EN 13606

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The overall goal of this Health informatics - Electronic Health Record Communication (EN 13606) European Standard is to define a rigorous and stable information architecture for communicating part or all of the Electronic Health Record (EHR) of a single subject of care (patient). This is to support the interoperability of systems and components that need to communicate (access, transfer, add or modify) EHR data via electronic messages or as distributed objects:

• preserving the original clinical meaning intended by the author;

• reflecting the confidentiality of that data as intended by the author and patient.

The name of this European Standard suggests that it is not intended to specify the internal architecture or database design of EHR systems or components, but the scope includes the use of an 'object'. This implies that the 'objects' can be stored, retrieved and exchanged. It is explicitly not intended to prescribe the kinds of clinical applications that might request or contribute EHR data in particular settings, domains or specialities. For this reason, the information model proposed here is called the EHR Extract, and might be used to define a message, an XML document or schema, or an object interface. The information model in this European Standard is an ISO RM-ODP Information Viewpoint of the EHR Extract. This European Standard considers the EHR to be the persistent longitudinal and potentially multi-enterprise or multi-national record of health and care provision relating to a single subject of care (the patient), created and stored in one or more physical systems in order to inform the subject’s future health care and to provide a medico-legal record of care that has been provided. Whilst an EHR service or system will need to interact with many other services or systems providing terminology, medical knowledge, guidelines, workflow, security, persons registries, billing etc. this European Standard has only touched on those areas if some persistent trace of such interactions is required in the EHR itself, and requires specific features in the reference model to allow their communication. This European Standard may offer a practical and useful contribution to the design of EHR systems but will primarily be realised as a common set of external interfaces or messages built on otherwise heterogeneous clinical systems.

The openEHR Framework is the basis of this new Electronic Health Record Communication Standard (EN 13606)

Technical approach[edit]

This European Standard has drawn on the practical experience that has been gained in implementing its European predecessor, ENV 13606, other EHR-related standards and specifications, commercial systems and demonstrator pilots in the communication of whole or part of patients’ EHRs, and on fifteen years of research findings in the field. This European Standard builds on ENV 13606, updating it in order to make it more rigorous and complete, to accommodate new requirements identified, to incorporate a robust means of applying the generic models to individual clinical domains, and to enable communication using HL7 version 3 messages. A mapping from the existing prestandard is also provided to support implementers of existing conformant systems. The technical approach to producing this European Standard has taken into account several contemporary areas of requirement.

a. In addition to a traditional message-based communication between isolated clinical systems, the Electronic Health Record will in some cases be implemented as a middleware component (a record server) using distributed object technology and/or web services.

b. “Customers” of such record services will be not only other electronic health record systems but also other middleware services such as security components, workflow systems, alerting and decision support services and other medical knowledge agents.

c. There is wide international interest in this work, and this European Standard has been drafted jointly through CEN and ISO with significant input from many member countries.

d. Mapping to HL7 version 3 has been considered an important goal, to enable conformance to this European Standard within an HL7 version 3 environment.

e. The R&D inputs on which ENV 13606 was based have moved forward since 1999 and important new contributions to the field have been taken into account. The openEHR foundation, integrating threads of R&D in Europe and Australia, is one such example.

Given the diversity of deployed EHR systems, this European Standard has made most features of EHR communication optional rather than mandatory. However, some degree of prescription is required to make EHR Extracts safely processable by an EHR recipient system. This European Standard will, in practice, usually be adopted alongside other health informatics standards that define particular aspects of health data representation. This European Standard can be used alongside key complementary standards, including the Health Level 7 Version 3 Reference Information Model (RIM), EN 14822-1, EN 14822-2, EN 14822-3, CEN/TS 14822-4 (GPIC), prEN 12967 (HISA) and EN13940-1 (CONTSYS).

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