MED. INFORM.
(1992), VOL. 17, NO. 2, 133-140
Telestroika in health care informatics: a challenge for standardization in Europe G . J. E. DE MOOR Medical Informatics Department, State University Gent, Belgium Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
(Received March 1992)
Abstract. T h i s article describes the actual user requirements of the health care sector in connection with telematics. T h e importance of standardization is stressed. T h e paper further gives an overview of t h e current standing of the activities of C E N T C 251 (European Standardization Committee. Technical Committee on Health Care Informatics). Keywords: Telematics; Standardization.
1. Introduction Today, the need for multi-system connectivity and electronic data transfer is growing in the health care sector. T h e necessity for integration of systems and for communication of information in this sector becomes evident when studying the variety of interested parties, the multitude of applications and their importance. T h e potential exchange of information between heterogeneous and independent information systems in hospitals, technical departments (cf. laboratory medicine, radiology, etc.), private medical offices, public authorities and the health care industry is very large and complex. T h e nature itself of health information (text, coded data, voice, signals and images) is very diverse too. Table 1 illustrates the most urgent requirements with regard to health care communications. All these requirements are evident through the fact that many experiments between those types of senders and receivers already exist, but unfortunately in a basic and heterogeneous way, using less efficient communication solutions. T h e essence of the matter-the approach-is usually incomplete and hence less adequate. Table 1.
User requirements.
Exchange of laboratory medicine data, especially fast and reliable access to laboratory test results Access to radiology text reports (interpretative comments) Prescriptions from doctors to pharmacies. Availability of hospital admission data, hospital discharge summaries. Data transfer from pharmaceutical industry, e.g. information on new drugs, adverse drug reactions, pharmaceutical trials, etc. Communication with central authorities in connection with epidemiology, external quality assessment schemes, utilization review, etc. Access to existing external literature and knowledge bases or expert systems.
Interpersonal mail between practitioners (e.g. general practitioners and specialists (cf. the GP information system becoming more and more the central repository of patient data). Images (c.f. emerging broadband services) from radiology, nuclear medicine, echography, microscopy (e.g. in the context of teleconsulting). Communication between hospitals and suppliers: orders, invoices, updates of files on articles, etc. Exchange with insurances, third party payers: billing.
0307-7640/92 $3.00 Q 1992 Taylor & Francis Ltd
G. J . E. De Moor
134
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
Figure 1 .
Telematics problem: increasing diversity.
QPL=jQ Physicians
Physicians
Physicians
Physldans
MAILBOX SERVER
2
1
Labs Figure 2.
-1 [RadlolDgy
e l= 1 :p
O n e of the solutions: the electronic mailbox.
This may be due to the fact that these interdisciplinary fields (medical informatics and health care telematics) are vast, and present difficulties in matching both medical knowledge and telematics with obvious results such as good analysis of the problem domain but wrong choice in informatics solutions or vice-versa. More alarming is the ascertainment that many of these telematics experiments in health care have been conducted on regional scales, and inevitably have resulted in the proliferation of incompatible solutions; hence the importance of standardization now.
2. Communication with the doctor’s office: a paradigm Considering all these needs, and bearing in mind the fact that in many countries the general practices are becoming the repository of the patient’s complete medical records, the difficult situation presented in figure 1 must be avoided. Some inherent problems of the situation shown in figure 1 are:
(1) (2) (3) (4) (5) (6)
higher investments (hardware, software, manpower); lack of user-friendliness; difficult end-user assistance; heterogeneous communication modes (different speeds, protocols, etc.); more difficult connection of new users and introduction of new services; complex billing of services.
T o solve these problems it is necessary to choose an appropriate and standard method of communication (e.g. X-400). T h e advantages of the solution presented in figure 2 are: (1) (2) (3) (4) (5) (6)
single connection for all services; end-user friendliness; minimum investment, pay as you use; one-stop shopping; simplification of format and protocol conversion; help facility.
Telestroika in health care informatics
135
A spiral p h e - n o m m
increase of the use of IT & T in the Health Care Sector
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
and growing Market
-
Better Communication Systems I
I
More
1 information Systems Figure 3 .
---~
Strategic impact (it' standards in health care informatics
T h e key to success factors when installing such medical telematics services are:
(1) use of standards (not only for the method of communication but also for the information itself: syntax and codes); (2) availability of the services (24 h/24 h); (3) growth potential of the services; (4) compliance with data protection and ethical requirements.
3. ED1 and standards: promises T h e benefits of state-of-the-art electronic data interchange (EDI), together with standards, will undoubtedly result in higher eficiency (direct integration of data locally), less maintenance (fewer conversion tables), less risk f o r technical monopolies (ethical issue in medicine), better data protection (cf. authentication, authorization, encryption), and cost savings. Studies have already shown that the use of standards is a k e y promoting factor in electronic communication, which in its turn significantly increases the application of informatics and the use of computers. T h e breakthrough of the medical informatics market will probably be caused by the introduction of medical telematics applications.
4.
CEN TC 251 on standards in health care informatics
It was only with the introduction of telematics in health care that an urgent need was disclosed for organized standardization activites and for a common use of standards in health care informatics. I n order to respond to this challenge the
G . J . E . De Moor
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
136
Technical Board (BT) of the European Standardization Committee (CEN) approved the establishment of a Technical Committee for Medical Informatics ( T C 251) in March 1990. Creation of CEN (TC251 and the occurrence of the A I M (Advanced Informatics in Medicine, 100 million ECUs) European Research Programme is not to be considered as mere coincidence. Already within the exploratory action of the programme of DG X I I I - F , providing funding for international research in medical informatics, several projects (about seven), addressed standardization or prestandardization (e.g. the E U C L I D E S project). Both research and development and standardization will undoubtedly cross-fertilize through complementarity and be of great significance to all future health care informatics and telematics efforts in Europe. Coordination of AIM and CEN projects (see Annexes to this article) will become possible through a concerted action on standardization. T h e objectives of CEN T C 251 are the organization, coordination and follow-up at a European level of standard development, including testing standards, in health care informatics. Since any standardization activity should begin by identifying the needs, determining the aims of the (pre)-standard(s) to be prepared and the interests that may be affected, the C E C issued a mandate (BC-IT-SI-05) to assess the actual situation of standardization in medical informatics. T h e recommendations originating from this mandate are part of the T C 251’s ‘Directory of requirements and Programme for the development of standards for Health Care Informatics’, in which the tasks for the working groups and project teams are described. T h e CEN T C 251 statements of principles are:
(1) Do not ‘over’-standardize. ( 2 ) Bottom-up (user needs) and top-down approach (models) are complementary and both will be followed at all levels ( T C , WG, P T ) . (3) T h e partitioning of the work strongly shapes the effort and will determine its success or failure (cf. importance of a taxonomy).
Table 2.
1.
Two schools of thought
Linkage of diversity bY Standard interfaces Heterogeneity is a reality in health care information systems Diversity is an advantage and enrichment. Hardware vendors and software developers will never build their strategy on portability (even if they give the impression that they are ready to do it). Therefore focus must on health care data interrhange standards.
2.
Transportability of software bY Standard (sub-)systems T h e health care informatics industry often supply to local markets products which arc ‘too much customized’ (expensive in development, expensive to buy, having a short life cycle, etc.). Agreement on common requirements at an international level will reduce the prices for health care information systems and open the market.
Telestroika in health care informatics
137
(4) There is a danger that tools may be used for the wrong purpose or outside their working limits and therefore a problem-based approach has to be preferred rather than a technique-driven one.
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
( 5 ) Medical informatics must be understood in its broader meaning as health care informatics. At the start attention will be forced at OSI layer 7 and above and to the data. (6) Duplication of work must be avoided. When the scope of a group is allinclusive o r overlaps too many others’ effort, this group has to accept a narrower range (cf. cooperation with EWOS, CENELEC T C 62, CEN T C 224, WEEB/MD 9, ANSI, HCPP, etc.). (7) Whenever there are opportunities to work cooperatively on an international basis one has to use these facilities in order to avoid conflicts and to make the standards more compatible (cf. cooperation with the ANSI Health Care Informatics Planning Panel in US, which was established in December 1991). T h e establishment of a ‘Fortress Europe’ and the creations of barriers to trade must be avoided. (8) Work will start only when a standard is really needed and wanted. Only realistic and feasible targets will be promoted: near-term and high-yield opportunities will be dealt with first. T h e reasoning that standardization in health care informatics is an extremely urgent issue has to be balanced against the fact that it has been overdue for many years. C E N T C 251 decided to constitute the following working groups: WG.1: WG.2: WG.3: WG.4: WG.5: WG.6: WG.7:
Health Care Information Modelling and Medical Records. Health Care Terminology, Semantics and Knowledge Bases. Health Care Communications and Messages. Medical Imaging and Multi-media. Communication with Medical Devices. Health Care Security, Privacy, Quality and Safety. Intermittently Connected Devices (including patient data cards).
Each working group supervises a number of project teams. T h e work in a project team is undertaken by especially assigned experts and is funded. Project teams have to be duly justified. They are small groups of trusted people preparing (full-time) a high-quality draft document, urgently required with a high probability of getting a rapid consensus. T h e actual (February 1992) total number of experts (representing the users, academic centres and industry) in the C E N T C 251 working groups and in the delegations at TC level is approximately 400. They constitute a rich network of technically and medically skilled people.
5. Conclusion Medicine is a complex discipline, and the doctor a supreme individualist. T h e formalization of this art is long and difficult, and consequently, standardization in medical informatics an ambitious task. While the European standardization structure is now well formulated and in place, Europeans should not neglect their identity and have confidence in themselves and in their rich cultural and technical traditions. Instead of accepting without
138
G . J . E . De Moor
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
criticism what is ‘available’ from outside, only because of its immediate availability, Europe will check, in the coming period, the validity of all existing solutions and will try to enrich proposals with its own knowledge whenever needed. It remains to be hoped that the general acceptance of the importance of telecommunications, which forms together with informatics the area of telematics, will serve as a sufficient catalyst to the reaction of standardization in health care informatics so much required.
Annexe A: Work items in CEN TC251’s Directory (version 1.40) Codes 1.1. 1.2. 1.3.
1.4. 1.5. 1.6. 1.7.
Titles Health Care Framework Medical Informatics-Vocabulary Health Care Information Systems Architecture Common Conceptual Schemes Health Care Information Model and Transaction Set Co-ordination Electronic Health Care Records Medical User Interface
2.14. 2.15.
Integration of Medical Data and Knowledge Base Systems Terminology and Coding System of Diseases Terminology and Coding Systems of Drugs Terminology and Coding Systems of Medical Procedures Terminology and Coding Systems of Manufactured Health Care Articles Standards for Notation of Units for ChemicaI/Physical Parameters in the Life Sciences Time Standards for Health Care-specific Problems European Machine Dictionary and Multilingual Medical Terminology Integrated System of Concepts Collection of Formalized Medical Knowledge Interchange Formats for Knowledge Bases Model for Representation of Semantics Metalanguage for Data Manipulation and Information Retrieval in Medical Databases and Knowledge Bases Statistical Databases for Medical, Epidemiological and Administrative Purposes Standard Drug Databases
3.1. 3.2. 3.3. 3.4. 3.5. 3.6. 3.7.a 3.8. 3.Y.
OSI Application Profiles for Health Care OSI Transport Profiles for Health Care OSI Management Profiles for Health Care Multi-media Medical Data Interchange Messages for Exchange of Laboratory Information Interchange Format for Reference to Articles Published in Biomedical Books and Journals Investigation of Syntaxes for Existing Interchange Formats to be used in Health Care Procedures for Registration of Coding Systems Related to Health Care Registration of Data Sets
4.1. 4.2. 4.3. 4.4. 4.5. 4.6. 4.7. 4.8. 4.9.
Functional Profiles for Medical Image Interchange Medical Image Management Standard Medical Image and Related Data Interchange Format Standards Standard Classification and Codes for Medical Image Processing Patterns for Calibration of IMAC Components Characteristics and Specification Standards for IMAC Components and Systems Medical Image Interchange: Conformance Testing of Standards Implementations Medical Image Interchange: Compression Schemes in Telemedicine Medical Data Interchange: HIS/RIS-PACS and HIS/RIS-Modality Interface
5.1. 5.2.
Vital Signs Information Representation Standard Interchange Format and Communication Protocol for Computerized Electrocardiography Interoperability of Medical Devices within Acute Care Units Clinical Analyser Interface to Laboratory Information Systems
2.1. 2.2. 2.3. 2.4. 2.5. 2.6. 2.7. 2.8. 2.9. 2.10. 2.11. 2.12. 2.13.
5.3. 5.4.
Telestroika in health care informatics
6.2. 6.3. 6.4. 6.5. 6.6.
Safety-related Standards for Health Care Security for Health Care Information Systems Harmonization of Ethical/Legal Issues Secure LJser Identification for Health Care Software Quality Assurance for llealth Care Evaluation of Physiological Analysis Systems
7.0. 7.1,
Intermittently Connected Devices: Data Content Off-line Device Interchange Format
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
6.1.
139
Annexe B: List of projects i n AIM -phase I1 Biomedical Technology Assessment and Management (BEAR.1). Computer Aided Movement Analysis in a Rehahilitation Context-I1 (CAMARC-11). C o m p u t e r VIsion in RAdiology (COVIRA). Diabetes Data Set Cards (DIABCARD). Logic Engineering in General Practice, Oncolo ared Care (DILEXIMA). Telematics for Bone Marrow Transplantation ( European Prototype for Integrated Care (EPIC). Prototype E M G Workstation ( E S T E E M ) . European Integrated Picture Archiving and Communication System in the €Iospital (EURIPACS). Framework for European Services in ‘Teleniedicine ( F E S T ) . Generalized Architecture for Languages Encyclopaedias and Nomenclatures in hledicine (GALEN). A General Architecture for Medical Knowledge-based Systems (G.4MES-Il). Good European Health Record (GEHR). Hospital Object Software Tools (HELIOS-2). Intelligent Decision-mapping Record Built in Verilied Multicentre Dataset ( I D M R ) . Integrated Rehabilitation Project (IREP) Standards in General Practice (ISAAC). Integrating Microscopy for Pathology Activities and Computer l‘echnology (IMPACI’). Knowledge Acquisition, Visualization, Refinement and Assessment System (KAk’AS-2). Interpretation of Medical Signals (;LIAGNOHKAIN). Medical Archive Generation with Object-oricntate~l‘I’echniques (RIARGOT) Measurement and Economic Modelling of the Performance of Health Care through Information Systems (MEMPHIS). An Access System for Medical Records using Natural Language (hlENELAS). Multimedia Interaction with Large Object-orientated Radiological and Clinical Databases ( M ILORD). Customization Environment for Multimedia Integrated Patient Dossiers (NUC1,ELIS). Open European Data Interchange and Processing for Electrocardiugraphy (OEDIPE). Optimization of Drug Prescriptions using Advanced Informatics (OFAT>E). Applications of Advanced Informatics and Telematics for Optimization of Clinical 1,aboratory Services (OPENLABS). Telematic System for Quality Assurance i n 0r:iI Health Care (ORATEL). Profiles of Care System (PROCAS). Strategic Health Informatics Networks for Europe (SHINE). Secure Environment for Information Systems in hledicine (SEISMED). Quality Assurance of User Informatics for Child Health in Europe (QUICHE). Software Applied to Multimodal Images and Education (SAhlMIE). Telematics for Anaesthesia and Intensive Therapy ( T A N I T ) . Telematics Technology for Harmonizing and I’romiiting Quality in Gastroenterology (TELEGASTRO).
Annexe C: List of acronyms .4IM ANSI CEN CEN-BT CEN-PT CEN-TC CEN-WG CENELEC
Advanced Informatics In hledicine American Kational Standards Institute Cornit6 Europien de Normalisation Comite Europeen de Kormalisation-Bureau Technique Comitt Europeen de Normalisation- Project Team Comite Europeen de Normaliaation-~’fechnical Committee ComitC. Europien de Normalisation~~-WorkG r o u p Comite Europeen de Normalisation Electrotechnique
Telestroika in health care informatics
140 EUCLIDES EWOS WEEB
European Clinical Laboratory Data Exchange Solution European Workshop on Open Systems Western European Edifact Board
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
References 1, Directory ofthe European Standardisation Requirements for Health Care Informatics and Programmefor the Dewelopment of Standards, T C 251, version 1.40 (1992-01-01). 2. NOOTHOVEN VAN GOOR, J., and CHRISTENSEN, J. P. (1992) Advances in Medical Informatics, Results of the A I M Exploratory Action (Oxford, 10s Press). 3 . MCDONALD, C. (1991) Standards for the electronic transfer of clinical data: progress and promises. Top Health Record Management, 11 (4),1-16.
(1992), VOL. 17, NO. 2, 133-140
Telestroika in health care informatics: a challenge for standardization in Europe G . J. E. DE MOOR Medical Informatics Department, State University Gent, Belgium Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
(Received March 1992)
Abstract. T h i s article describes the actual user requirements of the health care sector in connection with telematics. T h e importance of standardization is stressed. T h e paper further gives an overview of t h e current standing of the activities of C E N T C 251 (European Standardization Committee. Technical Committee on Health Care Informatics). Keywords: Telematics; Standardization.
1. Introduction Today, the need for multi-system connectivity and electronic data transfer is growing in the health care sector. T h e necessity for integration of systems and for communication of information in this sector becomes evident when studying the variety of interested parties, the multitude of applications and their importance. T h e potential exchange of information between heterogeneous and independent information systems in hospitals, technical departments (cf. laboratory medicine, radiology, etc.), private medical offices, public authorities and the health care industry is very large and complex. T h e nature itself of health information (text, coded data, voice, signals and images) is very diverse too. Table 1 illustrates the most urgent requirements with regard to health care communications. All these requirements are evident through the fact that many experiments between those types of senders and receivers already exist, but unfortunately in a basic and heterogeneous way, using less efficient communication solutions. T h e essence of the matter-the approach-is usually incomplete and hence less adequate. Table 1.
User requirements.
Exchange of laboratory medicine data, especially fast and reliable access to laboratory test results Access to radiology text reports (interpretative comments) Prescriptions from doctors to pharmacies. Availability of hospital admission data, hospital discharge summaries. Data transfer from pharmaceutical industry, e.g. information on new drugs, adverse drug reactions, pharmaceutical trials, etc. Communication with central authorities in connection with epidemiology, external quality assessment schemes, utilization review, etc. Access to existing external literature and knowledge bases or expert systems.
Interpersonal mail between practitioners (e.g. general practitioners and specialists (cf. the GP information system becoming more and more the central repository of patient data). Images (c.f. emerging broadband services) from radiology, nuclear medicine, echography, microscopy (e.g. in the context of teleconsulting). Communication between hospitals and suppliers: orders, invoices, updates of files on articles, etc. Exchange with insurances, third party payers: billing.
0307-7640/92 $3.00 Q 1992 Taylor & Francis Ltd
G. J . E. De Moor
134
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
Figure 1 .
Telematics problem: increasing diversity.
QPL=jQ Physicians
Physicians
Physicians
Physldans
MAILBOX SERVER
2
1
Labs Figure 2.
-1 [RadlolDgy
e l= 1 :p
O n e of the solutions: the electronic mailbox.
This may be due to the fact that these interdisciplinary fields (medical informatics and health care telematics) are vast, and present difficulties in matching both medical knowledge and telematics with obvious results such as good analysis of the problem domain but wrong choice in informatics solutions or vice-versa. More alarming is the ascertainment that many of these telematics experiments in health care have been conducted on regional scales, and inevitably have resulted in the proliferation of incompatible solutions; hence the importance of standardization now.
2. Communication with the doctor’s office: a paradigm Considering all these needs, and bearing in mind the fact that in many countries the general practices are becoming the repository of the patient’s complete medical records, the difficult situation presented in figure 1 must be avoided. Some inherent problems of the situation shown in figure 1 are:
(1) (2) (3) (4) (5) (6)
higher investments (hardware, software, manpower); lack of user-friendliness; difficult end-user assistance; heterogeneous communication modes (different speeds, protocols, etc.); more difficult connection of new users and introduction of new services; complex billing of services.
T o solve these problems it is necessary to choose an appropriate and standard method of communication (e.g. X-400). T h e advantages of the solution presented in figure 2 are: (1) (2) (3) (4) (5) (6)
single connection for all services; end-user friendliness; minimum investment, pay as you use; one-stop shopping; simplification of format and protocol conversion; help facility.
Telestroika in health care informatics
135
A spiral p h e - n o m m
increase of the use of IT & T in the Health Care Sector
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
and growing Market
-
Better Communication Systems I
I
More
1 information Systems Figure 3 .
---~
Strategic impact (it' standards in health care informatics
T h e key to success factors when installing such medical telematics services are:
(1) use of standards (not only for the method of communication but also for the information itself: syntax and codes); (2) availability of the services (24 h/24 h); (3) growth potential of the services; (4) compliance with data protection and ethical requirements.
3. ED1 and standards: promises T h e benefits of state-of-the-art electronic data interchange (EDI), together with standards, will undoubtedly result in higher eficiency (direct integration of data locally), less maintenance (fewer conversion tables), less risk f o r technical monopolies (ethical issue in medicine), better data protection (cf. authentication, authorization, encryption), and cost savings. Studies have already shown that the use of standards is a k e y promoting factor in electronic communication, which in its turn significantly increases the application of informatics and the use of computers. T h e breakthrough of the medical informatics market will probably be caused by the introduction of medical telematics applications.
4.
CEN TC 251 on standards in health care informatics
It was only with the introduction of telematics in health care that an urgent need was disclosed for organized standardization activites and for a common use of standards in health care informatics. I n order to respond to this challenge the
G . J . E . De Moor
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
136
Technical Board (BT) of the European Standardization Committee (CEN) approved the establishment of a Technical Committee for Medical Informatics ( T C 251) in March 1990. Creation of CEN (TC251 and the occurrence of the A I M (Advanced Informatics in Medicine, 100 million ECUs) European Research Programme is not to be considered as mere coincidence. Already within the exploratory action of the programme of DG X I I I - F , providing funding for international research in medical informatics, several projects (about seven), addressed standardization or prestandardization (e.g. the E U C L I D E S project). Both research and development and standardization will undoubtedly cross-fertilize through complementarity and be of great significance to all future health care informatics and telematics efforts in Europe. Coordination of AIM and CEN projects (see Annexes to this article) will become possible through a concerted action on standardization. T h e objectives of CEN T C 251 are the organization, coordination and follow-up at a European level of standard development, including testing standards, in health care informatics. Since any standardization activity should begin by identifying the needs, determining the aims of the (pre)-standard(s) to be prepared and the interests that may be affected, the C E C issued a mandate (BC-IT-SI-05) to assess the actual situation of standardization in medical informatics. T h e recommendations originating from this mandate are part of the T C 251’s ‘Directory of requirements and Programme for the development of standards for Health Care Informatics’, in which the tasks for the working groups and project teams are described. T h e CEN T C 251 statements of principles are:
(1) Do not ‘over’-standardize. ( 2 ) Bottom-up (user needs) and top-down approach (models) are complementary and both will be followed at all levels ( T C , WG, P T ) . (3) T h e partitioning of the work strongly shapes the effort and will determine its success or failure (cf. importance of a taxonomy).
Table 2.
1.
Two schools of thought
Linkage of diversity bY Standard interfaces Heterogeneity is a reality in health care information systems Diversity is an advantage and enrichment. Hardware vendors and software developers will never build their strategy on portability (even if they give the impression that they are ready to do it). Therefore focus must on health care data interrhange standards.
2.
Transportability of software bY Standard (sub-)systems T h e health care informatics industry often supply to local markets products which arc ‘too much customized’ (expensive in development, expensive to buy, having a short life cycle, etc.). Agreement on common requirements at an international level will reduce the prices for health care information systems and open the market.
Telestroika in health care informatics
137
(4) There is a danger that tools may be used for the wrong purpose or outside their working limits and therefore a problem-based approach has to be preferred rather than a technique-driven one.
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
( 5 ) Medical informatics must be understood in its broader meaning as health care informatics. At the start attention will be forced at OSI layer 7 and above and to the data. (6) Duplication of work must be avoided. When the scope of a group is allinclusive o r overlaps too many others’ effort, this group has to accept a narrower range (cf. cooperation with EWOS, CENELEC T C 62, CEN T C 224, WEEB/MD 9, ANSI, HCPP, etc.). (7) Whenever there are opportunities to work cooperatively on an international basis one has to use these facilities in order to avoid conflicts and to make the standards more compatible (cf. cooperation with the ANSI Health Care Informatics Planning Panel in US, which was established in December 1991). T h e establishment of a ‘Fortress Europe’ and the creations of barriers to trade must be avoided. (8) Work will start only when a standard is really needed and wanted. Only realistic and feasible targets will be promoted: near-term and high-yield opportunities will be dealt with first. T h e reasoning that standardization in health care informatics is an extremely urgent issue has to be balanced against the fact that it has been overdue for many years. C E N T C 251 decided to constitute the following working groups: WG.1: WG.2: WG.3: WG.4: WG.5: WG.6: WG.7:
Health Care Information Modelling and Medical Records. Health Care Terminology, Semantics and Knowledge Bases. Health Care Communications and Messages. Medical Imaging and Multi-media. Communication with Medical Devices. Health Care Security, Privacy, Quality and Safety. Intermittently Connected Devices (including patient data cards).
Each working group supervises a number of project teams. T h e work in a project team is undertaken by especially assigned experts and is funded. Project teams have to be duly justified. They are small groups of trusted people preparing (full-time) a high-quality draft document, urgently required with a high probability of getting a rapid consensus. T h e actual (February 1992) total number of experts (representing the users, academic centres and industry) in the C E N T C 251 working groups and in the delegations at TC level is approximately 400. They constitute a rich network of technically and medically skilled people.
5. Conclusion Medicine is a complex discipline, and the doctor a supreme individualist. T h e formalization of this art is long and difficult, and consequently, standardization in medical informatics an ambitious task. While the European standardization structure is now well formulated and in place, Europeans should not neglect their identity and have confidence in themselves and in their rich cultural and technical traditions. Instead of accepting without
138
G . J . E . De Moor
Inform Health Soc Care Downloaded from informahealthcare.com by Nyu Medical Center on 12/07/14 For personal use only.
criticism what is ‘available’ from outside, only because of its immediate availability, Europe will check, in the coming period, the validity of all existing solutions and will try to enrich proposals with its own knowledge whenever needed. It remains to be hoped that the general acceptance of the importance of telecommunications, which forms together with informatics the area of telematics, will serve as a sufficient catalyst to the reaction of standardization in health care informatics so much required.
Annexe A: Work items in CEN TC251’s Directory (version 1.40) Codes 1.1. 1.2. 1.3.
1.4. 1.5. 1.6. 1.7.
Titles Health Care Framework Medical Informatics-Vocabulary Health Care Information Systems Architecture Common Conceptual Schemes Health Care Information Model and Transaction Set Co-ordination Electronic Health Care Records Medical User Interface
2.14. 2.15.
Integration of Medical Data and Knowledge Base Systems Terminology and Coding System of Diseases Terminology and Coding Systems of Drugs Terminology and Coding Systems of Medical Procedures Terminology and Coding Systems of Manufactured Health Care Articles Standards for Notation of Units for ChemicaI/Physical Parameters in the Life Sciences Time Standards for Health Care-specific Problems European Machine Dictionary and Multilingual Medical Terminology Integrated System of Concepts Collection of Formalized Medical Knowledge Interchange Formats for Knowledge Bases Model for Representation of Semantics Metalanguage for Data Manipulation and Information Retrieval in Medical Databases and Knowledge Bases Statistical Databases for Medical, Epidemiological and Administrative Purposes Standard Drug Databases
3.1. 3.2. 3.3. 3.4. 3.5. 3.6. 3.7.a 3.8. 3.Y.
OSI Application Profiles for Health Care OSI Transport Profiles for Health Care OSI Management Profiles for Health Care Multi-media Medical Data Interchange Messages for Exchange of Laboratory Information Interchange Format for Reference to Articles Published in Biomedical Books and Journals Investigation of Syntaxes for Existing Interchange Formats to be used in Health Care Procedures for Registration of Coding Systems Related to Health Care Registration of Data Sets
4.1. 4.2. 4.3. 4.4. 4.5. 4.6. 4.7. 4.8. 4.9.
Functional Profiles for Medical Image Interchange Medical Image Management Standard Medical Image and Related Data Interchange Format Standards Standard Classification and Codes for Medical Image Processing Patterns for Calibration of IMAC Components Characteristics and Specification Standards for IMAC Components and Systems Medical Image Interchange: Conformance Testing of Standards Implementations Medical Image Interchange: Compression Schemes in Telemedicine Medical Data Interchange: HIS/RIS-PACS and HIS/RIS-Modality Interface
5.1. 5.2.
Vital Signs Information Representation Standard Interchange Format and Communication Protocol for Computerized Electrocardiography Interoperability of Medical Devices within Acute Care Units Clinical Analyser Interface to Laboratory Information Systems
2.1. 2.2. 2.3. 2.4. 2.5. 2.6. 2.7. 2.8. 2.9. 2.10. 2.11. 2.12. 2.13.
5.3. 5.4.
Telestroika in health care informatics
6.2. 6.3. 6.4. 6.5. 6.6.
Safety-related Standards for Health Care Security for Health Care Information Systems Harmonization of Ethical/Legal Issues Secure LJser Identification for Health Care Software Quality Assurance for llealth Care Evaluation of Physiological Analysis Systems
7.0. 7.1,
Intermittently Connected Devices: Data Content Off-line Device Interchange Format
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6.1.
139
Annexe B: List of projects i n AIM -phase I1 Biomedical Technology Assessment and Management (BEAR.1). Computer Aided Movement Analysis in a Rehahilitation Context-I1 (CAMARC-11). C o m p u t e r VIsion in RAdiology (COVIRA). Diabetes Data Set Cards (DIABCARD). Logic Engineering in General Practice, Oncolo ared Care (DILEXIMA). Telematics for Bone Marrow Transplantation ( European Prototype for Integrated Care (EPIC). Prototype E M G Workstation ( E S T E E M ) . European Integrated Picture Archiving and Communication System in the €Iospital (EURIPACS). Framework for European Services in ‘Teleniedicine ( F E S T ) . Generalized Architecture for Languages Encyclopaedias and Nomenclatures in hledicine (GALEN). A General Architecture for Medical Knowledge-based Systems (G.4MES-Il). Good European Health Record (GEHR). Hospital Object Software Tools (HELIOS-2). Intelligent Decision-mapping Record Built in Verilied Multicentre Dataset ( I D M R ) . Integrated Rehabilitation Project (IREP) Standards in General Practice (ISAAC). Integrating Microscopy for Pathology Activities and Computer l‘echnology (IMPACI’). Knowledge Acquisition, Visualization, Refinement and Assessment System (KAk’AS-2). Interpretation of Medical Signals (;LIAGNOHKAIN). Medical Archive Generation with Object-oricntate~l‘I’echniques (RIARGOT) Measurement and Economic Modelling of the Performance of Health Care through Information Systems (MEMPHIS). An Access System for Medical Records using Natural Language (hlENELAS). Multimedia Interaction with Large Object-orientated Radiological and Clinical Databases ( M ILORD). Customization Environment for Multimedia Integrated Patient Dossiers (NUC1,ELIS). Open European Data Interchange and Processing for Electrocardiugraphy (OEDIPE). Optimization of Drug Prescriptions using Advanced Informatics (OFAT>E). Applications of Advanced Informatics and Telematics for Optimization of Clinical 1,aboratory Services (OPENLABS). Telematic System for Quality Assurance i n 0r:iI Health Care (ORATEL). Profiles of Care System (PROCAS). Strategic Health Informatics Networks for Europe (SHINE). Secure Environment for Information Systems in hledicine (SEISMED). Quality Assurance of User Informatics for Child Health in Europe (QUICHE). Software Applied to Multimodal Images and Education (SAhlMIE). Telematics for Anaesthesia and Intensive Therapy ( T A N I T ) . Telematics Technology for Harmonizing and I’romiiting Quality in Gastroenterology (TELEGASTRO).
Annexe C: List of acronyms .4IM ANSI CEN CEN-BT CEN-PT CEN-TC CEN-WG CENELEC
Advanced Informatics In hledicine American Kational Standards Institute Cornit6 Europien de Normalisation Comite Europeen de Kormalisation-Bureau Technique Comitt Europeen de Normalisation- Project Team Comite Europeen de Normaliaation-~’fechnical Committee ComitC. Europien de Normalisation~~-WorkG r o u p Comite Europeen de Normalisation Electrotechnique
Telestroika in health care informatics
140 EUCLIDES EWOS WEEB
European Clinical Laboratory Data Exchange Solution European Workshop on Open Systems Western European Edifact Board
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References 1, Directory ofthe European Standardisation Requirements for Health Care Informatics and Programmefor the Dewelopment of Standards, T C 251, version 1.40 (1992-01-01). 2. NOOTHOVEN VAN GOOR, J., and CHRISTENSEN, J. P. (1992) Advances in Medical Informatics, Results of the A I M Exploratory Action (Oxford, 10s Press). 3 . MCDONALD, C. (1991) Standards for the electronic transfer of clinical data: progress and promises. Top Health Record Management, 11 (4),1-16.
