Incident: Vulnerabilities in Medical Devices Pose Serious Security Risks

Published Date: 2014-04-25

Postmortem Analysis
Timeline 1. The software failure incident happened in 2012 as mentioned in the article [25689]. (Note: The incident timeline was directly mentioned in the article, so there was no need for estimation.)
System 1. Drug infusion pumps 2. Bluetooth-enabled defibrillators 3. X-rays 4. Temperature settings on refrigerators 5. Digital medical records 6. Insulin pumps 7. Hardcoded passwords in medical devices 8. Surgery robots 9. Implantable cardiovascular defibrillators (ICDs) 10. CT scans [25689]
Responsible Organization 1. Lack of authentication, weak passwords, and hardcoded vendor passwords in medical devices were responsible for causing the software failure incident [25689].
Impacted Organization 1. Patients receiving medical treatment at the Midwest health care facilities [25689]
Software Causes 1. Lack of authentication to access or manipulate the medical equipment [25689] 2. Weak passwords or default and hardcoded vendor passwords like "admin" or "1234" [25689] 3. Embedded web servers and administrative interfaces that make it easy to identify and manipulate devices once an attacker finds them on a network [25689]
Non-software Causes 1. Lack of authentication to access or manipulate the equipment [25689] 2. Weak passwords or default and hardcoded vendor passwords like "admin" or "1234" [25689] 3. Embedded web servers and administrative interfaces that make it easy to identify and manipulate devices once an attacker finds them on a network [25689]
Impacts 1. Drug infusion pumps could be remotely manipulated to change the dosage doled out to patients, potentially leading to incorrect medication dosages and patient harm [25689]. 2. Bluetooth-enabled defibrillators could be manipulated to deliver random shocks to a patient's heart or prevent a medically needed shock from occurring, posing a serious risk to patient safety [25689]. 3. X-rays and medical records could be accessed by unauthorized individuals, leading to potential privacy breaches and misdiagnoses [25689]. 4. Temperature settings on refrigerators storing blood and drugs could be reset, causing spoilage of critical medical supplies [25689]. 5. Digital medical records could be altered, potentially causing physicians to misdiagnose, prescribe the wrong drugs, or administer unwarranted care [25689]. 6. Vulnerabilities in various medical devices, including infusion pumps, defibrillators, CT scans, and surgery robots, could allow for unauthorized access, manipulation, and potential harm to patients [25689].
Preventions 1. Implementing strong authentication mechanisms and encryption protocols for medical devices to prevent unauthorized access and manipulation [25689]. 2. Regularly updating and patching software on medical devices to address security vulnerabilities [25689]. 3. Conducting thorough security assessments and testing on all medical equipment to identify and mitigate potential risks [25689]. 4. Educating healthcare organizations about the high risks associated with vulnerable devices and the importance of prioritizing security measures [25689]. 5. Enforcing stricter regulations and guidelines for vendors to ensure that medical devices meet cybersecurity standards before being sold to customers [25689].
Fixes 1. Implementing strong authentication mechanisms to access and manipulate medical equipment, such as requiring unique and complex passwords for each device [25689]. 2. Ensuring encryption of communication between devices to prevent unauthorized access and data manipulation [25689]. 3. Regularly updating and patching software on medical devices to address security vulnerabilities [25689]. 4. Conducting thorough security assessments and testing on all medical equipment to identify and mitigate risks [25689]. 5. Enforcing FDA guidelines for medical devices that include cybersecurity clauses to allow for post-market device patching without requiring recertification [25689].
References 1. Scott Erven and his team [Article 25689]

Software Taxonomy of Faults

Category Option Rationale
Recurring one_organization, multiple_organization (a) The software failure incident related to vulnerabilities in medical equipment, such as drug infusion pumps, defibrillators, X-rays, and digital medical records, has happened at Essentia Health, a large chain of Midwest health care facilities where Scott Erven works as the head of information security [25689]. (b) The software failure incident involving security vulnerabilities in medical devices has been a widespread issue affecting multiple organizations in the healthcare industry. The article mentions that the health care industry is just now waking up to the security problems with medical equipment, and that the problems exist because medical equipment has only ever been regulated for reliability, effectiveness, and safety, not for security. The FDA and DHS issued a notice to the health care industry about problems with hard-coded passwords in medical devices after two researchers found them in about 300 medical devices, including ventilators, pumps, defibrillators, and surgical and anesthesia devices [25689].
Phase (Design/Operation) design, operation (a) The software failure incident related to the design phase can be seen in the article where it mentions security problems found in various medical equipment used at health care facilities. The vulnerabilities included lack of authentication, weak passwords, default and hardcoded vendor passwords, and embedded web servers that made it easy for attackers to access and manipulate devices once found on a network [25689]. (b) The software failure incident related to the operation phase is evident in the article where it discusses how hackers could gain access to vulnerable medical devices by infecting an employee's computer via a phishing attack, exploring internal networks to find vulnerable systems, or simply plugging a laptop into the network. The article highlights that once attackers gain a foothold into the network, they can easily scan and find vulnerable devices, indicating a failure in the operation or misuse of the system [25689].
Boundary (Internal/External) within_system, outside_system (a) within_system: The software failure incident described in the articles is primarily within the system. The vulnerabilities and security issues identified in medical equipment such as drug infusion pumps, defibrillators, X-rays, refrigerators, digital medical records, and other devices were due to factors originating from within the system itself. These issues include lack of authentication, weak passwords, default and hardcoded vendor passwords, unencrypted communication between devices, and vulnerable web interfaces allowing unauthorized access and manipulation of critical equipment [25689]. (b) outside_system: The software failure incident also involves contributing factors that originate from outside the system. Hackers could potentially gain access to the vulnerable medical devices by infecting an employee's computer via phishing attacks, exploring internal networks to find vulnerable systems, or physically plugging into the hospital network. The interconnected nature of the devices and their accessibility via internal networks accessible via the internet make them susceptible to attacks from external sources [25689].
Nature (Human/Non-human) non-human_actions, human_actions (a) The software failure incident occurring due to non-human actions: The article discusses various vulnerabilities in medical equipment used at health care facilities, such as drug infusion pumps, defibrillators, X-rays, refrigerators, and digital medical records. These vulnerabilities include lack of authentication, weak passwords, default and hardcoded vendor passwords, and embedded web servers that make it easy for attackers to access and manipulate the devices without human participation [25689]. (b) The software failure incident occurring due to human actions: The article mentions that some of the vulnerabilities in medical devices were discovered after a security consultancy performing a penetration test on an Essentia Health network found devices with security issues. Additionally, previous research by security experts highlighted problems with insulin pumps, defibrillators, and hardcoded passwords in medical devices, prompting the health care facility to conduct an extensive evaluation of all its equipment. This indicates that human actions, such as inadequate security testing and oversight, contributed to the software failure incident [25689].
Dimension (Hardware/Software) hardware, software (a) The software failure incident related to hardware: - The article discusses various vulnerabilities in medical equipment used in health care facilities, such as drug infusion pumps, defibrillators, X-rays, refrigerators, digital medical records, and surgery robots, which can be remotely manipulated due to security issues originating in the hardware components of these devices [25689]. (b) The software failure incident related to software: - The article highlights that some of the vulnerabilities in the medical devices were due to software-related issues, such as lack of authentication, weak passwords, default and hardcoded vendor passwords, and unencrypted communication between devices, making it easy for attackers to manipulate the equipment once they find them on a network [25689].
Objective (Malicious/Non-malicious) malicious, non-malicious (a) The software failure incident described in the article is malicious in nature. The incident involved vulnerabilities in various medical devices such as drug infusion pumps, defibrillators, X-rays, refrigerators, digital medical records, and more that could be remotely manipulated by attackers to change dosages, deliver random shocks, alter medical records, reset configurations, and cause harm to patients. The vulnerabilities included lack of authentication, weak passwords, hardcoded passwords, and unencrypted communication between devices, making it easy for attackers to access and manipulate the equipment [25689]. Additionally, the article mentions the risks associated with medical equipment due to the lack of security measures and the need for vendors to prioritize security in their devices to prevent such malicious attacks. (b) The software failure incident is also non-malicious in nature as it highlights the security vulnerabilities present in medical devices that were not intentionally introduced to harm the system. These vulnerabilities were discovered during a security evaluation conducted by Scott Erven and his team at Essentia Health, revealing issues with authentication, weak passwords, unencrypted communication, and lack of security measures in various medical equipment used in healthcare facilities. The incident sheds light on the lack of focus on security in the design and implementation of medical devices, emphasizing the need for better security practices and measures to protect patient data and ensure the safety of medical equipment [25689].
Intent (Poor/Accidental Decisions) poor_decisions (a) The intent of the software failure incident related to poor_decisions: - The software failure incident in the healthcare facilities was primarily due to poor decisions related to the lack of security measures in medical equipment. Scott Erven and his team found numerous vulnerabilities in devices such as drug infusion pumps, defibrillators, X-rays, refrigerators, and digital medical records, which could be remotely manipulated by attackers [25689]. - The vulnerabilities stemmed from common security holes like lack of authentication, weak passwords, default and hardcoded vendor passwords, and easily accessible web servers and administrative interfaces on the devices [25689]. - The healthcare industry's lack of awareness and the absence of security programs from vendors were highlighted as contributing factors to the security risks associated with medical equipment [25689]. - The FDA and DHS issued a notice to the health care industry about problems with hard-coded passwords in medical devices after researchers found them in about 300 devices, emphasizing the need for vendors to secure devices with encryption and authentication [25689]. (b) The intent of the software failure incident related to accidental_decisions: - The software failure incident was not primarily due to accidental decisions or unintended mistakes. Instead, it was a result of systemic issues related to the lack of security measures and vulnerabilities in medical devices [25689]. - The vulnerabilities found in the devices were not accidental but rather a consequence of poor security practices, lack of encryption, weak passwords, and inadequate authentication mechanisms [25689]. - The incident highlighted the need for a shift in focus towards assessing risks and implementing proper security measures in healthcare organizations, indicating a lack of intentional security measures rather than accidental oversights [25689].
Capability (Incompetence/Accidental) development_incompetence, accidental (a) The software failure incident related to development incompetence is evident in the article. The vulnerabilities in medical equipment, such as drug infusion pumps, defibrillators, X-rays, and digital medical records, were found to have common security holes like lack of authentication, weak passwords, and hardcoded vendor passwords [25689]. These issues indicate a lack of professional competence in ensuring the security of these critical devices. Additionally, the article highlights that the health care industry is just waking up to the security problems with medical equipment, suggesting a historical lack of emphasis on security in the development process [25689]. (b) The software failure incident related to accidental factors is also present in the article. The vulnerabilities discovered in various medical devices, including infusion pumps, defibrillators, and CT scans, were not intentional design choices but rather accidental oversights in the development process [25689]. The article mentions that the health care industry is now realizing the security problems with medical equipment, indicating that these issues were not deliberately introduced but rather overlooked due to a lack of focus on security during development [25689].
Duration temporary The software failure incident described in the article is more aligned with a temporary failure rather than a permanent one. The vulnerabilities and security issues identified in the medical equipment were due to specific contributing factors such as lack of authentication, weak passwords, default and hardcoded vendor passwords, and unencrypted communication between devices [25689]. These factors led to the potential for remote manipulation of devices, altering of medical records, changing dosage levels, and other critical issues. The incident is temporary in nature as it is caused by specific security flaws that can be addressed and fixed by implementing proper security measures and protocols.
Behaviour crash, omission, value, other (a) crash: The article mentions instances where devices such as drug infusion pumps, defibrillators, X-rays, and temperature settings on refrigerators storing blood and drugs could be remotely manipulated to change settings, wipe out configuration settings, or crash during emergencies [25689]. (b) omission: The software failure incident includes instances where digital medical records could be altered to cause misdiagnosis, prescription errors, or unwarranted care, leading to the omission of correct information in patient records [25689]. (c) timing: The article does not specifically mention any software failure incident related to timing issues. (d) value: The incident involves software vulnerabilities that could lead to incorrect drug dosage levels being administered through infusion pumps, alteration of radiation exposure limits in CT scans, and manipulation of defibrillators to deliver random shocks or prevent necessary shocks, resulting in incorrect value being delivered by the devices [25689]. (e) byzantine: The software failure incident does not exhibit behaviors of inconsistent responses or interactions. (f) other: The software failure incident also includes vulnerabilities in medical devices due to lack of authentication, weak passwords, default and hardcoded vendor passwords, and embedded web servers that make it easy for attackers to access and manipulate the devices [25689].

IoT System Layer

Layer Option Rationale
Perception sensor, actuator, processing_unit, network_communication, embedded_software (a) sensor: The article mentions vulnerabilities in medical equipment such as drug infusion pumps, defibrillators, X-rays, and refrigerators storing blood and drugs. These vulnerabilities could allow attackers to remotely manipulate the dosage of drugs, deliver random shocks, access X-rays, and reset temperature settings, indicating failures related to the sensor layer of the cyber-physical system [25689]. (b) actuator: The article discusses vulnerabilities in defibrillators that can be manipulated to deliver random shocks or prevent medically needed shocks, as well as infusion pumps with web administration interfaces for nurses to change drug dosage levels. These vulnerabilities point to failures related to the actuator layer of the cyber-physical system [25689]. (c) processing_unit: The article highlights issues with embedded web services that allow devices to communicate with each other and feed digital data directly to patient medical records. Vulnerabilities in these web services could lead to altered information in medical records, potentially causing misdiagnosis or incorrect prescriptions, indicating failures related to the processing unit layer of the cyber-physical system [25689]. (d) network_communication: The article discusses how many medical devices are connected to internal networks accessible via the internet, making them vulnerable to attacks. Hackers could gain access to these devices by infecting an employee's computer via a phishing attack or by plugging a laptop into the network, indicating failures related to network communication within the cyber-physical system [25689]. (e) embedded_software: The article mentions common security holes in medical devices, including lack of authentication, weak passwords, and hardcoded vendor passwords. These vulnerabilities in the embedded software of the devices contribute to the overall failure of the cyber-physical system's security [25689].
Communication connectivity_level The software failure incident described in the article [25689] is related to the communication layer of the cyber-physical system that failed at the connectivity level. The incident involved vulnerabilities in various medical devices such as drug infusion pumps, defibrillators, X-rays, refrigerators, and digital medical records that were accessible via internal networks. These vulnerabilities were due to factors introduced by the network layer, including lack of authentication, weak passwords, default and hardcoded vendor passwords, and embedded web servers that made it easy for attackers to identify and manipulate the devices once on the network. Additionally, the devices were connected to internal networks accessible via the internet, allowing hackers to gain access through various means like phishing attacks or direct network connections [25689].
Application TRUE The software failure incident described in the articles is related to the application layer of the cyber physical system. The failure involved vulnerabilities in various medical devices such as drug infusion pumps, defibrillators, X-rays, temperature settings on refrigerators, digital medical records, and surgery robots. These vulnerabilities allowed for remote manipulation, changing of dosages, delivering random shocks, altering medical records, resetting configurations, and other malicious actions [25689]. These issues were attributed to factors like lack of authentication, weak passwords, hardcoded passwords, and vulnerable web interfaces that allowed for unauthorized access and manipulation of the devices [25689].

Other Details

Category Option Rationale
Consequence harm, property, non-human, theoretical_consequence (a) death: The articles do not mention any instances of people losing their lives due to the software failure incident. [25689] (b) harm: The software failure incident could potentially lead to physical harm as it mentioned that defibrillators could be manipulated to deliver random shocks to a patient's heart or prevent a medically needed shock from occurring. [25689] (c) basic: The articles do not mention any impact on people's access to food or shelter due to the software failure incident. (d) property: The software failure incident could impact people's material goods, money, or data as it discussed vulnerabilities in medical equipment like drug infusion pumps, defibrillators, and X-rays that could be remotely manipulated or accessed by unauthorized individuals. [25689] (e) delay: The articles do not mention any instances of people having to postpone an activity due to the software failure incident. (f) non-human: The software failure incident impacted non-human entities such as medical equipment like drug infusion pumps, defibrillators, X-rays, refrigerators storing blood and drugs, and digital medical records that were found to be vulnerable to manipulation and hacking. [25689] (g) no_consequence: The articles do not mention that there were no real observed consequences of the software failure incident. (h) theoretical_consequence: The articles discuss potential consequences of the software failure incident, such as altering drug dosages, misdiagnoses, prescribing wrong drugs, administering unwarranted care, and causing spoilage of blood and drugs due to temperature settings being reset. [25689] (i) other: The articles do not mention any other specific consequences of the software failure incident beyond those discussed in the options (a) to (h).
Domain health The software failure incident discussed in the article is related to the **health** industry [25689]. The incident involved vulnerabilities in various medical devices used in healthcare facilities, such as drug infusion pumps, defibrillators, X-rays, refrigerators storing blood and drugs, digital medical records, temperature settings, and surgery robots. These vulnerabilities allowed for remote manipulation, unauthorized access, and potential harm to patients. The incident highlighted the lack of security measures in medical equipment and the risks associated with these devices being connected to internal networks accessible via the internet.

Sources

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