1、 I n t e r n a t i o n a l T e l e c o m m u n i c a t i o n U n i o n ITU-T H.830.7 TELECOMMUNICATION STANDARDIZATION SECTOR OF ITU (04/2017) SERIES H: AUDIOVISUAL AND MULTIMEDIA SYSTEMS E-health multimedia services and applications Interoperability compliance testing of personal health systems (HR
2、N, PAN, LAN, TAN and WAN) Conformance of ITU-T H.810 personal health system: Services interface Part 7: Consent management: Health Part 7: Consent Management. HFS Sender (Version 1.5, 2017-03-14), that was developed by the Personal Connected Health Alliance. A number of versions of this specificatio
3、n existed before transposition. This Recommendation includes an electronic attachment with the protocol implementation conformance statements (PICS) and the protocol implementation extra information for testing (PIXIT) required for the implementation of Annex A. History Edition Recommendation Approv
4、al Study Group Unique ID* 1.0 ITU-T H.837 2015-01-13 16 11.1002/1000/12255 1.0 ITU-T H.830.7 2015-01-13 16 11.1002/1000/12593 2.0 ITU-T H.830.7 2016-07-14 16 11.1002/1000/12926 3.0 ITU-T H.830.7 2017-04-13 16 11.1002/1000/13208 Keywords Conformance testing, Consent Management, Continua Design Guidel
5、ines, e-health, Health Part 7: Consent Management. HFS Sender (Version 1.5, 2017-03-14), that was developed by the Continua Health Alliance. The table below shows the revision history of this test specification; it may contain versions that existed before transposition. Version Date Revision history
6、 1.0 2012-10-05 Initial release for Test Tool DG2011 based on the requirements in b-CDG 2011. 1.1 2013-05-24 Initial release for Test Tool DG2012. This uses “TSS users of this Recommendation are therefore encouraged to investigate the possibility of applying the most recent edition of the Recommenda
7、tions and other references listed below. A list of the currently valid ITU-T Recommendations is regularly published. The reference to a document within this Recommendation does not give it, as a stand-alone document, the status of a Recommendation. ITU-T H.810 (2016) Recommendation ITU-T H.810 (2016
8、), Interoperability design guidelines for personal health systems. ITU-T H.812 Recommendation ITU-T H.812 (2016), Interoperability design guidelines for personal health systems: Services interface: Common certified capability class. _ 1 This Recommendation includes an electronic attachment with the
9、protocol implementation conformance statements (PICS) and the protocol implementation extra information for testing (PIXIT) required for the implementation of Annex A. 2 Rec. ITU-T H.830.7 (04/2017) ITU-T H.812.1 Recommendation ITU-T H.812.1 (2016), Interoperability design guidelines for personal he
10、alth systems: Services interface: Observation upload certified capability class. ITU-T H.812.2 Recommendation ITU-T H.812.2 (2016), Interoperability design guidelines for personal health systems: Services interface: Questionnaires certified capability class. ITU-T H.812.3 Recommendation ITU-T H.812.
11、3 (2016), Interoperability design guidelines for personal health systems: Services interface: Capability exchange certified capability class. ITU-T H.812.4 Recommendation ITU-T H.812.4 (2016), Interoperability design guidelines for personal health systems: Services interface: Authenticated persisten
12、t session certified capability class. HL7 CDA IG Health Level Seven (2011), HL7 Implementation Guide for Clinical Document Architecture, Release 2: Consent Directives, Release 1, HL7 Draft Standard for Trial Use. http:/www.hl7.org/documentcenter/public/standards/dstu/CDAR2_IG%20_CONSENTDIR_DSTU_2011
13、JAN.pdf IHE ITI TF-2b IHE IT TF-2b (2009), IHE ITI Infrastructure Technical Framework, Volume 2b: Transactions Part B. Revision 6.0 Final Text. 3 Definitions 3.1 Terms defined elsewhere None. 3.2 Terms defined in this Recommendation None. 4 Abbreviations and acronyms This Recommendation uses the fo
14、llowing abbreviations and acronyms: ATNA Audit Trail and Node Authentication ATS Abstract Test Suite CDA Clinical Document Architecture CDG Continua Design Guidelines CGM Continuous Glucose Monitor DUT Device Under Test GUI Graphical User Interface ebXML electronic business using extensible Markup L
15、anguage EHR Electronic Health Record HFS Health M Spec IHE ITI TF-2b Testable items ProvideProtocol12; M ProvideProtocol13; M ProvideProtocol2; M ProvideSource1; M Test purpose Check that: Consent Enabled HFS sender shall send the consent document at least once to the HFS receiver AND The Document S
16、ource shall generate Provide and Register Document Set-b transactions in MTOM/XOP format. AND The Document Source shall accept the response message in MTOM/XOP format. AND The Provide and Register Document Set-b transaction shall use SOAP12 and MTOM with XOP encoding. AND An implementation of the Do
17、cument Source actor shall be capable of submit one or more documents. Applicability C_SEN_000 AND C_SEN_GEN_002 AND C_SEN_GEN_003 Other PICS Initial condition The HFS simulated receiver has a WebService enabled with a consent management service. The HFS sender under test has a clinical document arch
18、itecture (CDA) ready to be sent to the respective service according to its needs. Test procedure 1. The HFS sender under test sends a “Provide and Register Document Set-b Request“ message. 2. Check that: a. In the HTTP header: action=“urn:ihe:iti:2007:ProvideAndRegisterDocumentSet-b“ Content-Type =
19、multipart/related boundary element is a MIMEBoundary type = “application/xop+xml“ b. In the SOAP message The namespace of the SOAP envelope is “http:/www.w3.org/2003/05/soap-envelope“ (SOAP 1.2) There are one or more xsdb:Document elements in the SOAP Body. 3. The simulated HFS receiver responds wit
20、h a “Provide and Register Document Set-b Response“ message 4. The HFS sender under test accepts the message (it does not give any error message). 10 Rec. ITU-T H.830.7 (04/2017) Pass/Fail criteria All steps are as specified within the test procedure above. Notes A.3 Subgroup 1.5.2: HFS metadata vali
21、dation (META) TP Id TP/HFS/SEN/CM/META/BV-000 TP label Metadata Syntactic Validation Coverage Spec IHE ITI TF-2b Testable items ProvideScope1; M ProvideProtocol9; M Spec ITU-T H.812 Testable items ConsentSender4; M ConsentSender 5; M Test purpose Check that: A Provide and Register Document Set-b tra
22、nsaction shall carry: - Metadata describing zero or more documents - Within metadata, one XDSDocumentEntry object per document - XDS Submission Set definition along with the linkage to new documents and references to existing documents - Zero or more XDS Folder definitions along with the linkage to
23、new or existing documents - Zero or more documents AND The element is defined as: - One element that contains the submission set metadata - Zero or more elements that contain the base64encoded data for the documents being submitted to the Document Repository. The also includes the document id attrib
24、ute (ihe:Document/id) of type xsd:anyURI to match the document ExtrinsicObject id in the metadata and providing the necessary linkage AND The consent document transmitted by the Consent Enabled HFS sender shall contain the same Patient Identifier as the HFS Observation measurement message(s). Applic
25、ability C_SEN_000 AND C_SEN_GEN_002 AND C_SEN_GEN_003 Other PICS Initial condition The simulated HFS receiver has a WebService enabled with a consent management service and a CommunicatePCDData service. The HFS sender under test has a CDA ready to be sent to the respective service according to its n
26、eeds. Test procedure 1. The HFS sender under test sends a “Provide and Register Document Set-b Request“ message to the consent management service and a “PCD-01“ message to the CommunicatePCDData service. 2. Check that in the SOAP body: a. There is only one element, and that it contains: o Only one e
27、lement, that contains: - A XDSDocumentEntry (ExtrinsicObject) element for each document - An XDS Submission Set definition along with the linkage to new Rec. ITU-T H.830.7 (04/2017) 11 documents and references to existing documents (RegistryPackage element) - Zero or more XDS Folder definitions alon
28、g with the linkage to new or existing documents. o Zero or more elements. b. The PID-3 element of the “PCD-01“ message is equal to SubmitObjectsRequest/RegistryObjectList/ExtrinsicObject/Slotname = sourcePatientId/ValueList/Value element of the metadata, and: o Subfields CX-1 and CX-4 are present. o
29、 Subfield CX-5 is not present. Pass/Fail criteria All steps are as specified within the test procedure above. Notes TP Id TP/HFS/SEN/CM/META/BV-001 TP label Metadata Submission Set Validation Coverage Spec ITU-T H.812 Testable items WANXDSSub-1; O WANXDSSub-2; M WANXDSSub-3; M WANXDSSub-4; M WANXDSS
30、ub-5; M WANXDSSub-6; M WANXDSSub-7; O WANXDSSub-8; M WANXDSSub-9; O WANXDSSub-10; M WANXDSSub-11; M WANXDSSub-12; M WANXDSSub-13; M WANXDSSub-14; M WANXDSSub-15; M Test purpose Check that: availabilityStatus element MAY be present AND author element SHALL be equal to Consent Directive /ClinicalDocum
31、ent/author AND authorInstitution element SHALL be equal to Consent Directive /ClinicalDocument/author/assignedAuthor/representedOrganization AND authorPerson element SHALL be equal to Consent Directive /ClinicalDocument/author/assignedAuthor/assignedPerson AND authorRole element SHALL be equal to Co
32、nsent Directive /ClinicalDocument/author/assignedAuthor/participationFunction AND authorSpecialty element SHALL be equal to Consent Directive /ClinicalDocument/author/assignedAuthor/code AND comments element MAY be present AND contentTypeCode element SHALL be present AND contentTypeCodeDisplayName e
33、lement MAY be present 12 Rec. ITU-T H.830.7 (04/2017) AND entryUUID element SHALL be equal to Consent Directive unique ID for submission set AND patientId element SHALL be mapped from /ClinicalDocument/recordTarget/patientRole/id AND sourceId element SHALL be present AND submissionTime element SHALL
34、 be present AND title element SHALL be equal to Consent Directive /ClinicalDocument/title AND uniqueId element SHALL be equal to Consent Directive /ClinicalDocument/id Applicability C_SEN_000 AND C_SEN_GEN_002 AND C_SEN_GEN_003 Other PICS Initial condition The simulated HFS receiver has a WebService
35、 enabled with a consent management service. The HFS sender under test has a CDA ready to be sent to the respective service according to its needs. Test procedure 1. The HFS sender under test sends a “Provide and Register Document Set-b Request“ message containing a CDA referenced in its body 2. Chec
36、k the following elements of the “Metadata in Submission Set“ section sent by the HFS sender under test and its concordance with the clinical document: a. availabilityStatus element may be present b. author element is equal to Consent Directive /ClinicalDocument/author c. authorInstitution element is
37、 equal to Consent Directive /ClinicalDocument/author/assignedAuthor/representedOrganization d. authorPerson element is equal to Consent Directive /ClinicalDocument/author/assignedAuthor/assignedPerson e. authorRole element is equal to Consent Directive /ClinicalDocument/author/participationFunction
38、f. authorSpecialty element Is equal to Consent Directive /ClinicalDocument/author/assignedAuthor/code g. comments element may be present h. contentTypeCode element Is present i. entryUUID element is equal to Consent Directive unique ID for submission set j. patientId element is mapped from /Clinical
39、Document/recordTarget/patientRole/id k. sourceId element is present l. submissionTime element is present m. title element is equal to Consent Directive /ClinicalDocument/title n. uniqueId element is equal to Consent Directive /ClinicalDocument/id. Pass/Fail criteria All steps are as specified within
40、 the test procedure above. Notes TP Id TP/HFS/SEN/CM/META/BV-002 TP label Metadata Document Entry Validation Rec. ITU-T H.830.7 (04/2017) 13 Coverage Spec ITU-T H.812 Testable items WANXDSDocEntry-1; O WANXDSDocEntry-2; M WANXDSDocEntry-3; M WANXDSDocEntry-4; M WANXDSDocEntry-5; M WANXDSDocEntry-6;
41、M WANXDSDocEntry-7; M WANXDSDocEntry-8; O WANXDSDocEntry-9; O WANXDSDocEntry-10; M WANXDSDocEntry-11; M WANXDSDocEntry-12; M WANXDSDocEntry-13; M WANXDSDocEntry-14; M WANXDSDocEntry-15; O WANXDSDocEntry-16; M WANXDSDocEntry-17; O WANXDSDocEntry-18; M WANXDSDocEntry-19; M WANXDSDocEntry-20; M WANXDSD
42、ocEntry-21; M WANXDSDocEntry-22; M WANXDSDocEntry-23; M WANXDSDocEntry-24; M WANXDSDocEntry-25; O WANXDSDocEntry-26; O WANXDSDocEntry-27; O WANXDSDocEntry-28; M WANXDSDocEntry-29; M WANXDSDocEntry-30; M WANXDSDocEntry-31; M WANXDSDocEntry-32; M WANXDSDocEntry-33; M WANXDSDocEntry-34; M WANXDSDocEntr
43、y-35; M WANXDSDocEntry-36; M WANXDSDocEntry-37; M WANXDSDocEntry-38; M WANXDSDocEntry-39; M WANXDSDocEntry-40; O WANXDSDocEntry-41; M WANXDSDocEntry-42; M WANXDSDocEntry-43; M Test purpose Check that: availabilityStatus element MAY be present AND author element SHALL be equal to Consent Directive /C
44、linicalDocument/author AND authorInstitution element SHALL be equal to Consent Directive /ClinicalDocument/author/assignedAuthor/representedOrganization/name, id AND authorPerson element SHALL be equal to Consent Directive /ClinicalDocument/author/assignedAuthor/assignedPerson AND authorRole element
45、 SHALL be equal to Consent Directive /ClinicalDocument/author/assignedAuthor/participationFunction/code AND authorSpecialty element SHALL be equal to Consent Directive /ClinicalDocument/author/assignedAuthor/participationFunction AND classCode element SHALL be present and SHALL use the LOINC code 57
46、016-8 AND classCodeDisplayName element MAY be present AND Comments element MAY be present AND confidentialityCode element SHALL be equal to Consent Directive 14 Rec. ITU-T H.830.7 (04/2017) /ClinicalDocument/confidentialityCode AND confidentialityCodeDisplayName element SHALL be equal to Consent Dir
47、ective /ClinicalDocument/confidentialityCode AND creationTime element SHALL be equal to Consent Directive /ClinicalDocument/effectiveTime AND entryUUID element SHALL be present AND eventCodeList element SHALL be equal to Consent Directive /ClinicalDocument/documentationOf/serviceEvent/code AND event
48、CodeDisplayNameList element MAY be present AND formatCode element SHALL be present and equal to “urn:continua:cd:2011” AND formatCodeDisplayName element MAY be present AND hash element SHALL be present AND healthcareFacilityTypeCode element SHALL be present AND healthcareFacilityTypeCodeDisplayName
49、element MAY be present AND languageCode element SHALL be equal to Consent Directive /ClinicalDocument/languageCode AND legalAuthenticator element SHALL be equal to Consent Directive /ClinicalDocument/legalAuthenticator AND mimeType element SHALL be equal to Consent Directive text/xml AND parentDocument element MAY come from /ClinicalDocument/relatedDocument/pare
