ITU-T H 830 7-2016 Conformance of ITU-T H 810 personal health devices WAN interface Part 7 Consent management Sender (Study Group 16)《ITU-T H 810的个人健康设备的一致性:广域网接口第7部分:同意管理:发送者(研究组1.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.830.7 TELECOMMUNICATION STANDARDIZATION SECTOR OF ITU (07/2016) 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 devices: WAN interface Part 7: Consent management: Sender Recommendation ITU-T H.830.7 ITU-T H-SERIES RECOMMENDATIONS AUDIOVISUAL AND MULTIMEDIA SYSTEMS CHARACTERISTICS OF VISUAL TELEPHONE SYSTEMS H.100H.199 INFRASTRUCTURE OF AUDIO

3、VISUAL SERVICES 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

4、 services architecture 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 Collabo

5、ration, definitions, 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 a

6、pplications and 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

7、 H.620H.629 Ubiquitous 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 mult

8、imedia application 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.

9、859 Multimedia e-health data exchange services H.860H.869 For further details, please refer to the list of ITU-T Recommendations. Rec. ITU-T H.830.7 (07/2016) i Recommendation ITU-T H.830.7 Conformance of ITU-T H.810 personal health devices: WAN interface Part 7: Consent management: Sender Summary R

10、ecommendation ITU-T H.830.7 is a transposition of Continua Health Alliance Test Tool DG2013, Test Suite Structure Part 7: Consent Management. Sender (Version 1.1, 2014-01-24), that was developed by the Continua Health Alliance. A number of versions of this specification existed before transposition.

11、 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. This Recommendation was initially approved as ITU-T H.837 (01/2015)

12、and later renumbered, without further modifications, as ITU-T H.830.7 (01/2015) for consistency with the numbering of new WAN interface conformance testing specifications. History Edition Recommendation Approval Study Group Unique ID* 1.0 ITU-T H.837 2015-01-13 16 11.1002/1000/12255 1.0 ITU-T H.830.

13、7 2015-01-13 16 11.1002/1000/12593 2.0 ITU-T H.830.7 2016-07-14 16 11.1002/1000/12926 Keywords Conformance testing, continua design guidelines, e-health, H.810, WAN interface, personal connected health devices, wide area network. _ * To access the Recommendation, type the URL http:/handle.itu.int/ i

14、n the address field of your web browser, followed by the Recommendations unique ID. For example, http:/handle.itu.int/11.1002/1000/11830-en. ii Rec. ITU-T H.830.7 (07/2016) FOREWORD The International Telecommunication Union (ITU) is the United Nations specialized agency in the field of telecommunica

15、tions, information and communication technologies (ICTs). The ITU Telecommunication Standardization Sector (ITU-T) is a permanent organ of ITU. ITU-T is responsible for studying technical, operating and tariff questions and issuing Recommendations on them with a view to standardizing telecommunicati

16、ons on a worldwide basis. The World Telecommunication Standardization Assembly (WTSA), which meets every four years, establishes the topics for study by the ITU-T study groups which, in turn, produce Recommendations on these topics. The approval of ITU-T Recommendations is covered by the procedure l

17、aid down in WTSA Resolution 1. In some areas of information technology which fall within ITU-Ts purview, the necessary standards are prepared on a collaborative basis with ISO and IEC. NOTE In this Recommendation, the expression “Administration“ is used for conciseness to indicate both a telecommuni

18、cation administration and a recognized operating agency. Compliance with this Recommendation is voluntary. However, the Recommendation may contain certain mandatory provisions (to ensure, e.g., interoperability or applicability) and compliance with the Recommendation is achieved when all of these ma

19、ndatory provisions are met. The words “shall“ or some other obligatory language such as “must“ and the negative equivalents are used to express requirements. The use of such words does not suggest that compliance with the Recommendation is required of any party. INTELLECTUAL PROPERTY RIGHTSITU draws

20、 attention to the possibility that the practice or implementation of this Recommendation may involve the use of a claimed Intellectual Property Right. ITU takes no position concerning the evidence, validity or applicability of claimed Intellectual Property Rights, whether asserted by ITU members or

21、others outside of the Recommendation development process. As of the date of approval of this Recommendation, ITU had not received notice of intellectual property, protected by patents, which may be required to implement this Recommendation. However, implementers are cautioned that this may not repre

22、sent the latest information and are therefore strongly urged to consult the TSB patent database at http:/www.itu.int/ITU-T/ipr/. ITU 2016 All rights reserved. No part of this publication may be reproduced, by any means whatsoever, without the prior written permission of ITU. Rec. ITU-T H.830.7 (07/2

23、016) iii Table of Contents Page 1 Scope . 1 2 References . 1 3 Definitions 2 3.1 Terms defined elsewhere 2 3.2 Terms defined in this Recommendation . 2 4 Abbreviations and acronyms 2 5 Conventions 3 6 Test suite structure (TSS) . 4 7 Electronic attachment . 6 Annex A Test purposes . 7 A.1 TP definit

24、ion conventions . 7 A.2 Subgroup 1.5.1: WAN XDR transaction (TRANS) . 8 A.3 Subgroup 1.5.2: WAN metadata validation (META) 9 A.4 Subgroup 1.5.3: WAN consent directive validation (CDV) . 16 Bibliography. 23 Electronic attachment: This Recommendation includes an electronic attachment with the protocol

25、 implementation conformance statements (PICS) and the protocol implementation extra information for testing (PIXIT) required for the implementation of Annex A. iv Rec. ITU-T H.830.7 (07/2016) Introduction This Recommendation is a transposition of Continua Health Alliance Test Tool DG2013, Test Suite

26、 Structure Part 7: Consent Management. Sender (Version 1.1, 2014-01-24), that was developed by the Continua Health Alliance. A number of versions of this specification existed before transposition and these can be found in the table below. Version Date Revision history 1.0 2012-10-05 Initial release

27、 for Test Tool DG2011 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 Recommendations and other references listed below. A list of the currently valid I

28、TU-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 (2015) Recommendation ITU-T H.810 (2015), Interoperability design guidelines for personal health systems. ITU-T

29、 H.810 (2016) Recommendation ITU-T H.810 (2016), Interoperability design guidelines for personal health systems. 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. _ 1 This Rec

30、ommendation 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. 2 Rec. ITU-T H.830.7 (07/2016) IEEE 11073-20601A IEEE 11073-20601A:2010, IEEE

31、 Health informatics Personal health device communication Part 20601: Application profile Optimized Exchange Protocol Amendment 1. 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 el

32、sewhere This Recommendation uses the following 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 systems. Some examples of managers in

33、clude 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: ATNA Audit Trail and Node Authentication ATS Abstract Test Suite CDA Clinical Do

34、cument Architecture CDG Continua Design Guidelines DUT Device Under Test ebXML electronic business using extensible Markup Language EHR Electronic Health Record INR International Normalized Ratio IUT Implementation Under Test MDS Medical Device System MTOM Message Transmission Optimization Mechanism

35、 NFC Near Field Communication PCD Patient Care Device PCO Point of Control and Observation PCT Protocol Conformance Testing PHD Personal Healthcare Device PHDC Personal Healthcare Device Class PHM Personal Healthcare Monitoring (report) Rec. ITU-T H.830.7 (07/2016) 3 PICS Protocol Implementation Con

36、formance Statement PIXIT Protocol Implementation extra Information for Testing S/MIME Secure/Multipurpose Internet Mail Extensions SDP Service Discovery Protocol SABTE Sleep Apnoea Breathing Therapy Equipment SOAP Simple Object Access Protocol TCRL Test Case Reference List TCWG Test and Certificatio

37、n Working Group TP Test Purpose TSS Test Suite Structure URI Uniform Resource Identifier USB Universal Serial Bus WAN Wide Area Network WDM Windows Driver Model WS Web Service WSDL Web Service Description Language XDR cross-enterprise Document Reliable interchange XDS.b cross-enterprise Document Sha

38、ring-b XML extensible Markup Language 5 Conventions The key words “SHALL“, “SHALL NOT“, “SHOULD“, “SHOULD NOT“, “MAY“, “MAY NOT“ in this Recommendation are to be interpreted as in b-ETSI SR 001 262. SHALL is equivalent to must or it is required to. SHALL NOT is equivalent to must not or it is not al

39、lowed. 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 required that. NOTE The above-mentioned key words are capitalized for illustrative purposes only and they do not appear cap

40、italized 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 designation. The list of terms that may be used in this Recommendation is provided in Table 1. 4 Rec. ITU-T H.830.7 (07/2016

41、) Table 1 List of designations associated with the various versions of the CDG CDG release Transposed as Version Description Designation 2016 plus errata ITU-T H.810 (2016) 6.1 Release 2016 plus errata noting all ratified bugs ITU-T H.810 (2016). 2016 6.0 Release 2016 of the CDG including maintenanc

42、e updates of the CDG 2015 and additional guidelines that cover new functionalities. Iris 2015 plus errata ITU-T H.810 (2015) 5.1 Release 2015 plus errata noting all ratified bugs ITU-T H.810 (2015). 2015 5.0 Release 2015 of the CDG including maintenance updates of the CDG 2013 and additional guideli

43、nes that cover new functionalities. Genome 2013 plus errata ITU-T H.810 (2013) 4.1 Release 2013 plus errata noting all ratified bugs b-ITU-T H.810 (2013). 2013 4.0 Release 2013 of the CDG including maintenance updates of the CDG 2012 and additional guidelines that cover new functionalities. Endorphi

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

45、 2.0 Release 2011 of the CDG including maintenance updates of the CDG 2010 and additional guidelines 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 the CDG Version 1 an

46、d additional guidelines that cover new functionalities b-CDG 2010. 1.5 1.0 1.0 First released version of the CDG b-CDG 1.0. 6 Test suite structure (TSS) The test purposes (TPs) for the WAN interface have been divided into the main subgroups specified below. Annex A describes the TPs for subgroups 1.

47、5.1 to 1.5.3 (shown in bold). Group 1: Sender (SEN) Group 1.1: Web services interoperability (WSI) Rec. ITU-T H.830.7 (07/2016) 5 Subgroup 1.1.1: Basic profile (BP) Subgroup 1.1.2: Basic security profile (BSP) Subgroup 1.1.3: Reliable messaging (RM) Group 1.2: SOAP (SOAP) Subgroup 1.2.1: SOAP header

48、s (HEAD) Group 1.3: Audit (ATNA) Subgroup 1.3.1: General (GEN) Subgroup 1.3.2: PCD-01 (PCD-01) Subgroup 1.3.3: Consent management (CM) Group 1.4: PCD-01 HL7 messages (PCD-01-DATA) Subgroup 1.4.1: General (GEN) Subgroup 1.4.2: Design guidelines (DG) Subgroup 1.4.3: Pulse oximeter (PO) Subgroup 1.4.4:

49、 Blood pressure monitor (BPM) Subgroup 1.4.5: Thermometer (TH) Subgroup 1.4.6: Weighing scales (WEG) Subgroup 1.4.7: Glucose meter (GL) Subgroup 1.4.8: Cardiovascular fitness and activity monitor (CV) Subgroup 1.4.9: Strength fitness equipment (ST) Subgroup 1.4.10: Independent living activity hub (HUB) Subgroup 1.4.11: Adherence monitor (AM) Subgroup 1.

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