Establishment of Requirements and Methodology for the Development and Implementation of GreyMatters, a Memory Clinic Information System.

INTRODUCTION: The aim of the paper is to establish the requirements and methodology for the development process of GreyMatters, a memory clinic system, outlining the conceptual, practical, technical and ethical challenges, and the experiences of capturing clinical and research oriented data along with the implementation of the system. METHODS: The methodology for development of the information system involved phases of requirements gathering, modeling and prototype creation, and 'bench testing' the prototype with experts. The standard Institute of Electrical and Electronics Engineers (IEEE) recommended approach for the specifications of software requirements was adopted. An electronic health record (EHR) standard, EN13606 was used, and clinical modelling was done through archetypes and the project complied with data protection and privacy legislation. RESULTS: The requirements for GreyMatters were established. Though the initial development was complex, the requirements, methodology and standards adopted made the construction, deployment, adoption and population of a memory clinic and research database feasible. The electronic patient data including the assessment scales provides a rich source of objective data for audits and research and to establish study feasibility and identify potential participants for the clinical trials. CONCLUSION: The establishment of requirements and methodology, addressing issues of data security and confidentiality, future data compatibility and interoperability and medico-legal aspects such as access controls and audit trails, led to a robust and useful system. The evaluation supports that the system is an acceptable tool for clinical, administrative, and research use and forms a useful part of the wider information architecture.

Evaluation of clinical information modeling tools.

OBJECTIVE: Clinical information models are formal specifications for representing the structure and semantics of the clinical content within electronic health record systems. This research aims to define, test, and validate evaluation metrics for software tools designed to support the processes associated with the definition, management, and implementation of these models. METHODOLOGY: The proposed framework builds on previous research that focused on obtaining agreement on the essential requirements in this area. A set of 50 conformance criteria were defined based on the 20 functional requirements agreed by that consensus and applied to evaluate the currently available tools. RESULTS: Of the 11 initiative developing tools for clinical information modeling identified, 9 were evaluated according to their performance on the evaluation metrics. Results show that functionalities related to management of data types, specifications, metadata, and terminology or ontology bindings have a good level of adoption. Improvements can be made in other areas focused on information modeling and associated processes. Other criteria related to displaying semantic relationships between concepts and communication with terminology servers had low levels of adoption. CONCLUSIONS: The proposed evaluation metrics were successfully tested and validated against a representative sample of existing tools. The results identify the need to improve tool support for information modeling and software development processes, especially in those areas related to governance, clinician involvement, and optimizing the technical validation of testing processes. This research confirmed the potential of these evaluation metrics to support decision makers in identifying the most appropriate tool for their organization. OBJECTIVO: Los Modelos de Información Clínica son especificaciones para representar la estructura y características semánticas del contenido clínico en los sistemas de Historia Clínica Electrónica. Esta investigación define, prueba y valida un marco para la evaluación de herramientas informáticas diseñadas para dar soporte en la en los procesos de definición, gestión e implementación de estos modelos. METODOLOGIA: El marco de evaluación propuesto se basa en una investigación previa para obtener consenso en la definición de requisitos esenciales en esta área. A partir de los 20 requisitos funcionales acordados, un conjunto de 50 criterios de conformidad fueron definidos y aplicados en la evaluación de las herramientas existentes. RESULTADOS: Un total de 9 de las 11 iniciativas identificadas desarrollando herramientas para el modelado de información clínica fueron evaluadas. Los resultados muestran que las funcionalidades relacionadas con la gestión de tipos de datos, especificaciones, metadatos y mapeo con terminologías u ontologías tienen un buen nivel de adopción. Se identifican posibles mejoras en áreas relacionadas con los procesos de modelado de información. Otros criterios relacionados con presentar las relaciones semánticas entre conceptos y la comunicación con servidores de terminología tienen un bajo nivel de adopción. CONCLUSIONES: El marco de evaluación propuesto fue probado y validado satisfactoriamente contra un conjunto representativo de las herramientas existentes. Los resultados identifican la necesidad de mejorar el soporte de herramientas a los procesos de modelado de información y desarrollo de software, especialmente en las áreas relacionadas con gobernanza, participación de profesionales clínicos y la optimización de la validación técnica en los procesos de pruebas técnicas. Esta investigación ha confirmado el potencial de este marco de evaluación para dar soporte a los usuarios en la toma de decisiones sobre que herramienta es más apropiadas para su organización.

Healthcare Engineering Defined: A White Paper.

Engineering has been playing an important role in serving and advancing healthcare. The term "Healthcare Engineering" has been used by professional societies, universities, scientific authors, and the healthcare industry for decades. However, the definition of "Healthcare Engineering" remains ambiguous. The purpose of this position paper is to present a definition of Healthcare Engineering as an academic discipline, an area of research, a field of specialty, and a profession. Healthcare Engineering is defined in terms of what it is, who performs it, where it is performed, and how it is performed, including its purpose, scope, topics, synergy, education/training, contributions, and prospects.

An Electronic Healthcare Record Server Implemented in PostgreSQL.

This paper describes the implementation of an Electronic Healthcare Record server inside a PostgreSQL relational database without dependency on any further middleware infrastructure. The five-part international standard for communicating healthcare records (ISO EN 13606) is used as the information basis for the design of the server. We describe some of the features that this standard demands that are provided by the server, and other areas where assumptions about the durability of communications or the presence of middleware lead to a poor fit. Finally, we discuss the use of the server in two real-world scenarios including a commercial application.

Development and evaluation of a memory clinic information system.

AIM: To describe the requirements, development and evaluation of a cognitive disorders and older persons' clinical and research application, outlining the conceptual and practical challenges. METHODS: A technology development methodology was used to develop a database of people being investigated for or diagnosed with cognitive disorders as well as their carers. The methodology involved phases of requirements gathering, modeling and prototype creation, and 'bench testing' the prototype with experts. RESULTS: This case study suggests that construction and population of a memory clinic and research database is feasible, but initial development is complex. Its utility can be evaluated to some extent and was found to be acceptable to most users. DISCUSSION AND CONCLUSIONS: The development of a system needs to take in account existing data collection methods and other information systems used. The GreyMatters system can be considered a supplementary or complementary health record that sits alongside the main Trust information system. Integrating data from multiple systems enhances utility to clinical and research users.

Evaluation of ISO EN 13606 as a result of its implementation in XML.

The five parts of the ISO EN 13606 standard define a means by which health-care records can be exchanged between computer systems. Starting within the European standardisation process, it has now become internationally ratified in ISO. However, ISO standards do not require that a reference implementation be provided, and in order for ISO EN 13606 to deliver the expected benefits, it must be provided not as a document, but as an operational system that is not vendor specific. This article describes the evolution of an Extensible Markup Language (XML) Schema through three iterations, each of which emphasised one particular approach to delivering an executable equivalent to the printed standard. Developing these operational versions and incorporating feedback from users of these demonstrated where implementation compromises were needed and exposed defects in the standard. These are discussed herein. They may require a future technical revision to ISO EN 13606 to resolve the issues identified.

Quality requirements for EHR archetypes.

The realisation of semantic interoperability, in which any EHR data may be communicated between heterogeneous systems and fully understood by computers as well as people on receipt, is a challenging goal. Despite the use of standardised generic models for the EHR and standard terminology systems, too much optionality and variability exists in how particular clinical entries may be represented. Clinical archetypes provide a means of defining how generic models should be shaped and bound to terminology for specific kinds of clinical data. However, these will only contribute to semantic interoperability if libraries of archetypes can be built up consistently. This requires the establishment of design principles, editorial and governance policies, and further research to develop ways for archetype authors to structure clinical data and to use terminology consistently. Drawing on several years of work within communities of practice developing archetypes and implementing systems from them, this paper presents quality requirements for the development of archetypes. Clinical engagement on a wide scale is also needed to help grow libraries of good quality archetypes that can be certified. Vendor and eHealth programme engagement is needed to validate such archetypes and achieve safe, meaningful exchange of EHR data between systems.

A data types profile suitable for use with ISO EN 13606.

ISO EN 13606 is a five part International Standard specifying how Electronic Healthcare Record (EHR) information should be communicated between different EHR systems and repositories. Part 1 of the standard defines an information model for representing the EHR information itself, including the representation of types of data value. A later International Standard, ISO 21090:2010, defines a comprehensive set of models for data types needed by all health IT systems. This latter standard is vast, and duplicates some of the functions already handled by ISO EN 13606 part 1. A profile (sub-set) of ISO 21090 would therefore be expected to provide EHR system vendors with a more specially tailored set of data types to implement and avoid the risk of providing more than one modelling option for representing the information properties. This paper describes the process and design decisions made for developing a data types profile for EHR interoperability.

Generic screen representations for future-proof systems, is it possible? There is more to a GUI than meets the eye.

BACKGROUND: Future-proof EHR systems must be capable of interpreting information structures for medical concepts that were not available at the build-time of the system. The two-model approach of CEN 13606/openEHR using archetypes achieves this by separating generic clinical knowledge from domain-related knowledge. The presentation of this information can either itself be generic, or require design time awareness of the domain knowledge being employed. OBJECTIVE: To develop a Graphical User Interface (GUI) that would be capable of displaying previously unencountered clinical data structures in a meaningful way. METHODS: Through "reasoning by analogy" we defined an approach for the representation and implementation of "presentational knowledge". A proof-of-concept implementation was built to validate its implementability and to test for unanticipated issues. RESULTS: A two-model approach to specifying and generating a screen representation for archetype-based information, inspired by the two-model approach of archetypes, was developed. There is a separation between software-related display knowledge and domain-related display knowledge and the toolkit is designed with the reuse of components in mind. CONCLUSIONS: The approach leads to a flexible GUI that can adapt not only to information structures that had not been predefined within the receiving system, but also to novel ways of displaying the information. We also found that, ideally, the openEHR Archetype Definition Language should receive minor adjustments to allow for generic binding.

Implementation of a query interface for a generic record server.

INTRODUCTION: This paper presents work to define a representation for clinical research queries that can be used for the design of generic interfaces to electronic healthcare record (EHR) systems. Given the increasing prevalence of EHR systems, with the potential to accumulate life-long health records, opportunities exist to analyse and mine these for new knowledge. This potential is presently limited by many factors, one of which is the challenge of extracting information from them in order to execute a research query. METHOD: There is limited pre-existing work on the generic specification of clinical queries. Sets of example queries were obtained from published studies and clinician reference groups. These were re-represented as structured logical expressions, from which a generalisable pattern (information model) was inferred. An iterative design and implementation approach was then pursued to refine the model and evaluate it. RESULTS: This paper presents a set of requirements for the generic representation of clinical research queries, and an information model to represent any arbitrary such query. A middleware component was implemented as an interface to an existing system that holds 20,000 anonymised cancer EHRs in order to validate the model. This component was interfaced in turn to a query design and results presentation tool developed by the Open University, to permit end user demonstrations and feedback as part of the evaluation. CONCLUSION: Although it is difficult to separate cleanly the evaluation of a theoretical model from its implementation, the empirical evaluation of the query-execution interface revealed that clinical queries of the kinds studied could all be represented and executed successfully. However, performance was a problem and this paper outlines some of the challenges faced in building generic components to handle specialised data structures on a large scale. The limitations of this work are also discussed. The work complements many years of European research and standardisation on the interoperable communication of electronic health records, by proposing a way in which one or more EHR systems might be queried in a standardised way.

Knowledge management for the protection of information in electronic medical records.

This paper describes foundational work investigating the protection requirements of sensitive medical information, which is being stored more routinely in repository systems for electronic medical records. These systems have increasingly powerful sharing capabilities at the point of clinical care, in medical research and for clinical and managerial audit. The potential for sharing raises concerns about the protection of individual patient privacy and challenges the duty of confidentiality by which medical practitioners are ethically and legally bound. By analysing the protection requirements and discussing the need to apply policy-based controls to discrete items of medical information in a record, this paper suggests that this is a problem for which existing privacy management solutions are not sufficient or appropriate to the protection requirements. It proposes that a knowledge management approach is required and it introduces a new framework based on the knowledge management techniques now being used to manage electronic medical record data. The background, existing work in this area, initial investigation methods, results to date and discussion are presented, and the paper is concluded with the authors' comments on the ramifications of the work.