DIN EN ISO 13606-1:2012-12

Worldwide efforts to support modern healthcare by means of information technology are being made by creation of so called eHealth Infrastructures. Corresponding developments for creation of a national health telematics platform (HTP) were also initiated in Germany. The task of such an HTP is to provide suitable methods and tools for those involved in healthcare. The central element of such platforms is the Electronic Health Record (EHR) - the collection point of all information about a patient and the treatment processes concerning him/her. Their design is a complex problem and shall include both aspects of data protection as well as their integration into existing and future medical information and application systems. International standards are necessary to solve these tasks. The efforts of Working Group 1 "Information models" of Technical Committee ISO/TC 251 "Health informatics" of the European Committee for Standardization (CEN) have led to the revision of the prestandard series ENV 13606 on the Electronic Healthcare Record (EHCR) Communication, which has now been adopted after several years of preparatory work. Its goal was to increase interoperability between information systems of the healthcare system. Future systems should be developed using the given structures, that means the developers of information systems and standards from industry and research are the addressees of the standard. The key focus is on the exchange of EHCRs or parts thereof. For this purpose the old pre-standard ENV 13606 specifies basic structures of an EHCR and its transmission. This pre-standard consists of four parts: Part 1: Extended Architecture - This part specifies the structural model of an EHCR to be transmitted. This is a Communication Review of an EHCR saved as required and consists of hierarchically structured components such as folders, compositions, headed sections and data items. Part 2: Domain Termlist - Whereas the Extended Architecture gives a structural model independent of clinical contents, the Domain Termlist allows a designation regarding the content of the elements of the structural model within a concrete EHCR. Part 3: Distribution Rules - This part gives a conceptual safety model for access control and auditing. This places the "Subject of Care" in the centre of control with regard to the subject of who may undertake what for what purpose in which manner and with which EHCR component. Part 4: Messages for the exchange of information - This part deals with the actual communication between EHCR systems, that is the exchange of parts of an EHCR or of the entire EHCR as a copy, of summaries of the EHCR or of messages for maintenance of consistency of distributed data sets. It specifies communication scenarios, the message concept and a Domain Information Model derived from Parts 1 to 3 as the basis of message specification. The revised new edition planned as a 5 part standard does not try to negate the previous pre-standards, but nonetheless follows some other approaches. The basic principle of EN 13606 remains the specification of a transmission standard for parts of electronic patient files saved in different places. It is not intended to standardize the internal realization of EHR systems. An EHR system 1 shall rather be enabled to answer the inquiry of an EHR system 2 for parts or the entirety of a locally stored EHR on a patient either negatively or by transmitting the requested information (a so-called EHR EXTRACT). During this process data protection is taken into account that system 2 decides in accordance with deposited data protection policies if and to what extent access by the requesting party is allowed. Patient-specific policies are part of every EHR. If EHR data are transmitted, the access control policies can be transmitted as well. In addition content requirements on the information to be exchanged are (for the time being) not specified by EN 13606. In fact structures are specified which allow users to specify content requirements for, for example, clinical findings or documents. On the path to semantic interoperability the interchangeability of specifications of this type that are as standardized as possible plays a significant role. So-called archetypes can, for example, be defined and published by organizations with corresponding definition languages where these archetypes serve as a plan for information units such as a blood pressure value or a first documentation from the disease management programme for diabetes. The definition is made independent of a certain (natural) language and can therefore be adapted to any language. Upon request and transfer of EHR EXTRACTs archetypes can then be referred to; it is not required for the EHR systems involved to structure and internally save the data in accordance with the relevant archetypes. Instead, they should be capable of composing and transferring the data in conformity with the respective archetypes. The five parts of EN 13606 which are currently being drafted in part are intended to implement these concepts. They are similar to the previous 4 parts, but the original first parts have now - broadly speaking - been split up into three parts; significant changes have been made. This is a list of the 5 new parts which are partly under preparation: Part 1: Reference model: The object-oriented modelled Reference model in terms of an adversarial information model is the communication basis of an EHR EXTRACT. A dual model approach is followed. The Reference model (model 1 and subject of this part), designed as an object-related information model, specifies those basic structures of an EHR that are the subject of a transmission; basically, this is independent of the content. In contrast, archetypes (model 2 and subject of Part 2) allow for formal description of schemes for combination of the thus defined basic elements in connection with the defined content or a clinical concept. Part 2: Archetypes: this part provides a generic information model and a formal language for representation and communication of the definitions of archetypes and their instances. Part 3: Terminology: Term Lists: Specification of defined terms for the designation of objects of the Reference model or their attributes and relations. Part 4: Security: This part provides security concepts in relation to the communication of EHR EXTRACTs which differ quite clearly from EN V 13606-3:2000. Part 5: Messages for Exchange: Similarly to ENV 13606-4:2000 this part provides the basis for message-based communication of EHR systems. The Reference model is part of EN 13606-1. As the first of the two models of the Dual Model approach it specifies the basic structures of EHR components to be transferred to a patient. It is described as an object system in the Unified Modelling Language (UML). The model is not intended to define the internal data structure of EHR systems, in fact these systems shall be capable of transferring the EHRs stored by them in accordance with the request of another EHR system in an instantiation of the Reference model. This instantiation can then be transferred and transmitted in the message structure in accordance with EN 13606-5, which is currently under revision. The basic idea of the Reference model is the transfer of an electronic health record extract (Class EHR EXTRACT) in the form of a corresponding message. Such an extract refers to any related person, organization, device or software product in the form of an index (class IDENTIFIED ENTITY in the DEMOGRAPHICS Package) which, in addition to the IDs of the entities contains identifying information in plain text form. Furthermore, the EHR EXTRACT can be linked with information regarding access control. Basis class of all contents to be transferred is the abstract class RECORD COMPONENT. In addition to structure objects such as folders (class FOLDER), compositions (class COMPOSITION), clusters (class CLUSTERS) and sections (class SECTION), the fundamental content-carrying objects entries (class ENTRY) and items (abstract class ITEM or class ELEMENT) are derived from RECORD COMPONENT. Folders allow for all types of hierarchical alignment of EHR contents, for example, concerning episodes of care, clinical departments, etcetera. Compositions represent a kind of bracket around clinical information which occurred during a definable clinical session (class CLINICAL SESSION) and has been documented by a person (composer). The actual content of the extract (abstract class CONTENT) may include entries, organized in sections, which refer to a definable clinical activity. The entries contain individual information units (such as a temperature value; class ELEMENT) structured in clusters, if necessary (for example, blood pressure values consisting of diastolic and systolic blood pressure). Multiple versions can be created for every EHR COMPONENT. Old versions can also be transferred if required; as a general rule, only current versions will be subject to questions. For this purpose, every EHR COMPONENT is linked with test information (class AUDIT INFO) containing information on the version of the component and which facilitates comprehension of the course of data changes by referring to the committer of the respective data. Every version can also be provided with legally effective attestations (class ATTESTATION INFO) which as a rule are each linked with the electronic signature of the attester. As a result Part 1 of EN 13606 provides the central basis for a standardization of the exchange of patient-oriented information between the persons involved in the provision of healthcare services targeted at temporal stability. The committee responsible for this standard is NA 063-07-02 AA "Interoperabilität" ("Interoperability") at DIN.