ASTM E1384 - 07(2013)

    Standard Practice for Content and Structure of the Electronic Health Record (EHR)

    Active Standard ASTM E1384 | Developed by Subcommittee: E31.25

    Book of Standards Volume: 14.01


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    Significance and Use

    4.1 This Guide has Four Parts:

    4.1.1 The first part (Section 5) identifies items of information carried in the traditional paper record organized by the source oriented structures common to paper records. The purpose of this section is to remind users of the spectrum of information that shall be accommodated by the logical structure of a EHR and to present a point of reference for the more abstract description of the patient record that follows.

    4.1.2 The second part (Section 6) presents a number of operational principles, including such matters as privacy and security that should guide the implementation and operation of EHRs.

    4.1.3 The third part (Section 7) describes a logical data organization and content (common data model) of an EHR. It is not a blueprint for constructing or implementing a EHR system. The model presents an organization according to the major informational structures and content of the EHR. The focus is on the structure required to store all clinically relevant patient information: those that describe the patient's state; the actions directed at the patient variables; and the actions initiated to diagnose, educate, or treat the patient. These are regarded as repository functions of the EHR. This standard does not describe all of the data structures required by applications that might use information contained in the EHR. In particular, the data structures used to control and guide the process of care such as utilization review or quality assurance, and the goals or thresholds (for example, mean length of stay) that might be used to judge the patient's care are not included.

    4.1.3.1 There are many different ways to implement physical structures that could map into the model presented. It is emphasized that this standard should neither impede technical progress nor define the precise manner in which the EHR system is implemented.

    4.1.3.2 The focus of this guide is on the kinds of information that should be included and upon a global description of the organization of that data within the EHR. This guide does not deal in detail with issues related to charges and billing for patient care, only the documentation required to support usual charging and administrative issues.

    4.1.3.3 This standard deals with the health information as it would be stored in the EHR, not as it would be sent as a message to or from the EHR. Pains have been taken to be sure that the information content from existing healthcare informatics messages that lie within the scope of the EHR can be mapped into the EHR structure. Where mappings are one-to-one, the EHR data elements have been cross referenced with the message fields. However, the EHR is not just a collection of messages. It makes stronger assumptions about the context in which it exists, so there is not perfect correspondence between the structure and content of messages on the one hand and the EHR on the other.

    4.1.3.4 This guide applies across a range of scales. Though the ultimate goal is a EHR that spans the entire nation and the lifetime of an individual, the reality is that EHRs are mostly of much smaller scope (for example, within institutions, communities, or states) and these can be implemented much sooner. This standard is intended to apply equally to all scopes of time and place. Within the scope of a EHR, all master tables and code systems (for example, service catalog, patient registry, patient identifier) will be held in common. It denotes extensions of text content for document format standards and references standard XML designation for document section tags.

    4.1.4 The fourth part (Sections 8, 9, 10) describes some alternative views (subsets of information presented in various orderings) of the content and proposes the minimum data elements contained in the EHR. What has been described as the “Longitudinal Health Record” (a very short précis of the patient's entire history) falls into this category. A set of “views” will serve as the user interface to the EHR for various customers. When all of the data is available in a EHR, providing different views of that data to satisfy various user needs and perspectives will be facilitated. Further, the kinds of views that are “required” and their dependencies (differing by institution, by specialty, by health/medical problem, by practitioner) will evolve over time. Section 10 is a repository of data elements to be used as an electronic health record data dictionary (Annex A1) (18).

    4.2 General—Healthcare Documentation:

    4.2.1 A patient's health record plays five unique roles: (1) It represents that patient's health history, that is, a record of the patient's health states and the health services provided, over time. (2) It provides a method for clinical communication and care planning among the individual healthcare practitioners serving the patient. (3) It serves as the legal document describing the healthcare services provided. (4) It is a source of data for clinical, health services, and outcomes research. (5) It serves as a major resource for healthcare practitioner education.

    4.2.2 Keeping complete and accurate records is an essential part of patient care management. Increasing specialization in healthcare and population mobility have increased the fragmentation of the traditional health record. The EHR offers a unified, coordinated, complete repository of patient health information. It includes such things as treatments, prescriptions, test results, diagnostic impressions, and significant genetic, environmental, and clinical healthcare data.

    4.2.3 The person's health record consists of the original documentation of their health information and of the associated health and clinical services provided at the various care sites including the results of tests and outcomes of treatments. Each care site will require basic data that may be common to all care sites, data specific to that particular type of care site, and data unique to the individual care site.

    4.2.4 The EHR serves all of the functions of the traditional record but has many advantages.

    4.2.4.1 It solves the logistic problems of easy access to the paper health/medical record. Information can be concurrently accessed from multiple locations.

    4.2.4.2 It will provide efficient communication of information to support coordination of services between care practitioners (See Specification E2369).

    4.2.4.3 It calls for data content to be stored so that it links to automatic reminders and alerts to avoid errors of omission and commission.

    4.2.4.4 By providing cross-patient retrievals it will provide the statistics needed by clinical, outcomes, health services and policy researchers as well as administrators and managers, to define better policies and practices to improve the healthcare process and make it efficient.

    4.2.5 The longitudinal healthcare record, which is the brief synopsis of the significant facts derived from the primary documentation, can be constructed from views of the elements described here.

    4.3 The Role of Standards in Healthcare Documentation:

    4.3.1 Healthcare informatics standards are essential for an efficient and affordable EHR. Even within a single institution, much of the information that should be stored in the EHR will come from other electronic sources. Message standards are needed to ensure that this data can be transmitted from a source system and received and stored with a EHR without requiring human intervention. The need for information from other healthcare facilities (the hospital would like nursing home records when the patient is admitted and vice versa when the patient is discharged) is even greater. Finally, standard terminology, codes, and formats are the sine qua non for aggregating many EHRs for research and policy purposes.

    4.3.2 The model for an EHR described here provides a general guideline that describes the data and data organization for an EHR and recommends minimal content requirements. It promotes common approaches to documentation. The model should be flexible enough to permit the storage of any kind of patient information deemed important by an individual provider, ensure that a minimum set of patient data is maintained, as well as information required by diagnostic and therapeutic services of the future.

    1. Scope

    1.1 This practice covers all types of healthcare services, including those given in ambulatory care, hospitals, nursing homes, skilled nursing facilities, home healthcare, and specialty care environments. 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). The vocabulary aims to encompass the continuum of care through all delivery models. This practice defines the persistent data needed to support Electronic Health Record system functionality.

    1.2 This practice has four purposes:

    1.2.1 Identify the content and logical data structure and organization of an Electronic Health Record (EHR) consistent with currently acknowledged patient record content. The record carries all health related information about a person over time. It may include history and physical, laboratory tests, diagnostic reports, orders and treatments documentation, patient identifying information, legal permissions, and so on. The content is presented and described as data elements or as clinical documents. This standard is consistent with eXtensible Markup Language (XML). See Document Type Definition (DTD) 2.1 and W3CXML Schema 1.0

    1.2.2 Explain the relationship of data coming from diverse sources (for example, clinical laboratory information management systems, order entry systems, pharmacy information management systems, dictation systems), and other data in the Electronic Health Record as the primary repository for information from various sources.

    1.2.3 Provide a common vocabulary for those developing, purchasing, and implementing EHR systems.

    1.2.4 Provide sufficient content from which data extracts can be compiled to create unique setting “views.”

    1.2.5 Map the content to selected relevant biomedical and health informatics standards.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    E1238 Specification for Transferring Clinical Observations Between Independent Computer Systems

    E1239 Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Electronic Health Record (EHR) Systems

    E1633 Specification for Coded Values Used in the Electronic Health Record

    E1639 Guide for Functional Requirements of Clinical Laboratory Information Management Systems

    E1714 Guide for Properties of a Universal Healthcare Identifier (UHID)

    E1715 Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems

    E1769 Guide for Properties of Electronic Health Records and Record Systems

    E2118 Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures

    E2369 Specification for Continuity of Care Record (CCR)

    E2473 Practice for the Occupational/Environmental Health View of the Electronic Health Record

    E2538 Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures

    HL007

    Other Health Informatics Standards

    ANSIASCX12: Version 3, Release 3 (1992) Available from DISA (Data Interchange Standards Association).

    HL7 Health Level Seven (HL7) Version 2.2 1994 Available from HL7, Mark McDougall, Executive Director, 900 Victors Way, Suite 122, Ann Arbor, MI 48108. (Version 2.4 and 2.5)

    NCPDPNationalCouncil Release 2, 1992 Available from NCPDP, 4201 North 24th Street, Suite 365, Phoenix, AZ 85016.

    X12.84 Healthcare Enrollment and Maintenance Transaction Set (834) Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.

    X12.85 Healthcare Claim Payment Transaction Set (835)

    X12.87 Healthcare Claim Transaction Set (837)

    ANSI Standards

    HealthInformationMan Glossary, American Health Information Management Association, 2006

    HL7EHRTC Electronic Health Record-System Functional Model, Release 1 February, 2007


    ICS Code

    ICS Number Code 01.140.20 (Information sciences); 35.240.30 (IT applications in information, documentation and publishing)

    UNSPSC Code

    UNSPSC Code 81111700(Management information systems MIS)


    Referencing This Standard

    DOI: 10.1520/E1384-07R13

    ASTM International is a member of CrossRef.

    Citation Format

    ASTM E1384-07(2013), Standard Practice for Content and Structure of the Electronic Health Record (EHR), ASTM International, West Conshohocken, PA, 2013, www.astm.org

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