ITU-T H 821-2014 Conformance of ITU-T H 810 personal health devices Health record network (HRN) interface (Study Group 16)《ITU-T H 810的个人健康设备的一致性：健康档案网络接口(研究组16)》.pdf

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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 (10/2014) 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 devices: Health record network (HRN) 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 SERVICES

3、 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 archi

4、tecture 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, definit

5、ions, 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 and

6、 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 Ubi

7、quitous 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 applicat

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

9、60H.869 For further details, please refer to the list of ITU-T Recommendations. Rec. ITU-T H.821 (10/2014) i Recommendation ITU-T H.821 Conformance of ITU-T H.810 personal health devices: Health record network (HRN) interface Summary Recommendation ITU-T H.821 is a transposition of Continua Health A

10、lliance Test Tool DG 2013, Test Suite Structure 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 publishe

11、d. 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 Recommendation ITU-T H.810 (2013), Interoperability design guidelines for personal health systems. HL7 CDA IG Health Level Seven (2011), HL7 Implementati

12、on Guide for Clinical Document Architecture, Release 2: Consent Directives, Release 1, HL7 Draft Standard for Trial Use. HL7 CDA-PHMR Health Level Seven (2010), HL7 Implementation Guide for CDA Release 2: Personal Healthcare Monitoring Report, DSTU Release 1.1. IEEE 11073-20601A IEEE 11073-20601A-20

13、10, IEEE Health informatics Personal health device communication Part 20601: Application profile Optimized Exchange Protocol Amendment 1. IETF RFC 3195 IETF RFC 3195 (2001), Reliable Delivery for syslog. _ 1 This Recommendation includes an electronic attachment with the protocol implementation extra

14、 information for testing (PIXIT) required for the implementation of Annex A. 2 Rec. ITU-T H.821 (10/2014) IETF RFC 3881 IETF RFC 3881 (2004), Security Audit and Access Accountability Message XML Data Definitions for Healthcare Applications. IHE ITF PIX PDQ IHE ITF PIX PDQ (2010), IHE IT Infrastructu

15、re, Technical Framework Supplement Patient Identifier Cross-Reference HL7 V3 (PIXV3) and Patient Demographic Query HL7 V3 (PDQV3) 0 Trial Implementation. IHE ITI-TF-1 IHE ITI TF 1 (2009), IHE IT Infrastructure Technical Framework, Volume 1 (ITI TF-1): Integration Profiles, Revision 6.0. IHE ITI-TF-2

16、 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). ISO/IEC 9646-1 ISO/IEC 9646-1 (1994), Information Technology Open Systems Interconnection Confor

17、mance testing methodology and framework Part 1: General concepts. 3 Definitions 3.1 Terms defined elsewhere 3.1.1 agent IEEE 11073-20601A: A node that collects and transmits personal health data to an associated manager. 3.1.2 manager IEEE 11073-20601A: A node receiving data from one or more agent s

18、ystems. Some examples of managers include a cellular phone, health appliance, set top box, or a computer system. 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 No

19、de Authentication ATS Abstract Test Suite CDA Clinical Document Architecture CDG Continua Design Guidelines DUT Device Under Test ebXML electronic business using extensible Markup Language EHR Electronic Health Record Rec. ITU-T H.821 (10/2014) 3 GUI Graphical User Interface HRN Health Record Networ

20、k HTTP Hypertext Transfer Protocol HTTPS Hypertext Transfer Protocol Secure INR International Normalized Ratio IUT Implementation Under Test MDS Medical Device System MTOM Message Transmission Optimization Mechanism NFC Near Field Communication NTP Network Time Protocol PAN Personal Area Network PCO

21、 Point of Control and Observation PCT Protocol Conformance Testing PHD Personal Healthcare Device PHDC Personal Healthcare Device Class PHM Personal Healthcare Monitoring (report) PHR Personal Healthcare Record PICS Protocol Implementation Conformance Statement PIXIT Protocol Implementation extra In

22、formation for Testing PO Point of Observation S/MIME Secure/Multipurpose Internet Mail Extensions SMTP Simple Mail Transfer Protocol SOAP Simple Object Access Protocol SUT System Under Test SSL Secure Socket Layer TCWG Test and Certification Working Group TE Test Equipment TI Testable Item TLS Trans

23、port Level Security TP Test Purpose TSS Test Suite Structure USB Universal Serial Bus XDM cross-enterprise Document Media interchange XDR cross-enterprise Document Reliable interchange XDS cross-enterprise Document Sharing 4 Rec. ITU-T H.821 (10/2014) XDS.b cross-enterprise Document Sharing-b XML ex

24、tensible Markup Language XOP XML-binary Optimized Packaging XPath XML Path language XSD XML Schema WAN Wide Area Network WDM Windows Driver Model WS Web Service 5 Conventions The key words “SHALL“, “SHALL NOT“, “SHOULD“, “SHOULD NOT“, “MAY“, “MAY NOT“ in this document are to be interpreted as in b-E

25、TSI SR 001 262. SHALL is equivalent to must or it is required to. SHALL NOT is equivalent to must not or it is not allowed. SHOULD is equivalent to it is recommended to. SHOULD NOT is equivalent to it is not recommended to. MAY is equivalent to is permitted. MAY NOT is equivalent to it is not requir

26、ed that. NOTE The above-mentioned key words are capitalized for illustrative purposes only and they do not appear capitalized within this Recommendation. Reference is made in the ITU-T H.800-series of Recommendations to different versions of the Continua design guidelines (CDG) by a specific designa

27、tion. The list of terms that may be used in this Recommendation is provided in Table 1. Furthermore, the 2013 edition of the Continua design guidelines, which is published as ITU-T H.810, is designated by “CDG 2013“ as an extension of the designations indicated in the bibliography. Table 1 List of d

28、esignations associated with the various versions of the CDG CDG name Transposed as Version Description Designation 2013 plus errata ITU-T H.810 4.1 CDG 2013 plus errata noting all ratified bugs. - 2013 - 4.0 Release 2013 of the CDG including maintenance updates of CDG 2012 and additional guidelines

29、that cover new functionalities. Endorphin 2012 plus errata - 3.1 CDG 2012 plus errata noting all ratified bugs b-CDG 2012. - 2012 - 3.0 Release 2012 of the CDG including maintenance updates of CDG 2011 and additional guidelines that cover new functionalities. Catalyst 2011 plus errata - 2.1 CDG 2011

30、 integrated with identified errata. - Rec. ITU-T H.821 (10/2014) 5 Table 1 List of designations associated with the various versions of the CDG CDG name Transposed as Version Description Designation 2011 - 2.0 Release 2011 of the CDG including maintenance updates of CDG 2010 and additional guideline

31、s that cover new functionalities b-CDG 2011. Adrenaline 2010 plus errata - 1.6 CDG 2010 integrated with identified errata. - 2010 - 1.5 Release 2010 of the CDG with maintenance updates of CDG Version 1 and additional guidelines that cover new functionalities b-CDG 2010. 1.5 1.0 - 1.0 First released

32、version of the CDG b-CDG 1.0. - 6 Test suite structure (TSS) The test purposes (TPs) of this Recommendation are found in Annex A and have been divided into two main groups: Group 1: HRN sender (SEN) Group 1.1: HRN direct sender (XDR) message acquisition and validation (DSMA) Group 1.2: HRN indirect

33、sender (XDM) message acquisition and validation (ISMA) Group 1.3: HRN message syntactic validation (XSV) Group 1.4: HRN message body (PHM report) CDG CDA conformance (CCDA) Group 1.5: HRN message body (PHM report) CDG CCD conformance (CCCD) Group 1.6: HRN message header (Metadata) semantic validatio

34、n (mapping with PHM report) (XMSV) Group 1.7: HRN adherence monitor validation (AM) Group 1.8: HRN ATNA validation (ATNA) Group 1.9: HRN document digital signature validation (DSG) Group 1.10: HRN patient identification validation (PIX) Group 1.11: HRN consent management (CM) Group 2: HRN receiver (

35、REC) NOTE TPs for Group 2 are for further study. 7 Electronic attachment The protocol implementation conformance statements (PICS) and the protocol implementation extra information for testing (PIXIT) required for the implementation of Annex A can be downloaded from http:/handle.itu.int/11.1002/2000

36、/12067. In the electronic attachment, letters “C“ and “I“ in the column labelled “Mandatory“ are used to distinguish between “PICS“ and “PIXIT“ respectively during testing. If the cell is empty, the corresponding PICS is “independent“. If the field contains a “C“, the corresponding PICS is dependent

37、 6 Rec. ITU-T H.821 (10/2014) on other PICS, and the logical expression is detailed in the “SCR_Expression“ field. The static conformance review (SCR) is used in the test tool to assert whether the PICS selection is consistent. Rec. ITU-T H.821 (10/2014) 7 Annex A Test purposes (TP) (This annex form

38、s an integral part of this Recommendation.) A.1 TP definition conventions The test purposes (TPs) are defined according to the following rules: TP Id: This is a unique identifier (TP/ ). It is specified according to the naming convention defined below: Each test purpose identifier is introduced by t

39、he prefix “TP“. : This is the test tool that will be used in the test case. HRN: Health record network : This is the device under test. SEN: HRN sender REC: HRN receiver (not used because it is out of scope of the developed test tool) : This identifies a group of test cases. : This identifies the ty

40、pe of testing. BV: valid behaviour test BI: invalid behaviour test : This is a sequential number that identifies the test purpose. TP label: This is the TPs title. Coverage: This contains the specification reference and clause to be checked by the TP. Spec: This indicates the earliest version of the

41、 specification from which the testable items to be checked by the TP were included. Testable item: This contains testable items to be checked by the TP. Test purpose: This is a description of the requirements to be tested. Applicability: This contains the PICS items that define if the test case is a

42、pplicable or not for a specific device. Initial condition: This indicates the state to which the DUT needs to be moved at the beginning of TC execution. Test procedure: This describes the steps to be followed in order to execute the test case. Pass/Fail criteria: This provides criteria to decide whe

43、ther the DUT passes or fails the test case. A.2 Test purposes structure The HRN protocol is based on the interchange of a single but complex XML message from the HRN sender (disease management service AHD/WAN device) to the HRN receiver (another WAN device or HRN device). The HRN test tool has to ve

44、rify the sender mode of the protocol only, which includes the HTTP and SOAP (HRN direct sender) or SMTP and S/MIME (HRN indirect sender) communication and the syntax and semantics of the XML message transmitted from the HRN sender. Test cases defined to implement these verifications are described be

45、low: 8 Rec. ITU-T H.821 (10/2014) HRN direct sender (XDR) message acquisition and validation (DSMA): This test case runs the HTTP/HTTPS server (configured with TLS and a key length of 128 bits) and the web service (WS) that is going to receive the XDR message from the HRN direct sender under test (X

46、DR Transport). Once the HRN sender has sent the message and if it conforms with the HTTP/HTTPS and SOAP 1.2 protocols b-SOAP 1.2, it will be received by the web server and stored in an internal structure that will be used by the subsequent XDR test cases. If there is an error with the communication,

47、 the test case timeout expires and it shows the HTTP/HTTPS server log which verifies that there has been a communication error or the received message is not conformant to minimal XML syntax requirements. This test case also runs the audit record repository server (configured with TLS) that is going

48、 to receive the audit record message from the HRN direct sender. Once the HRN sender has sent the audit record message and if it conforms with the RFC 3195 protocol it will be stored in a file that will be used in subsequent XDR test cases. In case of errors in the communication, the test case timeo

49、ut expires and it shows the audit repository log. Figure A.1 Message acquisition and HTTP and SOAP validation HRN indirect sender (XDM) message acquisition and validation (ISMA): This test case runs the SMTP mail server (configured with TLS and a key length of 128 bits) that is going to receive the XDM message from the HRN indirect sender (XDM transport) under test. Once the