Integrating Human Computer Interaction Testing into the Medical Device Approval Process

Medical devices that utilize computer software are becoming common place in today’s health care environment. In this paper we examine device failures in the area of the human computer interaction—a failure of the interface between the hardware/software in the medical device, and the person using the device. We make the case that human computer interaction testing—starting early on in the product development life cycle—should be required before medical devices are approved by the FDA. Use of human computer interaction testing of medical devices can improve device quality and user experience, and most importantly, has the potential to reduce serious health care outcome

The Marital and Physician Privileges—A Reprint of a Letter to a Congressman

A design of computer systems, that effectively supports the user, is a major goal within human-computer interaction. To achieve this, we must understand and master several tasks. These tasks concern firstly what to develop and secondly how to develop the system. The design and implementation of effective and efficient user interfaces is a prerequisite for the successful introduction of computer support in the medical domain. We base our work on a fundamental understanding of cognitive aspects of human-computer interaction, as well as on detailed analysis of the specific needs and requirements of the end users, i.e., the medical professionals. This thesis presents several approaches for development of systems for computer-supported work in health care. The solutions described concern vital problem areas: (1) the focus on the work tasks to be performed, (2) the cost of software and the way competition works in a networked world. Solutions to these problems can lead to more usable systems from a user's perspective but may also change the nature of computer applications

Surgery Training, Planning and Guidance Using the SOFA Framework

International audienceIn recent years, an active development of novel technologies dealing with medical training, planning and guidance has become an increasingly important area of interest in both research and health-care manufacturing. A combination of advanced physical models, realistic human-computer interaction and growing computational power is bringing new solutions in order to help both medical students and experts to achieve a higher degree of accuracy and reliability in surgical interventions. In this paper, we present three different examples of medical physically-based simulations implemented in a common software platform called SOFA. Each example represents a different application: training for cardiac electrophysiology, pre-operative planning of cryosurgery and per-operative guidance for laparoscopy. The goal of this presentation is to evaluate the realism, accuracy and efficiency of the simulations, as well as to demonstrate the potential and flexibility of the SOFA platform

Quid Pro Quod: Enhancing Patient Safety Via Minimizing Human-Computer Interactions Errors

The present describes an initial research project aiming at enhancing pa- tient safety. The overall goal is to minimize human-computer interactions errors that may occur via the use of Medical Information Systems (MIS) in health care units. The main idea is to extend the approach on design of usability and safety issues of generic medical devices, or safety critical systems design, to the problem domain of patient safety in the design of MIS. An understanding of errors and patient safety issues is presented and how these issues contribute to interaction errors in MIS. A plan of the research programm and related questions is presented. Is is expected that the outcome of a case study will be used for testing an evaluation framework, in development, that will take into account a rapid method for improving these aspects regarding the software development process

Formal techniques in the safety analysis of software components of a new dialysis machine

The paper is concerned with the practical use of formal techniques to contribute to the risk analysis of a new neonatal dialysis machine. The described formal analysis focuses on the controller component of the software implementation. The controller drives the dialysis cycle and deals with error management. The logic was analysed using model checking techniques and the source code was analysed formally, checking type correctness conditions, use of pointers and shared memory. The analysis provided evidence of the verification of risk control measures relating to the software component. The productive dialogue between the developers of the device, who had no experience or knowledge of formal methods, and the analyst using the formal analysis tools, provided a basis for the development of rationale for the effectiveness of the evidence. (C) 2019 Elsevier B.V. All rights reserved.This work has been funded by: EPSRC research grants EP/G059063/1 and EP/J008133/1: CHI+MED (Computer -Human Interaction for Medical Devices); and NanoSTIMA (ref. NORTE-01-0145-FEDER-000016) financed by the North Portugal Regional Operational Programme (NORTE 2020), under the PORTUGAL 2020 Partnership Agreement, and through the European Regional Development Fund (ERDF). Leo Freitas would like to acknowledge EPSRC Trams2 project for financial support, Andrew Sims for providing access to the dialyser, which was used as our case study and Aleksandrs Baklanovs for doing some of the source analysis as part of an undergraduate project

Using affective avatars and rich multimedia content for education of children with autism

Autism is a communication disorder that mandates early and continuous educational interventions on various levels like the everyday social, communication and reasoning skills. Computer-aided education has recently been considered as a likely intervention method for such cases, and therefore different systems have been proposed and developed worldwide. In more recent years, affective computing applications for the aforementioned interventions have also been proposed to shed light on this problem. In this paper, we examine the technological and educational needs of affective interventions for autistic persons. Enabling affective technologies are visited and a number of possible exploitation scenarios are illustrated. Emphasis is placed in covering the continuous and long term needs of autistic persons by unobtrusive and ubiquitous technologies with the engagement of an affective speaking avatar. A personalised prototype system facilitating these scenarios is described. In addition the feedback from educators for autistic persons is provided for the system in terms of its usefulness, efficiency and the envisaged reaction of the autistic persons, collected by means of an anonymous questionnaire. Results illustrate the clear potential of this effort in facilitating a very promising autism intervention