Ebook: Progress in Standardization in Health Care Informatics

In Europe. standardisation activities in healthcare informatics officially started in April 1990 with the establishment of Technical Committee 251 within the European Standardisation Committee (CEN TC 251).

In December 1991 the American National Standards Institute (ANSI) established its Healthcare Informatics Standards Planning Panel (HISPP).

Since then, standards developing organisations, standards users, researchers, government agencies and industry have been very active and have encouraged coordination and cooperation at an international level.

CEN TC251 and ANSI/HISPP are pleased to provide you with ‘Progress in Standardisation in Healthcare Informatics’ which predominantly features papers presented at a conference held in September 1992 in Geneva, Switzerland. This conference was held to present the current standing of important activities connected with healthcare infonnatics/telematics standards and to explore the ways of ensuring international coordination and cooperation worldwide.

It is encouraging to see the continued interest of a new and enthusiastic community of experts representing now not only the views of Europe and the United States but also of Australia and Japan.

Such a very promising and vast initiative could not be successful without the support and valuable advice of many people and friends. Amongst them we would like to thank Jan Van Herp, secretary of the Technical Board in CEN and chairman of ITSTC, who launched the idea of creating CEN TC251 (in Europe) and is continuing to encourage its activities. We are also grateful to Michel Audoux and An Deberdt, CEC DG XIII CS who agreed to fund the project-teams of CEN TC251 and consequently enabled the timely delivery of urgently needed standards for Europe. Our special thanks go also to Niels Rossing, head of AIM, CEC DGXIII C3 who supported CEN TC 251 from the very beginning and took all necessary measures to facilitate the exchange of results with the AIM Research and Development programme.

The progress in CEN TC251 could not have been achieved without the excellent work of Georges Van Maele, secretary of CEN TC251, who is to be considered as one of the engines behind the effort. We thank him for his important contribution.

The collaboration with U.S. through ANSI/HISPP has been made possible thanks to the enthusiasm and scientific background of J. Michael Fitzmaurice, Director of the Office of Science and Data Development (OSDD) of the Agency for Healthcare Policy and Research (AHCPR) of the Department of Health, of Melvin Greberman from the Food and Drug Administration (FDA) and of Clement McDonald, president of the American Medical Informatics Association (AMIA) and now chairman of ANSI/HISPP. We very much appreciate their coordinating efforts and overall support.

We also thank Yoichi Satomura, chairman of the Standardisation Committee of the Japanese Association for Medical Informatics (JAMI), Nagaaki Ohyama, chairman of the ISAC Committee from the Tokyo Institute of Technology, Masamitsu Oshima, chairman of MEDIS-DC, Takuja Naruse of the Ministry of Trade and Industry (MITI), and last but not least Koji Miura, director of the Health Policy Bureau of the Ministry of Health and Welfare who all together act as initiators of standardisation in healthcare informatics in Japan.

Finally, we would like to express our gratitude to Standards Australia and Roderick Neame, chairman of the Joint Technical Committee for Health Informatics (JTC IT/14) which is closely aligned with Standards New Zealand.

We are confident that the network of cooperation installed in this way, will guarantee the elaboration of high quality implementable healthcare informatics standards, which we believe will play in the future an indirect but important role in the achievement of better healthcare to the benefit of the patient.

Georges J.E. DE MOOR

Chairman CEN TC 251

This article describes the actual user requirements of the Health Care sector in connection with Telematics. The importance of standardisation is stressed. The paper further gives an overview of the Current standing of the activities of CEN TC 251 (European Standardisation Committee, Technical Committee on Health Care Informatics).

Standardization activities related to medical informatics in Japan are briefly introduced in this paper. Because two kinds of portable media that are MODs (Magneto Optical Disk) and IC cards are supposed to be practically used in medicine, standardization works are currently supported by Japanese government. With an introduction of the organizations their standards and policy are explained.

Activities to support the development and adoption of Standards in health informatics are now well started. The Standards Association of Australia formed a committee (IT/14) on Medical Informatics which met for the first time in February 1991: early in 1992 it changed its name to reflect a broader concern with “Health Informatics” rather than the rather narrower interpretation that many had chosen to place on the term “Medical Informatics”.

The Standards Association of New Zealand held the inaugural meeting of persons interested in constituting committee SC606 on Health Informatics in August of this year. A growing program of active collaboration between Australia and New Zealand was formalised in July of this year, whereby standards will for the most part be jointly developed and adopted regionally, and whereby the separate committees will be merged wherever practicable to form a single head Joint Technical Committee (JTC) for each domain of involvement.

The focus in Australia and New Zealand is at present very much on the need for standards to implement national health information networks. The progressive definition of network standards is prompting increased interest in the standards implemented within the systems and installations that must connect to the networks. The initial implementation of a national health information system in New Zealand is scheduled for 1st July 1993: detailed plans for an Australian health communications network are well advanced although no date for its implementation has been proposed.

This paper outlines the general structure of the standards committees in the Antipodes, and of their various sub-committees. It will also outline broad terms of reference of these groups, and the major areas of current interests, activity and developments.

The need for a healthcare information model as a component in a framework of standards for healthcare data interchange is identified. Key requirements for a method to support development of a healthcare information model are defined and recommendations for development of an Object Oriented Healthcare Information Model are presented.

In order that medical informaticians can create Open Systems for health care, they need to have a common language. Efforts in the 1980s at the National Library of Medicine to create a Medical Informatics Vocabulary (MIVoc) have been useful for document indexing purposes, but need to be continued and extended. The Committee of European Normalization Technical Committee 251 has created a project team for MIVoc, and that team has used both automatic and manual methods and referenced many sources in producing a vocabulary that has support from numerous experts in Europe.

MIVoc has both a glossary and a tree structure. The glossary has about 250 terms with detailed definitions that include various explanations and pointers. One critical pointer is the semantic link to other terms in MIVoc from a which a tree-structure is inferred. The success of MIVoc clearly depends on its being used, which in the long run depends also on the vocabulary being maintained.

The purpose of this paper is to describe the US efforts to identify and consolidate all standards activities relating to computer-based patient records.

This paper describes a proposed European standard for the Registration of Coding Schemes used in electronic healthcare information exchange. The requirements for such a standard are outlined together with the manner in which the work to meet these requirements has been carried out. The paper includes a summary of the main points contained in the proposed standard and in the supporting documents delivered by the project team. The paper concludes with a report on the progress of this proposal towards acceptance as a standard and a brief comment on how it may influence other work in medical informatics standardisation.

PT002s of TC251 of CEN has been established in order to identify structural elements for classification and coding of surgical procedures. This project team identified 10 types of characteristics that could describe any surgical procedure. These characteristics were grouped in three classes: objects (topography/e.g. body system and body site, pathology, side, material); actions (procedure, extent, numeral) and methods (instrument, material, topography). Syntax-rules are proposed as well as references to existing lexicons.

This structure is mainly addressed to developers of classifications of procedures. It allows retrieval of monoaxial classifications through a multiaxial representation, logical rules for updating, as well as a method to compare existing classification systems. It is still in development and discussion.

This paper briefly summarizes the characteristics of a computer-based medical terminology constructed by the author. Its size is around 140,000, systematized by meaning using a single attribute as key: similarity among instances covered by the term. This systematization resulted in a single hierarchical tree. Initial term typing was based on the knowledge patterns of the terms, represented by the arcs (relationships) among terms (nodes). Six different types of medical terms could be identified. For coding of a medical term, its position on the hierarchical tree was used, the semantic address. It is recommended that the semantic address should be used for worldwide compatibility.

A model of a coding and classification scheme is examplified in the domain of clinical laboratory sciences. It is for a multilingual thesaurus based on coded elementary concepts used to form coded composites or aggregates of preferred terms. These are for transmission over alphabet and language barriers.

Unification of medical coding systems is a perceived need involving a long-term task. Standards will support convergence of present coding systems towards a coherent set of tools. The Project Team “Model for Representation of Semantics” (CENITC251/PT003-MOSE) modeled existing tools to obtain a vocabulary apt to describe coding systems and terminologies. Requirements on faithfulness and safety, usefulness and purposiveness, coherence and integration were worked out, and the MOSE's 10 key principles for Standards in Medical Semantics were established.

ASTM subcommittee E31.15 on Health Knowledge Representation was formed to promote standards for defining and sharing health knowledge bases. Its first standard, the Arden Syntax, is focused on knowledge bases that can be represented as a set of independent modules called Medical Logic Modules (MLMs). The standard is in clinical use and has generated significant interest in industry and academics. The Extensions task group plans to extend the syntax where appropriate, to expand to other types of knowledge bases. The Validation/Verification task group is approaching the enormous problem of evaluating knowledge bases and the process of sharing them.

Following the issue of a “Study and Investigation” mandate by the European Commission in 1989, there has been a very substantial amount of work in the field of Medical Informatics, mainly undertaken by CEN and EWOS. This paper discusses the work being undertaken by the EWOS Healthcare Expert Group.

This paper gives a summary of the work done by CEN TC 251 PT 004. The project team objective has been to investigate syntaxes of existing interchange formats (IFs) to be used in healthcare. A set of evaluation criteria have been developed based on functional requirements from two healthcare domains. 5 IFs; ASN.l, ASTM E1238, EDIFACT, Euclides and ODA have been evaluated. ASN.l scores highest in the evaluation. However mapping from General Message Models (GMDs) to IF dependent message models (IFMDs) shows that all the IFs can be used. The project team recommends a strategy for development of GMDs, IFs and IFMDs.

The development of standard healthcare messages requires a full understanding of user needs, an appropriate organisation structure for developing consensus and a suitable methodology. This paper presents the current state of development in the European Standardisation Organisation's Working Group on Healthcare Messages and Communications (CEN TC251 WG3).

Two influential organizations in the development of medical data exchange standards in the United States of America are ASTM and HL7. A shared message structure has been adapted to diverse applications including hospital information systems and clinical laboratories. The basic approach is the exchange of ASCII messages. Messages segments relate to clinical entities and support a hierarchy of entities. Individual data fields are of variable length and bounded by delimiter characters. The feasibility of this approach has been confirmed by its adoption by a number of medical institutions and information system vendors.

This paper discusses the progress in the development and implementation of the HL7 standard, describes briefly the HL7 standard, provides an example of a typical data interchange, and presents advances in the management organisational structure of HL7.

Assessment of the current medical edi environment learns that “old” interchange formats are being used to represent information of highly complex and quickly evolving nature. Whenever the domain requirements are translated into acceptable messages according to these interchange format specifications, system developers use the latest technologies to implement the messages towards the distorted view imposed by the interchange format constraints. This situation, combined with the fact of coexistence of several interchange formats and the urgent need for more standardised message types, led to the specification of a new meta-syntax, supporting easy message definition and allowing the data-driven conversion between multiple interchange formats. As such, and supported by the development of interchange fonnat independent message descriptions, it may become a tool to support the medical edi needs of the future.