Externalities and Enterprise Software: Helping and Hindering Legal Compliance

Enterprise software helps organizations comply with laws and regulations, yet software itself creates negative externalities that can undermine rights and laws. Software developers are an important regulatory force, yet many know little about how law and software interact. This work examines developer understanding of legal concepts and examples of the software code and law relationship: payroll, Sarbanes Oxley Act, web accessibility, and data protection

Risk Management System for Medical Standalone Software

According to update of Medical Device Directive (MDD) by European Union in 2007, the software as such can be a medical device. The direct consequence of the change of the directive is, that now depending on the intended use of software, the software might be regulated according to the MDD. If the software is classified to be a medical device, manufacturer has to fulfill the requirements of MDD to get CE mark for software. Most of the requirements are fulfilled by using three standards: IEC 62304 Software life cycle processes, ISO 14971 Application of risk management to medical devices and ISO 13485 Quality management systems. The purpose of the thesis is to discuss the influence of regulation to medical device, classified as software, globally and in Europe and also the influence of three mandatory standards. The risk management standard is processed in more detail and the develop-ment of risk management system is based on it. The risk management system was con-structed according to characteristics of medical standalone software. The goal of the thesis was to model the risk factors in the software environment and build the risk man-agement system around the model. The risk management system is based on the Risk factors model, which is developed in this thesis. In the model, the use of software was divided into seven factors that together or alone could contribute a hazardous situation in using the software. The developed risk management system consisted of four parts: preliminary planning, software development, post-production use and operation, and production and post-production information collecting system. The risk management system is one of the essential requirements to launch new medical device. For a software, which is classified as a medical device there is no established a way to fulfill the regulative requirements of risk management system, because the change in the MDD is new. The thesis presents one approach to fulfill the requirements and produce more safe software. /Kir1

Flow and Frustration – an assessment of the impact of software design on the usability of applications within a working environment

Many people spend a lot of their time on computers in work environments, and their usage of these is different from their usage in leisure environments. This study addresses how to make the interactions in this type of task work for the user and thereby enable the user to be more efficient and productive at work. The literature survey considers the dichotomy of flow – as defined by Csikszentmihalyi – and frustration (defined here in Chapter 2). Through a series of surveys and experiments, this study examines how people think and process information during work-type activities. This is crucial to understanding how the “flow” state can be achieved because it is a central thesis that this is where these human processes are working at their best. The initial survey uses a questionnaire about the experience of work and leisure by the participants. The aim is to understand and define the difference between these experiences. Following this, interviews are used to draw out some significant aspects of positive and negative experience of computer usage. These features are then verified in a second empirical study using a different data source, which enables a more comprehensive questionnaire to be produced aimed at providing more detailed data for analysis to understand the types of users and the circumstances in they have used computer systems. This provides some insights into the experience that users have, against some demographics, demonstrating that, broadly, the categorisations are appropriate This study then explores the frustration aspect (and, by contrast, how to avoid frustration) using two experimental studies. The first looks specifically at the design of a user interface and the impact that this has on the usage. The second examines the processing and achievement of tasks with varying levels of “built in” frustration-inducing elements, including impossible tasks. This experiment shows that tasks that are simple to specify but difficult to achieve build up levels of frustration that are carried into further tasks and cause users to be less productive, even for simpler-seeming tasks. My thesis provides strong evidence for the validity of the flow concept as defined by Csikszentmihalyi and that this can be contrasted with frustration in a predictive dichotomy. It indicates that the concept works within the field of computer system usage, and there is some indication that providing an IT environment that encourages flow will provide a far more productive working environment than one which inhibits flow. The flow-frustration dichotomy is identified as a valid and productive one for computer interaction design. By understanding the flow-frustration dichotomy designers can aim to ensure interfaces enable user tasks that flow naturally enabling them to be free from frustration and therefore more efficient and productive