ASTM E2436-05

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An American National Standard
Designation: E2436 – 05
Standard Specification for the
Representation of Human Characteristics Data in Healthcare
Information Systems
This standard is issued under the fixed designation E2436; 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 (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
This document presents a standardized representation for the content and structure of human
characteristics data for use in electronic health records and healthcare information systems generally.
Many of the data available to clinicians, health researchers and educators, and healthcare planners
cannot be easily compared due to the variety in representing human characteristics. This document
standardizes the representation of these characteristics at the data tier of health information systems.
1. Scope 2. Referenced Documents
1.1 This document presents a standardized representation 2.1 ASTM Standards:
for the content and structure of human characteristics data for E1384 Practice for Content and Structure of the Electronic
use in healthcare information systems. Health Record (EHR)
1.2 This specification may be extended to apply to charac- E1633 Specification for Coded Values Used in the Elec-
teristics of non-human living things, such as in data systems tronic Health Record
supporting veterinary medicine. E2145 Practice for Information Modeling
1.3 The following provisions are within the scope of this 2.2 ANSI Standards
specification: ANSI 260.3-1993 MathematicalSignsandSymbolsforUse
1.3.1 Logical representation of human characteristics data in Physical Sciences and Technology (revision and redes-
for individuals and populations. ignation of ANSI/ASME Y10.20-1990).
1.3.2 Physical representation of human characteristics at the ANSI 1320.2-1998 IEEE Standard for Conceptual Model-
data tier of healthcare information systems. ing Language - Syntax and Semantics for IDEF1X97
1.4 The following provisions are outside the scope of this (IDEFobject)
specification: ANSI/ADA 1000 Standard Data Architecture for the Struc-
1.4.1 Thestandardizationofpolicyorregulationconcerning ture and Content of the Electronic Health Record, Febru-
the employment of human characteristics data described in this ary 2001.
specification. 2.3 ISO Standards
1.4.2 The establishment or standardization of legal con- ISO 639 Codesfortherepresentationofnamesoflanguages
straints over the use of human characteristics in conjunction ISO 2955 Representation of SI Units
with healthcare clinical or business processes. ISO 5218 Representation of the Human Sexes
1.4.3 Addressing or standardizing personal privacy, medi- ISO 8601 Representation of Dates
colegal, and system security provisions associated with docu- 2.4 Other Standards and Documents
mentinghumancharacteristicsorstoringhumancharacteristics American Heritage Dictionary
data. ANSI/ADA Specification 1000 Implementation Guide
1.5 This standard does not purport to address all of the HL7 2.x reference values.
safety concerns, if any, associated with its use. It is the National Institute of Standards and Technology, Federal
responsibility of the user of this standard to establish appro- Information Processing Standards Publications 184 Inte-
priate safety and health practices and determine the applica- grated Definition for Information Modeling (IDEFIX), 23
bility of regulatory limitations prior to use. December 1993.
This specification is under the jurisdiction of ASTM Committee E31 on
Healthcare Informatics and is the direct responsibility of Subcommittee E31.25 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Healthcare Data Management, Security, Confidentiality, and Privacy. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Nov. 15, 2005. Published July 17, 2006. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/E2436-05. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2436 – 05
3. Terminology 3.3.5 Metadata, n—Data about data, or information about
information, generally comprising a structured set of descrip-
3.1 Acronyms:
tive elements about any definable entity.
3.3.6 Physical Data Model, n—A graphical and textual
ADA = American Dental Association representation of the structural properties that are implemented
ANSI = American National Standards Institute
or able to be implemented in a database, consisting of tables,
CCR = ASTM standard Continuity of Care Record
columns and rows, and all the relationships that exist among
HL7 = Health Level Seven
these.
IDEF = Integrated Definition language
3.3.7 Table, n—The basic unit of storage in a relational
ISO = International Standards Organization
database management system; in the physical data model
LDM = Logical data model
analogous to the entity of the logical data model.
LOINC = Logical Observation Identifiers Names and
Codes
4. Reference Data Model
PDM = Physical data model
4.1 This specification is based upon the ANSI/ADA Speci-
XML = Extensible Markup Language
fication 1000 reference data model and expands upon data
3.2 Definitions:
structures found in the “Individual Characteristics” and “Popu-
3.2.1 Ethnicity, n—characteristics of a group of people
lation Characteristics” subject areas.
sharing a common and distinctive racial, national, religious,
4.1.1 The Individual Characteristics subject area of this
linguistic, or cultural heritage.
specification has been extended to include two additional
American Heritage Dictionary
entities/tables.
3.2.2 Language, n—A system of arbitrary signals, such as
4.1.1.1 Living Arrangement to allow the characterization
voice sounds, gestures, or written symbols, including its rules
and textual description of the residential life patterns and
for combining its components, such as words, as used by a
interpersonal life-dependencies of a patient or related indi-
nation, people, or other distinct community for communication
vidual.
of thoughts and feelings.
4.1.1.2 Individual Physical Characteristics to allow docu-
American Heritage Dictionary
mentation of administrative characteristics (e.g. height, eye
3.2.3 Living Arrangement, n—The setting or environment
color, hair color, etc.) not otherwise documented in this model.
in which an individual lives, such as family setting, as may
4.1.2 Inthisspecification,severalattributesaredeletedfrom
have impact on the individual’s health and course of care.
the Individual entity that are not relevant to personal charac-
3.2.4 Physical characteristic, n—a group of characteristics
teristics, and this entity is extended by adding reported and
previously used by convention as a means to describe an
derived dates of birth and death.
individual, e.g. by hair color, eye color, build, etc.
4.1.3 The following entities in theANSI/ADASpecification
3.2.5 Race, n—A local geographic or global human popu-
1000 Individual Characteristics subject area are not referenced
lation distinguished as a more or less distinct group by in this specification:
genetically transmitted physical characteristics.
4.1.3.1 Individual Object is employed inANSI/ADASpeci-
American Heritage Dictionary fication 1000 to carry object data descriptive of an individual
3.2.6 Religion, n—A personal or institutionalized system such as an identification image or biometric data. This data is
not considered as characteristics within the context of this
grounded in such belief and worship. A set of beliefs, values,
specification.
and practices based on the teachings of a spiritual leader.
4.1.3.2 Individual Taxonomy associative entity is not used
American Heritage Dictionary
in human health information systems. Where this specification
3.2.7 Sex Characteristic, n—Preferred term to more com-
isextendedtorepresentthecharacteristicsofnon-humanliving
pletely classify the multiple human sex characteristics. The
things, the taxonomy or genus reference and associative
term “Sex” is preferred as the biologically correct term rather
entities may be employed.
than the grammatical term “gender.”
4.1.4 Associated Individual and Pair Bond Status are em-
3.3 The following information modeling and technology
ployedinANSI/ADASpecification1000toallowtheconstruc-
terms are used in this document:
tion of complex networks of interpersonal relationships, such
3.3.1 Attribute, n—In a logical data model, an identifiable
as in an extended family or patterns of epidemiological
characteristic or data element of an entity.
contacts.This specification does not address such relationships
3.3.2 Column, n—In a database, a vertical space or dimen-
as these concepts are subsequently covered in a separate
sion in a database table that represents a particular domain of
standard.
data and hold values for a particular attribute; in the physical
4.2 Both Logical and Physical Data Models are presented in
data model analogous to the attribute of the logical data model.
Annex A1.
3.3.3 Entity, n—In a logical data model, a distinguishable
4.2.1 Annex A1 illustrates the logical data model normal-
object about which data is kept.
izedtotheThirdNormalForm.Atthislevel,thedatastructures
3.3.4 Logical Data Model, n—A graphical and textual
representation of the data properties that describes a business
function, process, or organization, consisting and all the
These modifications and extensions are under consideration for inclusion in the
relationships that exist among them. next scheduled revision of ANSI/ADA Specification 1000.
E2436 – 05
demonstrate the ability to connect the type of name element, a genus/taxonomy reference and associative entities/tables as
such as family name, with its text value. cited in ANSI/ADA Specification 1000. This allows the char-
4.2.2 Annex A1.6 illustrates a generic physical data model
acterization of individual non-human living things, and the
using Oracle 9.x datatypes.
inclusion of those of different species into mixed herds.
4.3 The models illustrated in this document are presented in
the ANSI standard IDEF1X data modeling notation.
6. Specification
4.4 Where the ANSI/ADA Specification 1000 data models
6.1 The logical data structure of a person’s characteristics is
have been enhanced, mixed case data names are employed to
composed of an association of reference entities with that
easily identify these changes.
person’s identifying entity, with the component attributes
reflecting the specific characteristics of the subject person. The
5. Significance and Use
structure and content of these associative entities varies with
5.1 This specification promotes the interoperability of
individuals and frequently over time. The physical structure
health information systems through enabling a single uniform
and content of these characteristics, along with reference data
representation of human characteristics at the data layer of
sources, are specified in Fig. A1.2.
healthcare information systems architecture (See Fig. 1).
6.2 Ageisaderivedvaluecalculatedusingthereporteddate
It presents a data structure that allows the recording, storage,
of birth; therefore, the individual’s age does not require data
editing, and retrieval of human characteristics independent of
storage as a separate item.
technology and the language, nationality, or culture of persons
or organizations involved in healthcare processes.
6.3 The data structure in this specification provides a
5.1.1 The intended use of this specification is to promote
framework for recording or storing human characteristics data:
interoperability at the physical data tier in healthcare informa-
this specification does not mandate or require that any specific
tion systems, and to enhance the design and development of
human characteristic be obtained, recorded or stored in an
data subsystems that contain human characteristics data for
information system.
individuals and populations.
5.1.2 The data structures in this specification can be readily
7. Compliance
transformed into presentation layer structures—for example,
7.1 To be compliant with this specification, designers,
into XML for presentation in the ASTM Continuity of Care
developers, and vendors of healthcare applications and infor-
Record or the HL7 standard Clinical Document Architecture,
mationsystemsshalluseaphysicaldatastructurederivedfrom
or into standard HL7 2.x messages.
the generic physical data model presented in this specification.
5.2 Clinical uses of this data structure include the classifi-
Physical data names and characteristics must be retained to
cation and storage of human characteristics for individuals and
promote data interoperability.
populations—for example, for use in clinical decision support
7.2 System designers and developers may adjust this ge-
and epidemiology to compare the individual to populations
consistent with best clinical and scientific practices. nericdatastructure,forexample,denormalize,forperformance
and storage considerations as appropriate to their specific
5.3 This specification may be extended for use in veterinary
medicineasdescribedinAppendixX1.Thisextensionincludes database management system.
FIG. 1 Where This Specification Applies to System Architecture
E2436 – 05
7.3 Systemdesigners,developers,andvendorsshouldtrans- ADA Specification 1000. Users should weigh the benefits of
form these characteristics data for human interaction at the usingthesereferencedataforinternaluseagainsttheimpacton
system presentation tier as appropriate to the ASTM CCR or achieving data interoperability across systems.
HL7 CDA standards. 7.6 All database entries of these data must record the date
7.4 Systemdesigners,developers,andvendorsshouldtrans- and time of the observation (date-time stamp).
form these characteristics data at the system presentation tier 7.7 System designers, developers and vendors may extend
for messaging between systems as appropriate to healthcare the data structure beyond the representation in this specifica-
messaging standards, for example, HL7 2.x, ASTM, ANSI tion by including additional characteristics tables and data
X12N, NCPDP, etc. elements.
7.5 System designers, developers, and vendors should use 7.7.1 ASTM Committee E31 should be notified of any
standard reference data to populate these tables, such as extension to these data structures for consideration in future
Specification E1633, HL7, LOINC, or the draft ASTM refer- evolution of this standard.
ence data set for
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