1、Designation: E2436 05 (Reapproved 2010) An American National StandardStandard Specification for theRepresentation of Human Characteristics Data in HealthcareInformation Systems1This standard is issued under the fixed designation E2436; the number immediately following the designation indicates the y
2、ear oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONThis document presents a standardized representation
3、for the content and structure of humancharacteristics 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 plannerscannot be easily compared due to the variety in representing
4、 human characteristics. This documentstandardizes the representation of these characteristics at the data tier of health information systems.1. Scope1.1 This document presents a standardized representationfor the content and structure of human characteristics data foruse in healthcare information sy
5、stems.1.2 This specification may be extended to apply to charac-teristics of non-human living things, such as in data systemssupporting veterinary medicine.1.3 The following provisions are within the scope of thisspecification:1.3.1 Logical representation of human characteristics datafor individuals
6、 and populations.1.3.2 Physical representation of human characteristics at thedata tier of healthcare information systems.1.4 The following provisions are outside the scope of thisspecification:1.4.1 The standardization of policy or regulation concerningthe employment of human characteristics data d
7、escribed in thisspecification.1.4.2 The establishment or standardization of legal con-straints over the use of human characteristics in conjunctionwith healthcare clinical or business processes.1.4.3 Addressing or standardizing personal privacy,medicolegal, and system security provisions associated
8、withdocumenting human characteristics or storing human charac-teristics data.1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determ
9、ine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E1384 Practice for Content and Structure of the ElectronicHealth Record (EHR)E1633 Specification for Coded Values Used in the ElectronicHealth RecordE2145 Practice for Information Modeling2.2 ANS
10、I StandardsANSI 260.3-1993 Mathematical Signs and Symbols for Usein Physical Sciences and Technology (revision and redes-ignation of ANSI/ASME Y10.20-1990).ANSI 1320.2-1998 IEEE Standard for Conceptual Model-ing Language - Syntax and Semantics for IDEF1X97(IDEFobject)ANSI/ADA 1000 Standard Data Arch
11、itecture for the Struc-ture and Content of the Electronic Health Record, Febru-ary 2001.2.3 ISO StandardsISO 639 Codes for the representation of names of languagesISO 2955 Representation of SI UnitsISO 5218 Representation of the Human SexesISO 8601 Representation of Dates2.4 Other Standards and Docu
12、mentsAmerican Heritage DictionaryANSI/ADA Specification 1000 Implementation GuideHL7 2.x reference values.1This specification is under the jurisdiction of ASTM Committee E31 onHealthcare Informatics and is the direct responsibility of Subcommittee E31.25 onHealthcare Data Management, Security, Confi
13、dentiality, and Privacy.Current edition approved June 1, 2010. Published September 2010. Originallyapproved in 2005. Last previous edition approved in 2005 as E243605. DOI:10.1520/E2436-05R10.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at ser
14、viceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesNOTICE: This standard has either been superseded and rep
15、laced by a new version or withdrawn.Contact ASTM International (www.astm.org) for the latest information1National Institute of Standards and Technology, FederalInformation Processing Standards Publications 184 Inte-grated Definition for Information Modeling (IDEFIX), 23December 1993.3. Terminology3.
16、1 Acronyms:ADA = American Dental AssociationANSI = American National Standards InstituteCCR = ASTM standard Continuity of Care RecordHL7 = Health Level SevenIDEF = Integrated Definition languageISO = International Standards OrganizationLDM = Logical data modelLOINC = Logical Observation Identifiers
17、Names and CodesPDM = Physical data modelXML = Extensible Markup Language3.2 Definitions:3.2.1 Ethnicity, ncharacteristics of a group of peoplesharing a common and distinctive racial, national, religious,linguistic, or cultural heritage.American Heritage Dictionary3.2.2 Language, nA system of arbitra
18、ry signals, such asvoice sounds, gestures, or written symbols, including its rulesfor combining its components, such as words, as used by anation, people, or other distinct community for communicationof thoughts and feelings.American Heritage Dictionary3.2.3 Living Arrangement, nThe setting or envir
19、onment inwhich an individual lives, such as family setting, as may haveimpact on the individuals health and course of care.3.2.4 Physical characteristic, na group of characteristicspreviously used by convention as a means to describe anindividual, e.g. by hair color, eye color, build, etc.3.2.5 Race
20、, nA local geographic or global human popu-lation distinguished as a more or less distinct group bygenetically transmitted physical characteristics.American Heritage Dictionary3.2.6 Religion, nA personal or institutionalized systemgrounded in such belief and worship. A set of beliefs, values,and pra
21、ctices based on the teachings of a spiritual leader.American Heritage Dictionary3.2.7 Sex Characteristic, nPreferred term to more com-pletely classify the multiple human sex characteristics. Theterm “Sex” is preferred as the biologically correct term ratherthan the grammatical term “gender.”3.3 Defi
22、nitions:The following information modeling andtechnology terms are used in this document:3.3.1 Attribute, nIn a logical data model, an identifiablecharacteristic or data element of an entity.3.3.2 Column, nIn a database, a vertical space or dimen-sion in a database table that represents a particular
23、 domain ofdata and hold values for a particular attribute; in the physicaldata model analogous to the attribute of the logical data model.3.3.3 Entity, nIn a logical data model, a distinguishableobject about which data is kept.3.3.4 Logical Data Model, nA graphical and textualrepresentation of the d
24、ata properties that describes a businessfunction, process, or organization, consisting and all therelationships that exist among them.3.3.5 Metadata, nData about data, or information aboutinformation, generally comprising a structured set of descrip-tive elements about any definable entity.3.3.6 Phy
25、sical Data Model, nA graphical and textualrepresentation of the structural properties that are implementedor able to be implemented in a database, consisting of tables,columns and rows, and all the relationships that exist amongthese.3.3.7 Table, nThe basic unit of storage in a relationaldatabase ma
26、nagement system; in the physical data modelanalogous to the entity of the logical data model.4. Reference Data Model4.1 This specification is based upon the ANSI/ADA Speci-fication 1000 reference data model and expands upon datastructures found in the “Individual Characteristics” and “Popu-lation Ch
27、aracteristics” subject areas.4.1.1 The Individual Characteristics subject area of thisspecification has been extended to include two additionalentities/tables.34.1.1.1 Living Arrangement to allow the characterizationand textual description of the residential life patterns andinterpersonal life-depen
28、dencies of a patient or related indi-vidual.4.1.1.2 Individual Physical Characteristics to allow docu-mentation of administrative characteristics (e.g. height, eyecolor, hair color, etc.) not otherwise documented in this model.4.1.2 In this specification, several attributes are deleted fromthe Indiv
29、idual entity that are not relevant to personalcharacteristics, and this entity is extended by adding reportedand derived dates of birth and death.4.1.3 The following entities in the ANSI/ADA Specification1000 Individual Characteristics subject area are not referencedin this specification:4.1.3.1 Ind
30、ividual Object is employed in ANSI/ADA Speci-fication 1000 to carry object data descriptive of an individualsuch as an identification image or biometric data. This data isnot considered as characteristics within the context of thisspecification.4.1.3.2 Individual Taxonomy associative entity is not u
31、sedin human health information systems. Where this specificationis extended to represent the characteristics of non-human livingthings, the taxonomy or genus reference and associativeentities may be employed.4.1.4 Associated Individual and Pair Bond Status are em-ployed inANSI/ADASpecification 1000
32、to allow the construc-tion of complex networks of interpersonal relationships, suchas in an extended family or patterns of epidemiologicalcontacts. This specification does not address such relationshipsas these concepts are subsequently covered in a separatestandard.3These modifications and extensio
33、ns are under consideration for inclusion in thenext scheduled revision of ANSI/ADA Specification 1000.E2436 05 (2010)24.2 Both Logical and Physical Data Models are presented inAnnex A1.4.2.1 Annex A1 illustrates the logical data model normal-ized to the Third Normal Form.At this level, the data stru
34、cturesdemonstrate the ability to connect the type of name element,such as family name, with its text value.4.2.2 Annex A1.6 illustrates a generic physical data modelusing Oracle 9.x datatypes.4.3 The models illustrated in this document are presented inthe ANSI standard IDEF1X data modeling notation.
35、4.4 Where the ANSI/ADA Specification 1000 data modelshave been enhanced, mixed case data names are employed toeasily identify these changes.5. Significance and Use5.1 This specification promotes the interoperability ofhealth information systems through enabling a single uniformrepresentation of huma
36、n characteristics at the data layer ofhealthcare information systems architecture (See Fig. 1).It presents a data structure that allows the recording, storage,editing, and retrieval of human characteristics independent oftechnology and the language, nationality, or culture of personsor organizations
37、 involved in healthcare processes.5.1.1 The intended use of this specification is to promoteinteroperability at the physical data tier in healthcare informa-tion systems, and to enhance the design and development ofdata subsystems that contain human characteristics data forindividuals and population
38、s.5.1.2 The data structures in this specification can be readilytransformed into presentation layer structuresfor example,into XML for presentation in the ASTM Continuity of CareRecord or the HL7 standard Clinical Document Architecture,or into standard HL7 2.x messages.5.2 Clinical uses of this data
39、 structure include the classifi-cation and storage of human characteristics for individuals andpopulationsfor example, for use in clinical decision supportand epidemiology to compare the individual to populationsconsistent with best clinical and scientific practices.5.3 This specification may be ext
40、ended for use in veterinarymedicine as described in Appendix X1. This extension in-cludes a genus/taxonomy reference and associative entities/tables as cited in ANSI/ADA Specification 1000. This allowsthe characterization of individual non-human living things, andthe inclusion of those of different
41、species into mixed herds.6. Specification6.1 The logical data structure of a persons characteristics iscomposed of an association of reference entities with thatpersons identifying entity, with the component attributesreflecting the specific characteristics of the subject person. Thestructure and co
42、ntent of these associative entities varies withindividuals and frequently over time. The physical structureand content of these characteristics, along with reference datasources, are specified in Fig. A1.2.6.2 Age is a derived value calculated using the reported dateof birth; therefore, the individu
43、als age does not require datastorage as a separate item.6.3 The data structure in this specification provides aframework for recording or storing human characteristics data:this specification does not mandate or require that any specifichuman characteristic be obtained, recorded or stored in aninfor
44、mation system.7. Compliance7.1 To be compliant with this specification, designers,developers, and vendors of healthcare applications and infor-mation systems shall use a physical data structure derived fromthe generic physical data model presented in this specification.Physical data names and charac
45、teristics must be retained topromote data interoperability.FIG. 1 Where This Specification Applies to System ArchitectureE2436 05 (2010)37.2 System designers and developers may adjust this ge-neric data structure, for example, denormalize, for performanceand storage considerations as appropriate to
46、their specificdatabase management system.7.3 System designers, developers, and vendors should trans-form these characteristics data for human interaction at thesystem presentation tier as appropriate to the ASTM CCR orHL7 CDA standards.7.4 System designers, developers, and vendors should trans-form
47、these characteristics data at the system presentation tierfor messaging between systems as appropriate to healthcaremessaging standards, for example, HL7 2.x, ASTM, ANSIX12N, NCPDP, etc.7.5 System designers, developers, and vendors should usestandard reference data to populate these tables, such asS
48、pecification E1633, HL7, LOINC, or the draft ASTM refer-ence data set for ANSI/ADA Specification 1000.7.5.1 Alternately, reference data used to populate thesetables can be derived from CMS approved sources, such asHL7 or LOINC, or the draft ASTM reference data for ANSI/ADA Specification 1000. Users
49、should weigh the benefits ofusing these reference data for internal use against the impact onachieving data interoperability across systems.7.6 All database entries of these data must record the dateand time of the observation (date-time stamp).7.7 System designers, developers and vendors may extendthe data structure beyond the representation in this specifica-tion by including additional characteristics tables and dataelements.7.7.1 ASTM Committee E31 should be notified of anyextension to these data structures for consideration in futureevolution
