Instrumental and Transformative Medical Technologies

This Article considers how medical technologies impact universality in health care. The universality principle, as embodied in the Patient Protection and Affordable Care Act (A CA), eliminated widespread discriminatory practices and provided financial assistance to those otherwise unable to become insured a democratizing federal act that was intended to stabilize health care policy nationwide. This Article posits that medical technology, as with all of medicine, can be universalizing or exclusionary and that this status roughly correlates to its being instrumental technology or transformative technology. Instrumental technology acts as a tool of medicine and often serves an existing aspect of health care; in contrast, transformative technology is pioneering, meaning it creates a new form of care or otherwise is novel. Instrumental and transformative medical technologies provide end points on a continuum, which provides a lens through which to examine whether medical technology has greater potential to facilitate universality or exclusion. The Article first examines where technologies fit on the instrumental-transformative continuum and then considers measures more specific to universality, namely improving the quality of medical care, access to care, or the cost of care. These considerations help to pinpoint the moment at which a technology may have a universalizing effect, if at all. The Article concludes with preliminary thoughts regarding whether the instrumental-transformative continuum helps to determine whether certain technologies should be adopted or supported publically or allowed to develop (or fail) organically.

Instrumental and Transformative Medical Technology

This Article considers how medical technologies impact universality in health care. The universality principle, as embodied in the Patient Protection and Affordable Care Act (ACA), eliminated widespread discriminatory practices and provided financial assistance to those otherwise unable to become insured—a democratizing federal act that was intended to stabilize health care policy nationwide. This Article posits that medical technology, as with all of medicine, can be universalizing or exclusionary and that this status roughly correlates to its being “instrumental technology” or “transformative technology.” Instrumental technology acts as a tool of medicine and often serves an existing aspect of health care; in contrast, transformative technology is pioneering, meaning it creates a new form of care or otherwise is novel. Instrumental and transformative medical technologies provide end points on a continuum, which provides a lens through which to examine whether medical technology has greater potential to facilitate universality or exclusion. The Article first examines where technologies fit on the instrumental-transformative continuum and then considers measures more specific to universality, namely improving the quality of medical care, access to care, or the cost of care. These considerations help to pinpoint the moment at which a technology may have a universalizing effect, if at all. The Article concludes with preliminary thoughts regarding whether the instrumental-transformative continuum helps to determine whether certain technologies should be adopted or supported publically or allowed to develop (or fail) organically

The Essence of Software Engineering

Software Engineering; Software Development; Software Processes; Software Architectures; Software Managemen

Information Technology as Coordination Infrastructure

Business information technology is traditionally viewed as information provision technology. In this view, organizations use their IT to implement databases that provide people with information when they want it. This view is persistent even though information provision is never an end in itself but always has the further purpose to support the coordination of activities of people. The role if IT as coordination technology became more prominent in the 1980s with the advent of network technology, that allowed activities across different businesses to be coordinated. This trend has accellerated since the growth of Internet usage, and today IT is used to support an increasingly varied range of processes performed by a variety of partners that do not all have a hierarchical relation to each other. This makes it difficult to analyze requirements for IT support and specify IT solutions: Business processes may not be well-defined, and interests of different businesses may clash. This report argues that to deal with this in requirements engineering and IT solution specification, business information technology should not be viewed as IT support for business processes but as IT support for the coordination of activities in one or more businesses. We will identify three basic coordination mechanisms, namely coordination by price, by management, and by shared norms, and for each of these mechanisms, we will identify requirements for IT support. The advent of flexible and standardized networking technology has facilitated the creation of novel coordination mechanisms within these three general paradigms, and we will give an inventory of generalized coordination mechanisms made possible by current IT. Finally, we will draw conclusions for requirements engineering methods for IT support for each of the coordination mechanisms identified by the framework

Full Stack Application Generation for Insurance Sales based on Product Models

The insurance market is segregated in various lines-of-business such as Life, Health, Property & Casualty, among others. This segregation allows product engineers to focus on the rules and details of a speci c insurance area. However, having di erent conceptual models leads to an additional complexity when a generic presentation layer application has to be continuously adapted to work with these distinct models. With the objective to streamline these continuous adaptations in an existent presentation layer, this work investigates and proposes the usage of code generators to allow a complete application generation, able to communicate with the given insurance product model. Therefore, this work compares and combines di erent code generation tools to accomplish the desired application generation. During this project, it is chosen an existing framework to create several software layers and respective components such as necessary classes to represent the Domain Model ; database mappings; Service layer; REST Application Program Interface (API); and a rich javascript-based presentation layer. As a conclusion, this project demonstrates that the proposed tool can generate the application already adapted and able to communicate with the provided conceptual model. Proving that this autonomous process is faster than the current manual development processes to adapt a presentation layer to an Insurance product model.O mercado segurador encontra-se dividido em várias linhas-de-negócio (e.g. Vida, Saúde, Propriedade) que têm naturalmente, diferentes modelos conceptuais para a representação dos seus produtos. Esta panóplia de modelos leva a uma dificuldade acrescida quando o software de camada de apresentação tem que ser constantemente adaptado aos novos modelos bem como ás alterações efetuadas aos modelos existentes. Com o intuito de suprimir esta constante adaptação a novos modelos, este trabalho visa a exploração e implementação de geradores de código de forma a permitir gerar toda uma aplicação que servirá de camada de apresentação ao utilizador para um dado modelo. Assim, este trabalho expõe e compara várias ferramentas de geração de código actualmente disponíveis, de forma a que seja escolhida a mais eficaz para responder aos objectivos estabelecidos. É então selecionada a ferramenta mais promissora e capaz de gerar vários componentes de software, gerando o seu modelo de domínio, mapeamento com as respectivas tabelas de base de dados, uma camada de lógica de negócio, serviços REST bem como uma camada de apresentação. Como conclusão, este trabalho apresenta uma solução que é capaz de se basear num modelo proveniente do sistema de modelação de produto e assim gerar completamente a aplicação de camada de apresentação desejada para esse mesmo modelo. Permitindo assim, um processo mais rápido e eficaz quando comparado com os processos manuais de desenvolvimento e de adaptação de código-fonte existentes

Enhancing the Auditability of the Agile XP Software Development Process in the Context of EU Medical Device Regulations

Nowadays, there is increasing reliance on software in the healthcare industry, such as software used for diagnostic or therapeutic purposes and software embedded in a medical device, often known as medical device software. Regulatory compliance has become increasingly visible in healthcare industries. Software development companies that develop medical devices software in Europe must comply with EU Medical Device Regulation (EU MDR) regulations in order to get the CE marking. Agile development practices are increasingly adopted by generic software development companies. For example, agile extreme programming (XP) is now considered a common model of choice for many business-critical projects. The reason behind that is that Agile XP has several benefits, such as developing high-quality software with a low cost and in a short period of time, with the capability to embrace any changing requirements during the development process. However, healthcare industries still have a low rate of agile adoption. This is due to the challenges that software developers face when using Agile XP within the stringent requirements of healthcare regulations. These challenges are the lack of fixed up-front planning, lack of documentation, traceability issues, and formality issues. Agile software companies must provide evidence of EU MDR conformity, and they need to develop their own procedures, tools, and methodologies to do so. As yet, there is no consensus on how to audit the Agile XP software companies to ensure that their software processes have been designed and implemented in conformity with EU MDR requirements. The motivation of this research is to assist the companies developing medical device software that wish to adopt Agile XP practices in their effort to meet the EU MDR certification requirements (CE marking). In addition, this research aims to help the information system auditors to extract auditing evidence that demonstrates conformity to the EU MDR requirements that must be met by Agile XP software organisations. This research will try to answer three main questions: Do Agile XP practices support the EU MDR requirements? Is it possible to adopt Agile XP practices when developing medical devices software? Is it possible to submit conformity evidence to EU MDR auditors? The main aim of this research is to enhance the auditability of the Agile XP software development process in the context of EU MDRs. This aim can be achieved by two main objectives: first, proposing an extension to the Agile XP user story to enhance the early planning activities of Agile XP according to EU MDR requirements. Second, designing an auditing model that covers the requirements of EU MDR. This auditing model should provide the EU MDR auditors with auditing evidence that the medical device software developed with an Agile XP process has fulfilled the requirements of EU MDR. The main contribution of this research study is the auditing model for EU MDR requirements that is aligned with the principles of Agile XP. The proposed auditing model would help auditors to audit the Agile XP development process of the medical device with regard to the EU MDR requirements in way of obtaining evidence in conformity to EU MDR requirements. And also, this auditing model can be considered as a guideline that would guide the Agile XP developers to follow the EU MDR requirements. The proposed auditing model has been assessed based on relevant case studies. As result, the evidence gathered shows at least partial support for the requirements in each case study. However, no case study has been demonstrated as supporting fully the auditing yardsticks of the proposed auditing model

Working Notes from the 1992 AAAI Workshop on Automating Software Design. Theme: Domain Specific Software Design

The goal of this workshop is to identify different architectural approaches to building domain-specific software design systems and to explore issues unique to domain-specific (vs. general-purpose) software design. Some general issues that cut across the particular software design domain include: (1) knowledge representation, acquisition, and maintenance; (2) specialized software design techniques; and (3) user interaction and user interface

Guidelines for analysis and modelling of reactive software systems

Dissertação de mestrado em Engenharia InformáticaReactive software systems are distinguished by their ability to interact with the environment in which they operate. Their behaviour is affected by a finite set of events that change the system global state. Such systems can be divided into three components: Controller, Users and Physical Entities; this division allows to model the particular behaviour of each component separately. Coloured Petri Nets (CPNs) are a modeling language suitable for behavioural modelling, thus it can be used in the context of these systems. Among several advantages (and some shortcomings), they allow CPN models to be simulated and the formally verified. This dissertation presents a set of guidelines for analysis and modeling of reactive software systems. The guidelines suggest how different components of a system can be identified and characterised. The guidelines also recommend various alternatives for modelling the system components with the CPN modelling language. The guidelines are illustrated with a practical example, which is modelled by means of CPN Tools, a tool for designing CPN models. The application of the guidelines allows CPN models specifically targeted for reactive software systems to benefit from executability, modularity, parameterization, and configurability.Os sistemas de software reativos são caracterizados pela sua capacidade de interagir com o meio em que se inserem. O comportamento dum sistema deste tipo é influenciado por eventos que, quando ocorrem, alteram o estado global desse sistema. Tais sistemas podem ser divididos em três componentes: Controlador, Entidades Físicas e Utilizadores; o que permite modelar sepa- radamente o comportamento que caracteriza cada um desses componentes. As Redes de Petri Coloridas (RdP Coloridas) são uma linguagem de mo- delação adequada a sistemas com uma significativa componente comporta- mental, pelo que podem ser usadas no contexto dos sistemas de software reativos. Entre diversas vantagens (e algumas limitações) elas permitem que os modelos sejam simulados e formalmente verificados. Este trabalho apresenta um conjunto de diretrizes de analise e modelação de sistemas de software reativos. No processo de analise, sugere-se como podem ser identificados e caracterizados os diferentes componentes de um sistema. No processo de modelação, recomendam-se varias formas de modelar cada componente com RdP Coloridas. As diretrizes são ilustradas com um exemplo pratico, o qual é modelado com o auxílio da ferramenta de desenho de RdP Coloridas, CPN Tools. A aplicação das diretrizes no contexto referido permite obter modelos que beneficiam de executabilidade, modularidade, parameterização e configurabilidade

Software maintenance cost estimation with fourth generation languages

This thesis addresses the problem of allocation of software maintenance resources in a commercial environment using fourth generation language systems. The activity of maintaining software has a poor image amongst software managers, as it often appears that there is no end product. This image will only improve when software maintenance can be discussed in business terms, one of the main reasons being that the maintenance costs can then be compared to the costs of not maintaining the system. Software maintenance will continue to exist in the fourth generation environment, as systems will still be required to evolve. Cost estimation is an imprecise science, as there are many variables such as human, technical, environmental and political which can effect the ultimate costs of software and the resources required to maintain it. Some of the factors appear more obvious than others, for example an experienced programmer can achieve a specific task in less time than an inexperienced one. To fully estimate software maintenance costs these factors need to be identified and weights assigned to them. This thesis examines a means to identify these factors and their weights, and produces the first cut of an equation which will enable the software maintenance resources in a fourth generation language to be estimated