1、Designation: E2369 12Standard Specification forContinuity of Care Record (CCR)1This standard is issued under the fixed designation E2369; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parent
2、heses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 The Continuity of Care Record (CCR) is a core data setof the most relevant administrative, demographic, and clinicalinformation facts about a patients
3、healthcare, covering one ormore healthcare encounters.2It provides a means for onehealthcare practitioner, system, or setting to aggregate all of thepertinent data about a patient and forward it to anotherpractitioner, system, or setting to support the continuity of care.1.1.1 The CCR data set inclu
4、des a summary of the patientshealth status (for example, problems, medications, allergies)and basic information about insurance, advance directives, caredocumentation, and the patients care plan. It also includesidentifying information and the purpose of the CCR. (See 5.1for a description of the CCR
5、s components and sections, andAnnex A1 for the detailed data fields of the CCR.)1.1.2 The CCR may be prepared, displayed, and transmittedon paper or electronically, provided the information requiredby this specification is included. When prepared in a structuredelectronic format, strict adherence to
6、 an XML schema and anaccompanying implementation guide is required to supportstandards-compliant interoperability. The Adjunct3to thisspecification contains a W3C XML schema and Annex A2contains an Implementation Guide for such representation.1.2 The primary use case for the CCR is to provide asnaps
7、hot 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 orto workflows, but is intended to facilitate the implementationof use cases and workflows. Any examples offered in thisspecification a
8、re not to be considered normative.41.3 To ensure interchangeability of electronic CCRs, thisspecification specifies XML coding that is required when theCCR is created in a structured electronic format.5This speci-fied XML coding provides flexibility that will allow users toprepare, transmit, and vie
9、w the CCR in multiple ways, forexample, in a browser, as an element in a Health Level 7 (HL7)message or CDA compliant document, in a secure email, as aPDF file, as an HTML file, or as a word processing document.It will further permit users to display the fields of the CCR inmultiple formats.1.3.1 Th
10、e CCR XML schema or .xsd (see theAdjunct to thisspecification) is defined as a data object that represents asnapshot of a patients relevant administrative, demographic,and clinical information at a specific moment in time. The CCRXML is not a persistent document, and it is not a messagingstandard.NO
11、TE 1The CCR XML schema can also be used to define an XMLrepresentation for the CCR data elements, subject to the constraintsspecified in the accompanying Implementation Guide (see Annex A2).1.3.2 Using the required XML schema in theAdjunct to thisspecification or other XML schemas that may be author
12、izedthrough joints efforts of ASTM and other standards develop-ment organizations, properly designed electronic healthcarerecord (EHR) systems will be able to import and export allCCR data to enable automated healthcare information trans-mission with minimal workflow disruption for practitioners.Equ
13、ally important, it will allow the interchange of the CCRdata between otherwise incompatible EHR systems.1.4 SecurityThe data contained within the CCR are pa-tient data and, if those data are identifiable, then end-to-endCCR document integrity and confidentiality must be provided1This specification i
14、s under the jurisdiction of ASTM Committee E31 onHealthcare Informatics and is the direct responsibility of Subcommittee E31.25 onHealthcare Data Management, Security, Confidentiality, and Privacy.Current edition approved Dec. 1, 2012. Published December 2012. Last previousversion published 2002 as
15、E236905e2. DOI: 10.1520/E2369-12.2A CCR is not intended to be a medical-legal clinical or administrativedocument entered into a patients record, but may in specific use cases be used insuch a manner, provided that accepted policies and procedures in adding such datato a patients record are followed.
16、 A personal health record, with the informationunder the control of the patient or their designated representative, would be anexample of such a use case, as would be importation into an electronic health recordsystem, a data repository, or a registry.3Available from ASTM International Headquarters.
17、 Order Adjunct No.ADJE2369. Original adjunct produced in 2006.4Since the CCR is a core data set of selected, relevant information, it is not adischarge summary, that is, it does not include all of a patients health informationthat would be routinely recorded at the time of discharge, nor is it the t
18、ransfer of anentire patient record.5The required XML may be as represented in the Adjunct to this specification orAnnex A2 or other XML representation made possible through joint efforts ofASTM and other standards development organizations.Copyright ASTM International, 100 Barr Harbor Drive, PO Box
19、C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the
20、 World Trade Organization Technical Barriers to Trade (TBT) Committee.1while conforming to regulations or other security,confidentiality, or privacy protections as applicable within thescope of this specification.1.4.1 Conditions of security and privacy for a CCR instancemust be established in a way
21、 that allows only properlyauthenticated and authorized access to the CCR documentinstance or its elements. The CCR document instance must beself-protecting when possible, and carry sufficient data embed-ded in the document instance to permit access decisions to bemade based upon confidentiality cons
22、traints or limitationsspecific to that instance.1.4.2 Additional Subcommittee E31.20 on Security andPrivacy guides, practices, and specifications will be publishedin support of the security and privacy needs of specific CCRuse cases. When a specification is necessary to assure interop-erability or o
23、ther required functionality, the CCR core schemawill be extended to meet the profile requirements of theunderlying use case, building upon existing standards andspecifications whenever possible.1.4.2.1 For profiles that require digital signatures, W3CsXML digital signature standard (http:/www.w3.org
24、/TR/xmldsig-core) will be used with digital certificates. Encryptionwill be provided using W3Cs XML encryption standard(http:/www.w3.org/TR/xmlenc-core).1.5 The CCR is an outgrowth of the Patient Care ReferralForm (PCRF) designed and mandated by the MassachusettsDepartment of Public Health for use p
25、rimarily in inpatientsettings.1.5.1 Unlike the PCRF, the CCR is designed for use in allclinical care settings.1.6 It is assumed that information contained in a CCR willbe confirmed as appropriate in clinical practice. For example,the CCR insurance fields should not be construed to address allreimbur
26、sement, authorization, or eligibility issues, and currentmedications and other critical data should be validated.1.7 Committee E31 gratefully acknowledges the Massachu-setts Medical Society, HIMSS (Health Information Manage-ment and Systems Society), the American Academy of FamilyPhysicians, theAmer
27、icanAcademy of Pediatrics, theAmericanMedical Association, the Patient Safety Institute, the AmericanHealth Care Association, the National Association for theSupport of Long Term Care, the Mobile Healthcare Alliance(MoHCA), the Medical Group Management Association(MGMA) and the American College of O
28、steopathic FamilyPhysicians (ACOFP) as co-leaders with ASTM in the stan-dards development and adoption, and joins them in invitingthe collaboration of all stakeholders, including other clinicalspecialty societies, other professional organizations, insurers,vendors, other healthcare institutions, dep
29、artments of publichealth, and other government agencies.1.8 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 determine the applica-bilit
30、y of regulatory limitations prior to use.1.9 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the Worl
31、d Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:6E1382 Test Methods for Determining Average Grain SizeUsing Semiautomatic and Automatic Image AnalysisE1384 Practice for Content and Structure of the ElectronicHealth Record (Withdrawn 2017)7E17
32、62 Guide for Electronic Authentication of Health CareInformation (Withdrawn 2017)7E1869 Guide for Confidentiality, Privacy, Access, and DataSecurity Principles for Health Information Including Elec-tronic Health Records (Withdrawn 2017)7E1985 Guide for User Authentication and Authorization(Withdrawn
33、 2017)7E1986 Guide for Information Access Privileges to HealthInformation (Withdrawn 2017)7E2084 Specification for Authentication of Healthcare Infor-mation Using Digital Signatures (Withdrawn 2009)7E2085 Guide on Security Framework for Healthcare Infor-mation (Withdrawn 2009)7E2086 Guide for Intern
34、et and Intranet Healthcare Security(Withdrawn 2009)7E2147 Specification for Audit and Disclosure Logs for Usein Health Information Systems (Withdrawn 2017)7E2182 Specification for Clinical XML DTDs in Healthcare(Withdrawn 2011)7E2183 Guide for XML DTD Design, Architecture andImplementation (Withdraw
35、n 2011)7E2184 Specification for Healthcare Document Formats(Withdrawn 2011)7E2211 Specification for Relationship Between a Person(Consumer) and a Supplier of an Electronic Personal(Consumer) Health Record (Withdrawn 2014)7E2212 Practice for Healthcare Certificate Policy (Withdrawn0)72.2 Other Refere
36、nces:Health Information Portability and Accountability Act, U.S.Congress, 1996ICD-9-CM (http:/www.cdc.gov/nchs/about/otheract/icd9/abticd9.htm)ICD-10-CM (http:/www.cdc.gov/nchs/icd/icd10cm.htm)LOINC (http:/www.loinc.org/)Massachusetts Department of Health Patient Care ReferralFormNDC (http:/www.fda.
37、gov/cder/ndc/)RxNorm (http:/www.nlm.nih.gov/research/umls/rxnorm_main.html)SNOMED (http:/www.snomed.org/)6For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standar
38、ds Document Summary page onthe ASTM website.7The last approved version of this historical standard is referenced onwww.astm.org.E2369 122W3C XML Digital Signature Standard (http:/www.w3.org/TR/xmldsig-core/)W3C XML Encryption Standard (http:/www.w3.org/TR/xmlenc-core)2.3 ASTM Adjuncts:W3C XML Schema
39、33. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 These terms also include the common terms seen inmany documents related to the CCR. See also Annex A1 fordefinitions of additional terms specific to this specification.3.1.2 actorsall the individuals, organizations, locations,an
40、d systems associated with the data in the CCR.3.1.3 attributefor the purposes of this specification, anattribute is a characteristic of data, representing one or moreaspects, descriptors, or elements of the data. In object-orientedsystems, attributes are characteristics of objects. In XML,attributes
41、 are characteristics of tags.3.1.4 CCR bodycontains the core patient-specific data in aCCR, for example, Insurance, Medications, Problems,Procedures, and the like.3.1.5 CCR componentsCCR Header, CCR Body, CCRFooter; each component is made of sections, which in turn aremade up of data fields.3.1.6 CC
42、R footercontains data defining all of the actors,as well as information about external references, all textcomments, and signatures associated with any data within theCCR.3.1.7 CCR headerdefines the document parameters, in-cluding its unique identifier, language, version, date/time, thepatient whose
43、 data it contains, who or what has generated theCCR, to whom or what the CCR is directed, and the CCRspurpose.3.1.8 commentsall text comments associated with anydata within the CCR not containing core relevant, clinical, oradministrative data, and not containing pointers to referencesexternal to the
44、 CCR.3.1.9 CDAthe HL7 CDA (Clinical Document Architec-ture) is a document markup standard for the structure andsemantics of exchanged clinical documents. E21823.1.10 complex data type or a groupconcepts used morethan once; defined by adding the post-fix Type.3.1.11 continuity of care record (CCR)a c
45、ore data set ofthe most relevant administrative, demographic, and clinicalinformation facts about a patients healthcare, covering one ormore healthcare encounters. It provides a means for onehealthcare practitioner, system, or setting to aggregate all of thepertinent data about a patient and forward
46、 it to anotherpractitioner, system, or setting to support the continuity of care.See Section 5 for a summary of CCR contents, and Annex A1for a detailed list of data fields.3.1.12 current procedural terminology (CPT)an annualreference published by the American Medical Association thatlists descripti
47、ve terms and identifying codes for reportingmedical services and procedures performed by physicians.3.1.13 data fieldsrequired or optional data within a sec-tion. Data fields may be repeated as often as necessary (seeAnnex A1).3.1.14 data objectsdiscrete patient-specific data(Medications, Problems,
48、Procedures, and the like).3.1.15 DERFNCPDPs Data Element Request Form usedto request an addition or modification to NCPDPs current ornew standards. www.ncpdp.org3.1.16 digital signaturedata associated with, or a crypto-graphic transformation of, a data unit that allows a recipient ofthe data unit to
49、 prove the source and integrity of the data unitand protect against forgery, for example, by the recipient.E20843.1.17 DMRdurable medical equipment3.1.18 document objectthe CCR as an XML document,consisting of a header, a body, and a footer, each built from aset of discrete XML building blocks.3.1.19 domain-specific applicationsadditional, optionalsets of CCR data elements specific to such areas as clinicalspecialties, institutions or enterprises, payers, diseasemanagement, and personal health records. Data sets for op-tional CCR domain-
