An overview of Health Informatics Standards
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1 An overview of Health Informatics Standards Management and Information Systems in Health Care in the Russian Federation, Moscow Y.Samyshkin, A.Timoshkin Centre for Health Management The Business School Imperial College 02/02/2004
2 Themes for presentation Purpose of informatics standards Areas of standardisation Health systems architecture Open nature of HIS International context and some European initiatives Systems interoperability Discussion and feedback 2
3 The purpose of standards in Health Information Systems 02/02/2004
4 The purpose of standards Maintenance of long term, meaningful, comparable, and compatible information on health and care Maintenance of well defined information structure which allows modular development and expandability of the health information systems Compatibility of hardware and software applications Achieving flexibility and cost-effective evolution of the design and development of information systems with no information loss Development of the integrated health information environment Ensuring security of data and information handling procedures in the systems 4
5 The need for integration of healthcare information Different platforms Ministry of Health Statistics Planning Feedback Regional Health Authorities Operational Planning Statistics Legacy Health Insurance Statistics Planning Health Service providers Financial Intermediaries Service use Payment systems Patients Government statistics Statistics Special programs authorities Reporting Service use Payments Patients Data exchange, communication, messaging Research and methodology units Statistics Program-specific analysis Aggregated information Other related authorities Feedback, Exchange Health information Other Service providers (eg social) Departmental systems: Patient administration Changing technologies Heterogeneous systems 02/02/2004 and service Y.Samyshkin. provision A.Timoshkin, Centre for Health Integration and interoperability of the systems Uses of information Health care Knowledge Analysis and service planning Management Patient treatment and care 5
6 Open systems approach As the health information standards, health organisations and information systems are constantly evolving: the existing systems should have an open architecture and consistent data structure enabling extensions and integration of new developments with minimum changes in the existing systems 6
7 Important factors for consideration - I There should be a clear definition of the health information tasks that have to be solved by implementation of standards Coordinating and prioritising of the introduction of standards as such changes in information systems will require financial expenditure and changes in the organisations Assessment of potential impact of the standards on the health information system development strategy of the country 7
8 Important factors for consideration - II Implementation of standards is not a purely technical matter and will usually involve changes in the operational aspects of the organisations that use HIS The development of standards involve the evaluation, revision, and development of tactics for changes in the existing information systems The process of standardisation in health information systems requires managerial and financial resources. Therefore prioritising activities and assessing longer term consequences of decisions made should be an important part of work on the standards 8
9 Criteria for selection of health information standards Deciding in what areas of the HIS the standards are critical: Terminology and semantics Communication protocols standards Standards for output information (reporting) Standards for source systems information Architecture standards Security / safety standards (processes) Information technology platform (s) 9
10 Criteria for selection of health information standards Whether a full specification of the standard available This is the open standard requirement A condition of involvement of many participants in development in the future Is the standard a part of the well established international standards Some country-specific standards are part of the international health information systems Such standards are supported by international organisations and projects 10
11 Criteria for selection of health information standards Market and sector acceptance Is the standard accepted de facto by other HIS systems in the country and internationally? Other health information systems How acceptance of the standard might affect, positively or adversely, other HIS and related developments in the country? 11
12 Criteria for selection of health information standards Relations to others Relations to other standards and whether implementation of the standard likely to cause changes in the use of other standards? Estimates of costs of acquiring the standard The direct cost of acquisition and use of the standard Cost of modifications to the existing systems, including the cost of staff training 12
13 International Developments and Organisational Structures 02/02/2004
14 Some information systems technical standards ISO TC 215 (ISO) HL7 (Health Level Seven) CIHI (Canadian, compatible with OECD) GEHR (OpenEHR Foundation) ICPC (EUPHID) SNOMED (Snomed, NHS Information Authority) Current Procedural Terminology (CPT) (U.S. The American Medical Association) OPCS-4, UK Classification of Operative Procedures (OPCS-4) DICOM - DICOM Standards Committee XML (W3C Consortium) 14
15 ISO WHO, Health for All Organisations CEN: European Commission for Standardisation Eurostat OECD, Health database Country-specific, e.g.: State Committee of the Russian Federation for Standardization and Metrology American National Standards Institute British Standards Institute 15
16 European Standardisation in Health Informatics 02/02/2004
17 CEN - European Committee for Standardisation Promotion of voluntary technical harmonization in Europe in conjunction with worldwide bodies and its partners in Europe In Europe, CEN also works in partnership with CENELEC - the European Committee for Electrotechnical Standardization ( and ETSI - the European Telecommunications Standards Institute 17
18 European Health Informatics Standards Sets technical standards TC European Commission for Standardisation Health CENELEC European Committee for Electrotechnical Standardization ETSI European Telecommunications Standards Institute Information Models Four working groups DICOM: Digital Imaging and Communication in Medicine EEG9 European Board for EDI/EC Standardization Expert Group 9 for Healthcare Health Level Seven (HL7) IMIA - WG16 - Working Group on Healthcare Informatics and Telematics Standards. Terminology and knowledge bases Security, safety and quality Technology for interoperability CEN European Committee for Standardisation ITU International Telecommuni cation Unit ISO International Standards Organisation OMG Object Management Group OSF Open Software Foundation 18
19 Example: standards for EHR Source: CEN/TC 251/N
20 CEN s working principles Voluntary membership Consensus on the content National commitment Technical coherence at the national and European level Integration with other international work 20
21 CEN / TC 251: European Standardization of Health Informatics The area of activity of CEN is standardization in the field of Health Information and Communications Technology (ICT) to achieve compatibility and interoperability between independent systems and to enable modularity This includes requirements on health information structure to support clinical and administrative procedures, and technical methods to support interoperable systems requirements regarding safety, security and quality Thematic activities CEN/TC251, workgroups 21
22 WG1: communication between independent information systems within and between organisations Information models Open systems Supporting quality patient care Electronic healthcare records Standardised health care messages Minimising risks and handling sensitive information 22
23 WG2: semantic organisation of information and knowledge Terms, concepts and the interrelationship of concepts Structures for systems including those for multi-axial coding schemes Guidelines for the production of coding systems and knowledge bases 23
24 WG3: Quality, safety and security Development of protection profiles for various sectors or application areas detailed protocols for various core security services Evaluation and certification of IT products and IT systems The three main areas Intercommunication of data between devices and information systems Integration of data for information representation Communication of health care record data between source departments and other legitimate users in the healthcare sector 24
25 Quality of information systems Quality is the totality of features and characteristics of a product, process or service that bear on its ability to satisfy its stated or intended needs. Two important features of the overall quality of such systems are the safety and the security of the systems, and these elements will become even more important as information systems are increasingly used for safetyand security-critical applications 25
26 Security of health information systems Security is related to the prevention of breaches of confidentiality, integrity and availability. In healthcare information systems, the main reason for the major concern with confidentiality, is the protection of privacy of the individuals. The patients have to trust health care establishments to care for the very sensitive information they give them. Systems are to be understood in a wider sense, including the surrounding procedures. 26
27 Safety of health information systems Safety if the expectation that systems do not, under defined conditions, enter a state that could cause human death or injury. In this definition however, a 'system' will include the software, the hardware, the users of the system and the procedures and practices related to the working of the system. It is not sufficient to analyse a software system without considering how it is used and the environment in which it is used. Software does not actually kill or injure people - it is the associated hardware or the actions of inaccurately informed staff that may cause harm 27
28 WG4: Middleware particularly medical imaging and multimedia and medical device communication in integrated healthcare. Develop and promote standards that enable the interoperability of devices and information systems in health informatics. 1. Intercommunication of data between devices and information systems 2. Integration of data for multimedia representation 3. Communication of such data between source departments and other legitimate users elsewhere in the healthcare sector, in order to facilitate electronic healthcare record provision. 28
29 Interoperability of health information systems 02/02/2004
30 Important questions What? Functionality and data that need to be shared between systems Relation with different decisions of the systems integration solution Where? Location of the integration points in the architecture of interoperable systems Specification for interoperability in participating systems How? The most suitable interoperability model Concrete integration technologies and standards Technical infrastructure needed to support the solution When? during the systems development cycle or existing systems need to be integrated Adapted from J. Mykkanen, et al. A process for specifying integration for multi-tier applications in healthcare, International Journal of Medical Informatics (2003) 70, 173/182 30
31 The seven-tier interoperability model 1. Technical interfaces 2. Technical infrastructure 3. The application infrastructure 4. Functional interfaces 5. Semantics 6. The functional reference model 7. The development lifecycle P. Herzum, O. Sims, Business Component Factory, Wiley Computer Publishing, New York,
32 The seven-tier interoperability model 1. Technical interfaces Which technologies are used for the implementation of the interoperability? Different technical interfaces include database-level interfaces, message based, document-based or file-based bridges, or application programming interfaces (APIs) 2. Technical infrastructure How to support the communication technically? Activation, error handling, naming, technical security etc. are considerations on technical infrastructure level. Normally there are two choices for implementing the interoperability on this level: either the invoking system adapts to the target system (model knowledge) or both systems share common protocols (common context, shared services 32
33 The seven-tier interoperability model 3. The application infrastructure This includes architectural conventions, interface style, central system design patterns etc, which have often remained implicit to the applications. Positioning integration points in multi-tier application architecture is a key question on this level. 4. Functional interfaces They are the precise interfaces of the services. They are typically either data-oriented (such as HL7 message definitions) or processing-oriented (such as the Object Management Group (OMG) healthcare service definitions). In either case, functional interfaces usually contain data definitions, either as message (field) definitions, or as definitions of operation parameters. 33
34 The seven-tier interoperability model 5. Semantics This is knowledge about the exact meaning of the functional interfaces. For two systems to interoperate, the meanings and allowed values of each operation and data element in the interfaces must be specified, in addition to the interface itself 6. The functional reference model It consists of the underlying system-specific models that affect the interoperability. For example, if the length of a data field is shorter in client system, than in server system, or if the data item needed in the client system is not at all implemented in the server system, the retrieved value cannot be meaningfully used in the client system. Also: the shared reference models for data and functionality on this level * These models are typically implemented using different technologies in different systems 34
35 7. The development lifecycle It extends the interoperability between systems to include the early phases of the systems lifecycle, including requirements, analysis, and design phases Systems interoperate more easily if similar architectural conventions and decisions, common modelling standards and exchange formats are utilised throughout the lifecycle. 35
36 Examples of use of standards at different interoperability levels Adapted from J. Mykkanen, et al. A process for specifying integration for multi-tier applications in healthcare, International Journal of Medical Informatics (2003) 70, 173/182 36
37 Discussion Health Information Standards in the Russian Federation in the context of the development of Health Information Strategy 02/02/2004
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