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Keith A Pauley - One of the best experts on this subject based on the ideXlab platform.
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Healthcare Software assurance
American Medical Informatics Association Annual Symposium, 2006Co-Authors: Jason G Cooper, Keith A PauleyAbstract:Abstract Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of Software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with Healthcare Software systems, embedded Software in medical instrumentation, and other Healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete Software assurance activities. In addition, the FDA’s Software oversight processes require enhancement to include increasingly complex Healthcare systems such as Hospital Information Systems (HIS). The importance of complete Software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted. Introduction Software assurance is an oversight activity encompassing all phases of Software development, including hardware-Software integration activities. The assurance processes used, and the breadth and depth of their scope, will depend on several factors the most important of which is Software criticality. These activities integrate the concepts of quality assurance, safety assessment, and independent verification and validation analyses (see Figure 1). In the Healthcare Software arena, the most rigorous of assurance processes should be employed. Figure 1 – Software Assurance Process The methods employed in Software assurance have grown into industry and government standards. These standards are routinely enforced in mission and life-critical Software efforts, such as those employed by NASA and the Department of Defense. However, problems with process documentation, requirements, specifications, and quality-control issues continue to persist in Software systems today [1]. The United States’ federal regulatory requirements for medical devices, Software embedded in such devices, as well as standalone Software systems, leave a margin for necessary improvement. Software is not only used to create new Healthcare information technology solutions where system criticality is higher – it is also being used to manufacture certain medical devices and in medical device validation studies prior to market release [2]. All variants of critical, Healthcare-oriented Software systems should require comparable levels of federal oversight and independent review. Traditionally, medical devices have utilized a majority of hardware controls to operate safety-critical functionality. Software is becoming more pervasive in all facets of medical device design and development. As transitions from hardware to Software controls occur, there exists a more pressing need for formalized Software assurance processes. A well-documented and infamous industry example of assurance failures was highlighted in the Therac-25 incidents [3]. The Therac-25, a computerized
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AMIA - Healthcare Software assurance.
AMIA ... Annual Symposium proceedings. AMIA Symposium, 2006Co-Authors: Jason G Cooper, Keith A PauleyAbstract:Abstract Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of Software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with Healthcare Software systems, embedded Software in medical instrumentation, and other Healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete Software assurance activities. In addition, the FDA’s Software oversight processes require enhancement to include increasingly complex Healthcare systems such as Hospital Information Systems (HIS). The importance of complete Software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted. Introduction Software assurance is an oversight activity encompassing all phases of Software development, including hardware-Software integration activities. The assurance processes used, and the breadth and depth of their scope, will depend on several factors the most important of which is Software criticality. These activities integrate the concepts of quality assurance, safety assessment, and independent verification and validation analyses (see Figure 1). In the Healthcare Software arena, the most rigorous of assurance processes should be employed. Figure 1 – Software Assurance Process The methods employed in Software assurance have grown into industry and government standards. These standards are routinely enforced in mission and life-critical Software efforts, such as those employed by NASA and the Department of Defense. However, problems with process documentation, requirements, specifications, and quality-control issues continue to persist in Software systems today [1]. The United States’ federal regulatory requirements for medical devices, Software embedded in such devices, as well as standalone Software systems, leave a margin for necessary improvement. Software is not only used to create new Healthcare information technology solutions where system criticality is higher – it is also being used to manufacture certain medical devices and in medical device validation studies prior to market release [2]. All variants of critical, Healthcare-oriented Software systems should require comparable levels of federal oversight and independent review. Traditionally, medical devices have utilized a majority of hardware controls to operate safety-critical functionality. Software is becoming more pervasive in all facets of medical device design and development. As transitions from hardware to Software controls occur, there exists a more pressing need for formalized Software assurance processes. A well-documented and infamous industry example of assurance failures was highlighted in the Therac-25 incidents [3]. The Therac-25, a computerized
Jason G Cooper - One of the best experts on this subject based on the ideXlab platform.
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Healthcare Software assurance
American Medical Informatics Association Annual Symposium, 2006Co-Authors: Jason G Cooper, Keith A PauleyAbstract:Abstract Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of Software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with Healthcare Software systems, embedded Software in medical instrumentation, and other Healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete Software assurance activities. In addition, the FDA’s Software oversight processes require enhancement to include increasingly complex Healthcare systems such as Hospital Information Systems (HIS). The importance of complete Software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted. Introduction Software assurance is an oversight activity encompassing all phases of Software development, including hardware-Software integration activities. The assurance processes used, and the breadth and depth of their scope, will depend on several factors the most important of which is Software criticality. These activities integrate the concepts of quality assurance, safety assessment, and independent verification and validation analyses (see Figure 1). In the Healthcare Software arena, the most rigorous of assurance processes should be employed. Figure 1 – Software Assurance Process The methods employed in Software assurance have grown into industry and government standards. These standards are routinely enforced in mission and life-critical Software efforts, such as those employed by NASA and the Department of Defense. However, problems with process documentation, requirements, specifications, and quality-control issues continue to persist in Software systems today [1]. The United States’ federal regulatory requirements for medical devices, Software embedded in such devices, as well as standalone Software systems, leave a margin for necessary improvement. Software is not only used to create new Healthcare information technology solutions where system criticality is higher – it is also being used to manufacture certain medical devices and in medical device validation studies prior to market release [2]. All variants of critical, Healthcare-oriented Software systems should require comparable levels of federal oversight and independent review. Traditionally, medical devices have utilized a majority of hardware controls to operate safety-critical functionality. Software is becoming more pervasive in all facets of medical device design and development. As transitions from hardware to Software controls occur, there exists a more pressing need for formalized Software assurance processes. A well-documented and infamous industry example of assurance failures was highlighted in the Therac-25 incidents [3]. The Therac-25, a computerized
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AMIA - Healthcare Software assurance.
AMIA ... Annual Symposium proceedings. AMIA Symposium, 2006Co-Authors: Jason G Cooper, Keith A PauleyAbstract:Abstract Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of Software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with Healthcare Software systems, embedded Software in medical instrumentation, and other Healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete Software assurance activities. In addition, the FDA’s Software oversight processes require enhancement to include increasingly complex Healthcare systems such as Hospital Information Systems (HIS). The importance of complete Software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted. Introduction Software assurance is an oversight activity encompassing all phases of Software development, including hardware-Software integration activities. The assurance processes used, and the breadth and depth of their scope, will depend on several factors the most important of which is Software criticality. These activities integrate the concepts of quality assurance, safety assessment, and independent verification and validation analyses (see Figure 1). In the Healthcare Software arena, the most rigorous of assurance processes should be employed. Figure 1 – Software Assurance Process The methods employed in Software assurance have grown into industry and government standards. These standards are routinely enforced in mission and life-critical Software efforts, such as those employed by NASA and the Department of Defense. However, problems with process documentation, requirements, specifications, and quality-control issues continue to persist in Software systems today [1]. The United States’ federal regulatory requirements for medical devices, Software embedded in such devices, as well as standalone Software systems, leave a margin for necessary improvement. Software is not only used to create new Healthcare information technology solutions where system criticality is higher – it is also being used to manufacture certain medical devices and in medical device validation studies prior to market release [2]. All variants of critical, Healthcare-oriented Software systems should require comparable levels of federal oversight and independent review. Traditionally, medical devices have utilized a majority of hardware controls to operate safety-critical functionality. Software is becoming more pervasive in all facets of medical device design and development. As transitions from hardware to Software controls occur, there exists a more pressing need for formalized Software assurance processes. A well-documented and infamous industry example of assurance failures was highlighted in the Therac-25 incidents [3]. The Therac-25, a computerized
Volker Haarslev - One of the best experts on this subject based on the ideXlab platform.
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towards a framework for requirement change management in Healthcare Software applications
Conference on Object-Oriented Programming Systems Languages and Applications, 2007Co-Authors: Arash Shabannejad, Volker HaarslevAbstract:Requirements volatility is an issue in Software development life cycle which often originated from our incomplete knowledge about the domain of interest. In this paper, we propose an agent-based approach to manage evolving requirements in biomedical Software applications using an integrated ontology-driven framework.
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OOPSLA Companion - Towards a framework for requirement change management in Healthcare Software applications
Companion to the 22nd ACM SIGPLAN conference on Object oriented programming systems and applications companion - OOPSLA '07, 2007Co-Authors: Arash Shaban-nejad, Volker HaarslevAbstract:Requirements volatility is an issue in Software development life cycle which often originated from our incomplete knowledge about the domain of interest. In this paper, we propose an agent-based approach to manage evolving requirements in biomedical Software applications using an integrated ontology-driven framework.
Michael Luck - One of the best experts on this subject based on the ideXlab platform.
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AOSE - Analysing the Suitability of Multiagent Methodologies for e-Health Systems
Lecture Notes in Computer Science, 2013Co-Authors: Emilia Garcia, Gareth Tyson, Simon Miles, Michael Luck, Adel Taweel, Tjeerd Van Staa, Brendan DelaneyAbstract:Online e-health systems are being proposed and developed at an ever increasing rate. However, the progress relies on the interoperability of local Healthcare Software, and is often hampered by ad hoc methods leading to closed systems with a multitude of protocols, terminologies, and design approaches. Agent-oriented Software engineering (AOSE) seems intuitively a good approach for developing more open systems. While agent-based e-health systems have been developed, the general hypothesis of the suitability of AOSE has not been evaluated. In this paper, we test that hypothesis, including a case study of applying a normative agent methodology to a particular real-world e-health system, and present an analysis of the strengths and weaknesses of AOSE for e-health.
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OTM Workshops - Agent-oriented Software engineering of distributed ehealth systems
Lecture Notes in Computer Science, 2013Co-Authors: Adel Taweel, Emilia Garcia, Simon Miles, Michael LuckAbstract:Development of distributed ehealth systems is increasingly becoming a common necessity to work across organisations to provide efficient services. This requires Healthcare information to be accessible, under appropriate safeguards, for research or Healthcare. However, the progress relies on the interoperability of local Healthcare Software, and is often hampered by ad hoc development methods leading to closed systems with a multitude of protocols, terminologies, and design approaches. The ehealth domain, by requirements, includes autonomous organisations and individuals, e.g. patients and doctors, which would make AOSE a good approach to developing systems that are potentially more open yet retain more local control and autonomy. The paper presents the use of AOSE to develop a particular distributed ehealth system, IDEA, and evaluates its suitability to develop such systems in general.
Alka Agrawal - One of the best experts on this subject based on the ideXlab platform.
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a fuzzy topsis based analysis toward selection of effective security requirements engineering approach for trustworthy Healthcare Software development
BMC Medical Informatics and Decision Making, 2020Co-Authors: Tarique Jamal Ansari, Fahad Ahmed Alzahrani, Dhirendra Pandey, Alka AgrawalAbstract:Today’s Healthcare organizations want to implement secure and quality Healthcare Software as cyber-security is a significant risk factor for Healthcare data. Considering security requirements during trustworthy Healthcare Software development process is an essential part of the quality Software development. There are several Security Requirements Engineering (SRE) methodologies, framework, process, standards available today. Unfortunately, there is still a necessity to improve these security requirements engineering approaches. Determining the most suitable security requirements engineering method for trustworthy Healthcare Software development is a challenging process. This study is aimed to present security experts’ perspective on the relative importance of the criteria for selecting effective SRE method by utilizing the multi-criteria decision making methods. The study was planned and conducted to identify the most appropriate SRE approach for quality and trustworthy Software development based on the security expert’s knowledge and experience. The hierarchical model was evaluated by using fuzzy TOPSIS model. Effective SRE selection criteria were compared in pairs. 25 security experts were asked to response the pairwise criteria comparison form. The impact of the recognized selection criteria for effective security requirements engineering approaches has been evaluated quantitatively. For each of the 25 participants, comparison matrixes were formed based on the scores of their responses in the form. The consistency ratios (CR) were found to be smaller than 10% (CR = 9.1% < 10%). According to pairwise comparisons result; with a 0.842 closeness coefficient (Ci), STORE methodology is the most effective security requirements engineering approach for trustworthy Healthcare Software development. The findings of this research study demonstrate various factors in the decision-making process for the selection of a reliable method for security requirements engineering. This is a significant study that uses multi-criteria decision-making tools, specifically fuzzy TOPSIS, which used to evaluate different SRE methods for secure and trustworthy Healthcare application development.
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A fuzzy TOPSIS based analysis toward selection of effective security requirements engineering approach for trustworthy Healthcare Software development.
BMC medical informatics and decision making, 2020Co-Authors: Tarique Jamal Ansari, Dhirendra Pandey, Fahad Ahmed Al-zahrani, Alka AgrawalAbstract:Today’s Healthcare organizations want to implement secure and quality Healthcare Software as cyber-security is a significant risk factor for Healthcare data. Considering security requirements during trustworthy Healthcare Software development process is an essential part of the quality Software development. There are several Security Requirements Engineering (SRE) methodologies, framework, process, standards available today. Unfortunately, there is still a necessity to improve these security requirements engineering approaches. Determining the most suitable security requirements engineering method for trustworthy Healthcare Software development is a challenging process. This study is aimed to present security experts’ perspective on the relative importance of the criteria for selecting effective SRE method by utilizing the multi-criteria decision making methods. The study was planned and conducted to identify the most appropriate SRE approach for quality and trustworthy Software development based on the security expert’s knowledge and experience. The hierarchical model was evaluated by using fuzzy TOPSIS model. Effective SRE selection criteria were compared in pairs. 25 security experts were asked to response the pairwise criteria comparison form. The impact of the recognized selection criteria for effective security requirements engineering approaches has been evaluated quantitatively. For each of the 25 participants, comparison matrixes were formed based on the scores of their responses in the form. The consistency ratios (CR) were found to be smaller than 10% (CR = 9.1%
