ASTM E1769-95
(Guide)Standard Guide for Properties of Electronic Health Records and Record Systems (Withdrawn 2004)
Standard Guide for Properties of Electronic Health Records and Record Systems (Withdrawn 2004)
SCOPE
1.1 This guide covers the current understanding of the requirements for the electronic health record (EHR) that is using currently available technology to document clinical activities and related information generated during care of individuals.
1.2 This guide sets forth the fundamental principles for an electronic health record system, and its major attributes, with reference to the Automated Primary Record of Care (see Guide E1384), which proposes content and organization of automated health care records generated in various clinical settings.
WITHDRAWN RATIONALE
This guide covers the current understanding of the requirements for the electronic health record (EHR) that is using currently available technology to document clinical activities and related information generated during care of individuals.
Formerly under the jurisdiction of Committee E31 on Healthcare Informatics, this guide was withdrawn in April 2004 in accordance with section 10.6.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
General Information
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn. Contact ASTM
International (www.astm.org) for the latest information.
An American National Standard
Designation:E1769–95
Standard Guide for
Properties of Electronic Health Records and Record
Systems
This standard is issued under the fixed designation E 1769; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope for authorized purposes and are responsible for protecting any
person-specific data from unauthorized access.
1.1 This guide covers the current understanding of the
3.1.4 clinical—pertaining to patient care.
requirements for the electronic health record (EHR) that is
3.1.4.1 clinical informatics—the field that concerns itself
using currently available technology to document clinical
with the cognitive, information processing, and communica-
activities and related information generated during care of
tion tasks of health-care practice, education and research,
individuals.
including the information science and the technology to
1.2 This guide sets forth the fundamental principles for an
support these tasks.
electronic health record system, and its major attributes, with
3.1.5 clinical encounter—an instance of direct (face-to-
reference to theAutomated Primary Record of Care (see Guide
face) interaction, regardless of the setting, between a patient
E 1384), which proposes content and organization of auto-
andapractitionervestedwithprimaryandautonomousrespon-
matedhealthcarerecordsgeneratedinvariousclinicalsettings.
sibility for diagnosing, evaluating; or treating the patient’s
2. Referenced Documents
conditionorprovidingsocialworkerservices,oracombination
thereof. (Encounters do not include ancillary services, visits or
2.1 ASTM Standards:
telephone contacts.) (See Guide E 1384.)
E 1238 Specification for Transferring Clinical Observations
3.1.6 clinical episode—a chain of events in a period of time
Between Independent Computer Systems
duringwhichclinicalcareisprovidedforanillnessoraclinical
E 1384 Guide for Description for Content and Structure of
problem, rendered either in an ambulatory or hospital inpatient
an Automated Primary Record of Care
setting. (See Guide E 1384.)
E 1460 Specification for Defining and Sharing Modular
3.1.6.1 electronic health clinical episode record—the docu-
HealthKnowledgeBases(ArdenSyntaxforMedicalLogic
mentation in an electronic record of care given and services
Modules)
rendered during a series of encounters over a cohesive time
3. Terminology
period, such as during a hospitalization.
3.1.7 disidentified health-care data—health-care data that
3.1 Definitions:
doesnotrevealtheidentityofthepersonorthecareprovider(s)
3.1.1 ancillary service visit—appearance of an outpatient in
(organizations or professionally licensed practitioners), or
a unit of a hospital or outpatient facility to receive service(s),
both. Disidentified health-care data are viewed as data with
test(s), or procedures; it is not counted as an encounter. (See
virtually no risk to the person’s rights to privacy or to the
Guide E 1384.)
health-care provider’s rights to privacy (for example, pooled
3.1.2 authorized health-care practitioner—individual(s) li-
secondary diagnoses from a population of one thousand
censed or certified (registered) to deliver care to patients.
diabetics).
3.1.3 authorized users—all those who have received ex-
3.1.8 documentation of a clinical encounter— (with a
plicit formal permission both from the person, or person’s
person) typically includes description of the patient’s past
guardian, and from the operative authorities of the electronic
health history, clinical observations, diagnostic studies, health
health patient record system, to access specific data pertaining
care interventions, medication history, the patient’s clinical
tothatperson.Authorizedusersmayusetheaccesseddataonly
course and outcome, as well as care-related documents.
3.1.9 computer-based information system—a computer-
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
based organized arrangement of hardware, software, data, and
Informatics and is the direct responsibility of Subcommittee E31.28 on Electronic
communication that provides storage and access to electronic
Health Records .
records and functions as an orderly system.
Current edition approved Dec. 10, 1995. Published February 1996.
Annual Book of ASTM Standards, Vol 14.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn. Contact ASTM
International (www.astm.org) for the latest information.
E1769–95
3.1.10 electronic health encounter record (EHER)— such as the person’s industrial health hazards, risk factors,
documentation of the care given in association with a single genetic background, etc. A partial list of such terms includes:
clinical encounter. 3.2.1 Automated Clinical Record (ACR).
3.2.2 Automated Health-Care Record (AHR).
3.1.11 electronic health record—(1) collection of data and
3.2.3 Computer-based Electronic Health Records (CEHR).
information gathered or generated to record clinical care
3.2.4 Computer-based Patient Record (CPR or CBPR), as
rendered to an individual. It is to be noted that the EHR is a
used in the Institute of Medicine report.
virtual entity where the actual physical information may be
3.2.5 Computerized Patient Information (CPI).
distributed across various systems and geographies. (2)a
3.2.6 Computerized Patient Record (CPR).
comprehensive, structured set of clinical, demographic, envi-
3.2.7 Electronic Patient Encounter Record (EPER).
ronmental, social, and financial data and information in elec-
3.2.8 Electronic Medical Record (EMR).
tronic form, documenting the health care given to a single
3.2.9 Electronic Health-Care Record (EHCR), emerging in
individual.
CEN documents in Europe.
3.1.12 electronic health record system (EHRS)—an assem-
3.2.10 Electronic Patient Record (EPR).
blageoftechnical,administrative,operational,communication,
3.2.11 Paperless Health Care Record (PHR).
and computer-based automated functions organized to accept,
process, store, transmit, and retrieve electronic clinical infor-
4. Significance and Use
mation for various purposes such as assistance in health-care
4.1 Ever since the early 1960s, when the first digital
delivery and evaluation.
computers became commercially available, numerous impor-
3.1.13 electronic health record system—supports the EHR.
tant efforts have been made to transfer patient information care
It provides practitioner reminders and alerts, and it facilitates
documentation recorded on paper to electronic health records.
access to expert knowledge bases. The operative EHRS shall
Initially, highly structured questionnaires, in the form of
permit authorized health-care staff to enter, verify, manage, 4
checklists, were tried. In some later attempts, the computer
process, transmit, retrieve, view, or print, or a combination
served as a repository of data and free text, but without
thereof; any or all of the EHR data.The EHRS shall permit the
processing of the narrative portions. This type of system
algorithmic creation of longitudinal electronic health care files.
represents an early form of computer storage. Recent advances
The EHRS shall allow authorized user access to EHR data for
in automation of clinical text processing have helped to change
purposes such as clinical, educational, administrative, finan-
the perception of electronic health records and serve as a
cial, quality improvement, utilization review, policy formula-
foundation of this guide.
tion, and research, as defined in the authorization agreement
4.2 Increased recognition of the need for automated access
with each legitimate user. The EHRS shall protect the data
to clinical data, together with development of more sophisti-
from unauthorized access.
cated tools for managing these data, have focused intense
3.1.14 electronic record—data and information stored as a interest on electronic health data. See the Institute of Medicine
logical entity on computer-compatible media such as magnetic report entitled, “The Computer-Based Patient Record, An
tape, disk, optical media, etc. Essential Technology for Health Care.”
4.3 Current experience with EHR is still limited. However,
3.1.15 granularity—the size of the information grains that
it seems important to define the fundamental characteristics of
can be directly retrieved. The smallest discrete information
an EHR at this time in order to ensure some basic uniformity,
entities determine the granularity of the record. The smallest
compatibility, and comparability among developing EHRs and
unitary information is a clinical fact: the shortest form repre-
clinical data banks. In addition, a catalog of our current
senting an observation, finding or statement.
understanding of EHR characteristics can serve as a focal point
3.1.16 identifiable health-care data—datadirectlyrelatedto
for adding to this understanding.
a person’s health care that are combined with, or can be readily
4.4 During the history of automated clinical records, the
associated with, the identity of the person, practitioner, setting,
goals have changed. Initially, one goal was to transfer the
or program, or combination thereof. Identifiers typically in-
recorded information from paper onto the computer without
clude items such as person name, guardian, date of birth, home
much change in the role of the patient record, per se, or access
address, work address, date of admission, date of discharge,
toit.Insharpcontrast,thecurrentlyevolving“newgeneration”
hospital identifiers, and practitioner(s) identifiers.
of electronic health records is viewed as a major source of
3.1.17 longitudinal electronic health care file—a chain of
information for the entire health-care industry and for the
chronologically identified records on the same person docu-
patient community. This drastic change in the expected avail-
menting the care given at different times and perhaps in
ability of EHRS calls for critical assessment of the various
different settings.
aspects of the electronic health record, which is the purpose of
3.1.18 structured information—finite data organized ac-
this guide, and for establishing a conceptual frame of reference
cording to one or more sets of relationships.
3.2 Synonyms and Terms Related to Electronic Health
Institute of Medicine Report, “The Computer-based Patient Record: An
Record—Recently, there has been a proliferation of synonyms
Essential Technology for Health Care,” Washington, DC, 1991.
andacronymsforconceptsrelatingtoanEHR.Thetermslisted
Gabrieli, E. R., “Automated Processing of Narrative Medical Text—A New
below are all viewed as subsets of the electronic health record
Tool for Clinical Drug Studies,” Journal of Medical Systems, Vol 13, 1989, pp.
because they may not include some comprehensive aspects 95–102.
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn. Contact ASTM
International (www.astm.org) for the latest information.
E1769–95
forunderstandingwhatismeantbytheterms“electronichealth 5.7 Response Time of EHRS—In support of user activities,
record” and “record system,” illuminating the granularity of the response time of the EHRS shall be rapid enough so as to
information needed. support the various users’ activities or train of thought.
5.8 Accessibility of EHR Data—Validated information shall
5. Criteria and Characteristics for an Electronic Health be readily accessible to authorized users and to specific
Record patients, if so requested.
5.9 Reliability of EHR—The EHR shall be generated and
5.1 Input into EHR— Input may be by an authorized person
maintained with adequate assurance that it can be viewed as a
(human input) or electronically from an automated system.
primarysourceofinformationforalltheactivitiesitisintended
Human input may occur using different devices such as a
to support. Provision shall exist to allow retention and con-
keyboard, pointing device, light pen, touch screen, bar code, or
tinuous availability of data.
voice. Automated input may occur from patient monitors,
5.10 Security of EHR:
laboratory instrument outputs, bar codes, CT scans, images,
5.10.1 Adequate data security measures shall be maintained
electronic data transfers, or other methods. Information may be
by the EHRS to protect the person’s right to privacy while
generated from a wide variety of sources across the continuum
permitting efficient access to data needed by authorized users.
of care.
5.10.2 The EHRS security system shall be sufficiently
5.2 Data Source Identification—The source of data and
flexible to permit an institutional data center to carry out its
information entered shall be identified (source’s role, location,
own unique set of security policies.The security system should
and system used), and the associated date and time shall be
be designed to be compatible with developing standards for
recorded. This applies to human, instrument, and automated
privacy, confidentiality, and security.
input. Source, in this context, refers to the computer system,
instrument, or individual designated by the EHRS to enter data 5.10.3 For each access to data the EHRS security system
shall:
into the EHR.
5.3 Input Validation— Data and information entered into 5.10.3.1 Certify user identity and authorization level before
the EHR shall be appropriately validated. The validation allowing access,
mechanism shall state the data source. 5.10.3.2 Identify each person whose information is being
5.4 Transaction Accountability—The EHRS shall maintain requested,
an incorruptible automated audit trail of all activities, system
5.10.3.3 Establish the role or relationship, or both, of the
usage,andloggingstatistics.Theaudittrailshouldbesufficient person requesting information to the object of such request:
to account for each instance of human and automated access
patient, practitioner, organization,
and retrieval. For example at a minimum the EHRS should:
5.10.3.4 Record the date/time and location of EHR data
5.4.1 Provide audit trails sufficient to track accountability
access,
for each designated step/task in the clinical or operational
5.10.3.5 Record the nature of the EHR access: view, create,
process (for example, who, what, when, where),
amend, or copy to external media,
5.4.2 Provide audit trails sufficient to track accountability
5.10.3.6 Record the scope of access (for example, identified
for each access to a designated confidential record: t
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