Prototyping Closed Loop Physiologic Control With the Medical Device Coordination Framework

Medical devices historically have been monolithic units – developed, validated, and approved by regulatory authorities as standalone entities. Despite the fact that modern medical devices increasingly incorporate connectivity mechanisms that enable device data to be streamed to electronic health records and displays that aggregate data from multiple devices, connectivity is not being leveraged to allow an integrated collection of devices to work together as a single system to automate clinical work flows. This is due, in part, to current regulatory policies which prohibit such interactions due to safety concerns. In previous work, we proposed an open source middleware framework and an accompanying model-based development environment that could be used to quickly implement medical device coordination applications – enabling a “systems of systems” paradigm for medical devices. Such a paradigm shows great promise for supporting many applications that increase both the safety and effectiveness of medical care as well as the efficiency of clinical workflows. In this paper, we report on our experience using our Medical Device Coordination Framework (MDCF) to carry out a rapid prototyping of one such application – a multi-device medical system that uses closed loop physiologic control to a affect better patient outcomes for Patient Controlled Anelgesic (PCA) pumps

Safety justification of healthcare applications using synthetic datasets

Background: Increasing numbers of intelligent healthcare applications are developed by analysing big data, on which they are trained. It is necessary to assure that such applications will be safe for patients; this entails validation against datasets. But datasets cannot be shared easily, due to privacy, and consent issues, resulting in delaying innovation. Realistic Synthetic Datasets (RSDs), equivalent to the real datasets, are seen as a solution to this. Objective: To develop the outline for safety justification of an application, validated with an RSD, and identify the safety evidence the RSD developers will need to generate. Method: Assurance case argument development approaches were used, including high level data related risk identification. Result: An outline of the justification of such applications, focusing on the contribution of the RSD. Conclusions: Use of RSD will require specific arguments and evidence, which will affect the adopted methods. Mutually supporting arguments can result in a compelling justification

Design Pillars for Medical Cyber-Physical System Middleware

Our goal is to improve patient outcomes and safety through medical device interoperability. To achieve this, it is not enough to build a technically perfect system. We present here our work toward the validation of middleware for use in interoperable medical cyber-physical systems. This includes clinical requirements, together with our methodology for collecting them, and a set of eighteen `design pillars\u27 that document the non-functional requirements and design goals that we believe are necessary to build a successful interoperable medical device system. We discuss how the clinical requirements and design pillars are involved in the selection of a middleware for our OpenICE implementation

A Decision Support Framework for Public Healthcare: An approach to Follow-up Support Service

The literature on the development of measurement help researchers consider two broad issues: the qualitative tasks of conceptually modelling constructs and operationalizing them in a set of indicators and the more quantitative issues of using estimation procedures to convert their data into estimates. While these issues are interdependent, these two streams of literature have been largely separate. With this paper, we aim to contribute toward the establishment of integral guidance on measurement development. We propose a conceptual framework that should connect more explicitly the qualitative issues of measurement design with its quantitative issues. By analysing common sources of error, we show how it can be used to identify the sources of error specific to a measurement. We further provide initial guidelines on how problematic indicators can be remedied. Finally, we suggest how future research could take a next step in synthesizing qualitative with quantitative issues to provide more integral guidelines

Understanding user participation in information security risk management

Risk management is the continuing process to control and manage the risk in organisation for identifying, accessing and controlling threats to an organisation’s capital and earning. The implementation of information security risk management (ISRM) helps to address the risks to information processed by an organisation that may help the organisation to manage the risk effectively. Involving the user throughout the process of ISRM is important to ensure that it provides an effective security risk management (SRM). There are limited evidence shows that user participation is important in ISRM. Therefore, the aim of this paper to investigate user participation in ISRM from user participation and access control constructs. A quantitative method is implemented by distributing a questionnaire to two different organisational backgrounds to 20 respondents. This paper presents the initial findings that user participation play a significant role towards ISRM by presenting the results from the two constructs. The findings contribute to the body of knowledge that understanding user participation in ISRM shows that the process of risk management is different between two organisational backgrounds

Understanding the Benefits of Agile Software Development in Regulated Environments

Agile software development has become increasingly popular in recent years. Applying agile methods, companies expect flexible planning, early delivery of the software product, and a continuous improvement of the development process itself. However, in regulated environments the use of agile development is not yet common practice. In such environments, various regulatory requirements apply which affect the software development process. This paper examines the use of agile software development in the regulated medical device industry and explores reasons for using agile methods although their use is limited. We interviewed agile software development teams in three different companies using semi-structured interviews. Using grounded theory methodology, we identify reasons why companies are using agile methods, even though problems and barriers exist. Our main achievement is the development of four categories, which describe the benefit of agile software development in regulated environments. These categories are master complexity, reduce effort, improve usability, and promote collaboration

Tailoring Software Development Methodologies for Reliability

In recent times, many organizations have sought ways of improving the quality of software products due to the complexity and continuous change in technological trends. These trends have given rise to more sophisticated software systems, which are required for proper functioning at all times. Most research literature proposes tailoring of standard development methodologies due to their inadequacies and inability to meet up with users’ needs and system requirements. Reliability engineering has become an approach towards addressing software systems complexity, and also serve as a guarantee towards quality conformance and assurance of software products. In this research paper, the importance of reliability and tailoring is discussed to lay the foundation for the integration of basic reliability engineering techniques into software development