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Über dieses Buch

This book constitutes revised selected papers from the jointly held conferences FHIES 2014, 4th International Symposium on Foundations of Health Information Engineering and Systems, and SEHC 2014, 6th International Workshop on Software Engineering in Health Care. The meeting took place in Washington, DC, USA, in July 2014.

The 16 papers presented in this volume were carefully reviewed and selected from 23 submissions. They deal with security aspects of health information systems; medical devices in cyberphysical systems; the process of providing healthcare and of monitoring patients; and patient safety and the assurance of medical systems.



Patient Flow Monitoring Systems: Investigation of Alternatives

Hospitals need to reduce wait times in emergency rooms to ensure timely delivery of services. This paper provides an in-depth investigation and evaluation of three distinct approaches to provide real time monitoring of patient flow. The three approaches differ in the number and nature of their data sources. The results suggest that additional data sources provide only little improvements in the monitoring capabilities. Monitoring patient flow can be achieved in real time with potentially little need for expensive and complex integration with hospital information systems by collecting location data or by using data collected from electronic forms.
Omar Badreddin, Liam Peyton

Retrofitting Communication Security into a Publish/Subscribe Middleware Platform

The Medical Device Coordination Framework (MDCF) is an open source middleware package for interoperable medical devices, designed to support the emerging Integrated Clinical Environment (ICE) interoperability standard. As in any open system, medical devices connected to the MDCF or other ICE-like network should be authenticated to defend the system against malicious, dangerous, or otherwise unauthorized devices. In this paper, we describe the creation and integration of a pluggable, flexible authentication system into the almost 18,000 lines of MDCF codebase, and evaluate the performance of proof-of-concept device authentication providers. The framework is sufficiently expressive to support arbitrary modules implementing arbitrary authentication protocols using arbitrarily many rounds of communication. In contrast with the expected costs in securing nontrivial systems, often involving major architectural changes and significant degradation of system performance, our solution requires the addition of just over 1,000 lines of code (\(\sim {}\)5.56%), and incurs performance overhead only from the authentication protocols themselves, rather than from the framework.
Carlos Salazar, Eugene Y. Vasserman

Towards an AADL-Based Definition of App Architecture for Medical Application Platforms

There is a growing trend of developing software applications that integrate and coordinate the actions of medical devices. Unfortunately, these applications are being built in an ad-hoc manner without proper regard for established distributed systems engineering techniques. We present a tool prototype based on the OSATE2 distribution of the Eclipse IDE that targets the development of Medical Application Platform (MAP) apps. Our toolset provides an editing environment and translator for app architectures, i.e., their components and connections. The toolset generates interface definitions and glue code for the underlying MAP middleware, and it supports development of the business logic which the developer must write to complete the application within the same Eclipse-based environment. We also present a clinical scenario as a motivating example, trace its development through the toolset, and evaluate our work based on the experience.
Sam Procter, John Hatcliff, Robby

Energy-Aware Model-Driven Development of a Wearable Healthcare Device

The healthcare domain is experiencing an expansion of wearable embedded devices. These devices are typically battery powered and expected to deliver a safe and reliable service to the patient regardless of its power reserves. Being energy efficient brings an additional level of complexity to the development of these solutions. In this paper we propose the application of a well-founded model-driven energy-aware approach to tackle the energy consumption in such solutions addressing all their critical subsystems: control software, communication and mechanical components. The approach enables exploration of the design space, reduces prototyping costs and helps in build confidence in the proposed solution. We demonstrate this approach in a case study focused on the development of an intelligent compression stocking to treat leg-venous insufficiency. We also discuss how this approach has benefited the development of the actual device.
José Antonio Esparza Isasa, Peter Gorm Larsen, Finn Overgaard Hansen

Reasoning About Confidence and Uncertainty in Assurance Cases: A Survey

Assurance cases are structured logical arguments supported by evidence that explain how systems, possibly software systems, satisfy desirable properties for safety, security or reliability. The confidence in both the logical reasoning and the underlying evidence is a factor that must be considered carefully when evaluating an assurance case; the developers must have confidence in their case before the system is delivered and the assurance case reviewer, such as a regulatory body, must have adequate confidence in the case before approving the system for use. A necessary aspect of gaining confidence in the assurance case is dealing with uncertainty, which may have several sources. Uncertainty, often impossible to eliminate, nevertheless undermines confidence and must therefore be sufficiently bounded. It can be broadly classified into two types, aleatory (statistical) and epistemic (systematic). This paper surveys how researchers have reasoned about uncertainty in assurance cases. We analyze existing literature to identify the type of uncertainty addressed and distinguish between qualitative and quantitative approaches for dealing with uncertainty.
Lian Duan, Sanjai Rayadurgam, Mats P. E. Heimdahl, Anaheed Ayoub, Oleg Sokolsky, Insup Lee

Building Semantic Causal Models to Predict Treatment Adherence for Tuberculosis Patients in Sub-Saharan Africa

Poor adherence to prescribed treatment is a major factor contributing to tuberculosis patients developing drug resistance and failing treatment. Treatment adherence behaviour is influenced by diverse personal, cultural and socio-economic factors that vary between regions and communities. Decision network models can potentially be used to predict treatment adherence behaviour. However, determining the network structure (identifying the factors and their causal relations) and the conditional probabilities is a challenging task. To resolve the former we developed an ontology supported by current scientific literature to categorise and clarify the similarity and granularity of factors.
Olukunle A. Ogundele, Deshendran Moodley, Christopher J. Seebregts, Anban W. Pillay

From Requirements to Code: Model Based Development of a Medical Cyber Physical System

The advanced use of technology in medical devices has improved the way health care is delivered to patients. Unfortunately, the increased complexity of modern medical devices poses challenges for development, assurance, and regulatory approval. In an effort to improve the safety of advanced medical devices, organizations such as FDA have supported exploration of techniques to aid in the development and regulatory approval of such systems. In an ongoing research project, our aim is to provide effective development techniques and exemplars of system development artifacts that demonstrate state of the art development techniques.
In this paper we present an end-to-end model-based approach to medical device software development along with the artifacts created in the process. While outlining the approach, we also describe our experiences, challenges, and lessons learned in the process of formulating and analyzing the requirements, modeling the system, formally verifying the models, generating code, and executing the generated code in the hardware for generic patient controlled analgesic infusion pump (GPCA). We believe that the development artifacts and techniques presented in this paper could serve as a generic reference to be used by researchers, practitioners, and authorities while developing and evaluating cyber physical medical devices.
Anitha Murugesan, Mats P. E. Heimdahl, Michael W. Whalen, Sanjai Rayadurgam, John Komp, Lian Duan, Baek-Gyu Kim, Oleg Sokolsky, Insup Lee

Demonstrating that Medical Devices Satisfy User Related Safety Requirements

One way of contributing to a demonstration that a medical device is acceptably safe is to show that the device satisfies a set of requirements known to mitigate hazards. This paper describes experience using formal techniques to model an IV infusion device and to prove that the modelled device captures a set of requirements. The requirements chosen for the study are based on a draft proposal developed by the US Food and Drug Administration (FDA). A major contributor to device related errors are (user) interaction errors. For this reason the chosen models and requirements focus on user interface related issues.
Michael D. Harrison, Paolo Masci, Jose Creissac Campos, Paul Curzon

Secure and Customizable EHR Management Services with COASTmed

The exchange of electronic health records (EHR) among multiple parties and for multiple purposes raises nontrivial concerns. Unfortunately, privacy and operational policies granting individual access privileges to parties are often artifacts foreign to healthcare systems, thus EHR security is all the more frail. Moreover, current web service technologies that constitute many EHR systems treat users uniformly, making it more difficult for information consumers to use this data for specific purposes. Therefore, there is a need for EHR systems that offer secure, policy compliant access to data services and enable users to obtain the required information according to their individual authority. We present COASTmed, a notional EHR system that simultaneously offers provider-controlled differential service access and user-controlled customization. Our prototype is founded on the architectural principles of the COAST style and leverages the Rei policy language.
Alegria Baquero, Richard N. Taylor

Process Execution and Enactment in Medical Environments

Process models are increasingly recognized as an important asset for higher-quality healthcare. They may be used for analyzing, documenting, and explaining complex medical processes to the stakeholders involved in the process. Models may also be used for driving single processes or for orchestrating multiple ones. Model-driven software technologies therefore appear promising. In particular, process enactment provides software-based support for executing operational processes. A wide variety of possible enactment schemes are available in medical environments, e.g., to maintain daily medical worklists, to issue warnings or reminders in specific process states, to schedule tasks competing for resources, to provide on-the-fly advice in case of staff unavailability, and so forth. Such variety of possible process enactments calls for a common conceptual framework for defining, comparing, classifying, and integrating them. The paper introduces such a framework and describes a number of patterns for process execution and enactment based on it. These patterns result from a simple generic, goal-oriented model of medical process execution aiming at clarifying the role of software within the process and its environment. The patterns are illustrated on two real, non-trivial case studies.
Bernard Lambeau, Christophe Damas, Axel van Lamsweerde

Engineering a Performance Management System to Support Community Care Delivery

The engineering of health information technology (HIT) often focuses on clinical or hospital focused tasks. As more care is provided in the community there is an increasing need to monitor goals of care related to patient care delivery. These goals are often measured through performance metrics. Before we can track performance metrics we need to articulate the data and processes that define the metrics. However, the data sources are often varied and the processes ill-defined making it hard to engineer systems to collect and analyze metrics. Further, the ability to share data between organizations is impacted by culture, technology and privacy issues. To date there are few methodological approaches for modeling a health system from the perspective of metrics, data sources, and touch points to enable performance management of community based healthcare delivery. This paper addresses those shortcomings and presents a methodology for modeling goals, metrics and data to enable engineering of business intelligence applications for performance management of community based care.
Pillar Mata, Craig Kuziemsky, Jaspreet Singh, Aladdin Baarah, Liam Peyton

Towards Continuous Certification of Clinical Information Systems

Clinical information systems (CISs) play an increasingly pivotal role in modern health care delivery. They are safety-critical as well as sensitive with respect to security and privacy concerns. In the light of ongoing reports on CISs failures and technology-induced adverse events, policy-makers and regulators have been struggling to identify effective ways to ensure the quality of these systems. Existing regulatory frameworks and controls do not readily apply to CISs. This paper identifies the shortcomings of existing regulatory controls and proposes a new framework for regulating CIS, based on a notion of continuous certification. We exemplify the application of the proposed framework with a real-world case study of a perioperative CIS.
Jens H. Weber, Craig Kuziemsky

Applying Information System Hazard Analysis to an Episodic Document Context

In spite of wide spread knowledge in the Clinical Information Technology (CIT) community about the unintended and sometimes hazardous consequences of the implementation and use of this technology, the application of systematic hazard analysis techniques in the domain for implementation projects, change management operations, or even prospective or retrospective static analysis have been sparsely reported. We report on the application of the Information Systems Hazard Analysis (ISHA) process to a conceptual architecture based on implementations of an electronic medical document exchange standard which was recently prescribed in British Columbia, Canada. The application of the technique with a focus on control coordination hazards identified a number of well known CIT hazards as well as a variety of less known hazards which the context presents.
Fieran Mason-Blakley, Jens Weber, Abdul Roudsari, Morgan Price

Using PVSio-web to Demonstrate Software Issues in Medical User Interfaces

We have used formal methods technology to investigate software and user interface design issues that may induce use error in medical devices. Our approach is based on mathematical models that capture safety concerns related to the use of a device. We analysed nine commercial medical devices from six manufacturers with our approach, and precisely identified 30 design issues. All identified issues can induce use errors that could lead to adverse clinical consequences, such as numbers being incorrectly entered. An issue with formal approaches is in making results accessible to developers, human factors experts and clinicians. In this paper, we use our tool PVSio-web to demonstrate the identified issues: PVSio-web allows us to generate realistic and interactive user interface prototypes from the same mathematical models used for analysis. Users can explore the behaviour of the prototypes by pressing buttons on realistic user interfaces that reproduce the functionality and visual representation of the real devices. Users can examine the device behaviour resulting from any interaction. Key sequences identified from analysis can be used to explore in detail the identified design issues in an accessible way.
Paolo Masci, Patrick Oladimeji, Paul Curzon, Harold Thimbleby

A Tool for Analyzing Clinical Datasets as Blackbox

We present a technique for the automatic identification of clinically-relevant patterns in medical datasets. To preserve patient privacy, we propose and implement the idea of treating medical dataset as a black box for both internal and external users of data. The proposed approach directly handles clinical data queries on a given medical dataset, unlike the conventional approach of relying on the data de-identification process. Our integrated toolkit combines software engineering technologies such as Java EE and RESTful web services, which allows exchanging medical data in an unidentifiable XML format and restricts users to computed information. Existing techniques could make it possible for an adversary to succeed in data re-identification attempts by applying advanced computational techniques; therefore, we disallow the use of retrospective processing of data. We validate our approach on an endoscopic reporting application based on openEHR and MST standards. The implemented prototype system can be used to query datasets by clinical researchers, governmental or non-governmental organizations in monitoring health care services to improve quality of care.
Nafees Qamar, Yilong Yang, Andras Nadas, Zhiming Liu, Janos Sztipanovits


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