Electronic Health Record Standards

136 © 2006 IMIA and Schattauer GmbH Electronic Health Record Standards D. Kalra CHIME, University College London, London, United Kingdom Summary Introduction This paper summarises the key EHR stand- Objectives:This paper seeks to provide an overview of the ards that are presently being developed to initiatives that are proceeding internationally to develop Clinical care increasingly requires healthcare meet these requirements. standards for the exchange of electronic health record (EHR) professionals to access patient record infor- information between EHR systems. mation that may be distributed across multi- Methods:The paper reviews the clinical and ethico-legal ple sites, held in a variety of paper and elec- requirements and research background on the representation tronic formats, and represented as mixtures The Need for Generic and and communication of EHR data, which primarily originates from of narrative, structured, coded and multi- Interoperable EHRs Europe through a series of EU funded Health Telematics projects media entries. A longitudinal person-centred over the past thirteen years. The major concepts that underpin electronic health record (EHR) is a much- Patient care increasingly requires clinical the information models and knowledge models are summarised. anticipated solution to this problem, but the practitioners to access detailed and complete These provide the requirements and the best evidential basis from which HER communications standards should be challenge of providing clinicians of any health records in order to manage the safe developed. profession or speciality with an integrated and effective delivery of complex and Results: The main focus of EHR communications standardisation and relevant view of the complete health and knowledge-intensive health care, and to is presently occurring at a European level, through the health care history of each patient under their share this information within and between Committee for European Normalisation (CEN). The major care has so far proved difficult to meet. This care teams [5]. Patients nowadays also constructs of the CEN 13606 model are outlined. Complementary need is now widely recognised to be a major require access to their own EHR to an extent activity is taking place in ISO and in HL7, and some of these obstacle to the safe and effective delivery of that permits them to play an active role in efforts are also summarised. health services, by clinical professions, by their health management. These require- Conclusion: There is a strong prospect that a generic EHR health service organisations and by govern- ments are becoming more urgent as the focus interoperability standard can be agreed at a European (and ments internationally. of health care delivery shifts progressively hopefully international) level. Parts of the challenge of EHR interoperability cannot yet be standardised, because good From an academic vision in the late 1980’s from specialist centres to community solutions to the preservation of clinical meaning across the Electronic Health Record (EHR) has e- settings and to the patient’s personal heterogeneous systems remain to be explored. Further research volved to become centre-stage in the nation- environment. and empirical projects are therefore also needed. al health informatics strategies of most Euro- However, much of the fine-grained clinical Haux R, Kulikowski C, editors. IMIA Yearbook of Medical pean countries, and internationally [1-4]. information on which future care depends Informatics 2006. Methods Inf Med 2006; 45 Suppl 1: S136- International research over the past fifteen is still captured into paper records or within 44. years has highlighted the clinical, ethical and isolated clinical databases. Even very mod- technical requirements that need to be met ern computerised health information sy- Keywords in order to effect this transition. There is a stems limit the ability of users to extract clin- Electronic health records, interoperability, standardisation, need for interoperability standards meeting ical details in a form that can be communi- information model these requirements that can permit clinical cated to other such systems, and few computer systems to share health record data products can import clinical information whilst preserving faithfully the clinical received from external systems. meaning of the individual authored contribu- The main way in which integrated health tions within it. Concerns about protecting care has been managed up to now, apart from the confidentiality of sensitive personal in- via paper-based letters and reports, has been formation must also be addressed if through defined sets of electronic messages, consumer confidence is to be maintained transmitted for example using EDIFACT or when EHRs are widely accessible. HL7. Most national health services have IMIA Yearbook of Medical Informatics 2006 137 Electronic Health Record Standards adopted a suite of these messages to support accommodate the individuality of the additional requirements on the rigour with purchaser-provider communications, clinician as well as the patient [9]. Tange which health record entries are attributed, organisation and service administration, suggests that the flexibility of data entry and represented and managed. billing, and to manage health care inter- support of narratives are major reasons for The way in which individual clinical state- ventions (e.g. screening) for public health the retention of paper records by many ments are hierarchically nested within a purposes. However, few such messages have clinicians [10]. record confers an important context for their been developed to support the clinical shared Extensive investigations of user and enter- interpretation. Aspects of certainty, severity care process itself and, where they have been, prise requirements have taken place over and the absence of findings must be capable these tend to be condition-specific such as many years to capture the health record in- of rigorous and unambiguous representation. for the management of diabetes or for ante- formation needs across primary, secondary For example, a patient with a family history natal care. However, single-disease ap- and tertiary care, between professions and of diabetes or in whom diabetes has been proaches are no longer rich enough to under- across countries. These requirements have excluded must not erroneously be retrieved pin good health care. been distilled and analysed by expert groups, in a search for diabetic patients. Table 1 This recognition is not new. In a 1999 US internationally, in order to identify the essen- below summarises the kinds of clinical and Medical Records Institute survey of EHR tial information that must be accommodated medico-legal context that needs to be Trends and Usage (reported in [6]) over 70% within an EHR architecture to: mapped to classes and attributes within an of respondents regarded the need to share • capture faithfully the original meaning EHR architecture [21]. patient record information between different intended by the author of a record entry health care sites as the major clinical driver or set of entries; • for EHRs. In 1998 Shortliffe wrote: provide a framework appropriate to the needs of professionals and enterprises to “System integration has emerged as a key The EHR Architectural analyse and interpret EHRs on an individ- element in the reinvention of environments ual or population basis; Approach for patient data management and health • incorporate the necessary medico-legal promotion. The ability to achieve the future constructs to support the safe and rele- The architectural approach to representing vision of integrated health records depends vant communication of EHR entries the EHR has its origins in research under- in part on current research initiatives related between professionals working on diffe- taken through the EU Third, Fourth And to the role of the global information rent sites, whilst respecting the privacy Fifth Health Telematics Framework Pro- infrastructure in supporting health and wishes of individual patients. grammes. The increasing limitations of health care.” [7] paper-based records, the potential benefits The most detailed review of this domain has of electronic health records and the ak- been published by the GEHR [11-15], knowledged challenges of delivering these EHCR Support Action [16] and Synapses in practice have stimulated a considerable Requirements for Represent- projects [17], which informed the subse- investment in research and development ing and Communicating EHRs quent European EHR pre-standards [18,19] over the past decade. Between 1991 and and ongoing EHR research. These require- 1998 the European Union provided 47 Mil- Good health records are not just a scattered ments have now been consolidated by ISO lion ECU of direct funding support to accumulation of health related data about as an International Technical Specification, research projects whose budgets totalled 76 individuals. Entries are made as formal which provides a single point of reference Million ECU [22]. contributions to a growing and evolving for the core EHR requirements [20]. Considerable research has been undertaken story, through which the authors are account- The communication of EHR information is over the past fifteen years to develop archi- able for health care actions performed or complex because much of clinical meaning tecture formalisms to capture healthcare data not performed. At any point in time a pa- is derived not from individual

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