A review on recent advances in implanted medical devices security

The Implanted Medical Devices (IMD) industry has grown over the past few decades and is expected to grow in the coming ones. Being an asset for the health and quality of life of a patient, the availability of IMD-related products, their increasing complexity and advances in communication capabilities do not seem to have been seamlessly accompanied by cybersecurity concerns. Recent IMD can be integrated in the concept of IoT (Internet of Things) and thus, they are also exposed to attacks impacting on privacy and, above all, on the health and even the life of the device users. While in an early stage of the IMD development, the security procedures were based on the existing classic protocols and models and their functional capabilities were the focus of development, recent efforts have been made to address security from the start. In this paper we review the most recent contributions on the cybersecurity of IMD products and we highlight innovative ideas that represent new design and development paradigms of these devices next generations. In this review it is reinforced that the technological evolution and the progressive access of attackers to resources capable of exploiting multiple vulnerabilities can have a crucial impact in the IMD already implanted in the patient's body, designed to remain in operation for many years. Also, it brings the need to develop novel and robust protocols to guarantee security compatible with constrained computing resources and extremely low energy requirements to be feasible. Finally, the security and privacy concerns regarding this kind of devices should be addressed in the design phase and policies must move from damage mitigation to threat prevention.5311-8814-F0ED | Sara Maria da Cruz Maia de Oliveira PaivaN/

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

The Effect of Chemical Regulations on the Aerospace and Defence Industries

The motivation for this research stems from the author working within the Aerospace and Defence (AD) sector for nearly 19 years. It was during the development phase of IPC-1754 data exchange standard, the author, came to the firm belief, that whilst AD supply chain actors would begin to share data in a harmonised format via the IPC-1754 data exchange standard, there was a clear lack of understanding amongst several AD supply chain actors on how to collate, analyse, assess, and report internal data in a consistent manner. The main aim of this research is: To develop a conceptual framework enabling identification of articles (products) potentially at risk from chemical regulations supporting decision making processes for AD organisations

Strategic group mapping and strategy canvas analysis of the environmental consulting sector : a project-based dissertation on the German Market : a public archival data web-content analysis

Nesta dissertação na modalidade de projeto tive a oportunidade de entrar em contacto com uma Pequena Média empresa no setor de consultoria ambiental, onde me foi pedido para realizar uma análise à competição no mercado alemão, focando-me em mercados específicos em que a empresa se planeia especializar (Nanomateriais, Biocidas e Instrumentos Médicos). É possível observar que as leis ambientais mais restritivas, desenvolvimentos dentro da química e consciência ambiental estão a criar um grande potencial para crescimento e relevância deste setor. Gestão estratégica e categorização estratégica desenvolveram muitas correntes de pesquisa e no entanto, ferramentas estratégicas ainda não foram utilizadas para analisar o setor da Consultoria ambiental, que tem sido negligenciado na literatura. Através de uma análise de dados de arquivamento públicos (websites, páginas de LinkedIn, e relatórios anuais), foi possível aplicar ferramentas estratégicas (Mapeamento de grupos estratégicos e o Canvas estratégico) a uma amostra de 57 empresas de consultoria ambiental no mercado alemão assim como recolher sinais de competitividade e tamanho das empresas. Nesta análise pode-se comprovar que a revolução digital, sustentabilidade e responsabilidade corporativa já se encontram presentes nesta indústria, que várias empresas oferecem tanto apoio ambiental com foco regulatório e de gestão como um apoio ambiental com foco cientifico, procurando eficiência ambiental e redução de desperdício, e que nanomateriais parecem ser o mercado menos presente em websites, comparativamente com o mercado dos biocidas e dos instrumentos médicos. Este trabalho permitiu demonstrar o valor que ferramentas estratégicas podem ter, mesmo quando aplicado a informação publica, neste caso de websites, e também demonstrar as respetivas limitações, permitindo-nos ter uma melhor visão das nuances estratégicas e estrutura de um setor negligenciado. Para além disso, o contexto da análise estratégica também demonstra que o Brexit pode agir como um catalisador de expansão geográfica, o que é um impacto estratégico que ainda não tinha sido estudado previamente em empresas nesta indústria.In this project-based dissertation I had the chance to work with an environment consulting SME, where I was asked to do a competitor analysis of the German Market in particular sectors in which they will focus on (Nanomaterials, Biocides and Medical Devices). It is possible to observe that the increasingly stringent environmental policies, chemistry developments and environmental consciousness are creating a great potential for the growth in size and relevance of this sector. Strategic management and strategic categorization have developed into many streams of research, and however, strategic tools still haven’t been used to describe the environmental consulting sector, which has been overlooked in the literature. Through an analysis of public archival data (Company website, LinkedIn and annual reports), it was possible apply the Strategic group mapping and Strategy canvas frameworks to a sample of 57 environmental consulting companies in the German market, as well as to collect other signs of competitiveness and size. In this analysis it was found that the digital revolution, sustainability and corporate responsibility are already present in this industry, it was found that many companies are providing not only environmental regulatory and managerial support but at the same time providing scientific support, focusing on environmental efficiency and waste management, and that nanomaterials seem to be the least featured market in companies websites comparatively to biocides and medical devices. This paper allowed to demonstrate the value that strategic tools can have, even when applied to public website-content, as well as to demonstrate their limitations, allowing us to give a better overview of the strategic nuances and structure of an overlooked sector. Moreover, the context of this company’s strategic analysis also showcases that Brexit can act as a catalyst of geographical expansion, which is a strategical impact in this industry that hasn’t been studied before for companies in this industry

Research into the design of distributed directory services

Distributed, computer based communication is becoming established within many working environments. Furthermore, the near future is likely to see an increase in the scale, complexity and usage of telecommunications services and distributed applications. As a result, there is a critical need for a global Directory service to store and manage communication information and therefore support the emerging world-wide telecommunications environment. This thesis describes research into the design of distributed Directory services. It addresses a number of Directory issues ranging from the abstract structure of information to the concrete implementation of a prototype system. In particular, it examines a number of management related issues concerning the management of communication information and the management of the Directory service itself. The following work develops models describing different aspects of Directory services. These include data access control and data integrity control models concerning the abstract structure and management of information as well as knowledge management, distributed operation and replication models concerning the realisation of the Directory as a distributed system. In order to clarify the relationships between these models, a layered directory architecture is proposed. This architecture provides a framework for the discussion of directory issues and defines the overall structure of this thesis. This thesis also describes the implementation of a prototype Directory service, supported by software tools typical of those currently available within many environments. It should be noted that, although this thesis emphasises the design of abstract directory models, development of the prototype consumed a large amount of time and effort and prototyping activities accounted for a substantial portion of this research. Finally, this thesis reaches a number of conclusions which are applied to the emerging ISO/CCITT X. 500 standard for Directory services, resulting in possible input for the 1988-92 study period

Survey and Systematization of Secure Device Pairing

Secure Device Pairing (SDP) schemes have been developed to facilitate secure communications among smart devices, both personal mobile devices and Internet of Things (IoT) devices. Comparison and assessment of SDP schemes is troublesome, because each scheme makes different assumptions about out-of-band channels and adversary models, and are driven by their particular use-cases. A conceptual model that facilitates meaningful comparison among SDP schemes is missing. We provide such a model. In this article, we survey and analyze a wide range of SDP schemes that are described in the literature, including a number that have been adopted as standards. A system model and consistent terminology for SDP schemes are built on the foundation of this survey, which are then used to classify existing SDP schemes into a taxonomy that, for the first time, enables their meaningful comparison and analysis.The existing SDP schemes are analyzed using this model, revealing common systemic security weaknesses among the surveyed SDP schemes that should become priority areas for future SDP research, such as improving the integration of privacy requirements into the design of SDP schemes. Our results allow SDP scheme designers to create schemes that are more easily comparable with one another, and to assist the prevention of persisting the weaknesses common to the current generation of SDP schemes.Comment: 34 pages, 5 figures, 3 tables, accepted at IEEE Communications Surveys & Tutorials 2017 (Volume: PP, Issue: 99