EHR Related Standards

Provides a categorial structure and the combinatorial rules to be compliant with in order to support the exchange of surgical procedure information between different national classifications and languages within Europe.

EN: European Standard (Valid as national standard in all CEN countries)

1.1 This guide covers all types of healthcare services, including those given in acute care hospitals, nursing homes, skilled nursing facilities, home healthcare, and specialty care environments as well as ambulatory care. They apply both to short term contacts (for example, emergency rooms and emergency medical service units) and long term contacts (primary care physicians with long term patients). At this time, the standard vocabulary reflects more traditional care. As the standard evolves in the next revisions, the vocabulary will more adequately encompass the entire continuum of care through all delivery models, health status measurement, preventive case, and health education content. 1.2 This guide has five purposes. The first is to identify the content and logical structure of a Electronic Health Record (EHR). The record carries all health related information about a patient over time. It includes such things as observations or descriptions of the patient (for example, the physician's or nurse practitioner's history and physical, laboratory tests, diagnostic imaging reports), provider's orders for observations and treatments, documentation about the actions carried out (for example, therapies or drugs administered), patient identifying information, legal permissions, and so on. 1.2.1 The second goal is to define the relationship of data coming from diverse source systems (for example, clinical laboratory information management systems, order entry systems, pharmacy information management systems, dictation systems), and the data stored in the Electronic Health Record. Recalling that the EHR is the primary repository for information from various sources, the structure of the EHR is receptive to the data that flow from other systems. 1.2.2 Third, in order to accelerate the adoption of EHRs, this guide provides a common vocabulary, perspective, and references for those developing, purchasing, and implementing EHR systems, but it does not deal either with implementation or procurement. 1.2.3 Fourth, this guide describes examples of a variety of views by which the logical data structure might be accessed/displayed in order to accomplish various functions. 1.2.4 Fifth, this guide relates the logical structure of the EHR to the essential documentation currently used in the healthcare delivery system within the United States in order to promote consistency and efficient data transfer. It maps to the clinical data currently in existing data systems and patient care records.

1.1 This specification covers the identification of the lexicons to be used for the data elements identified in Appendix X1 of Guide E 1384. It is intended to unify the representations for: (1) primary record of care data elements, (2) the data elements identified in other standard statistical data sets, (3) data elements used in other healthcare data message exchange format standards, or (4) in data gathering forms for this purpose, and (5) in data derived from these elements in order that data recorded in the course of patient care be exchangeable and be the source of accurate statistical and resource management data. This specification is applicable to all paper and automated systems.

This standard addresses the definition and structuring of information that is communicated or referred to in communication between application entities. It provides a common representation of all application entities present in the application processes within the various devices independent of the syntax. The definition of association control and lower layer communication is outside the scope of this International Standard.

prEN: Draft of a European Standard (European Standard under development)

ISO: International Standard (Already published document (Publication stage))

This standard covers nomenclature architecture for point-of-care (POC) medical device communication (MDC). It defines the overall architecture of the organization and relationships among nomenclature components and provides specifications of semantics and syntaxes. It is intended for use within the context of IEEE Std 1073,1 which sets out the relationship between this and other documents in the POC MDC series.

prEN: Draft of a European Standard (European Standard under development)

ISO: International Standard (Already published document (Publication stage))

This standard describes an IrDA-based, cable-connected local area network (LAN) for the interconnection of computers and medical devices and is suitable for new device designs, but is particularly targeted to modifications of legacy devices. The term legacy devices refers to equipment that is : - already in use in clinical facilities; - in active production at the facilities of medical device manufacturers; - beyond the initial stages of engineering development.

prEN: Draft of a European Standard (European Standard under development)

ISO: International Standard (Already published document (Publication stage))

1.1 This practice covers the identification of the information that is necessary to document emergency medical care in an electronic, paperless patient record system that is designed to improve efficiency and cost-effectiveness. 1.2 This practice is a view of the data elements to document the types of emergency medical information that should be included in the electronic health record. 1.2.1 The patient's summary record and derived data sets will be described separately from this practice. 1.2.2 As a view of the electronic health record, the information presented will conform to the structure defined in other ASTM standards for the electronic health record. 1.3 This practice is intended to amplify Guides E 1239 and F 1629 and the formalisms described in Practices E 1384 and E 1715. 1.3.1 This practice details the use of data elements already established in these standards and other national guidelines for use during documentation of emergency care in the field or in a treatment facility and places them in the context of the object models for health care in Practice E 1384 that will be the vehicle for communication standards for health care data. The data elements and the attributes referred to in this practice are based on national guidelines whenever available. The EMS definitions are based on those generated from the previous EMS consensus conference sponsored by NHTSA and from ASTM task group F 30.03.03 on EMS Management Information Systems. The Emergency Department (ED) definitions are based on the Data Elements for Emergency Department Systems (DEEDS) distributed by the Centers for Disease Control in June 1997. The hospital discharge definitions are based on recommendations from the Centers for Medicare and Medicaid Services (CMS) for Medicare and Medicaid payment and from the Department of Health and Human Services for the Uniform Hospital Discharge Data Set. Because the current trend is to store data as text, the codes for the attribute values have been determined as unnecessary and thus are eliminated from this document. The ASTM process allows for the data elements to be updated as the national consensus changes. When national or professional guides do not exist, or whenever there is a conflict in the existing EMS, ED, hospital or other guides, the committee will recommend a process for resolving the conflict or an explanation of the conflict within each guide. 1.3.2 This practice reinforces the concepts set forth in Guide E 1239 and Practice E 1384 that documentation of care in all settings shall be seamless and be conducted under a common set of precepts using a common logical record structure and common terminology. 1.4 The electronic health record focuses on the patient. 1.4.1 In particular, the computer-based patient record sets out to ensure that the data document includes: The occurrence of the emergency, The symptoms requiring emergency medical treatment, and potential complications resulting from preexisting conditions, The medical/mental assessment/diagnoses established, The treatment rendered, and The outcome and disposition of the patient after emergency treatment. 1.4.2 The electronic health record consists of subsets of data for the emergency patient that have been captured by different care providers at the time of treatment at the scene and en route, in the emergency department, and in the hospital or other emergency health care settings. 1.4.3 The electronic record focuses on the documentation of information that is necessary to support patient care but does not define appropriate care.

The purpose of this strandars is to assemble and collate a set of clinical and technical requirements for an electronic health record architecture (EHRA) that supports using, sharing, and exchanging electronic health records across different health sectors, different countries, and different models of healthcare delivery. It gives requirements for the architecture but not the specifications of the architecture itself.

TS: Technical Specification (Already published Technical Specification (Publication stage))

The CDA, which was until recently known as the Patient Record Architecture (PRA), provides an exchange model for clinical documents (such as discharge summaries and progress notes) and brings the healthcare industry closer to the realization of an electronic medical record.

This standard describes a pragmatic classification of electronic health records, provides simple definitions for the main categories of EHR and provides supporting descriptions of the characteristics of electronic health records and record systems.

TR: Technical Report (Already published Technical Report (Publication stage))

The overall goal is to deliver a communication architectural standard for Electronic Healthcare Records. To the healthcare organisation and the clinicians this architecture offers protection for their investment in clinical information against the vagaries of incompatible systems and from the changes arising from the passage of time. To the individual person, in so far as their health and care depends upon the safe communication of clinical information, the architecture offers a more direct benefit both immediately and longer term with respect to continuity of care. The standard is organised in for parts: - Part 1 : Extended architecture - Part 2 : Domain termlist - Part 3 : Distribution rules - Part 4 : Messages for the exchange of information

EN: European Standard (Valid as national standard in all CEN countries)

DIS: Draft International Standard (Enquiry stage)

1.1 This Practice is intended to assemble a logical occupational/environmental health view of the already defined general structure and vocabulary for the Electronic Health Record (EHR) and to suggest the ways in which this view can be used to support employee health assessments and other healthcare delivered at the work site. This view is consistent with the ANSI/ADA Clinical Concept Data Model 2005, which identified the major data entities that will need to be involved. This view would complement other views addressed in other settings of care for the employee and could logically either request other EHR data or deliver to other practitioner requesters record systems portions of occupational/environmental health data that have been recorded at the work site. This practice does not deal with the specific implementation of the content and it also does not either suggest or recommend implementation techniques. Likewise, it does not suggest standards of care. These functions are dealt with in other domains.

Specifies a procedure for the registration of coding schemes used in health care for any purpose. It also specifies the allocation of a unique Health Care Coding Scheme Designator (HCD) to each registered coding scheme. A code value can thus be given an unambiguous meaning by association with an HCD. The method by which an HCD and a code value are associated is not defined by this standard. The association is achieved in any manner appropriate to the syntax used.

EN: European Standard (Valid as national standard in all CEN countries)

1.1 The Continuity of Care Record (CCR) is a core data set of the most relevant administrative, demographic, and clinical information facts about a patients healthcare, covering one or more healthcare encounters.² It provides a means for one healthcare practitioner, system, or setting to aggregate all of the pertinent data about a patient and forward it to another practitioner, system, or setting to support the continuity of care. 1.1.1 The CCR data set includes a summary of the patients health status (for example, problems, medications, allergies) and basic information about insurance, advance directives, care documentation, and the patients care plan. It also includes identifying information and the purpose of the CCR. (See 5.1 for a description of the CCRs components and sections, and Annex A1 for the detailed data fields of the CCR.) 1.1.2 The CCR may be prepared, displayed, and transmitted on paper or electronically, provided the information required by this specification is included. When prepared in a structured electronic format, strict adherence to an XML schema and an accompanying implementation guide is required to support standards-compliant interoperability. The Adjunct³ to this specification contains a W3C XML schema and contains an Implementation Guide for such representation. 1.2 The primary use case for the CCR is to provide a snapshot in time containing the pertinent clinical, demographic, and administrative data for a specific patient. 1.2.1 This specification does not speak to other use cases or to workflows, but is intended to facilitate the implementation of use cases and workflows. Any examples offered in this specification are not to be considered normative.&sup4; 1.3 To ensure interchangeability of electronic CCRs, this specification specifies XML coding that is required when the CCR is created in a structured electronic format.&sup5; This specified XML coding provides flexibility that will allow users to prepare, transmit, and view the CCR in multiple ways, for example, in a browser, as an element in a Health Level 7 (HL7) message or CDA compliant document, in a secure email, as a PDF file, as an HTML file, or as a word processing document. It will further permit users to display the fields of the CCR in multiple formats. 1.3.1 The CCR XML schema or .xsd (see the Adjunct to this specification) is defined as a data object that represents a snapshot of a patients relevant administrative, demographic, and clinical information at a specific moment in time. The CCR XML is not a persistent document, and it is not a messaging standard. Note 1-The CCR XML schema can also be used to define an XML representation for the CCR data elements, subject to the constraints specified in the accompanying Implementation Guide (see Annex A2). 1.3.2 Using the required XML schema in the Adjunct to this specification or other XML schemas that may be authorized through joints efforts of ASTM and other standards development organizations, properly designed electronic healthcare record (EHR) systems will be able to import and export all CCR data to enable automated healthcare information transmission with minimal workflow disruption for practitioners. Equally important, it will allow the interchange of the CCR data between otherwise incompatible EHR systems. 1.4 Security-The data contained within the CCR are patient data and, if those data are identifiable, then end-to-end CCR document integrity and confidentiality must be provided while conforming to regulations or other security, confidentiality, or privacy protections as applicable within the scope of this specification. 1.4.1 Conditions of security and privacy for a CCR instance must be established in a way that allows only properly authenticated and authorized access to the CCR document instance or its elements. The CCR document instance must be self-protecting when possible.

Describes a standard for representing the content of classification systems, especially in a medical context, to enable a XML representation of a classification. The syntax will be limited to mono hierarchical systems. Major part of the work involved will be in determining how fine-grained and detailed the syntax needs to be. For illustration purposes in the annex a sample is given, but this by no means is meant to denote the scope.

prEN: Draft of a European Standard (European Standard under development)

This European standard provides guidance for the description, planning and development of new systems as well as for the integration of existing information systems, both within one enterprise and across different healthcare organisations through an architecture integrating the common data and business logic into a specific architectural layer (i.e. the middleware), distinct from individual applications and accessible throughout the whole information system through services. The standard is organised in three parts: - Part 1 specifies the overall characteristics of the architecture, formalises the specification methodology and the conformance criteria, details the Enterprise Viewpoint of the architecture - Part 2 specifies the Information Viewpoint of the architecture - Part 3 specifies the Computational viewpoint of the architecture Each document is self-consistent and is independently utilisable for the intended purposes also by different types of users.

prEN: Draft of a European Standard (European Standard under development)

The RIM deals with a static model of health and health care information as viewed within the scope of HL7 standards development activities.

ISO: International Standard (Already published document (Publication stage))

Continuity of care implies the management of health information in two different perspectives: - local management of information about the subject of care, at the site of care provision, - information interchange between health care providers. This European pre-standard seeks to identify and define those processes which relate to the continuity of care. It specifically addresses aspects of sharing patient related information needed in the process of care. It identifies and defines relevant data and information flows, together with their relationships to "time slots". In order to support the delivery of high quality care to each patient, and to facilitate continuity of care, a full understanding is needed of the temporal aspects of the delivery of health care, the role ofeach party in the health care process, and their interaction in the patient's environment. The concepts describing the characteristics of the ongoing process of care should not differ in nature from those that are used to structure and organise the data locally in the Electronic Health Care Record. The standard is organised in three parts: - Part 1 : Extended architecture - Part 2 : Domain termlist

prEN: Draft of a European Standard (European Standard under development)