ones [74617]. The vulnerabilities were found in the software delivery network and the lack of "digital code signing" to validate the legitimacy and integrity of software updates, which could lead to the installation of tainted updates that compromise the security of the system [74617]. (b) The software failure incident related to the operation phase is highlighted by the potential cybersecurity vulnerabilities in Medtronic's products and systems, including the ability for an attacker to remotely access and modify patients' pacemaker data [74617]. Additionally, a separate vulnerability in a Medtronic insulin pump was discovered that could allow an attacker to remotely dose a patient with extra insulin, emphasizing the risks associated with the operation of these medical devices [74617].
Boundary (Internal/External) within_system, outside_system (a) The software failure incident reported in the articles is primarily within_system. The incident involved vulnerabilities in Medtronic's infrastructure that could be exploited to control implanted pacemakers remotely, deliver unnecessary shocks, or withhold necessary shocks, posing a significant risk to patients [74617]. Researchers discovered a chain of vulnerabilities within Medtronic's software delivery network and pacemaker programmers, which could be manipulated to install tainted updates and gain control over the devices [74617]. The lack of digital code signing in the software was highlighted as a critical issue that could have mitigated these vulnerabilities [74617]. (b) The software failure incident also involved outside_system factors as the vulnerabilities were discovered by external researchers, Billy Rios and Jonathan Butts, from security firms Whitescope and QED Secure Solutions, respectively [74617]. The Department of Homeland Security and the Food and Drug Administration also got involved in addressing the vulnerabilities in Medtronic's pacemaker programmers and related equipment [74617]. The incident highlighted the importance of external scrutiny and collaboration in identifying and addressing software vulnerabilities in critical medical devices.
Nature (Human/Non-human) non-human_actions, human_actions (a) The software failure incident in the article is primarily related to non-human actions. The incident involved vulnerabilities in Medtronic's infrastructure that could be exploited by attackers to remotely control implanted pacemakers, deliver unnecessary shocks, or withhold necessary shocks from patients [74617]. The vulnerabilities were discovered by researchers who created a proof of concept to demonstrate the existence of these vulnerabilities without directly breaking into the system [74617]. (b) Human actions also played a role in this software failure incident. The researchers, Billy Rios and Jonathan Butts, disclosed the vulnerabilities they found to Medtronic, but the company took 10 months to vet the submission and then opted not to take action to secure the network [74617]. Additionally, the lack of implementing digital code signing by Medtronic was highlighted as a human action that could have mitigated the vulnerabilities but was not done [74617].
Dimension (Hardware/Software) hardware, software (a) The software failure incident reported in the articles is primarily related to hardware vulnerabilities in implanted pacemakers manufactured by Medtronic. Researchers discovered a chain of vulnerabilities in Medtronic's infrastructure that could allow an attacker to control implanted pacemakers remotely, deliver unnecessary shocks, or withhold necessary shocks, posing a significant risk to patients [74617]. (b) The software failure incident also involves software vulnerabilities in Medtronic's infrastructure. Researchers identified issues in Medtronic's software delivery network, lack of digital code signing, and vulnerabilities in how pacemaker programmers connect to the software delivery network. These software vulnerabilities could be exploited to install tainted updates, control the programmers, and potentially affect implanted pacemakers [74617].
Objective (Malicious/Non-malicious) malicious (a) The software failure incident described in the article is malicious in nature. Researchers Billy Rios and Jonathan Butts discovered vulnerabilities in Medtronic's infrastructure that could allow an attacker to remotely control implanted pacemakers, deliver unnecessary shocks, or withhold necessary shocks, potentially causing harm to patients [74617]. The incident involved the installation of malware directly on implanted pacemakers, which could be exploited by attackers to manipulate the devices and endanger patients' lives. The researchers highlighted the risks associated with these vulnerabilities and expressed frustration over the time taken by Medtronic to address the issues, emphasizing the potential for altering therapy and causing harm [74617].
Intent (Poor/Accidental Decisions) poor_decisions (a) The intent of the software failure incident: - The software failure incident involving vulnerabilities in Medtronic's pacemaker programmers and software delivery network can be attributed to poor decisions made by the company. Researchers Billy Rios and Jonathan Butts discovered a chain of vulnerabilities that could allow an attacker to remotely control implanted pacemakers, deliver unnecessary shocks, or withhold necessary shocks from patients [74617]. - Despite being informed about these vulnerabilities, Medtronic took 10 months to vet the submission and then opted not to take action to secure the network, stating that the risks were controlled and the residual risk was acceptable. This delayed response and lack of action indicate poor decision-making on the part of Medtronic [74617].
Capability (Incompetence/Accidental) development_incompetence (a) The software failure incident in the article is related to development incompetence. Researchers Billy Rios and Jonathan Butts discovered vulnerabilities in Medtronic's infrastructure that could allow an attacker to control implanted pacemakers remotely, deliver unnecessary shocks, or withhold necessary shocks, potentially causing harm to patients [74617]. (b) The software failure incident is not related to accidental factors but rather to vulnerabilities introduced due to development incompetence and lack of proper security measures in the software and infrastructure of the pacemaker system.
Duration permanent, temporary (a) The software failure incident in the article is more of a permanent nature. Researchers Billy Rios and Jonathan Butts have been working on identifying vulnerabilities in Medtronic's infrastructure for nearly two years. Despite their efforts and disclosures, some issues remain unresolved, leaving patients susceptible to risks of altering therapy and potential harm [74617]. (b) The software failure incident can also be seen as temporary in some aspects. For example, Medtronic did resolve a cloud vulnerability found by the researchers, indicating a temporary fix for that specific issue. However, the overall concerns and vulnerabilities identified by Rios and Butts have persisted over time, suggesting a more permanent nature of the software failure incident [74617].
Behaviour omission, value, other (a) crash: The software failure incident described in the articles does not specifically mention a crash where the system loses state and does not perform any of its intended functions. (b) omission: The incident involves potential failures related to omission, such as the risk of altering therapy, delivering shocks patients don't need, or withholding necessary shocks from happening in pacemaker patients due to vulnerabilities in the software [74617]. (c) timing: The articles do not mention a failure related to timing, where the system performs its intended functions but at incorrect times. (d) value: The software failure incident includes failures related to the system performing its intended functions incorrectly, such as the risk of an attacker remotely controlling implanted pacemakers, delivering unnecessary shocks, or denying necessary shocks [74617]. (e) byzantine: The incident does not exhibit failures related to a byzantine behavior where the system behaves erroneously with inconsistent responses and interactions. (f) other: The other behavior observed in the software failure incident is the lack of proper security measures like digital code signing, which could prevent tainted updates from being installed and mitigate the vulnerabilities exploited by attackers [74617].

IoT System Layer

Layer Option Rationale
Perception network_communication, embedded_software The software failure incident discussed in the articles is related to the embedded software layer of the cyber physical system that failed. Researchers discovered vulnerabilities in Medtronic's infrastructure that an attacker could exploit to control implanted pacemakers remotely, deliver shocks patients don't need or withhold ones they do, and cause real harm. The vulnerabilities were found in Medtronic's software delivery network, which brings updates to supporting equipment like home monitors and pacemaker programmers. Additionally, the attack capitalized on a lack of "digital code signing" to install tainted updates that let an attacker control the programmers and spread to implanted pacemakers. The programmers running on the Windows XP operating system were also highlighted as a vulnerability. These issues point to failures introduced by errors in the embedded software layer of the cyber physical system [74617].
Communication link_level, connectivity_level The software failure incident reported in the articles is related to the communication layer of the cyber physical system that failed at both the link_level and connectivity_level. 1. At the link_level: The incident involved vulnerabilities in how pacemaker programmers connect to Medtronic's software delivery network. Researchers discovered a series of vulnerabilities in the communication between the programmers and the network, which allowed for the installation of tainted updates that could be used to control the programmers and potentially spread to implanted pacemakers [74617]. 2. At the connectivity_level: The failure also involved a cloud vulnerability that allowed an attacker to remotely access and modify patients' pacemaker data. Additionally, there was a separate vulnerability in a Medtronic insulin pump that could enable an attacker to remotely dose a patient with extra insulin. These vulnerabilities highlight issues at the network level that could be exploited to manipulate medical devices remotely [74617].
Application TRUE The software failure incident described in the article [74617] was related to vulnerabilities in the software delivery network and pacemaker programmers used in Medtronic's infrastructure. Researchers discovered a chain of vulnerabilities that could allow an attacker to control implanted pacemakers remotely, deliver shocks patients don't need, or withhold necessary shocks. The vulnerabilities included issues with authentication, lack of integrity checks, and the absence of digital code signing to validate software legitimacy and integrity. These vulnerabilities were present in the software delivery network and the pacemaker programmers, which are part of the application layer of the cyber physical system that failed due to bugs and security flaws.

Other Details

Category Option Rationale
Consequence death, harm, theoretical_consequence (a) death: The software failure incident involving vulnerabilities in Medtronic's pacemaker programmers could potentially lead to altering therapy, delivering shocks patients don't need, or withholding necessary shocks, which could result in real harm or even death for pacemaker patients [74617].
Domain health (a) The failed system was related to the health industry, specifically affecting pacemaker patients. Researchers discovered vulnerabilities in Medtronic's infrastructure that could allow attackers to remotely control implanted pacemakers, deliver unnecessary shocks, or withhold necessary shocks, posing a significant risk to patients' lives [74617]. The incident involved software vulnerabilities in Medtronic's pacemaker programmers and other relevant equipment used in healthcare settings [74617]. The vulnerabilities could potentially lead to altering therapy, causing harm, and even remotely controlling pacemakers [74617]. The software failure incident highlighted the importance of addressing cybersecurity risks in medical devices to ensure patient safety [74617].

Sources

Back to List