The European Committee for Standardization (CEN) Standard Architecture for Healthcare Information Systems (ENV 12967), Health Informatics Service Architecture or HISA is a standard that provides guidance on the development of modular open information technology (IT) systems in the healthcare sector. Broadly, architecture standards outline frameworks which can be used in the development of consistent, coherent applications, databases and workstations. This is done through the definition of hardware and software construction requirements and outlining of protocols for communications. [1] The HISA standard provides a formal standard for a service-oriented architecture (SOA), specific for the requirements of health services, based on the principles of Open Distributed Processing. [2] The HISA standard evolved from previous work on healthcare information systems architecture commenced by Reseau d’Information et de Communication Hospitalier Europeen (RICHE) in 1989, and subsequently built upon by a number of organizations across Europe. [3]
The HISA standard was developed by CEN Technical Committee (TC) 251, the technical committee for Health Informatics within the federation of European national standards bodies (CEN). [4] The CEN/TC 251 was made up of four working groups, covering: information models; systems of concepts and terminology; security; and technologies for interoperable communication. [5] Working Group I were responsible for information models and completed the specifications that became the HISA standard. Working Group I worked with experts from across Europe, plus contributors from Australia and the United States in the development and finalization of ENV 12967.
The CEN HISA standard was adopted by the International Organization for Standardization (ISO) in 2009, with the stated aim of ISO 12967 being to provide guidance on:
EN/ISO 12967 is broken down into three parts: Enterprise Viewpoint; Information Viewpoint; and Computational Viewpoint, all of which deal with different aspects of ensuring service architecture supports openness and vendor-independence. [7]
Part One: Enterprise Viewpoint
The Enterprise Viewpoint component of EN/ISO 12967 provides health services with guidance in describing, planning and developing new IT systems, utilizing an open distributed processing approach. In addition to this it provides direction for the integration of existing information systems, within the one enterprise and across different healthcare organizations. Part one of the standard sets forth the common enterprise-level requirements (e.g. workflows, authorizations) that must be supported through the HISA, which integrates the common data and business logic into a specific architectural layer (i.e. the middleware), accessible throughout the whole information system of the health service. [8]
Part Two: Information Viewpoint
The Information Viewpoint component of EN/ISO 12967 sets forth the fundamental characteristics of the information model to be implemented by the middleware to provide comprehensive, integrated storage of the common enterprise data and to support the fundamental business processes of the healthcare organisation, as defined in ISO 12967 Part One. The specifications were designed to be universally relevant, whilst being sufficiently specific to allow implementers to derive an efficient design of the system for their organisation. This specification does not aim to provide a fixed, complete specification of all possible data that may be necessary for any given health service. It specifies only a set of characteristics, in terms of overall organisation and individual information objects, identified as fundamental and common to all healthcare organizations. [9]
Part Three: Computational Viewpoint
The Computational Viewpoint component of EN/ISO 12967 provides details on the fundamental characteristics of the computational model to be implemented by the middleware, to provide a comprehensive and integrated interface to the common, fundamental business processes of the health service. The computational model, like the information model is designed to be universally relevant, whilst still being sufficiently specific to allow implementers to derive an efficient design of the system for their organisation, irrespective of the specifics of the pre-existing information technology environment in which it will be implemented. [10]
The implementation of a modular, open architecture in healthcare IT systems (as specified by the HISA) relies upon disparate heterogeneous applications interacting and communicating through a middleware layer, made up of common services. In the case of the HISA, these common services are divided into Healthcare-related Common Services and Generic Common Services. [11]
Healthcare-related Common Services (HCS)
Healthcare-related Common Services are those middleware components responsible for supporting the functionalities and information relevant to the healthcare business domain, including subject of care, activities, resources, authorization, health characteristics and concepts. [12]
Generic Common Services (GCS)
Generic Common Services are those middleware components are those middleware components responsible for supporting the generic functionality and information requirements that are non-specific to the healthcare domain, and may be broadly relevant to any information system in the business domain. [13]
Health informatics is the study and implementation of computer structures and algorithms to improve communication, understanding, and management of medical information. It can be viewed as a branch of engineering and applied science.
Health Level Seven, abbreviated to HL7, is a range of global standards for the transfer of clinical and administrative health data between applications with the aim to improve patient outcomes and health system performance. The HL7 standards focus on the application layer, which is "layer 7" in the Open Systems Interconnection model. The standards are produced by Health Level Seven International, an international standards organization, and are adopted by other standards issuing bodies such as American National Standards Institute and International Organization for Standardization. There are a range of primary standards that are commonly used across the industry, as well as secondary standards which are less frequently adopted.
Message-oriented middleware (MOM) is software or hardware infrastructure supporting sending and receiving messages between distributed systems. Message-oriented middleware is in contrast to streaming-oriented middleware where data is communicated as a sequence of bytes with no explicit message boundaries. Note that steaming protocols are almost always built above protocols using discrete messages such as frames Ethernet), datagrams UDP, packets IP, cells ATM, et al.
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An electronic health record (EHR) is the systematized collection of patient and population electronically stored health information in a digital format. These records can be shared across different health care settings. Records are shared through network-connected, enterprise-wide information systems or other information networks and exchanges. EHRs may include a range of data, including demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, vital signs, personal statistics like age and weight, and billing information.
openEHR is an open standard specification in health informatics that describes the management and storage, retrieval and exchange of health data in electronic health records (EHRs). In openEHR, all health data for a person is stored in a "one lifetime", vendor-independent, person-centred EHR. The openEHR specifications include an EHR Extract specification but are otherwise not primarily concerned with the exchange of data between EHR-systems as this is the focus of other standards such as EN 13606 and HL7.
The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare,made to enable information system interoperability and to improve medical research and related areas of healthcare. The standards support medical research from protocol through analysis and reporting of results and have been shown to decrease resources needed by 60% overall and 70–90% in the start-up stages when they are implemented at the beginning of the research process. Since December 2016, CDISC standards are mandatory for submission to US FDA.
The HL7 Clinical Document Architecture (CDA) is an XML-based markup standard intended to specify the encoding, structure and semantics of clinical documents for exchange. In November 2000, HL7 published Release 1.0. The organization published Release 2.0 with its "2005 Normative Edition".
Reference Model of Open Distributed Processing (RM-ODP) is a reference model in computer science, which provides a co-ordinating framework for the standardization of open distributed processing (ODP). It supports distribution, interworking, platform and technology independence, and portability, together with an enterprise architecture framework for the specification of ODP systems.
The European Institute for Health Records or EuroRec Institute is a non-profit organization founded in 2002 as part of the ProRec initiative. On 13 May 2003, the institute was established as a non-profit organization under French law. Current President of EuroRec is Prof. Dipak Kalra. The institute is involved in the promotion of high quality Electronic Health Record systems in the European Union. One of the main missions of the institute is to support, as the European authorised certification body, EHRs certification development, testing and assessment by defining functional and other criteria.
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CEN/TC 251 is a technical decision making body within the European Committee for Standardization (CEN) working on standardization in the field of Health Information and Communications Technology (ICT) in the European Union. The goal is to achieve compatibility and interoperability between independent systems and to enable modularity in Electronic Health Record systems.
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A view model or viewpoints framework in systems engineering, software engineering, and enterprise engineering is a framework which defines a coherent set of views to be used in the construction of a system architecture, software architecture, or enterprise architecture. A view is a representation of the whole system from the perspective of a related set of concerns.
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Christopher G. Chute is a Bloomberg Distinguished Professor at Johns Hopkins University, physician-scientist and biomedical informatician known for biomedical terminologies and health information technology (IT) standards. He chairs the World Health Organization Revision Steering Group for the revision of the International Classification of Diseases (ICD-11).
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