233 research outputs found
Cybersecurity in implantable medical devices
Mención Internacional en el título de doctorImplantable Medical Devices (IMDs) are electronic devices implanted within
the body to treat a medical condition, monitor the state or improve the
functioning of some body part, or just to provide the patient with a capability
that he did not possess before [86]. Current examples of IMDs
include pacemakers and defibrillators to monitor and treat cardiac conditions;
neurostimulators for deep brain stimulation in cases such as epilepsy
or Parkinson; drug delivery systems in the form of infusion pumps; and a
variety of biosensors to acquire and process different biosignals.
Some of the newest IMDs have started to incorporate numerous communication
and networking functions—usually known as “telemetry”—,
as well as increasingly more sophisticated computing capabilities. This
has provided implants with more intelligence and patients with more autonomy,
as medical personnel can access data and reconfigure the implant
remotely (i.e., without the patient being physically present in medical facilities).
Apart from a significant cost reduction, telemetry and computing
capabilities also allow healthcare providers to constantly monitor the patient’s
condition and to develop new diagnostic techniques based on an
Intra Body Network (IBN) of medical devices [25, 26, 201].
Evolving from a mere electromechanical IMD to one with more advanced
computing and communication capabilities has many benefits but
also entails numerous security and privacy risks for the patient. The majority
of such risks are relatively well known in classical computing scenarios,
though in many respects their repercussions are far more critical in the case
of implants. Attacks against an IMD can put at risk the safety of the patient
who carries it, with fatal consequences in certain cases. Causing an intentional
malfunction of an implant can lead to death and, as recognized by the
U.S. Food and Drug Administration (FDA), such deliberate attacks could
be far more difficult to detect than accidental ones [61]. Furthermore, these
devices store and transmit very sensitive medical information that requires
protection, as dictated by European (e.g., Directive 95/46/ECC) and U.S.
(e.g., CFR 164.312) Directives [94, 204].
The wireless communication capabilities present in many modern IMDs
are a major source of security risks, particularly while the patient is in open
(i.e., non-medical) environments. To begin with, the implant becomes no
longer “invisible”, as its presence could be remotely detected [48]. Furthermore,
it facilitates the access to transmitted data by eavesdroppers who
simply listen to the (insecure) channel [83]. This could result in a major privacy breach, as IMDs store sensitive information such as vital signals,
diagnosed conditions, therapies, and a variety of personal data (e.g., birth
date, name, and other medically relevant identifiers). A vulnerable communication
channel also makes it easier to attack the implant in ways similar
to those used against more common computing devices [118, 129, 156],
i.e., by forging, altering, or replying previously captured messages [82].
This could potentially allow an adversary to monitor and modify the implant
without necessarily being close to the victim [164]. In this regard,
the concerns of former U.S. vice-president Dick Cheney constitute an excellent
example: he had his Implantable Cardioverter Defibrillator (ICD)
replaced by another without WiFi capability [219].
While there are still no known real-world incidents, several attacks on
IMDs have been successfully demonstrated in the lab [83, 133, 143]. These
attacks have shown how an adversary can disable or reprogram therapies
on an ICD with wireless connectivity, and even inducing a shock state to
the patient [65]. Other attacks deplete the battery and render the device
inoperative [91], which often implies that the patient must undergo a surgical
procedure to have the IMD replaced. Moreover, in the case of cardiac
implants, they have a switch that can be turned off merely by applying a
magnetic field [149]. The existence of this mechanism is motivated by the
need to shield ICDs to electromagnetic fields, for instance when the patient
undergoes cardiac surgery using electrocautery devices [47]. However, this
could be easily exploited by an attacker, since activating such a primitive
mechanism does not require any kind of authentication.
In order to prevent attacks, it is imperative that the new generation of
IMDs will be equipped with strong mechanisms guaranteeing basic security
properties such as confidentiality, integrity, and availability. For example,
mutual authentication between the IMD and medical personnel is
essential, as both parties must be confident that the other end is who claims
to be. In the case of the IMD, only commands coming from authenticated
parties should be considered, while medical personnel should not trust any
message claiming to come from the IMD unless sufficient guarantees are
given.
Preserving the confidentiality of the information stored in and transmitted
by the IMD is another mandatory aspect. The device must implement
appropriate security policies that restrict what entities can reconfigure the
IMD or get access to the information stored in it, ensuring that only authorized
operations are executed. Similarly, security mechanisms have to
be implemented to protect the content of messages exchanged through an insecure wireless channel.
Integrity protection is equally important to ensure that information has
not been modified in transit. For example, if the information sent by the
implant to the Programmer is altered, the doctor might make a wrong decision.
Conversely, if a command sent to the implant is forged, modified,
or simply contains errors, its execution could result in a compromise of the
patient’s physical integrity.
Technical security mechanisms should be incorporated in the design
phase and complemented with appropriate legal and administrative measures.
Current legislation is rather permissive in this regard, allowing the
use of implants like ICDs that do not incorporate any security mechanisms.
Regulatory authorities like the FDA in the U.S or the EMA (European
Medicines Agency) in Europe should promote metrics and frameworks for
assessing the security of IMDs. These assessments should be mandatory
by law, requiring an adequate security level for an implant before approving
its use. Moreover, both the security measures supported on each IMD
and the security assessment results should be made public.
Prudent engineering practices well known in the safety and security domains
should be followed in the design of IMDs. If hardware errors are
detected, it often entails a replacement of the implant, with the associated
risks linked to a surgery. One of the main sources of failure when treating
or monitoring a patient is precisely malfunctions of the device itself.
These failures are known as “recalls” or “advisories”, and it is estimated
that they affect around 2.6% of patients carrying an implant. Furthermore,
the software running on the device should strictly support the functionalities
required to perform the medical and operational tasks for what it was
designed, and no more [66, 134, 213].
In Chapter 1, we present a survey of security and privacy issues in
IMDs, discuss the most relevant mechanisms proposed to address these
challenges, and analyze their suitability, advantages, and main drawbacks.
In Chapter 2, we show how the use of highly compressed electrocardiogram
(ECG) signals (only 24 coefficients of Hadamard Transform) is enough
to unequivocally identify individuals with a high performance (classification
accuracy of 97% and with identification system errors in the order of
10−2). In Chapter 3 we introduce a new Continuous Authentication scheme
that, contrarily to previous works in this area, considers ECG signals as
continuous data streams. The proposed ECG-based CA system is intended
for real-time applications and is able to offer an accuracy up to 96%, with
an almost perfect system performance (kappa statistic > 80%). In Chapter 4, we propose a distance bounding protocol to manage access control of
IMDs: ACIMD. ACIMD combines two features namely identity verification
(authentication) and proximity verification (distance checking). The
authentication mechanism we developed conforms to the ISO/IEC 9798-2
standard and is performed using the whole ECG signal of a device holder,
which is hardly replicable by a distant attacker. We evaluate the performance
of ACIMD using ECG signals of 199 individuals over 24 hours,
considering three adversary strategies. Results show that an accuracy of
87.07% in authentication can be achieved. Finally, in Chapter 5 we extract
some conclusions and summarize the published works (i.e., scientific
journals with high impact factor and prestigious international conferences).Los Dispositivos Médicos Implantables (DMIs) son dispositivos electrónicos
implantados dentro del cuerpo para tratar una enfermedad, controlar
el estado o mejorar el funcionamiento de alguna parte del cuerpo, o simplemente
para proporcionar al paciente una capacidad que no poseía antes
[86]. Ejemplos actuales de DMI incluyen marcapasos y desfibriladores
para monitorear y tratar afecciones cardíacas; neuroestimuladores para la
estimulación cerebral profunda en casos como la epilepsia o el Parkinson;
sistemas de administración de fármacos en forma de bombas de infusión; y
una variedad de biosensores para adquirir y procesar diferentes bioseñales.
Los DMIs más modernos han comenzado a incorporar numerosas funciones
de comunicación y redes (generalmente conocidas como telemetría)
así como capacidades de computación cada vez más sofisticadas. Esto
ha propiciado implantes con mayor inteligencia y pacientes con más autonomía,
ya que el personal médico puede acceder a los datos y reconfigurar
el implante de forma remota (es decir, sin que el paciente esté
físicamente presente en las instalaciones médicas). Aparte de una importante
reducción de costos, las capacidades de telemetría y cómputo también
permiten a los profesionales de la atención médica monitorear constantemente
la condición del paciente y desarrollar nuevas técnicas de diagnóstico
basadas en una Intra Body Network (IBN) de dispositivos médicos
[25, 26, 201].
Evolucionar desde un DMI electromecánico a uno con capacidades de
cómputo y de comunicación más avanzadas tiene muchos beneficios pero
también conlleva numerosos riesgos de seguridad y privacidad para el paciente.
La mayoría de estos riesgos son relativamente bien conocidos en los
escenarios clásicos de comunicaciones entre dispositivos, aunque en muchos
aspectos sus repercusiones son mucho más críticas en el caso de los
implantes. Los ataques contra un DMI pueden poner en riesgo la seguridad
del paciente que lo porta, con consecuencias fatales en ciertos casos.
Causar un mal funcionamiento intencionado en un implante puede causar
la muerte y, tal como lo reconoce la Food and Drug Administration (FDA)
de EE.UU, tales ataques deliberados podrían ser mucho más difíciles de
detectar que los ataques accidentales [61]. Además, estos dispositivos almacenan
y transmiten información médica muy delicada que requiere se
protegida, según lo dictado por las directivas europeas (por ejemplo, la Directiva 95/46/ECC) y estadunidenses (por ejemplo, la Directiva CFR
164.312) [94, 204].
Si bien todavía no se conocen incidentes reales, se han demostrado con
éxito varios ataques contra DMIs en el laboratorio [83, 133, 143]. Estos
ataques han demostrado cómo un adversario puede desactivar o reprogramar
terapias en un marcapasos con conectividad inalámbrica e incluso
inducir un estado de shock al paciente [65]. Otros ataques agotan
la batería y dejan al dispositivo inoperativo [91], lo que a menudo implica
que el paciente deba someterse a un procedimiento quirúrgico para reemplazar
la batería del DMI. Además, en el caso de los implantes cardíacos,
tienen un interruptor cuya posición de desconexión se consigue simplemente
aplicando un campo magnético intenso [149]. La existencia de este
mecanismo está motivada por la necesidad de proteger a los DMIs frete
a posibles campos electromagnéticos, por ejemplo, cuando el paciente se
somete a una cirugía cardíaca usando dispositivos de electrocauterización
[47]. Sin embargo, esto podría ser explotado fácilmente por un atacante,
ya que la activación de dicho mecanismo primitivo no requiere ningún tipo
de autenticación.
Garantizar la confidencialidad de la información almacenada y transmitida
por el DMI es otro aspecto obligatorio. El dispositivo debe implementar
políticas de seguridad apropiadas que restrinjan qué entidades
pueden reconfigurar el DMI o acceder a la información almacenada en él,
asegurando que sólo se ejecuten las operaciones autorizadas. De la misma
manera, mecanismos de seguridad deben ser implementados para proteger
el contenido de los mensajes intercambiados a través de un canal inalámbrico
no seguro.
La protección de la integridad es igualmente importante para garantizar
que la información no se haya modificado durante el tránsito. Por ejemplo,
si la información enviada por el implante al programador se altera, el
médico podría tomar una decisión equivocada. Por el contrario, si un comando
enviado al implante se falsifica, modifica o simplemente contiene
errores, su ejecución podría comprometer la integridad física del paciente.
Los mecanismos de seguridad deberían incorporarse en la fase de diseño
y complementarse con medidas legales y administrativas apropiadas.
La legislación actual es bastante permisiva a este respecto, lo que permite
el uso de implantes como marcapasos que no incorporen ningún mecanismo
de seguridad. Las autoridades reguladoras como la FDA en los Estados
Unidos o la EMA (Agencia Europea de Medicamentos) en Europa deberían
promover métricas y marcos para evaluar la seguridad de los DMIs.
Estas evaluaciones deberían ser obligatorias por ley, requiriendo un nivel
de seguridad adecuado para un implante antes de aprobar su uso. Además,
tanto las medidas de seguridad implementadas en cada DMI como los resultados
de la evaluación de su seguridad deberían hacerse públicos.
Buenas prácticas de ingeniería en los dominios de la protección y la
seguridad deberían seguirse en el diseño de los DMIs. Si se detectan errores
de hardware, a menudo esto implica un reemplazo del implante, con
los riesgos asociados y vinculados a una cirugía. Una de las principales
fuentes de fallo al tratar o monitorear a un paciente es precisamente el
mal funcionamiento del dispositivo. Estos fallos se conocen como “retiradas”,
y se estima que afectan a aproximadamente el 2,6 % de los pacientes
que llevan un implante. Además, el software que se ejecuta en el
dispositivo debe soportar estrictamente las funcionalidades requeridas para
realizar las tareas médicas y operativas para las que fue diseñado, y no más
[66, 134, 213].
En el Capítulo 1, presentamos un estado de la cuestión sobre cuestiones
de seguridad y privacidad en DMIs, discutimos los mecanismos más relevantes
propuestos para abordar estos desafíos y analizamos su idoneidad,
ventajas y principales inconvenientes. En el Capítulo 2, mostramos
cómo el uso de señales electrocardiográficas (ECGs) altamente comprimidas
(sólo 24 coeficientes de la Transformada Hadamard) es suficiente para
identificar inequívocamente individuos con un alto rendimiento (precisión
de clasificación del 97% y errores del sistema de identificación del orden
de 10−2). En el Capítulo 3 presentamos un nuevo esquema de Autenticación
Continua (AC) que, contrariamente a los trabajos previos en esta
área, considera las señales ECG como flujos de datos continuos. El sistema
propuesto de AC basado en señales cardíacas está diseñado para aplicaciones
en tiempo real y puede ofrecer una precisión de hasta el 96%,
con un rendimiento del sistema casi perfecto (estadístico kappa > 80 %).
En el Capítulo 4, proponemos un protocolo de verificación de la distancia
para gestionar el control de acceso al DMI: ACIMD. ACIMD combina
dos características, verificación de identidad (autenticación) y verificación
de la proximidad (comprobación de la distancia). El mecanismo de autenticación
es compatible con el estándar ISO/IEC 9798-2 y se realiza utilizando
la señal ECG con todas sus ondas, lo cual es difícilmente replicable
por un atacante que se encuentre distante. Hemos evaluado el rendimiento
de ACIMD usando señales ECG de 199 individuos durante 24 horas, y
hemos considerando tres estrategias posibles para el adversario. Los resultados
muestran que se puede lograr una precisión del 87.07% en la au tenticación. Finalmente, en el Capítulo 5 extraemos algunas conclusiones
y resumimos los trabajos publicados (es decir, revistas científicas con alto
factor de impacto y conferencias internacionales prestigiosas).Programa Oficial de Doctorado en Ciencia y Tecnología InformáticaPresidente: Arturo Ribagorda Garnacho.- Secretario: Jorge Blasco Alís.- Vocal: Jesús García López de Lacall
Security and privacy issues in implantable medical devices: A comprehensive survey
Bioengineering is a field in expansion. New technologies are appearing to provide a more efficient treatment of diseases or human deficiencies. Implantable Medical Devices (IMDs) constitute one example, these being devices with more computing, decision making and communication capabilities. Several research works in the computer security field have identified serious security and privacy risks in IMDs that could compromise the implant and even the health of the patient who carries it. This article surveys the main security goals for the next generation of IMDs and analyzes the most relevant protection mechanisms proposed so far. On the one hand, the security proposals must have into consideration the inherent constraints of these small and implanted devices: energy, storage and computing power. On the other hand, proposed solutions must achieve an adequate balance between the safety of the patient and the security level offered, with the battery lifetime being another critical parameter in the design phase. (C) 2015 Elsevier Inc. All rights reserved.This work was partially supported by the MINECO Grant TIN2013-46469-R (SPINY: Security and Privacy in the Internet of You)
Security and privacy issues in implantable medical devices: A comprehensive survey
Bioengineering is a field in expansion. New technologies are appearing to provide a more efficient treatment of diseases or human deficiencies. Implantable Medical Devices (IMDs) constitute one example, these being devices with more computing, decision making and communication capabilities. Several research works in the computer security field have identified serious security and privacy risks in IMDs that could compromise the implant and even the health of the patient who carries it. This article surveys the main security goals for the next generation of IMDs and analyzes the most relevant protection mechanisms proposed so far. On the one hand, the security proposals must have into consideration the inherent constraints of these small and implanted devices: energy, storage and computing power. On the other hand, proposed solutions must achieve an adequate balance between the safety of the patient and the security level offered, with the battery lifetime being another critical parameter in the design phase
IMDfence: Architecting a Secure Protocol for Implantable Medical Devices
Over the past decade, focus on the security and privacy aspects of implantable medical
devices (IMDs) has intensified, driven by the multitude of cybersecurity vulnerabilities found in various
existing devices. However, due to their strict computational, energy and physical constraints, conventional
security protocols are not directly applicable to IMDs. Custom-tailored schemes have been proposed instead
which, however, fail to cover the full spectrum of security features that modern IMDs and their ecosystems so
critically require. In this paper we propose IMDfence, a security protocol for IMD ecosystems that provides a
comprehensive yet practical security portfolio, which includes availability, non-repudiation, access control,
entity authentication, remote monitoring and system scalability. The protocol also allows emergency access
that results in the graceful degradation of offered services without compromising security and patient safety.
The performance of the security protocol as well as its feasibility and impact on modern IMDs are extensively
analyzed and evaluated. We find that IMDfence achieves the above security requirements at a mere less than
7% increase in total IMD energy consumption, and less than 14 ms and 9 kB increase in system delay and
memory footprint, respectively
Security Trade-offs in Cyber Physical Systems: A Case Study Survey on Implantable Medical Devices
The new culture of networked systems that offer everywhere accessible services has given rise to various types of security trade-offs. In fact, with the evolution of physical systems that keep getting integrated with cyber frameworks, cyber threats have far more critical effects as they get reflected on the physical environment. As a result, the issue of security of cyber physical systems requires a special holistic treatment. In this paper, we study the trade-off between security, safety and availability in such systems and demonstrate these concepts on implantable medical devices as a case study. We discuss the challenges and constraints associated with securing such systems and focus on the trade-off between security measures required for blocking unauthorized access to the device, and the safety of the patient in emergency situations where such measures must be dropped to allow access. We analyze the up to date proposed solutions and discuss their strengths and limitations
Experimental Security Analysis of Connected Pacemakers
Medical devices and their connectivity capabilities are providing a variety of benefits to the healthcare domain, including remote monitoring, automated alerts, and improved patient outcomes. However, these medical devices introduce a range of new potential cyber security risks when connected to the Internet, affecting the patient or the healthcare infrastructure. In this paper, we systematically analyze the security issues of connected pacemakers. In particular, we use a black box testing methodology against a commercial pacemaker device and the network infrastructure. Our main objective is to understand how the data is sent from a bedside monitor in the patient’s home to the backend server hosted by the pacemaker manufacturer, and whether or not this data is protected from a cyber security perspective. To do so, we leveraged several hardware related vulnerabilities found in the bedside monitor to obtain the firmware of the device and then reverse engineered the proprietary communication protocol. We demonstrate how vulnerabilities in this protocol can be leveraged to allow an attacker to perform a man-in-the-middle attack on the pacemaker.publishedVersio
THE BLE CLOAKER: SECURING IMPLANTABLE MEDICAL DEVICE COMMUNICATION OVER BLUETOOTH LOW ENERGY LINKS
Historically Implantable Medical Devices (IMDs) such as pacemakers have only been able to communicate to external devices through close proximity means of communication, primarily through inductive telemetry. Because of the unlikelihood of an adversary being able to gain access to an IMD through this type of communication, these devices were never designed with security in mind. However the recent advent of IMDs that are equipped with long-range wireless capabilities has made it necessary to consider how to secure these devices from malicious attacks.
This work presents an implementation of prior work that developed a theoretical security model whose specific intent was to secure IMDs with long-range wireless capabilities against both passive and active adversaries, while also ensuring the safety of the patient. This implementation is known as the Bluetooth Low Energy (BLE) Cloaker model and provides a prototype system that uses BLE as the long-range communication medium between an emulated IMD, an external programmer, and the BLE Cloaker device itself. The BLE Cloaker acts as a secure data proxy between the IMD and the external programmer. This prototype shows the benefits and drawbacks of this theoretical model when used in a real world system as well as the security strengths and weaknesses of using BLE as the wireless link in a medical application
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