Safety-Critical Systems and Agile Development: A Mapping Study

In the last decades, agile methods had a huge impact on how software is developed. In many cases, this has led to significant benefits, such as quality and speed of software deliveries to customers. However, safety-critical systems have widely been dismissed from benefiting from agile methods. Products that include safety critical aspects are therefore faced with a situation in which the development of safety-critical parts can significantly limit the potential speed-up through agile methods, for the full product, but also in the non-safety critical parts. For such products, the ability to develop safety-critical software in an agile way will generate a competitive advantage. In order to enable future research in this important area, we present in this paper a mapping of the current state of practice based on {a mixed method approach}. Starting from a workshop with experts from six large Swedish product development companies we develop a lens for our analysis. We then present a systematic mapping study on safety-critical systems and agile development through this lens in order to map potential benefits, challenges, and solution candidates for guiding future research.Comment: Accepted at Euromicro Conf. on Software Engineering and Advanced Applications 2018, Prague, Czech Republi

An Agile Quality Management System For Laboratory Developed Tests

ABSTRACT AN AGILE QUALITY MANAGEMENT SYSTEM FOR LABORATORY DEVELOPED TESTS By RITA D’ANGELO MAY 2017 Advisor: Dr. Ratna Babu Chinnan Major: Industrial & Systems Engineering Degree: Doctor of Philosophy Statement of the Problem: We explore the 2014 draft guidance by the FDA entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDT) extended from the medical device industry and discuss how these requirements may be applicable to laboratory medicine. We introduce terms, definitions and provide a call for action for leaders to prepare for the potential adherence to regulatory requirements and explore if compliance was achievable in a laboratory environment to design, develop and validate Laboratory Developed Tests. If not, why not, and what would be the limiting steps. Method: We perform interviews with laboratory professionals to explore their concerns and challenges regarding the FDA draft guidance then translate the results into strategic factors. Based on the feedback, we surveyed laboratory experts in the field of LDT to develop and test strategic factors that would comprise an effective quality management system framework (QMS) to comply with the FDA proposal. We describe the methodology to translate the strategic factors into a design that would transform the existing laboratory structure into a regulatory quality management system. Conclusion: Nine interviewees and 35 survey respondents shared the importance of risk classification, process validation, patient safety and general ambiguity for the development of LDT. We utilize the top supporting statements and associated factors chosen by experts as extremely important for LDT development as the building blocks for implementation of a regulatory QMS framework. The framework includes six phases of implementation: 1) establishment of a leadership support structure, 2) training, 3) pre-assessment of current laboratory processes, 4) adoption of design control, 5) process controls, 6) process validation and the application of an agile Stage Gate technique for test development. Respondents agree that a regulatory agile quality management system is needed in laboratories that develop LDT. Utilizing the strategic factors, we develop a novel approach to LDT design, development and testing that extends the existing laboratory structure with a proven product development methodology technique called agile stage gate hybrid with the assignment of dedicated, accountable cross-functional teams for go/no-go approvals at every step and institute a coordinator position to review, document and expedite LDT development throughout the testing process

Ethical competence of a physiotherapist : Concept and evaluation

Interest in physiotherapy ethics and ethical competence have internationally increased during the last ten years. Physiotherapy raises ethical issues that should be actively discussed – ethical competence is a key area of professional expertise in physiotherapy. The aim of the study was to identify ethical problems that physiotherapists encounter and to analyse the concept of ethical competence in order to clarify and verify the definition of the concept in physiotherapy. The aim was also to develop an instrument to assess physiotherapists’ ethical competence. This study included four Phases. In the Identification phase I, a descriptive and correlational study design was chosen to describe ethical problems that physiotherapists encounter, and to find out how the demographic data influence encountering ethical problems (n=116). The Theoretical phase II consisted of a concept analysis of the concept ethical competence. The results of the Theoretical phase formed the basis for the development of the instrument. In the Empirical phase III, a newly developed, mainly structured instrument (PECET) was used to evaluate ethical competence of a physiotherapist (n=839). The Analytical phase IV included verification of the concept ethical competence. The conceptualisation was based on the Hybrid model by Schwartz-Barcott and Kim. Based on the results, physiotherapists encounter ethical problems related to everyday ethics even weekly. Ethical competence is needed to solve these issues. The concept of ethical competence is defined in terms of character strength, ethical awareness, moral judgement skills and willingness to do good. As these attributes were all illustrated in physiotherapists’ responses, the concept was verified in physiotherapy. Measured with the PECET, most of the respondents evaluated themselves highly ethically competent. Ethical codes of conduct were not well known among the respondents. The results of the study provide a theoretical framework for the concept of ethical competence and the development of the PECET, a thought-provoking tool as a part of ethical reflection, to evaluate the ethical competence of health professionals. In the future, research on ethical competence should be continued with more extensive data. It is also necessary to look at patients' views on ethical care and the importance of guidelines in ethical decision-making, in practice and during education.Fysioterapeutin eettinen osaaminen – Käsite ja arviointi Kiinnostus fysioterapian etiikkaa ja eettistä osaamista kohtaan on lisääntynyt viimeisen kymmenen vuoden aikana. Fysioterapia herättää eettisiä kysymyksiä, joista tulisi keskustella – Eettinen osaaminen määritellään yhdeksi fysioterapian ammatillisen osaamisen ydinalueeksi. Tämän tutkimuksen tarkoituksena oli kuvata fysioterapeuttien työssään kohtaamia eettisiä ongelmia ja analysoida eettisen osaamisen käsitettä käsitteen määritelmän selventämiseksi ja todentamiseksi fysioterapian käytännössä. Tarkoituksena oli myös kehittää mittari arvioimaan fysioterapeutin eettistä osaamista. Tutkimus suoritettiin neljässä vaiheessa: Identifikaatiovaihe I koostui niiden eettisten ongelmien kuvaamisesta, joita fysioterapeutit kohtaavat, sekä taustamuuttujien vaikutuksesta eettisten ongelmien kohtaamiseen (n=116). Teoreettinen vaihe II koostui käsitteen eettinen kompetenssi käsiteanalyyttisestä tarkastelusta. Teoreettisen vaiheen tulokset muodostivat perustan mittarin kehittämiselle. Empiirisessä vaiheessa III kerättiin aineisto fysioterapeutin eettisen osaamisen arvioimiseksi (n=839) itsearviointimittaria (PECET) käyttäen. Analyyttinen vaihe IV sisälsi eettisen kompetenssin käsitteen todentamisen fysioterapiakontekstissa. Käsitteellistäminen tehtiin hyödyntäen Schwartz-Barcott & Kimin Hybridistä mallia. Tulosten perusteella eettiset ongelmat ovat fysioterapeuteille jopa viikoittaisia. Näiden haasteiden ratkaisemiseksi tarvitaan eettistä osaamista. Eettisen kompetenssin käsitteen voidaan ajatella sisältävän luonteen vahvuuden, eettisen tietoisuuden, eettisen päätöksentekotaidon ja halun tehdä hyvää, ja näiden ominaispiirteiden esiintyessä fysioterapeuttien vastauksissa käsitteen olemassaolo voitiin todentaa. Tulosten perusteella suurin osa kyselyyn vastanneista fysioterapeuteista arvioi osaamisensa tason hyväksi kaikilla eettisen osaamisen alueilla. Eettisiä ohjeita ei tunnettu hyvin. Tutkimuksen tulokset tarjoavat teoreettisen kehyksen eettisen osaamisen käsitteelle ja PECET-mittarin kehittämiselle, tavoitteena terveydenhuollon ammattilaisten eettisen osaamisen arvioiminen käytännössä ja jo koulutuksen aikana. Tulevaisuudessa eettisen osaamisen tutkimusta kannattaa jatkaa laajemmalla aineistolla. Jatkossa on tarpeen tarkastella myös asiakkaiden näkemyksiä eettisestä hoidosta ja eettisten ohjeiden merkitystä eettisessä päätöksenteossa

A HYBRID METHODOLOGY FOR MODELING RISK OF ADVERSE EVENTS IN COMPLEX HEALTHCARE SETTINGS

Despite efforts to provide safe, effective medical care, adverse events still occur with some regularity. While risk cannot be entirely eliminated from healthcare activities, an important goal is to develop effective and durable mitigation strategies to render the system `safer'. In order to do this, though, we must develop models that comprehensively and realistically characterize the risk. In the healthcare domain, this can be extremely challenging due to the wide variability in the way that healthcare processes and interventions are executed and also due to the dynamic nature of risk in this particular domain. In this study we have developed a generic methodology for evaluating dynamic changes in adverse event risk in acute care hospitals as a function of organizational and non-organizational factors, using a combination of modeling formalisms. First, a system dynamics (SD) framework is used to demonstrate how organizational level and policy level contributions to risk evolve over time, and how policies and decisions may affect the general system-level contribution to adverse event risk. It also captures the feedback of organizational factors and decisions over time and the non-linearities in these feedback effects. Second, Bayesian Belief Network (BBN) framework is used to represent patient-level factors and also physician level decisions and factors in the management of an individual patient, which contribute to the risk of hospital-acquired adverse event. The model is intended to support hospital decisions with regards to staffing, length of stay, and investment in safeties, which evolve dynamically over time. The methodology has been applied in modeling the two types of common adverse events; pressure ulcers and vascular catheter-associated infection, and has been validated with eight years of clinical data

A hybrid model for managing personal health records in South Africa

Doctors can experience difficulty in accessing medical information of new patients. One reason for this is that the management of medical records is mostly institution-centred. The lack of access to medical information may negatively affect patients in several ways. These include new medical tests that may need to be carried out at a cost to the patient and doctors prescribing drugs to which the patient is allergic. This research investigates how patients can play an active role in sharing their personal health records (PHRs) with doctors located in geographically separate areas. In order to achieve the goal of this research, existing literature concerning medical health records and standards was reviewed. A literature review of techniques that can be used to ensure privacy of health information was also undertaken. Interview studies were carried out with three medical practices in Port Elizabeth with the aim of contextualising the findings from the literature study. The Design Science Research methodology was used for this research. A Hybrid Model for Managing Personal Health Records in South Africa is proposed. This model allows patients to view their PHRs on their mobile phones and medical practitioners to manage the patients’ PHRs using a web-based application. The patients’ PHR information is stored both on a cloud server and on mobile devices hence the hybrid nature. Two prototypes were developed as a proof of concept; a mobile application for the patients and a web-based application for the medical practitioners. A field study was carried out with the NMMU health services department and 12 participants over a period of two weeks. The results of the field study were highly positive. The successful evaluation of the prototypes provides empirical evidence that the proposed model brings us closer to the realisation of ubiquitous access to PHRS in South Africa

Data security in European healthcare information systems

This thesis considers the current requirements for data security in European healthcare systems and establishments. Information technology is being increasingly used in all areas of healthcare operation, from administration to direct care delivery, with a resulting dependence upon it by healthcare staff. Systems routinely store and communicate a wide variety of potentially sensitive data, much of which may also be critical to patient safety. There is consequently a significant requirement for protection in many cases. The thesis presents an assessment of healthcare security requirements at the European level, with a critical examination of how the issue has been addressed to date in operational systems. It is recognised that many systems were originally implemented without security needs being properly addressed, with a consequence that protection is often weak and inconsistent between establishments. The overall aim of the research has been to determine appropriate means by which security may be added or enhanced in these cases. The realisation of this objective has included the development of a common baseline standard for security in healthcare systems and environments. The underlying guidelines in this approach cover all of the principal protection issues, from physical and environmental measures to logical system access controls. Further to this, the work has encompassed the development of a new protection methodology by which establishments may determine their additional security requirements (by classifying aspects of their systems, environments and data). Both the guidelines and the methodology represent work submitted to the Commission of European Communities SEISMED (Secure Environment for Information Systems in MEDicine) project, with which the research programme was closely linked. The thesis also establishes that healthcare systems can present significant targets for both internal and external abuse, highlighting a requirement for improved logical controls. However, it is also shown that the issues of easy integration and convenience are of paramount importance if security is to be accepted and viable in practice. Unfortunately, many traditional methods do not offer these advantages, necessitating the need for a different approach. To this end, the conceptual design for a new intrusion monitoring system was developed, combining the key aspects of authentication and auditing into an advanced framework for real-time user supervision. A principal feature of the approach is the use of behaviour profiles, against which user activities may be continuously compared to determine potential system intrusions and anomalous events. The effectiveness of real-time monitoring was evaluated in an experimental study of keystroke analysis -a behavioural biometric technique that allows an assessment of user identity from their typing style. This technique was found to have significant potential for discriminating between impostors and legitimate users and was subsequently incorporated into a fully functional security system, which demonstrated further aspects of the conceptual design and showed how transparent supervision could be realised in practice. The thesis also examines how the intrusion monitoring concept may be integrated into a wider security architecture, allowing more comprehensive protection within both the local healthcare establishment and between remote domains.Commission of European Communities SEISMED proje

A comprehensive clinical guideline model and a reasoning mechanism for AAL systems

The progressive ageing of population combined with the need for comfort in situations of disease and disability are pushing healthcare organizations and governments to find new solutions to enable people to live longer in their preferred environment, while having access to quality healthcare services. iGenda is an Ambient Assisted Living platform that provides constant monitoring to people with this type of needs. The use of a Computer-Interpretable Guideline model for decision making is one of the features of this platform. The model used to represent Clinical Practice Guidelines gathers a set of features that make guidelines more dynamic and easily implementable. The model is defined using Ontology Web Language, profiting from the existing constructors provided by this language. It is based on a set of primitive tasks, namely Plans, Actions, Questions and Decisions. Focusing on decision support, a method for dealing with incomplete information about the clinical parameters of a health record is presented. The objective is to keep a continuous flow of information through the decision process and assuring that an outcome is always achieved. The usefulness of the integration of guideline recommendations with a reason mechanism capable of handling incomplete information is demonstrated through a case study about the diagnosis of metabolic syndrome.(undefined