ITU-T H 821-2017 Conformance of ITU-T H 810 personal health system Healthcare information system interface (Study Group 16).pdf

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.821 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 (HRN,

2、 PAN, LAN, TAN and WAN) Conformance of ITU-T H.810 personal health system: Healthcare information system interface Recommendation ITU-T H.821 ITU-T H-SERIES RECOMMENDATIONS AUDIOVISUAL AND MULTIMEDIA SYSTEMS CHARACTERISTICS OF VISUAL TELEPHONE SYSTEMS H.100H.199 INFRASTRUCTURE OF AUDIOVISUAL SERVICE

3、S General H.200H.219 Transmission multiplexing and synchronization H.220H.229 Systems aspects H.230H.239 Communication procedures H.240H.259 Coding of moving video H.260H.279 Related systems aspects H.280H.299 Systems and terminal equipment for audiovisual services H.300H.349 Directory services arch

4、itecture for audiovisual and multimedia services H.350H.359 Quality of service architecture for audiovisual and multimedia services H.360H.369 Telepresence H.420H.429 Supplementary services for multimedia H.450H.499 MOBILITY AND COLLABORATION PROCEDURES Overview of Mobility and Collaboration, defini

5、tions, protocols and procedures H.500H.509 Mobility for H-Series multimedia systems and services H.510H.519 Mobile multimedia collaboration applications and services H.520H.529 Security for mobile multimedia systems and services H.530H.539 Security for mobile multimedia collaboration applications an

6、d services H.540H.549 Mobility interworking procedures H.550H.559 Mobile multimedia collaboration inter-working procedures H.560H.569 BROADBAND, TRIPLE-PLAY AND ADVANCED MULTIMEDIA SERVICES Broadband multimedia services over VDSL H.610H.619 Advanced multimedia services and applications H.620H.629 Ub

7、iquitous sensor network applications and Internet of Things H.640H.649 IPTV MULTIMEDIA SERVICES AND APPLICATIONS FOR IPTV General aspects H.700H.719 IPTV terminal devices H.720H.729 IPTV middleware H.730H.739 IPTV application event handling H.740H.749 IPTV metadata H.750H.759 IPTV multimedia applica

8、tion frameworks H.760H.769 IPTV service discovery up to consumption H.770H.779 Digital Signage H.780H.789 E-HEALTH MULTIMEDIA SERVICES AND APPLICATIONS Personal health systems H.810H.819 Interoperability compliance testing of personal health systems (HRN, PAN, LAN, TAN and WAN) H.820H.859 Multimedia

9、 e-health data exchange services H.860H.869 For further details, please refer to the list of ITU-T Recommendations. Rec. ITU-T H.821 (04/2017) i Recommendation ITU-T H.821 Conformance of ITU-T H.810 personal health system: Healthcare information system interface Summary Recommendation ITU-T H.821 pr

10、ovides a test suite structure (TSS) and the test purposes (TP) for the healthcare information system (HIS) interface, based on the requirements defined in the Recommendations of the ITU-T H.810 sub-series, of which Recommendation ITU-T H.810 (2016) is the base Recommendation. The objective of this t

11、est specification is to provide a high probability of interoperability at this interface. Recommendation ITU-T H.821 is a transposition of Continua Test Tool DG2016, Test Suite Structure it may contain versions that existed before transposition. Version Date Revision history 1.1 2012-10-05 Initial r

12、elease for Test Tool DG2011. It uses “TSS users of this Recommendation are therefore encouraged to investigate the possibility of applying the most recent edition of the Recommendations and other references listed below. A list of the currently valid ITU-T Recommendations is regularly published. The

13、 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), Interoperability design guidelines for personal health systems. ITU-T H.813 Recommendation ITU-T H.813 (2016), Intero

14、perability design guidelines for personal health systems: Healthcare information system (HIS) interface. 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/do

15、cumentcenter/public/standards/dstu/CDAR2_IG%20_CONSENTDIR_DSTU_2011JAN.pdf HL7 CDA-PHMR Health Level Seven (2010), HL7 Implementation Guide for CDA Release 2: Personal Healthcare Monitoring Report, DSTU Release 1.1. http:/www.hl7.org/documentcenter/public/standards/dstu/CDAR2_IG_PHMRPTS_R1.1_DSTU_20

16、10OCT.zip IETF RFC 3195 IETF RFC 3195 (2001), Reliable Delivery for syslog. https:/datatracker.ietf.org/doc/rfc3195 _ 1 This Recommendation includes an electronic attachment with the protocol implementation conformance statements (PICS) and the protocol implementation extra information for testing (

17、PIXIT) required for the implementation of Annex A. 2 Rec. ITU-T H.821 (04/2017) IETF RFC 3881 IETF RFC 3881 (2004), Security Audit and Access Accountability Message XML Data Definitions for Healthcare Applications. https:/datatracker.ietf.org/doc/rfc3881 IHE ITF PIX PDQ IHE ITF PIX PDQ (2010), IHE I

18、T Infrastructure, Technical Framework Supplement Patient Identifier Cross-Reference HL7 V3 (PIXV3) and Patient Demographic Query HL7 V3 (PDQV3) Trial Implementation. http:/ IHE ITI-TF-1 IHE ITI TF 1 (2009), IHE IT Infrastructure Technical Framework, Volume 1 (ITI TF-1): Integration Profiles, Revisio

19、n 6.0. http:/ IHE ITI-TF-2 IHE ITI TF 2 (2009), IHE IT Infrastructure Technical Framework, Volume 2 (ITI TF-2), Revision 6.0. It comprises three sub-volumes: 2a (Transactions Part A), 2b (Transactions Part B) and 2x (Appendices). http:/ http:/ http:/ IHE TFS XUA+ IHE TFS XUA+ (2010), IHE IT Infrastr

20、ucture (ITI), Technical Framework Supplement: Cross-Enterprise User Assertion - Attribute Extension (XUA+). Trial Implementation. http:/ ITU-T X.290 Recommendation ITU-T X.290 (1995), OSI conformance testing methodology and framework for protocol Recommendations for ITU-T applications General concep

21、ts. 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: AM Adherence Monitor ATNA Audit Trail and Node Authentication ATS Abstract Test Suite CDA Clinical Docume

22、nt Architecture CDG Continua Design Guidelines CGM Continuous Glucose Monitor DSG Digital Signature Validation Rec. ITU-T H.821 (04/2017) 3 DUT Device Under Test ebXML electronic business using extensible Markup Language EHR Electronic Health Record GUI Graphical User Interface HIS Healthcare Inform

23、ation System HFS Health M RDC_XDR-3; M RDC_XDR-5; M RDC_XDR-7; M MGDC_XDR-3; M MGDC_XDR-5; M GenSDC_XDR-1; M GenSDC_XDR-2; M GenSDC_XDR-4; R Spec IHE ITI-TF-1 Testable items XDSMD-1; M XDSMD-4; O XDSMD-17; M XDSMD-18; M XDSMD-20; M XDSMD-23; M XDSMD-24; M XDSMD-25; M XDSMD-26; M XDSMD-27; M XDSMD-30

24、; M XDSMD-32; M XDSMD-33; M XDSMD-34; M XDSMD-35; M XDSMD-36; M XDSMD-37; M XDSMD-40; C XDSMD-41; M XDSMD-42; R XDSMD-44; M AuditTT-1 Audit_RT-2 ChainTrust-3 Audit_RT-3 OtherCert-2 Rel_Syslog-1 HTTP_Conn-1 Rel_Syslog-2 HTTP_Conn-2 Test purpose Check that: HIS message is received from the SUT and it

25、is conformant to the HTTPS and SOAP protocols AND Is conformant to minimal XML requirements AND Audit Record message is conformant to minimal transport requirements Applicability C_HRN_SEN_000 AND C_HRN_SEN_001 Other PICS Rec. ITU-T H.821 (04/2017) 15 Initial condition The SUT is ready to send the m

26、essage to the test equipment (TE) Test procedure 1. The simulated HIS receiver (test tool) initiates the server applications and the web service (as an XDR receiver) which will receive the HIS message from the HIS direct sender under test during a specific time. 2. The simulated HIS receiver (test t

27、ool) initiates the audit repository that will receive the ATNA message. 3. The simulated HIS receiver (test tool) sends a public certificate to the HIS direct sender under test and it has to accept it. 4. The audit repository of the simulated HIS receiver (test tool) sends a public certificate to th

28、e secure application with the following characteristics: a. X509 certificate b. based on RSA key c. key length in the range of 1024-4096. 5. The HIS direct sender under test sends an XDR message to the simulated HIS receiver (test tool) which receives the message and verifies that it conforms to HTT

29、P/HTTPS and SOAP 1.2 protocols; if TLS is used, the encryption suite should be TLS_RSA_WITH_AES_128_CBC_SHA. 6. The MIME header for this metadata part shall be set to text/xml 7. Attributes that shall be present in the SOAP envelope: a. eb:id b. xlink:href c. xlink:role=http:/ d. eb:Schema:eb:locati

30、on=http:/ eb:version=1.0. 8. The registry metadata in an XML file containing the SubmitObjectsRequest shall be inside the payload of the SOAP message. 9. Check that if the message contains a “multipart document“: a. The multipart packaging transmits the MIME-type of each part. b. Each part containin

31、g a document has associated with it a document ID that is unique within the scope of this message. c. Each part shall contain a Content-Location header set to the name of “start“ part file preceded by the name of the “sub-directory“ where to save the part. 10. The HIS direct sender under test sends

32、an audit record message to the audit repository. 11. The audit repository receives the audit record message and verifies that: a. TLS is used and the encryption suite is TLS_RSA_WITH_AES_128_CBC_SHA. b. It conforms to a reliable syslogs COOKED profile (IETF RFC 3195). Pass/Fail criteria The received

33、 HIS message conforms to the HTTP/HTTPS and SOAP 1.2 protocols and conforms to the minimal XML requirements (i.e. it contains a well-formed XML document with the PHM report attachment). Checked values are as detailed in steps 5 to 9. In step 4, the HIS sender under test must accept the public certif

34、icate. The received audit message conforms to Reliable Syslog (IETF RFC 3195) and complies with the values detailed in step 11. Notes The test tool stores the received XDR message and audit record message in internal files that will be used by the subsequent test cases. 16 Rec. ITU-T H.821 (04/2017)

35、 A.4 Group 1.2: HIS indirect sender (XDM) message acquisition and validation (ISMA) TP Id TP/HIS/SEN/ISMA/BV-000 TP label HIS indirect sender (XDM) Message Acquisition and Validation (ISMA) Coverage Spec ITU-T H.813 Testable items RIC_XDM-2; M RIC_XDM-3; R RIC_XDM-4; O MGIC_XDM-18; M RIC_XDM-5; M RI

36、C_XDM-6; M MGIC_XDM-1; M MGIC_XDM-2; M MGIC_XDM-3; M MGIC_XDM-4; M MGIC_XDM-5; M MGIC_XDM-6; M MGIC_XDM-7; M MGIC_XDM-8; M MGIC_XDM-9; M MGIC_XDM-10; M MGIC_XDM-11; M MGIC_XDM-12; M MGIC_XDM-13; M MGIC_XDM-14; M MGIC_XDM-16; R MGIC_XDM-17; R GenSIC_XDM-1; M GenSIC_XDM-2; M GenO_XDM-2; R Spec IHE ITI

37、-TF-1 Testable items ActTrans_XDM-1; M ZIPOverEma-1; C MediaCont-1; O MessS_XDM-2; M MessS_XDM-3; O MedF_XDM-3; M MedF_XDM-4; M ContOverw-1; M ContOverw-2; M ContOverw-3; M ContOverw-5; M ContOverw-6; M ContOverw-7; M ContOverw-8; M ContOverw-9; O ContOverw-10; M ContOverw-11; M ContOverw12; M ContO

38、verw-13; O ContOverw-14; M ContOverw-15; M ContOverw-16; M ContOverw-17; O ContOverw-18; M ContOverw-19; M ContOverw-20; M ContOverw-21 M ContOverw-22; R Rec. ITU-T H.821 (04/2017) 17 ContOverw-23; M ContOverw-24; O ContOverw-25; M ContOverw-26; M ContOverw-27; M ContOverw-28; M ContOverw-29; M Cont

39、Overw-30; M RespMsg_XDM-1; M RespMsg_XDM-2; R MediaID-2; C MediaID-4; M MediaID-5; M MediaID-6; R BasicPat-1; C BasicPat-2; C BasicPat-3; C BasicPat-4; C BasicPat-5; C BasicPat-6; C BasicPat-7; C BasicPat-8; C SecConsider-2; M SecConsider-3; M SecConsider-4; M AuditTT-1 Audit_RT-2 ChainTrust-3 Audit

40、_RT-3 OtherCert-2 Rel_Syslog-1 HTTP_Conn-1 Rel_Syslog-2 HTTP_Conn-2 Test purpose Check that: HIS message is received from the SUT and it is conformant to the XDM specifications AND Audit Record message is conformant to minimal transport requirements Applicability C_HRN_SEN_000 AND C_HRN_SEN_002 Othe

41、r PICS Initial condition The SUT is ready to send an email containing a ZIP file to the test tool. Test procedure 1. The simulated HIS receiver (test tool) initiates the SMTP client that will receive the XDM message from the HIS sender under test during a specific time. 2. The simulated HIS receiver

42、 (test tool) initiates the audit repository that will receive the ATNA message. 3. The audit repository of the simulated HIS receiver (test tool) will send a public certificate to the secure application with the following characteristics and it has to be accepted: a. X509 certificate b. based on RSA

43、 key c. key length in the range of 1024-4096. 4. The HIS indirect sender under test sends an XDM message to the simulated HIS indirect receiver (test tool). 5. The HIS indirect receiver (test tool) receives the message and verifies that it conforms to SMTP and S/MIME protocols. 6. Check within the e

44、mail subject: 18 Rec. ITU-T H.821 (04/2017) a. Email subject shall start with XDM/1.0/DDM. b. It is recommended to add the document ID (within the subject). 7. Check within the email attachments: a. The email message shall contain a ZIP file. 8. The ZIPs contents are extracted and the resulting stru

45、cture is checked: a. files “README.TXT“ and “INDEX.HTM“ and the folder “IHE_XDM“ are in the root directory level; b. the “IHE_XDM“ folder shall contain only one subfolder named “SUBSET01“; c. file “METADATA.XML“ exists; d. “METADATA.XML“ file has to contain a “URI“ element referencing the location o

46、f the PHM report file; e. The PHM file is located in the specified element of the METADATA.XML; f. executable files (.exe, .msi, .bat, .com) are not allowed. 9. The test tool stores the documents in an internal structure (i.e. file) that will be used by the subsequent test cases. 10. The HIS direct

47、sender under test sends an audit record message to the audit repository. 11. The audit repository receives the audit record message and verifies: a. TLS is used and the encryption suite is TLS_RSA_WITH_AES_128_CBC_SHA. b. It conforms to a reliable syslogs COOKED profile (IETF RFC 3195). Pass/Fail criteria Email must conform to steps 3 to 5. Attached zip file must be conformant to step 6. The received audit message conforms to Reliable Syslog (IETF RFC 3195) Checked values are as