Gilbert regan
Dundalk Institute of Technology, Computing and Mathematics, Department Member
- Software Development, Software Reengineering, Software Requirements, Software Process Improvement and Assessment, Software Maintenance, Software requirements traceability, and 21 moreMedical Device Design, Requirements Engineering, Requirements Management, Software traceability, Requirements Traceability, Medical device software traceability, Software Engineering, Medical devices, Software Engineering education, Software Requirement Engineering, Qualitative methodology, Information Retrieval, Case Study Research, Focus Groups, Software, Empirical Software Engineering, Software Engineering Economics, Barry W. Boehm, ISO/IEC 12207, Computer Science, and Research Methodologyedit
Research Interests:
Research Interests:
Identification and re-identification are two major security and privacy threats to medical imaging data. De-identification in DICOM medical data is essential to preserve the privacy of patients’ Personally Identifiable Information (PII)... more
Identification and re-identification are two major security and privacy threats to medical imaging data. De-identification in DICOM medical data is essential to preserve the privacy of patients’ Personally Identifiable Information (PII) and requires a systematic approach. However, there is a lack of sufficient detail regarding the de-identification process of DICOM attributes, for example, what needs to be considered before removing a DICOM attribute. In this paper, we first highlight and review the key challenges in the medical image data de-identification process. In this paper, we develop a two-stage de-identification process for CT scan images available in DICOM file format. In the first stage of the de-identification process, the patient’s PII—including name, date of birth, etc., are removed at the hospital facility using the export process available in their Picture Archiving and Communication System (PACS). The second stage employs the proposed DICOM de-identification tool fo...
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The open and cooperative nature of cyber-physical systems (CPS) poses a significant new challenge in assuring dependability. A European-funded project named DEIS addresses this important and unsolved challenge by developing technologies... more
The open and cooperative nature of cyber-physical systems (CPS) poses a significant new challenge in assuring dependability. A European-funded project named DEIS addresses this important and unsolved challenge by developing technologies that facilitate the efficient synthesis of components and systems based on their dependability information. The key innovation that is the aim of DEIS is the corresponding concept of a Digital Dependability Identity (DDI). A DDI contains all the information that uniquely describes the dependability characteristics of a CPS or CPS component.
Research Interests:
Research Interests: Computer Science, Requirements Engineering, Software Process Improvement and Assessment, Software Development, Software Engineering education, and 6 moreEmpirical Software Engineering, Trace, Software Requirement Engineering, Requirements Management, Software traceability, and Requirements Traceability
Research Interests:
Research Interests:
Research Interests:
Abstract. Developing safety critical software is a complex process. Due to the fact that medical device software failure can lead to catastrophic consequences, numerous standards have been developed which govern software development in... more
Abstract. Developing safety critical software is a complex process. Due to the fact that medical device software failure can lead to catastrophic consequences, numerous standards have been developed which govern software development in the medical device domain. Risk management has an important role in medical device software development as it is important to ensure that safe software is developed. Demonstrating traceability of requirements right throughout the medical device software development and maintenance lifecycles is an important part of demonstrating that ‘safe ’ software has been produced through adopting defined processes. Consequently, medical device standards and guidelines emphasise the need for traceability. This paper outlines the extent and diversity of traceability requirements within medical device standards and guidelines, and identifies the requirements for traceability through each phase of the software development lifecycle. The paper also summarises the find...
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Research Interests:
Cyber-Physical-Systems (CPS) are systems of collaborating computational entities. Concepts such as autonomous cars, smart electric grid, implanted medical devices and smart manufacturing are some practical examples of CPS. However, the... more
Cyber-Physical-Systems (CPS) are systems of collaborating computational entities. Concepts such as autonomous cars, smart electric grid, implanted medical devices and smart manufacturing are some practical examples of CPS. However, the open and cooperative nature of CPS poses a significant new challenge in assuring dependability. The DEIS project addresses this important and unsolved challenge by developing technologies that facilitate the efficient synthesis of components and systems based on their dependability information. The key innovation that is the aim of DEIS is the corresponding concept of a Digital Dependability Identity (DDI). A DDI contains all the information that uniquely describes the dependability characteristics of a CPS or CPS component. DDIs are synthesised at development time and are the basis for the (semi-)automated integration of components into systems during development, as well as for the fully automated dynamic integration of systems into systems of syste...
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Wireless Body Area Network (WBAN) based healthcare applications are gaining popularity due to advancements in sensors and wireless communication. WBAN based healthcare applications collect health-related data and this makes them more... more
Wireless Body Area Network (WBAN) based healthcare applications are gaining popularity due to advancements in sensors and wireless communication. WBAN based healthcare applications collect health-related data and this makes them more attractive to attackers. Assuring security and privacy of the data in a WBAN application is a key challenge for an organization. Most developers have limited knowledge of market-specific regulatory requirements and security standards, and there are a vast number of security controls with insufficient implementation details. This makes it challenging for developers to implement countermeasures to assure security and privacy. The goal of this paper is to present the methodology used to develop a data security and privacy risk management framework for WBAN healthcare applications. Furthermore, we outline how the framework addresses the aforementioned challenges.
Research Interests:
Cyber-Physical-Systems (CPS), such as smart cars and implanted medical devices, are systems of collaborating computational entities. The open and cooperative nature of CPS poses a significant new challenge in assuring dependability. The... more
Cyber-Physical-Systems (CPS), such as smart cars and implanted medical devices, are systems of collaborating computational entities. The open and cooperative nature of CPS poses a significant new challenge in assuring dependability. The DEIS project addresses this important and unsolved challenge through its key innovation which is the concept of a Digital Dependability Identity (DDI). A DDI contains all the information that uniquely describes the dependability characteristics of a CPS or CPS component. Data protection and privacy is a key component of dependability and is regulated by the General Data Protection Regulation (GDPR) for all European Union (EU) and European Economic Area (EEA) citizens.
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Requirements validation, compliance verification and impact analysis are important activities that are performed during the software development lifecycle. Traceability of requirements through the software development lifecycle (SDLC) is... more
Requirements validation, compliance verification and impact analysis are important activities that are performed during the software development lifecycle. Traceability of requirements through the software development lifecycle (SDLC) is essential in the development of safety critical software. Organisations such as the Food and Drug Administration and the Federal Aviation Authority in the United States require traceability as part of their approval process. However, despite its criticality there is extensive digression in the practices and usefulness of traceability across development projects. Many projects’ traceability efforts are simply focused on satisfying regulations and do not leverage the many benefits of traceability. Traceability, if fully implemented is an important tool for managing system development and there are a number of published best practices to help companies with this implementation. By means of a literature review we record a list of the commonly accepted b...
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Software failure in the medical device domain can lead to injury or death. Controlling this risk is fundamental to producing quality software. To produce quality software, an effective requirements and hazards traceability process is... more
Software failure in the medical device domain can lead to injury or death. Controlling this risk is fundamental to producing quality software. To produce quality software, an effective requirements and hazards traceability process is required. Hence traceability is central to medical device software development. It is also an essential requirement for regulatory approval. The necessity for traceability is reinforced by the medical device standards and guidelines. In this paper we outline how traceability is an important part of medical device software development, what standards contain reference to traceability, and which specific clauses within those standards companies should refer to when defining their traceability processes. We also summarise the findings obtained when a lightweight assessment method (Med-Trace), that we created, based upon the traceability practices within these standards, was implemented in two SME organizations.
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Assuring security and privacy of data is a key challenge for organizations when developing WBAN applications. The reasons for this challenge include (i) developers have limited knowledge of market-specific regulatory requirements and... more
Assuring security and privacy of data is a key challenge for organizations when developing WBAN applications. The reasons for this challenge include (i) developers have limited knowledge of market-specific regulatory requirements and security standards, and (ii) there are a vast number of security controls with insufficient implementation detail. To address these challenges, we have developed a WBAN data security and privacy risk management framework. The goal of this paper is trifold. First, we present the methodology used to develop the framework. The framework was developed by considering recommendations from legislation and standards. Second, we present the findings from an initial validation of the framework’s usability and effectiveness of the security and privacy controls. Finally, we present an updated version of the framework and explain how it addresses the aforementioned challenges.
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Research Interests:
Digital transformation fundamentally changes established practices in public and private sector. Hence, it represents an opportunity to improve the value creation processes (e.g., “industry 4.0”) and to rethink how to address... more
Digital transformation fundamentally changes established practices in public and private sector. Hence, it represents an opportunity to improve the value creation processes (e.g., “industry 4.0”) and to rethink how to address customers' needs such as “data-driven business models” and “Mobility-as-a-Service”. Dependable, collaborative and autonomous systems are playing a central role in this transformation process. Furthermore, the emergence of data-driven approaches combined with autonomous systems will lead to new business models and market dynamics. Innovative approaches to reorganise the value creation ecosystem, to enable distributed engineering of dependable systems and to answer urgent questions such as liability will be required. Consequently, digital transformation requires a comprehensive multi-stakeholder approach which properly balances technology, ecosystem and business innovation. Targets of this paper are (a) to introduce digital transformation and the role of / op...
