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This document describes the activities of ASTM Committee E-31 in the area of standards for computer systems in medical applications. Some of these efforts have already culminated in published standards, some are well along in the development process, and some are just getting started.
It has become abundantly clear that standards of recording clinical terms in human-readable, computer-processable format are indispensable. Controlled medical terminology is the missing link in health information standards (in fact, medical terminology can be viewed as the mother of all standards); its absence interferes with the business of healthcare and impedes the core processes of healing and maintaining health. Medicine has lacked the controlled common medical vocabulary that would enable universal sharing of data at the point of care and ensure reliable information for determining health intervention effectiveness. Simple clinical and code content alone has proven insufficient for healthcare enterprises to successfully manage the terminology problem; the "lexical runtime engine," formerly called a vocabulary server (VOSER), which manages the vocabulary ontology and serves up the relevant vocabulary to users of applications in the clinical environment, has recently become a reality.
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The potential impact of the computer on the practice of obstetrics has long been recognized and is slowly being realized. Computers are already essential in many administrative aspects of obstetrics and indispensable in data storage and analysis for clinical research. Emerging applications include computer systems for taking the perinatal history, storage and on-line interpretation of fetal monitor tracings, information retrieval for case management and research purposes, and computer-assisted instruction. Future applications offer possibilities of computerized consulting for support of obstetric decisions and sophisticated case simulations for continuing education.
Shared care concepts such as managed care and continuity of care are based on extended communication and cooperation between different health professionals or between them and the patient respectively. Health information systems and their components, which are very different in their structure, behavior, data and their semantics as well as regarding implementation details used in different environments for different purposes, have to provide intelligent interoperability. Therefore, flexibility, portability, and future orientation must be guaranteed using the newest development of model driven architecture. The ongoing work for the German health telematics platform based on an architectural framework and a security infrastructure is described in some detail. This concept of future proof health information networks with virtual electronic health records as core application starts with multifunctional electronic health cards. It fits into developments currently performed by many other developed countries.
BACKGROUND: Clinical information systems frequently use intranet and Internet technologies. However these technologies have emphasized sharing and not security, despite the sensitive and private nature of much health information. Digital certificates (electronic documents which recognize an entity or its attributes) can be used to control access in clinical intranet applications. OBJECTIVES: To outline the need for access control in distributed clinical database systems, to describe the use of digital certificates and security policies, and to propose the architecture for a system using digital certificates, cryptography and security policy to control access to clinical intranet applications. METHODS: We have previously developed a security policy, DIMEDAC (Distributed Medical Database Access Control), which is compatible with emerging public key and privilege management infrastructure. In our implementation approach we propose the use of digital certificates, to be used in conjunction with DIMEDAC. RESULTS: Our proposed access control system consists of two phases: the ways users gain their security credentials; and how these credentials are used to access medical data. Three types of digital certificates are used: identity certificates for authentication; attribute certificates for authorization; and access-rule certificates for propagation of access control policy. Once a user is identified and authenticated, subsequent access decisions are based on a combination of identity and attribute certificates, with access-rule certificates providing the policy framework. CONCLUSIONS: Access control in clinical intranet applications can be successfully and securely managed through the use of digital certificates and the DIMEDAC security policy.
It proves difficult to achieve a good measure of security in medical informatics applications. A number of reasons for this are analyzed. It is argued, that standardisation will help in solving this problem to a certain extent, but a more complete solution is possible when this is used in close conjunction with legal instruments (e.g. EU directives) and advice of a less strict nature, like guidelines. On the whole, a pragmatic step-by-step approach is needed, although there are signs that the general environment for these developments is improving.
The evaluation of complex medical informatics applications involves not only the information system, but also its impact on the organizational environment in which it is implemented. In instances where these applications cannot be evaluated with traditional experimental methods, computer simulation provides a flexible approach to evaluation. The construction of a computer simulation model involves the development of a model that represents important aspects of the system under evaluation. Once validated, the model can be used to study the effects of variation in system inputs, differences in initial conditions and changes in the structure of the system. Three examples are discussed, namely, a wide-area health care network, physician order entry into a hospital information system, and the use of an information system designed to prevent medical errors that lead to adverse drug events in hospitals.
This chapter reviews the motives behind the promotion, development and application of practice guidelines, defined as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances'. It surveys the state of progress and future prospects for telematics applications in this area, and reports the action points recommended by the 1994 AIM Conference. There exists significant evidence that use of guidelines can improve healthcare process and outcome, and that computerised aids assist this effect, they may also enhance the potential uses of guidelines and protocols for audit, resource management and shared care. A standard generic model for computerised representation of guidelines as knowledge bases in a common format has been proposed and may be a key factor in future progress. The development of computerised patient records of adequate scope and quality is generally recognised as an essential condition for computer-aided guideline use. Support for development, dissemination and application of healthcare guidelines and use has emerged, notably through the AIM EPISTOL study, as a feasible and useful application area of medical knowledge-based systems. It is essential that telematics developments in this field are grounded in an understanding of the healthcare practices to which guidelines are being applied, and of the changes in practice which guideline use may entail.
OBJECTIVE: The development of computational Grids is making huge amounts of computing power and data storage available for a lot of scientific applications. At this stage of development, the use of the Grid is mainly based on Command Line Interface (CLI) tools that are not very friendly and can be considered an obstacle to the use of these powerful tools. The objective of this paper is to present a solution to this problem. METHODS: To ease the access of new users to the grid the GENIUS (Grid Enabled web eNvironment for site Independent User job Submission) grid portal has been jointly developed by INFN and NICE within the context of both the Italian INFN Grid and the European DataGrid Projects. Here we devote particular care to the description of job creation and submission and the services for transparent access to user's data and applications. RESULTS: Using GENIUS, the obstacle of complicated CLI can be overtaken and simple web interfaces can be built for specific user communities and applications. Here we show examples in the field of bio-medical applications. CONCLUSIONS: The use of Grid can be made easy with the use of Grid portals such as GENIUS.
PURPOSE: This description focuses on the expressiveness and flexibility of OpenSDE: an application that supports recording of structured narrative data. METHODS: OpenSDE enables data entry with (customizable) forms based on trees of medical concepts. The relevant scope for data entry can be tailored per medical domain by construction of a domain-specific tree. OpenSDE is intended for structuring narrative data to make these available for both care and research. RESULTS: The OpenSDE application is currently in use at several departments in our academic hospital, including radiology, neurology, pediatrics, and child psychiatry. OpenSDE is available for all in open source.
Informatics is the discipline that process efficiently all the necessary data to obtain information. The data acquisition, processing and interpretation is realized through traditional as well as automated means. Medical Informatics is the union of all methods of informatics in medicine including the preparation of medical data required for the application of these methods. Due to the need to keep up with the increasing amount of data that modern medicine is receiving and efficiently process it to obtain meaningful information, we propose the creation of a department of Medical Informatics in our Medical School to: 1) Teach the basic principles of medical informatics to undergraduate and graduate students, including lectures in: Information technics, medical terminology, medical linguistics, international classification of diseases, Hospital informations Systems, practical application of computing in medicine as Oncocyn, Mycin, etc., as well as external data bases. 2) Help the health sciences personnel to obtain and transfer medical information through the National and International Electronic Networks of Medical Information.
The British Child Health System has been designed and widely implemented to support equity of access to preventive child health services, using case-based integrated records. Lately, telematics has been increasingly applied to improve the timeliness of data entry. A special project has been established to monitor overall quality of the system's use and of the resultant preventive services. The telematics application has been found to be a potential threat to quality in a way which would apply to all remote networked patient-based systems. The demonstration will show the methodology and interim results.
A formalized "top to bottom" design approach was described in [1] for distributed applications built on databases, which were considered as a medium between virtual and real user environments for a specific medical application. Merging different components within a unified distributed application posits new essential problems for software. Particularly protection tools, which are sufficient separately, become deficient during the integration due to specific additional links and relationships not considered formerly. E.g., it is impossible to protect a shared object in the virtual operating room using only DBMS protection tools, if the object is stored as a record in DB tables. The solution of the problem should be found only within the more general application framework. Appropriate tools are absent or unavailable. The present paper suggests a detailed outline of a design and testing toolset for access differentiation systems (ADS) in distributed medical applications which use databases. The appropriate formal model as well as tools for its mapping to a DMBS are suggested. Remote users connected via global networks are considered too.
A review of evaluation literature concerning CDSSs indicates that randomized controlled clinical trials (RCTs) are the 'gold standard' for evaluation. While this approach is excellent for studying system or clinical performance, it is not well suited to answering questions concerning whether systems will be used or how they will be used. Because lack of use of CDSS has been of concern for some years, other evaluation research designs are needed to address those issues. This paper critiques RCT and experimental evaluation approaches and presents alternative approaches to evaluation that address questions outside the scope of the usual RCT and experimental designs. A wide range of literature is summarized to illustrate the value of evaluations that take into account social, organizational, professional, and other contextual considerations. Many of these studies go beyond the usual measures of systems performance or physicians' behavior by focusing on 'fit' of the system with other aspects of professional and organizational life. Because there is little explicit theory that informs many evaluations, the paper then reviews CDSS evaluations informed by social science theories. Lastly, it proposes a theoretical social science base of social interactionism. An example of such an approach is given. It involves a CDSS in psychiatry and is based on Kaplan's 4Cs, which focus on communication, control, care, and context. Although the example is a CDSS, the evaluation approach also is useful for clinical guideline implementation and other medical informatics applications. Similarly, although the discussion is about social interactionism, the more important point is the need to broaden evaluation through a variety of methods and approaches that investigate social, cultural, organizational, cognitive, and other contextual concerns. Methodological pluralism and a variety of research questions can increase understanding of many influences concerning informatics applications development and deployment.
This paper describes an authoritative, non-proprietary information resource that provides an efficient mechanism for embedding specialized clinical knowledge into the design of healthcare telecommunications systems. The resource marries two types of data interchange standards, a message/electronic-document standard and a terminology standard. In technical terms, it is part protocol and part database. Industry, academia, professional specialty societies, and the federal government participated in its development. The development of multi-specialty content has broadly engaged biomedical domain experts to an unprecedented degree in voluntary, non-proprietary message/document-standards development. The resource is the SNOMED DICOM Microglossary (SDM), a message-terminology (or document-content) mapping resource. The message/electronic-document standard is DICOM (Digital Imaging and Communications in Medicine). The terminology standard is SNOMED, (Systematized Nomenclature of Human and Veterinary Medicine). The SDM specifies the mapping of multi-specialty imaging terminology from SNOMED to DICOM data elements. DICOM provides semantic constraints and a framework for discourse that are lacking in SNOMED. Thus the message standard and the computer-based terminology both depend upon and complete each other. The combination is synergistic. By substitution of different templates of specialty terminology from the SDM, a generic message template, such as the DICOM Visible Light (Color Diagnostic) Image or the DICOM Structured Reporting specification can be reconfigured for diverse applications. Professional societies, with technical assistance from the College of American Pathologists, contribute and maintain their portions of the terminology, and can use SDM templates and term lists in clinical practice guidelines for the structure and content of computer-based patient records.
We present here a framework of core components of an ambulatory care computing environment, based on clinical and functional needs and workflow scenarios. We have established this framework through the use of two study devices: a vision of the clinical office of the future, and a survey of possible computer applications, both designed to help clinicians and practice directors communicate their information needs to systems designers. Clinicians prioritize applications based on strategic and practice goals: support for clinical users' workflow, improved quality of care, reduced cost of care, and the ability to measure performance and status. By reorganizing the needed functionality from a clinical viewpoint into a technical viewpoint, we are able to identify core information components for systems design. Based on this analysis, information needs in the ambulatory environment can be divided into five primary functions: patient data retrieval, documentation, communication, knowledge resources, and aggregate reporting. Three other fundamental processes--knowledge-based interventions, information integration, and confidentiality--run through all of these front-line functions. Component applications and data structures built with this framework in mind will afford a maximum combination of functionality and flexibility to handle future changes in the clinical environment.
Virtual patient records provide a means for integrated access to patient information that may be scattered around different healthcare settings. Within the boundaries of a health district providing all levels of care, this concept can be implemented in a corporate Intranet environment to support longitudinal patient care activities across the participating healthcare providers. In this context, a virtual patient record implementation enables autonomous healthcare providers to operate in a cooperative working environment and apply continuity of care. Workflow and web services technologies provide an appropriate infrastructure for satisfying collaboration and coordination requirements by integrating heterogeneous healthcare applications and by automatically routing the medical information needed to authorized actors in a healthcare process. This paper presents a virtual patient record architecture that allows integrating geographically dispersed medical information within a health district and enhancing collaboration and coordination of authorized workgroups using workflow and web services technologies. An implementation of the proposed architecture is also presented.