Published Date: 2019-07-16
| Postmortem Analysis | |
|---|---|
| Timeline | 1. The software failure incident involving vulnerabilities in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines, which led to the creation of a malicious Android app by researchers, was first raised in August 2018 at the Black Hat security conference in Las Vegas [87134]. 2. The article discussing the incident was published on July 16, 2019 [87134]. Estimation: The incident occurred in August 2018. |
| System | 1. Medtronic's MiniMed and MiniMed Paradigm insulin pump lines [Article 87134] |
| Responsible Organization | 1. Researchers Billy Rios and Jonathan Butts from QED Security Solutions were responsible for causing the software failure incident by discovering vulnerabilities in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines and developing an Android app to exploit these flaws [Article 87134]. |
| Impacted Organization | 1. Patients using Medtronic's MiniMed and MiniMed Paradigm insulin pump lines were impacted by the software failure incident [Article 87134]. |
| Software Causes | 1. Vulnerabilities in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines allowed attackers to remotely target the pumps to withhold insulin or trigger a potentially lethal overdose [Article 87134]. 2. Lack of encryption in the communication between the remote controls and the pumps made it relatively easy for attackers to capture and manipulate the signals [Article 87134]. 3. Inadequate protection mechanisms in the affected insulin pump models, making it impossible to patch the flaws or completely disable the remote feature [Article 87134]. 4. The presence of vulnerabilities in the older MiniMed pumps that were specifically sought after by a group of diabetes patients known as "loopers" for biohacking purposes [Article 87134]. |
| Non-software Causes | 1. Lack of encryption in the communication between the remote controls and the insulin pumps [Article 87134]. 2. Vulnerabilities in the radio frequencies used by the remote controls and pumps [Article 87134]. 3. Inability to patch the flaws in the affected insulin pump models or disable the remote feature [Article 87134]. 4. Difficulty in coordinating a voluntary recall on an international level due to regulatory challenges [Article 87134]. |
| Impacts | 1. The software failure incident involving vulnerabilities in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines had the potential to allow attackers to remotely withhold insulin from patients or trigger potentially lethal overdoses, leading to serious health risks [Article 87134]. 2. The failure to address the vulnerabilities in a timely manner resulted in researchers resorting to drastic measures, such as creating an Android app that could exploit the flaws to demonstrate the severity of the threat, ultimately leading to a full replacement program being implemented [Article 87134]. 3. Patients using the affected insulin pumps faced the risk of unauthorized insulin dosing, potentially leading to harmful effects on their health, as attackers could override a patient's attempts to administer insulin or repeatedly give them doses of insulin [Article 87134]. 4. The incident highlighted the lack of encryption in the communication between the remote controls and the pumps, making it relatively easy for attackers to reverse engineer the signal and manipulate the devices, posing a significant security and safety concern for patients [Article 87134]. 5. The failure to address the cybersecurity issues promptly resulted in a voluntary recall program being initiated by Medtronic, impacting roughly 4,000 vulnerable pumps in the United States and raising concerns about the security of similar medical devices worldwide [Article 87134]. |
| Preventions | 1. Implementing encryption for communications between the insulin pumps and remote controls could have prevented the vulnerability exploited by attackers [Article 87134]. 2. Conducting thorough security assessments and addressing vulnerabilities promptly after being made aware of them could have prevented the software failure incident [Article 87134]. 3. Providing a mechanism for easily updating or replacing vulnerable devices with more secure models could have prevented the exploitation of the software flaws [Article 87134]. |
| Fixes | 1. A full replacement program for the affected insulin pumps ultimately went into effect at the end of June [Article 87134]. 2. Medtronic announced a voluntary recall program for the vulnerable insulin pump models a week after the research group demonstrated its proof of concept app to FDA officials in mid-June [Article 87134]. 3. Medtronic has released newer pump models that communicate in completely different ways to address the cybersecurity concerns [Article 87134]. 4. Medtronic and regulators acknowledged the flaws in the affected insulin pump models and initiated a voluntary recall program to replace the vulnerable pumps [Article 87134]. | References | 1. Researchers Billy Rios and Jonathan Butts from QED Security Solutions [Article 87134] 2. Food and Drug Administration (FDA) [Article 87134] 3. Department of Homeland Security [Article 87134] 4. Medtronic [Article 87134] |
| Category | Option | Rationale |
|---|---|---|
| Recurring | one_organization | (a) The software failure incident related to vulnerabilities in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines has happened again within the same organization. The incident involved disturbing vulnerabilities that could allow attackers to remotely target the pumps to withhold insulin or trigger a potentially lethal overdose. Despite being aware of the vulnerabilities for years, Medtronic had not implemented a fix until researchers developed a proof of concept app that could exploit the flaws [87134]. (b) The software failure incident involving vulnerabilities in Medtronic's insulin pumps is not explicitly mentioned to have occurred at other organizations or with their products and services in the provided article. |
| Phase (Design/Operation) | design, operation | (a) The software failure incident related to the design phase is evident in the vulnerabilities discovered by researchers Billy Rios and Jonathan Butts in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines. The attackers could remotely target these pumps due to flaws in the design, allowing them to withhold insulin from patients or trigger potentially lethal overdoses. Despite the awareness raised by the researchers and warnings from regulatory bodies, Medtronic and regulators failed to implement a fix, leading the researchers to develop an Android app that could exploit the vulnerabilities [87134]. (b) The software failure incident related to the operation phase is highlighted by the ease with which attackers could exploit the vulnerabilities in the MiniMed pumps. The communication between the remote controls and the pumps was not encrypted, making it relatively easy for hackers to reverse engineer the signal and send malicious commands to the pumps. This flaw in the operation of the system allowed attackers to remotely control the pumps through a smartphone app, potentially causing harm to patients by giving them incorrect doses of insulin or overriding their attempts to administer insulin [87134]. |
| Boundary (Internal/External) | within_system | (a) The software failure incident related to the vulnerabilities in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines can be categorized as within_system. The vulnerabilities that allowed attackers to remotely target the pumps and potentially harm patients were inherent to the design and implementation of the devices themselves. Researchers discovered flaws in the communication protocols and encryption mechanisms of the pumps, which enabled them to create a malicious app that could control the pumps [87134]. |
| Nature (Human/Non-human) | non-human_actions, human_actions | (a) The software failure incident in the article was primarily due to non-human actions. Researchers Billy Rios and Jonathan Butts discovered vulnerabilities in Medtronic's insulin pumps that could be exploited remotely to withhold insulin or trigger a lethal overdose. They built an Android app to demonstrate the flaws, which ultimately led to a full replacement program for the affected pumps [Article 87134]. (b) However, human actions also played a role in this software failure incident. Despite the researchers' efforts to raise awareness and the warnings issued by regulatory bodies, Medtronic and regulators initially did not present a plan to fix or replace the vulnerable devices. It was only after the researchers demonstrated their proof of concept app to FDA officials that Medtronic announced a voluntary recall program [Article 87134]. |
| Dimension (Hardware/Software) | hardware, software | (a) The software failure incident related to hardware: - The vulnerabilities in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines were discovered by researchers Billy Rios and Jonathan Butts [Article 87134]. - The communication between the remote controls and the pumps was not encrypted, making it relatively easy for attackers to capture and manipulate the signals [Article 87134]. - An attacker could use readily available software to program a radio that masquerades as a legitimate MiniMed remote, enabling them to control the pump remotely [Article 87134]. - The attack required knowledge of the pump's serial number to direct commands to the right device, similar to needing a phone number to make a call [Article 87134]. - The attack was limited to a certain range but could be extended with signal-boosting equipment [Article 87134]. (b) The software failure incident related to software: - The vulnerabilities in the insulin pumps allowed attackers to remotely control the pumps through a smartphone app developed by the researchers [Article 87134]. - The flaws in the affected insulin pump models could not be patched, leading to the need for a full replacement program [Article 87134]. - Medtronic and regulators acknowledged that there was no way to patch the software flaws in the affected models or to completely disable the remote feature [Article 87134]. - The vulnerabilities in the older MiniMed pumps were exploited by a group of diabetes patients known as "loopers" to create an artificial pancreas through a biohack [Article 87134]. |
| Objective (Malicious/Non-malicious) | malicious | (a) The software failure incident described in the article is malicious in nature. Researchers discovered vulnerabilities in Medtronic's insulin pumps that could be exploited by attackers to remotely withhold insulin from patients or trigger potentially lethal overdoses. The researchers even went as far as building an Android app that could use these flaws to harm individuals [87134]. The incident involved intentional actions to exploit the vulnerabilities for harmful purposes. |
| Intent (Poor/Accidental Decisions) | poor_decisions | (a) The intent of the software failure incident was due to poor decisions made by Medtronic and regulators. Researchers Billy Rios and Jonathan Butts discovered vulnerabilities in Medtronic's insulin pumps, which could be exploited by attackers to harm patients. Despite being aware of the issue for years, Medtronic and regulators failed to implement a fix or replacement program until drastic measures were taken by the researchers to demonstrate the severity of the threat [Article 87134]. This delay in addressing the vulnerabilities and the lack of proactive measures to protect patients can be attributed to poor decisions made by the involved parties. |
| Capability (Incompetence/Accidental) | accidental | (a) The software failure incident in the article was not due to development incompetence but rather due to vulnerabilities in the Medtronic MiniMed and MiniMed Paradigm insulin pump lines that were discovered by researchers Billy Rios and Jonathan Butts [Article 87134]. (b) The software failure incident in the article was accidental in nature as the vulnerabilities in the insulin pumps were not intentionally created by the developers but were discovered by the researchers who then developed an Android app to demonstrate the potential risks associated with these vulnerabilities [Article 87134]. |
| Duration | permanent, temporary | The software failure incident related to the vulnerabilities in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines can be considered as both permanent and temporary. Permanent: - The vulnerabilities in the insulin pump lines were discovered by researchers Billy Rios and Jonathan Butts two years ago, and despite months of negotiations with Medtronic and regulators, no fix was implemented [Article 87134]. - Medtronic and regulators acknowledged that there was no way to patch the flaws on the affected insulin pump models or completely disable the remote feature [Article 87134]. Temporary: - A full replacement program for the vulnerable pumps went into effect at the end of June after the researchers demonstrated their proof of concept app to FDA officials in mid-June [Article 87134]. - Medtronic announced a voluntary recall program a week after the researchers demonstrated their app to FDA officials [Article 87134]. These points indicate that the software failure incident had both permanent aspects in terms of the inherent vulnerabilities that could not be patched and temporary aspects in terms of the eventual recall and replacement program that was initiated. |
| Behaviour | crash, omission, value, other | (a) crash: The software failure incident in the article can be categorized as a crash. The vulnerabilities discovered in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines allowed attackers to remotely target the pumps to withhold insulin from patients or trigger a potentially lethal overdose. The researchers even went to the extent of building an Android app that could exploit these flaws to harm individuals [Article 87134]. (b) omission: The software failure incident can also be categorized as an omission. The vulnerabilities in the insulin pumps allowed attackers to override a patient's attempts to give themselves insulin or repeatedly give a patient doses of insulin without their consent. This omission of control from the patients' side led to potential harm [Article 87134]. (c) timing: The software failure incident does not align with a timing failure. The issue was not related to the system performing its intended functions too late or too early. Instead, the vulnerabilities allowed attackers to manipulate the system to harm patients [Article 87134]. (d) value: The software failure incident can be categorized as a value failure. The vulnerabilities in the insulin pumps enabled attackers to send commands that the pumps would trust and execute, leading to incorrect administration of insulin doses and potentially harmful outcomes for the patients [Article 87134]. (e) byzantine: The software failure incident does not align with a byzantine failure. The system did not exhibit inconsistent responses or interactions; rather, the vulnerabilities allowed for consistent exploitation by attackers to control the insulin pumps [Article 87134]. (f) other: The software failure incident can be categorized as a security vulnerability. The flaws in the insulin pumps' design and communication protocols allowed for unauthorized access and control by attackers, leading to potential harm to patients. This security vulnerability highlights the importance of robust security measures in medical devices to prevent malicious exploitation [Article 87134]. |
| Layer | Option | Rationale |
|---|---|---|
| Perception | network_communication, embedded_software | (a) sensor: The software failure incident related to vulnerabilities in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines was not directly attributed to sensor errors but rather to flaws in the communication between the remote controls and the pumps. The vulnerability allowed attackers to manipulate the pumps remotely without the need for physical access or sensor manipulation [87134]. (b) actuator: The failure was not directly linked to actuator errors but rather to the lack of encryption in the communication between the remote controls and the insulin pumps. Attackers could exploit this vulnerability to send commands to the pumps that they would trust and execute, essentially acting as a malicious remote control [87134]. (c) processing_unit: The software failure incident did not involve errors in the processing unit of the insulin pumps but rather focused on the lack of encryption and security measures in the communication protocols between the pumps and the remote controls. This allowed attackers to manipulate the pumps remotely using readily available software and a smartphone app [87134]. (d) network_communication: The failure in this incident was directly related to vulnerabilities in the network communication between the remote controls and the insulin pumps. The lack of encryption and security in the communication protocols enabled attackers to send malicious commands to the pumps, exploiting the communication channel to control the devices remotely [87134]. (e) embedded_software: The software failure incident was attributed to vulnerabilities in the embedded software of the insulin pumps, specifically in the communication protocols between the pumps and the remote controls. The lack of encryption and security measures in the embedded software allowed attackers to manipulate the pumps remotely, posing serious risks to patients using the devices [87134]. |
| Communication | link_level | The software failure incident related to the communication layer of the cyber physical system that failed was at the link_level. Researchers discovered vulnerabilities in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines that allowed attackers to remotely target the pumps and manipulate their communication with the remote controls [87134]. The vulnerabilities were related to the radio frequencies on which the remote and pump communicated, lack of encryption in the communications, and the ability to reverse engineer the signal to send malicious commands to the pumps. This indicates a failure at the link_level of the communication layer in the cyber physical system. |
| Application | TRUE | [87134] The software failure incident described in the article is related to the application layer of the cyber physical system. The failure was due to vulnerabilities in the Medtronic MiniMed and MiniMed Paradigm insulin pump lines that allowed attackers to remotely target the pumps to withhold insulin or trigger potentially lethal overdoses. The vulnerabilities were exploited through an Android app developed by researchers, indicating that the failure was a result of bugs and security flaws in the application layer of the insulin pumps. |
| Category | Option | Rationale |
|---|---|---|
| Consequence | death, harm, theoretical_consequence | (a) death: The software failure incident involving vulnerabilities in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines had the potential to cause death. Researchers developed an Android app that could exploit the flaws in the pumps to withhold insulin from patients or trigger a potentially lethal overdose, highlighting the serious risk to patients' lives [Article 87134]. The researchers created a "killer app" that could be used to harm or even kill individuals by manipulating the insulin pumps remotely [Article 87134]. (b) harm: The software failure incident could have resulted in physical harm to individuals. Attackers could use the vulnerabilities in the insulin pumps to give patients doses of insulin repeatedly or override a patient's attempts to administer insulin, potentially causing harm to the patients [Article 87134]. (h) theoretical_consequence: There were potential consequences discussed regarding the software failure incident that did not occur. The vulnerabilities in the insulin pumps could have led to serious harm or even death, but the full extent of these consequences was theoretical as the researchers demonstrated the risks through a proof of concept app rather than actual incidents of harm or fatalities [Article 87134]. |
| Domain | health | (a) The failed system in the incident was related to the health industry, specifically affecting medical devices used by diabetes patients. The vulnerabilities discovered in Medtronic's MiniMed and MiniMed Paradigm insulin pump lines allowed attackers to remotely target the pumps to withhold insulin from patients or trigger potentially lethal overdoses [Article 87134]. The incident highlighted the critical importance of cybersecurity in the healthcare sector to ensure patient safety and prevent malicious attacks on medical devices. |
Article ID: 87134