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.830.8 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 8: Consent Management: Health Part 8: Consent Management. HFS Receiver (Version 1.4, 2017-03-14), that was developed by the Personal Connected Health Alliance. A number of versions of this specificat
3、ion 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 Appr
4、oval Study Group Unique ID* 1.0 ITU-T H.838 2015-01-13 16 11.1002/1000/12256 1.0 ITU-T H.830.8 2015-01-13 16 11.1002/1000/12594 2.0 ITU-T H.830.8 2016-07-14 16 11.1002/1000/12928 3.0 ITU-T H.830.8 2017-04-13 16 11.1002/1000/13209 Keywords Conformance testing, Consent Management, Continua Design Guid
5、elines, e-health, Health Part 8: Consent Management. HFS Receiver (Version 1.4, 2017-03-14), that was developed by the Personal Connected Health Alliance. The table below shows the revision history of this test specification; it may contain versions that existed before transposition. Version Date Re
6、vision history 1.0 2012-10-05 Initial release for Test Tool DG2011 based on the requirements in b-CDG 2011. 1.0 2013-05-24 Initial release for Test Tool DG2012. This is the same version as “TSS users of this Recommendation are therefore encouraged to investigate the possibility of applying the most
7、recent edition of the Recommendations 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)
8、Recommendation ITU-T H.810 (2016), 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
9、 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. Rec. ITU-T H.830.8 (04/2017) ITU-T H.812.1 Recommendation ITU-T H.812.1 (2016), Interoperability des
10、ign guidelines for personal health 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
11、.3 Recommendation ITU-T H.812.3 (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 inte
12、rface: Authenticated persistent session certified capability class. IHE ITI TF-2 IHE ITI TF 2 (2010), Integrating the Healthcare Enterprise, IHE IT Infrastructure Technical Framework, Volume 2 (ITI TF-2), Revision 7.0. It comprises three sub-volumes: 2a (Transactions Part A), 2b (Transactions Part B
13、) and 2x (Appendices). http:/ http:/ http:/ 3 Definitions 3.1 Terms defined elsewhere None. 3.2 Terms defined in this Recommendation None. 4 Abbreviations and acronyms This Recommendation uses the following abbreviations and acronyms: ATNA Audit Trail and Node Authentication ATS Abstract Test Suite
14、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 Language EHR Electronic Health Record HFS Health M Spec IHE ITI TF-2, Volume 2b Testable items Provide
15、Response1; M ProvideResponse2; M ProvideProtocol2; M ProvideProtocol10; M ProvideProtocol11; M Test purpose Check that: Consent Enabled HFS Observation receiver shall be able to receive, HL7 CDA R2 Consent Directives consent document(s) AND The Document Repository shall send a Provide and Register D
16、ocument Set-b Response when the processing of a Provide and Register Document Set-b Request is complete AND The Provide and Register Document Set-b Response message shall carry the status of the requested operation and an error message if the requested operation failed. AND The Provide and Register
17、Document Set-b transaction shall use SOAP12 and MTOM with XOP encoding. AND The Document Repository shall accept documents in a Provide and Register Document Set-b transaction in MTOM/XOP format. AND The response message shall use MTOM/XOP format Applicability C_REC_000 AND C_REC_GEN_002 AND C_REC_G
18、EN_003 Other PICS Initial condition The receiver under test has published the document recipient service and is ready to receive a “Provide and Register Document Set-b Request“ sent by the simulated HFS sender. Test procedure 1 The simulated HFS sender sends a “Provide and Register Document Set-b Re
19、quest“ with a clinical document architecture (CDA) using MTOM/XOP. 2 The receiver under test responds with a “Provide and Register Document Set-b Response“ with status = “urn:oasis:names:tc:ebxml-regrep:ResponseStatusType:Success“ using SOAP12 b-SOAP 1.2. Pass/Fail criteria All steps are as specifie
20、d within the test procedure above. Notes Rec. ITU-T H.830.8 (04/2017) A.3 Subgroup 2.5.2: HFS Service Validation (SER) TP Id TP/HFS/REC/CM/SER/BV-000 TP label Service WSDL Coverage Spec IHE ITI TF-2, Volume 2b Testable items ProvideProtocol3; M ProvideProtocol4; M ProvideProtocol5; M ProvideProtocol
21、6; M ProvideProtocol7; M ProvideProtocol8; M Test purpose Check that: The following types shall be imported (xsd:import) in the /definitions/types section of the WSDL: - namespace=“urn:oasis:names:tc:ebxml-regrep:xsd:rs:3.0“, schema=“rs.xsd“ - namespace=“urn:ihe:iti:xds-b:2007“, schemaLocation=“IHEX
22、DS.xsd“ AND The /definitions/message/part/element attribute of the Provide and Register Document Set-b Request message of the WSDL shall be defined as “ihe:ProvideAndRegisterDocumentSetRequest“ AND The /definitions/message/part/element attribute of the Provide and Register Document Set-b Response me
23、ssage of the WSDL shall be defined as “ihe:RegistryResponse“ AND The /definitions/portType/operation/input/wsaw:Action attribute for the Provide and Register Document Set-b Request message of the WSDL shall be defined as “urn:ihe:iti:2007:ProvideAndRegisterDocumentSet-b“ AND The /definitions/portTyp
24、e/operation/output/wsaw:Action attribute for the Provide and Register Document Set-b Response message of the WSDL shall be defined as “urn:ihe:iti:2007:ProvideAndRegisterDocumentSet-bResponse“ AND The /definitions/portType/operation/soap12:operation/soapAction attribute of the WSDL shall be defined
25、as “urn:ihe:iti:2007:ProvideAndRegisterDocumentSet-b“ Applicability C_REC_000 AND C_REC_GEN_002 AND C_REC_GEN_003 Other PICS Initial condition The receiver under test has published its WSDL description for a Consent Management service Test procedure 1 Look up the WSDL description using the correspon
26、ding URL given by the receiver under test (I_REC_CM_001). Check that: a. There are two xsd:import elements in the definitions/types section for which the namespaces are: o namespace=“urn:oasis:names:tc:ebxml-regrep:xsd:rs:3.0“ o namespace=“urn:ihe:iti:xds-b:2007“ b. /definitions/message/part/element
27、 = “ihe:ProvideAndRegisterDocumentSetRequest“ for the “Provide and Register Document Set-b Request“ c. /definitions/message/part/element = “ihe:RegistryResponse“ for the “Provide and Register Document Set-b Response“ Rec. ITU-T H.830.8 (04/2017) 11 d. /definitions/portType/operation/input/wsaw:Actio
28、n = “urn:ihe:iti:2007:ProvideAndRegisterDocumentSet-b“ for the “Provide and Register Document Set-b Request“ e. /definitions/portType/operation/input/wsaw:Action = “urn:ihe:iti:2007:ProvideAndRegisterDocumentSet-bResponse“ for the “Provide and Register Document Set-b Response“ f. /definitions/portTy
29、pe/operation/soap12:operation/soapAction = “urn:ihe:iti:2007:ProvideAndRegisterDocumentSet-b“ Pass/Fail criteria All steps are as specified within the test procedure above. Notes TP Id TP/HFS/REC/CM/SER/BV-001 TP label Service Metadata Validation Coverage Spec IHE ITI TF-2, Volume 2b Testable items
30、ProvideRecipient3; M ProvideRecipient5; O ProvideRecipient7; C Test purpose Check that: A Document Repository shall validate the following metadata elements received as part of a Provide and Register transaction: - XDSDocumentEntry.uniqueId - XDSSubmissionSet.sourceId AND If a XDSSubmissionSet.sourc
31、eId element is received, a Document Repository may choose to accept submissions only from certain sources and use this field to perform the filtering. AND If the attributes “hash“ and “size“ are received in a Provide and Register Document Set-b ITI-41 transaction, they shall be ignored. Applicabilit
32、y C_REC_000 AND C_REC_GEN_002 AND C_REC_GEN_003 Other PICS Initial condition The receiver under test has published the document recipient service and is ready to receive a “Provide and Register Document Set-b Request“ sent by the simulated sender. Test procedure 1 The Simulated HFS sender sends a “P
33、rovide and Register Document Set-b Request“ message including XDSSubmissionSet.sourceId, XDSDocumentEntry.uniqueId, XDSDocumentEntry.hash and XDSDocumentEntry.size elements with correct values. 2 The HFS receiver under test responds with a “Provide and Register Document Set-b Response“ with status S
34、uccess 3 The simulated HFS sender sends a “Provide and Register Document Set-b Request“ message including an XDSDocumentEntry.hash element with a wrong value 4 The receiver under test responds with a “Provide and Register Document Set-b Response“ with status Success 5 The simulated HFS sender sends
35、a “Provide and Register Document Set-b Request“ message including an XDSDocumentEntry.size element with a wrong value 6 The receiver under test responds with a “Provide and Register Document Set-b Response“ with status Success 7 The simulated HFS sender sends a “Provide and Register Document Set-b R
36、equest“ message including a different XDSSubmissionSet.sourceId element Rec. ITU-T H.830.8 (04/2017) 8 The receiver under test may accept or may not accept the message. Pass/Fail criteria All steps are as specified within the test procedure above. Notes TP Id TP/HFS/REC/CM/SER/BV-002 TP label Multip
37、le Documents and Errors Coverage Spec IHE ITI TF-2, Volume 2b Testable items ProvideReqActions3; M ProvideRecipient1; M Test purpose Check that: A detected failure it shall result in an error message being returned to the Document Source thus terminating this transaction. AND A Document Repository s
38、hall be capable of accepting submissions containing multiple documents. Applicability C_REC_000 AND C_REC_GEN_002 AND C_REC_GEN_003 Other PICS Initial condition The receiver under test has published the document recipient service and is ready to receive a “Provide and Register Document Set-b Request
39、“ sent by the simulated sender. Test procedure 1 The simulated HFS sender sends a “Provide and Register Document Set-b Request“ with two documents using MTOM/XOP 2 The receiver under test responds with a “Provide and Register Document Set-b Response“ with status = “urn:oasis:names:tc:ebxml-regrep:Re
40、sponseStatusType:Success“ 3 The simulated HFS sender sends a “Provide and Register Document Set-b Request“ without attaching a document using MTOM/XOP 4 The receiver under test responds with a “Provide and Register Document Set-b Response“ with status = “urn:oasis:names:tc:ebxml-regrep:ResponseStatu
41、sType:Failure“. Pass/Fail criteria All steps are as specified within the test procedure above. Notes Rec. ITU-T H.830.8 (04/2017) 13 Bibliography b-ITU-T H.810 (2013) Recommendation ITU-T H.810 (2013), Interoperability design guidelines for personal health systems. b-ITU-T H.810 (2015) Recommendatio
42、n ITU-T H.810 (2015), Interoperability design guidelines for personal health systems. b-CDG 1.0 Continua Health Alliance, Continua Design Guidelines v1.0 (2008), Continua Design Guidelines. b-CDG 2010 Continua Health Alliance, Continua Design Guidelines v1.5 (2010), Continua Design Guidelines. b-CDG
43、 2011 Continua Health Alliance, Continua Design Guidelines (2011), “Adrenaline“ Continua Design Guidelines. b-CDG 2012 Continua Health Alliance, Continua Design Guidelines (2012), “Catalyst“, Continua Design Guidelines. b-CDG 2013 Continua Health Alliance, Continua Design Guidelines (2013), “Endorph
44、in“, Continua Design Guidelines. b-CDG 2015 Continua Health Alliance, Continua Design Guidelines (2015), “Genome“, Continua Design Guidelines. b-CDG 2016 Personal Connected Health Alliance, Continua Design Guidelines (2016), “Iris“, Continua Design Guidelines. b-ETSI SR 001 262 ETSI SR 001 262 v1.8.
45、1 (2003): ETSI drafting rules. https:/docbox.etsi.org/MTS/MTS/10-PromotionalMaterial/MBS-20111118/Referenced%20Documents/Drafting%20Rules.pdf b-HL7 CDA IG Health Level Seven (2011), Health Level Seven, HL7 Implementation Guide for Clinical Document Architecture, Release 2: Consent Directives, Releas
46、e 1, HL7 Draft Standard for Trial Use. http:/www.hl7.org/documentcenter/public/standards/dstu/CDAR2_IG%20_CONSENTDIR_DSTU_2011JAN.pdf b-HFSR PICS construction, installation and protection of cables and other elements of outside plant Series M Telecommunication management, including TMN and network m
47、aintenance Series N Maintenance: international sound programme and television transmission circuits Series O Specifications of measuring equipment Series P Telephone transmission quality, telephone installations, local line networks Series Q Switching and signalling, and associated measurements and
48、tests Series R Telegraph transmission Series S Telegraph services terminal equipment Series T Terminals for telematic services Series U Telegraph switching Series V Data communication over the telephone network Series X Data networks, open system communications and security Series Y Global information infrastructure, Internet protocol aspects, next-generation networks, Internet of Things and smart cities Series Z Languages and general software aspects for telecommunication systems
