Process of designing robust, dependable, safe and secure software for medical devices: Point of care testing device as a case study

This article has been made available through the Brunel Open Access Publishing Fund.Copyright © 2013 Sivanesan Tulasidas et al. This paper presents a holistic methodology for the design of medical device software, which encompasses of a new way of eliciting requirements, system design process, security design guideline, cloud architecture design, combinatorial testing process and agile project management. The paper uses point of care diagnostics as a case study where the software and hardware must be robust, reliable to provide accurate diagnosis of diseases. As software and software intensive systems are becoming increasingly complex, the impact of failures can lead to significant property damage, or damage to the environment. Within the medical diagnostic device software domain such failures can result in misdiagnosis leading to clinical complications and in some cases death. Software faults can arise due to the interaction among the software, the hardware, third party software and the operating environment. Unanticipated environmental changes and latent coding errors lead to operation faults despite of the fact that usually a significant effort has been expended in the design, verification and validation of the software system. It is becoming increasingly more apparent that one needs to adopt different approaches, which will guarantee that a complex software system meets all safety, security, and reliability requirements, in addition to complying with standards such as IEC 62304. There are many initiatives taken to develop safety and security critical systems, at different development phases and in different contexts, ranging from infrastructure design to device design. Different approaches are implemented to design error free software for safety critical systems. By adopting the strategies and processes presented in this paper one can overcome the challenges in developing error free software for medical devices (or safety critical systems).Brunel Open Access Publishing Fund

A Reference Architecture Proposal for Secure Data Management in Mobile Health

Mobile health (mHealth) is becoming a prominent component of healthcare. As the border between wearable consumer devices and medical devices begins to thin, we extend the mHealth definition including sports, lifestyle, and wellbeing apps that may connect to smart bracelets and watches as well as medical device apps running on consumer platforms and dedicated connected medical devices. This trend raises security and privacy concerns, since these technologies collect data ubiquitously and continuously, both on the individual user and on the surroundings. Security issues include lack of authentication and authorization mechanisms, as well as insecure data transmission and storage. Privacy issues include users' lack of control on data flow, poor quality consent management, and limitations on the possibility to remain anonymous. In response to these threats, we propose an advanced reference platform, securing the use of wearables and mobile apps in the mHealth domains through citizens' active protection and information

A Cognitive Framework to Secure Smart Cities

The advancement in technology has transformed Cyber Physical Systems and their interface with IoT into a more sophisticated and challenging paradigm. As a result, vulnerabilities and potential attacks manifest themselves considerably more than before, forcing researchers to rethink the conventional strategies that are currently in place to secure such physical systems. This manuscript studies the complex interweaving of sensor networks and physical systems and suggests a foundational innovation in the field. In sharp contrast with the existing IDS and IPS solutions, in this paper, a preventive and proactive method is employed to stay ahead of attacks by constantly monitoring network data patterns and identifying threats that are imminent. Here, by capitalizing on the significant progress in processing power (e.g. petascale computing) and storage capacity of computer systems, we propose a deep learning approach to predict and identify various security breaches that are about to occur. The learning process takes place by collecting a large number of files of different types and running tests on them to classify them as benign or malicious. The prediction model obtained as such can then be used to identify attacks. Our project articulates a new framework for interactions between physical systems and sensor networks, where malicious packets are repeatedly learned over time while the system continually operates with respect to imperfect security mechanisms

Developing a comprehensive information security framework for mHealth: a detailed analysis

It has been clearly shown that mHealth solutions, which is the use of mobile devices and other wireless technology to provide healthcare services, deliver more patient-focused healthcare, and improve the overall efficiency of healthcare systems. In addition, these solutions can potentially reduce the cost of providing healthcare in the context of the increasing demands of the aging populations in advanced economies. These solutions can also play an important part in intelligent environments, facilitating real-time data collection and input to enable various functionalities. However, there are several challenges regarding the development of mHealth solutions: the most important of these being privacy and data security. Furthermore, the use of cloud computing is becoming an option for the healthcare sector to store healthcare data; but storing data in the cloud raises serious concerns. This paper investigates how data are managed both on mHealth devices as well as in the cloud. Firstly, a detailed analysis of the entire mHealth domain is undertaken to determine domain-specific features and a taxonomy for mHealth, from which a set of security requirements are identified in order to develop a new information security framework. It then examines individual information security frameworks for mHealth devices and the cloud, noting similarities and differences. Furthermore, key mechanisms to implement the new framework are discussed and the new framework is then presented. Finally, the paper presents how the new framework could be implemented in order to develop an Advanced Digital Medical Platform

Usability and Security in Medication. Administration Applications

The traditional process of filling the medicine trays and dispensing the medicines to the patients in the hospitals is manually done by reading the printed paper medicinechart. This process can be very strenuous and error-prone, given the number of sub-tasksinvolved in the entire workflow and the dynamic nature of the work environment.Therefore, efforts are being made to digitalise the medication dispensation process byintroducing a mobile application called Smart Dosing application. The introduction ofthe Smart Dosing application into hospital workflow raises security concerns and callsfor security requirement analysis. This thesis is written as a part of the smart medication management project at EmbeddedSystems Laboratory, A˚bo Akademi University. The project aims at digitising the medicine dispensation process by integrating information from various health systems, and making them available through the Smart Dosing application. This application is intended to be used on a tablet computer which will be incorporated on the medicine tray. The smart medication management system include the medicine tray, the tablet device, and the medicine cups with the cup holders. Introducing the Smart Dosing application should not interfere with the existing process carried out by the nurses, and it should result in minimum modifications to the tray design and the workflow. The re-designing of the tray would include integrating the device running the application into the tray in a manner that the users find it convenient and make less errors while using it. The main objective of this thesis is to enhance the security of the hospital medicine dispensation process by ensuring the security of the Smart Dosing application at various levels. The methods used for writing this thesis was to analyse how the tray design, and the application user interface design can help prevent errors and what secure technology choices have to be made before starting the development of the next prototype of the Smart Dosing application. The thesis first understands the context of the use of the application, the end-users and their needs, and the errors made in everyday medication dispensation workflow by continuous discussions with the nursing researchers. The thesis then gains insight to the vulnerabilities, threats and risks of using mobile application in hospital medication dispensation process. The resulting list of security requirements was made by analysing the previously built prototype of the Smart Dosing application, continuous interactive discussions with the nursing researchers, and an exhaustive state-of-the-art study on security risks of using mobile applications in hospital context. The thesis also uses Octave Allegro method to make the readers understand the likelihood and impact of threats, and what steps should be taken to prevent or fix them. The security requirements obtained, as a result, are a starting point for the developers of the next iteration of the prototype for the Smart Dosing application.Siirretty Doriast

EXECUTABLE ARCHIVES: Software integrity for data readability and validation of archived studies

© 2021 author(s). The text of this paper is published under a CC-BY license (https://creativecommons.org/licenses/by/4.0/)This paper presents practices and processes for managing software integrity to support data archiving for long term use in response to the regulatory requirements. Through a case study of a scientific software decommissioning, we revisit the issues of archived data readability. Established software lifecycle management processes are extended with archiving and data integrity requirements for retention of data and revalidation of data analyses. That includes the software transition from operational to archival use within the Executable Archive model that extends the traditional data archive with computing environments with software installations required to reproduce study results from the archived records. The content use requirements are an integral part of both data access and the software management considerations, assuring that data integrity is fully supported by the software integrityPeer reviewe

The Dyadic Dance during Deployment: Veteran and Partner Romantic Attachment

A strong family unit and dyadic relationship can buffer against the possible development of depression and Posttraumatic Stress Disorder (PTSD). A growing body of literature has been investigating how couples communicate during a combat separation. However, there has not been a robust framework to conceptualize the findings; this paper posits that attachment theory can fill this gap. This study was a cross-sectional retrospective design that included twenty-two heterosexual dyads. Nine modes of communication were assessed: letters, care packages, email, telephone, text with phone, social networking, Skype, instant messenger and instant messenger with video. Also, frequency of communication was examined for each of the different modes of communication. In line with prior research, the modes of communication were placed into categories, delayed and interactive forms of communication. This study found that attachment style and frequency of communication affects combat veterans’ and their partners’ differently. Partner anxiety was negatively correlated with all assessment instruments that measured post-deployment constructs: relationship satisfaction, depression, perceived PTSD of their veteran, self-reported stress, and family functioning. Conceptually, attachment theory suggests that the deployed service member’s caregiving behavioral system is activated whereas the stateside partner’s attachment behavioral system is activated

Does insecure attachment lead to (mis)wired brains? Emotion, cognition, and attachment: an outlook through psychophysiological pathways

2346, 2360, 2560The evolutionary-based attachment theory (Bowlby, 1969, 1973, 1980) asserts that approach/attachment or avoidance/withdrawal tendencies may reflect distinct regulation strategies underlying individual differences in attachment styles. The influence of the internal working models of attachment on emotion and cognition, and more recently, on its psychophysiological underpinnings has been a central focus of research. Despite the endeavours at clarifying this modulatory influence in behaviour, inconsistent results have prevented definite answers. Aiming at contributing to the current knowledge in the filed, and embedded in a psychophysiological framework, the present thesis brings together findings of empirical studies focusing on the regulation abilities in attentional bias towards emotion information. Following an integrative approach, these studies coupled behavioural responses with measures of skin conductance, heart rate, and eye movements. Findings of these studies converge to show distinctive features between regulation strategies deployed by insecure attached individuals when processing threat-related information on visual attention tasks, as measured by behavioural (Study I), sympathetic (Study II), and eye movement (Study III) responses. Taken together these findings point up the evolutionary value of the attachment behavioural system, providing support for fundamental distinctions between insecure attachment styles, both at a behavioural and physiological level. Considering recent advances emerging in the filed, results are discussed within in a comprehensive and all-encompassing approach.Fundamentada num cenário evolucionista, a teoria da vinculação (Bowlby, 1969, 1973, 1980) considera que comportamentos de aproximação/evitamento reflectem estratégias de regulação subjacentes a diferenças individuais nos estilos de vinculação. Neste âmbito, a natureza dos modelos internos dinâmicos têm sido um foco central na investigação, tendo sido dada particular atenção à sua influência nos processos emocionais e cognitivos e, mais recentemente, às suas bases psicofisiológicas. Contudo, apesar de vários estudos terem examinado estas questões, a ausência de dados consistentes acerca dos mecanismos que poderão contribuir para esta influência estão ainda por conhecer de modo consistente. Visando contribuir para o conhecimento neste campo, a presente tese reúne um conjunto de estudos empíricos que, numa perspectiva psicofisiológica, focam a acção das estratégias de regulação associadas aos estilos de vinculação insegura – ansiosa e evitante –, nos enviesamentos atencionais no processamento de informação emocional. Numa abordagem integrativa, estes estudos combinam respostas comportamentais com medidas fisiológicas: condutância da pele; frequência cardíaca; e movimentos oculares. Utilizando tarefas de atenção visual, os resultados destes estudos apoiam a hipótese de que os estilos de vinculação insegura estão relacionados com estratégias de regulação específicas no processamento de estímulos potencialmente ameaçadores, avaliadas através de respostas comportamentais (Estudo I), do sistema nervoso simpático (Estudo II), e dos movimentos oculares (Estudo III). Globalmente, os resultados corroboraram o valor evolutivo do sistema comportamental de vinculação, dando suporte para diferenças entre os estilos de vinculação insegura, tanto a nível comportamental como fisiológico. Considerando progressos científicos emergentes, os resultados são discutidos numa abordagem compreensiva e abrangente

A mixed methods analysis of the relationship between attachment, post-traumatic stress, and post-traumatic growth among United States service members

The impact of secure military relationships on US service members’ response to trauma during military service was examined in this mixed methods study. Veterans with and without combat exposure evidence a high rate of post-traumatic stress disorder (PTSD) and the military has tried to institute resilience-based programs in anticipation of the psychological challenges experienced by soldiers. At the same time, research has shown that some service members report positive outcomes associated with military service including the phenomena of post-traumatic growth (PTG). The constructs from attachment theory (safe haven and exploration) have begun to be the focus of research with service members and have been linked to PTG. In the current study, the statistical relationships and qualitative dimensions among attachment, PTSD, and PTG were examined. The quantitative portion of this study found that the more safe and secure service members rated their relationships with fellow service members, their unit, and their leaders, the fewer PTSD symptoms they reported and the more likely they were to experience post-traumatic growth, independent of demographics (age, education level, rank), and combat exposure. The qualitative portion of this study reported the broad and varied lived experiences of service members’ relationships – providing many answers to the question of how relationships matter. Implications of these findings for military programs and policies and future research directions are discussed