Adapting a System-Theoretic Hazard Analysis Method for the Analysis of an eHealth Interoperability Conformance Profile.

Interoperability between heterogenous (health) IT systems relies on standards, which are communicated to system vendors in the form of so-called conformance profiles. Clinical information systems are often subjected to mandatory conformance testing and certification prior to being admitted into the health information exchange (HIE). The requirements specified in conformance profiles are therefore instrumental for ensuring the correctness and safety of the emerging HIE network. How can we ensure the quality and safety of conformance requirements themselves? We have adapted a system-theoretic hazard analysis method (STPA) for this purpose and applied it to an industrial case study in British Columbia, the Clinical Data eXchange (CDX) system. Our results indicate that the method is effective in detecting missing and erroneous constraints.

Applying Bidirectional Transformations to the Design of Interoperable EMR Systems.

Interoperability between heterogeneous health information systems has remained an elusive goal despite decades of exchange standards development and implementation initiatives. Empirical studies have shown that in many cases, implemented interoperability interfaces fail to function correctly. Unfortunately, the health informatics literature provides little guidance on how to best design and assure interoperability interfaces. Still, healthcare is not the only industry that requires the exchange of highly complex semantic data structures. Similar requirements can be observed in the engineering industry, where complex data models maintained by various types of development tools and environments must be synchronized over a product's life cycle. Research on how to best address this challenge has led to the development of the concept of bidirectional transformations (BX) and associated design theories, methods, and tools. While BX approaches have received little attention in e-Health interoperability applications to date, we believe that they can also facilitate the implementation and assurance of interoperability in that domain. In this paper, we cast the health information exchange (HIE) challenge as a BX problem, review applicable BX theories, and discuss their practical applications from the perspective of software engineers who are tasked with constructing and assuring bidirectional interoperability interfaces for health information systems. We further design a proof-of-concept interoperability interface using BX design methods in the context of a real-world interoperability standard initiative. We compare the new BX-based interoperability interface with a preexisting, conventionally designed implementation. We find that the BX design offers similar runtime performance while providing improved maintainability, testability, and modularity.

Lead User Design: Medication Management in Electronic Medical Records.

Improvements in medication management may lead to a reduction of preventable errors. Usability and user experience issues are common and related to achieving benefits of Electronic Medical Records (EMRs). This paper reports on a novel study that combines the lead user method with a safety engineering review to discover an innovative design for the medication management module in EMRs in primary care. Eight lead users were recruited that represented prescribers and clinical pharmacists with expertise in EMR design, evidence-based medicine, medication safety and medication research. Eight separate medication management module designs were prototyped and validated, one with each lead user. A parallel safety review of medicaiton management was completed. The findings were synthesized into a single common set of goals, activities and one interactive, visual prototype. The lead user method with safety review proved to be an effective way to elicit diverse user goals and synthesize them into a common design. The resulting design ideas focus on meeting the goals of quality, efficiency, safety, reducing the cognitive load on the user, and improving communication wih the patient and the care team. Design ideas are being adapted to an existing EMR product, providing areas for further work.

Taming the Data Quality Dragon--A Theory and Method for Data Quality by Design.

A lack of data quality (DQ) is often a significant inhibitor impeding the realization of cost and quality benefits expected from Clinical Information Systems (CIS). Attaining and sustaining DQ in CIS has been a multi-faceted and elusive goal. The current literature on DQ in health informatics mainly consists of empirical studies and practitioners' reports, but often lack a holistic approach to addressing DQ 'by design'. This paper seeks to present a general framework for clinical DQ, which blends foundational engineering theories with concepts and methods from health informatics. We define an architectural viewpoint for designing and reasoning about DQ. We introduce the notion of DQ Probes for monitoring and assuring DQ during system operation. The concepts presented have been validated in a real-world case study.

Information System Hazard Analysis: A Method for Identifying Technology-induced Latent Errors for Safety.

Many health information and communication technologies (ICT) are safety-critical; moreover, reports of technology-induced adverse events related to them are plentiful in the literature. Despite repeated criticism and calls to action, recent data collected by the Institute of Medicine (IOM) and other organization do not indicate significant improvements with respect to the safety of health ICT systems. A large part of the industry still operates on a reactive "break & patch" model; the application of pro-active, systematic hazard analysis methods for engineering ICT that produce "safe by design" products is sparse. This paper applies one such method: Information System Hazard Analysis (ISHA). ISHA adapts and combines hazard analysis techniques from other safety-critical domains and customizes them for ICT. We provide an overview of the steps involved in ISHA and describe.

Multi-National, Multi-Institutional Analysis of Clinical Decision Support Data Needs to Inform Development of the HL7 Virtual Medical Record Standard.

An important barrier to the widespread dissemination of clinical decision support (CDS) is the heterogeneity of information models and terminologies used across healthcare institutions, health information systems, and CDS resources such as knowledge bases. To address this problem, the Health Level 7 (HL7) Virtual Medical Record project (an open, international standards development effort) is developing community consensus on the clinical information exchanged between CDS engines and clinical information systems. As a part of this effort, the HL7 CDS Work Group embarked on a multinational, collaborative effort to identify a representative set of clinical data elements required for CDS. Based on an analysis of CDS systems from 20 institutions representing 4 nations, 131 data elements were identified as being currently utilized for CDS. These findings will inform the development of the emerging HL7 Virtual Medical Record standard and will facilitate the achievement of scalable, standards-based CDS.