ITU-T H 812 1-2015 Interoperability design guidelines for personal health systems WAN interface Observation upload certified device class (Study Group 16)《个人健康系统互操作性设计指南 广域网接口:观察上传.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.812.1 TELECOMMUNICATION STANDARDIZATION SECTOR OF ITU (11/2015) SERIES H: AUDIOVISUAL AND MULTIMEDIA SYSTEMS E-health multimedia services and applications Interoperability design guidelines for personal health systems: WA

2、N interface: Observation upload certified device class Recommendation ITU-T H.812.1 ITU-T H-SERIES RECOMMENDATIONS AUDIOVISUAL AND MULTIMEDIA SYSTEMS CHARACTERISTICS OF VISUAL TELEPHONE SYSTEMS H.100H.199 INFRASTRUCTURE OF AUDIOVISUAL SERVICES General H.200H.219 Transmission multiplexing and synchro

3、nization 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 architecture for audiovisual and multimedia services H.350H.35

4、9 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, definitions, protocols and procedures H.500H.509 Mobility for H-

5、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 services H.540H.549 Mobility interworking procedures H.5

6、50H.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 Ubiquitous sensor network applications and Internet of Thing

7、s 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 application frameworks H.760H.769 IPTV service discovery up to co

8、nsumption 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 e-health data exchange services H.860H.869 For further de

9、tails, please refer to the list of ITU-T Recommendations. Rec. ITU-T H.812.1 (11/2015) i Recommendation ITU-T H.812.1 Interoperability design guidelines for personal health systems: WAN interface: Observation upload certified device class Summary The Continua Design Guidelines (CDG) define a framewo

10、rk of underlying standards and criteria which are required to ensure the interoperability of devices and data used for personal connected health. It also contains additional design guidelines for interoperability that further clarify or reduce the options in underlying standards or specifications, o

11、r by adding a feature missing in an underlying standard or specification. This specification defines the design guidelines for the Observation upload certified device class (CDC), whose function is to transfer an observation measurement from the medical device to a WAN application over the wide area

12、 network (WAN). This Recommendation is part of the “ITU-T H.810 interoperability design guidelines for personal health systems“ subseries, which is outlined in the table below: Mapping of CDG 2013, ITU-T H.810 and restructured ITU-T H.810-series Part Elements Clauses in the 2013 CDG “Endorphin“ Clau

13、ses in ITU-T H.810 (2013) Restructured ITU-T H.810-series (2015) Part 0 System overview Up to clause 3, plus Annex A and Appendix G Up to clause 6, plus Annex A and Appendix V ITU-T H.810 System overview Part 1 TAN/PAN/LAN Clauses 4 to 7, Appendices C, D, M Clauses 7 to 10, Appendices I, II, XI ITU-

14、T H.811 TAN-PAN-LAN interface Part 2 WAN Clause 8, Appendices H, I, J, K Clause 11; Appendices VI, VII, VIII, IX ITU-T H.812 WAN interface ITU-T H.812.1 Observation upload ITU-T H.812.2 Questionnaires ITU-T H.812.3 Capability exchange ITU-T H.812.4 Authenticated persistent session Part 3 HRN Clause

15、9, Appendices E, F, L Clause 12, Appendices III, IV, X H.813 HRN interface History Edition Recommendation Approval Study Group Unique ID* 1.0 ITU-T H.812.1 2015-11-29 16 11.1002/1000/12654 * To access the Recommendation, type the URL http:/handle.itu.int/ in the address field of your web browser, fo

16、llowed by the Recommendations unique ID. For example, http:/handle.itu.int/11.1002/1000/11830-en. ii Rec. ITU-T H.812.1 (11/2015) FOREWORD The International Telecommunication Union (ITU) is the United Nations specialized agency in the field of telecommunications, information and communication techno

17、logies (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 telecommunications on a worldwide basis. The World Telecom

18、munication 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 laid down in WTSA Resolution 1. In some area

19、s 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 telecommunication administration and a recognized oper

20、ating 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 mandatory provisions are met. The words “shal

21、l“ 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 attention to the possibility that the prac

22、tice 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 others outside of the Recommendation develo

23、pment 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 represent the latest information and are therefo

24、re 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.812.1 (11/2015) iii Table of Contents Page 0 Introduct

25、ion xi 0.1 Organization xi 0.2 CDC guideline releases and versioning . xi 0.3 Whats new. xi 1 Scope 1 2 References 1 3 Definitions . 1 4 Abbreviations and acronyms . 1 5 Conventions . 1 6 Use case . 1 6.1 Observation upload to the server . 1 6.1.1 Chosen standards and profiles . 1 6.1.2 Data payload

26、 2 6.1.3 WAN protocol (informative) . 2 7 Behavioural models . 3 7.1 SOAP implementation . 3 7.1.1 Observation upload using SOAP 3 7.2 REST implementation . 5 7.2.1 Capabilities exchange 5 7.2.2 Observation upload using hData . 7 7.3 Security 8 7.3.1 Secure point-to-point communication . 9 7.3.2 Aud

27、iting . 10 7.3.3 Entity identity assertion . 10 7.3.4 Reliability 12 8 Implementation guidance (informative) 14 8.1 AHD conceptual model . 14 8.2 Overview of operation . 14 8.3 Certified device classes for observation upload 15 8.4 Sample service description SOAP . 17 8.5 Device observation consumer

28、 WSDL . 18 8.6 Device observation consumer XSD . 18 8.7 Messaging examples 19 iv Rec. ITU-T H.812.1 (11/2015) Page 8.8 Communicate PCD data 19 8.9 Communicate PCD data response . 20 8.10 CommunicatePCDData example with security . 20 8.10.1 STS request . 21 8.10.2 STS response . 22 8.10.3 Communicate

29、PCDData request. 24 8.10.4 CommunicatePCDData response 25 8.11 hData Observation upload example . 26 9 The PCD-01 document payload. 27 9.1 PCD-01 fundamentals . 27 9.1.1 MSH header. 27 9.1.2 PID patient info . 28 9.1.3 OBR observation request 28 9.1.4 OBX observation result . 28 9.2 Document structu

30、re . 29 9.3 AHD, MDS and metric OBXes . 29 9.4 Segment structure 31 9.5 PCD-01 format “on the wire“ 33 9.6 HL7 data types . 33 9.7 PID segment 34 10 OBX segment fundamentals 35 10.1 Encoding OBX segments 35 10.2 Object Hierarchy . 36 10.2.1 Hierarchy levels. 37 10.2.2 Hierarchy Examples 37 10.2.3 Ob

31、ject Hierarchy for Compounds . 38 10.3 Timestamping 38 10.4 The coincident timestamp pair 40 10.5 AHD-OBXes . 41 10.6 MDS-OBXes . 43 10.7 Metric OBXes 44 10.7.1 Mapping the 11073 observational attributes in OBX-5 and data type inOBX-2 44 10.8 Date-Time-Adjustment 45 11 Guidelines 45 11.1 MSH 45 11.2

32、 PID . 46 11.3 OBR . 46 Rec. ITU-T H.812.1 (11/2015) v Page 11.4 OBX . 46 Annex A Normative guidelines for common aspects (This annex forms an integral part of this Recommendation.) . 47 Annex B Normative guidelines for hData (This annex forms an integral part of this Recommendation.) . 48 Annex C N

33、ormative guidelines for SOAP (This annex forms an integral part of this Recommendation.) . 50 Annex D Normative guidelines data payload (This annex forms an integral part of this Recommendation.) . 52 D.0 Mapping from ISO/IEEE 11073-20601to the Continua WAN 54 D.0.1 Terminologies and conventions . 5

34、4 D.0.2 Protocol-dependent information 54 D.0.3 WAN-specific nomenclature . 55 D.0.4 ISO/IEEE 11073-20601 General object/Attribute mapping 55 D.1 OBX encoding guidelines . 58 D.1.1 Guidelines for encoding the AHD-OBX segments . 58 D.1.2 Guidelines for encoding the MDS-OBX segments . 63 D.1.3 Guideli

35、nes for encoding the Metric-OBX segments . 75 D.1.4 Special situations . 92 D.1.5 Timestamping and time synchronization . 96 D.1.6 Metric object attribute mappings overview . 107 D.1.7 Numeric (subclass of Metric) 107 D.1.8 RT-SA (subclass of Metric) . 108 D.1.9 Enumeration (subclass of Metric) . 10

36、8 Annex E Mapping from the IEEE 11073-104xx device specializations to the Continua WAN (This annex forms an integral part of this Recommendation.) 109 E.1 AHD 109 E.1.1 Modelling . 109 E.1.2 Containment tree 110 E.2 MDS object . 111 E.2.1 Modelling . 111 E.2.2 Containment tree 111 E.3 Metric OBXes .

37、 112 E.3.1 10404 Pulse Oximeter 113 E.3.2 10407 Blood pressure monitor . 118 E.3.3 10408 Thermometer . 120 E.3.4 10415 Weighing scales 123 E.3.5 10417 Glucose meter . 125 vi Rec. ITU-T H.812.1 (11/2015) Page E.3.6 10418 INR meter 133 E.3.7 10441 Cardiovascular fitness and activity monitor . 135 E.3.

38、8 10442 Strength fitness equipment 151 E.3.9 10471 Independent living activity hub 156 E.3.10 10472 Adherence monitor 167 E.3.11 10421 Peak expiratory flow monitor . 170 E.3.12 10420 Body composition analyser . 172 E.3.13 IEEE 10406 basic 1-3 lead ECG 175 E.3.14 10424 Sleep apnoea breathing therapy

39、equipment (SABTE) 180 E.4 HL7 Unsolicited observation result . 197 E.4.1 MSH . 197 E.4.2 PID . 200 E.4.3 OBR . 202 E.4.4 OBX . 204 E.4.5 PV1 206 E.4.6 NTE 207 E.4.7 TQ1 207 E.4.8 MSA . 207 E.4.9 ERR 208 E.4.10 HL7 v2.6 error tables . 210 E.5 HL7 Data types Observations 210 E.5.1 CWE . 211 E.5.2 DTM

40、. 212 E.5.3 NM . 213 E.5.4 ST 213 E.5.5 NA - numeric array 213 E.5.6 XAD . 214 E.5.7 XPN 215 E.6 Other HL7 data types 216 E.6.1 CX 216 E.6.2 ID coded value for HL7 defined tables 217 E.6.3 IS coded value for user-defined tables . 217 E.6.4 SI sequence ID . 218 E.6.5 SN structured numeric . 218 E.6.6

41、 XTN . 219 E.7 HL7 control characters 221 Rec. ITU-T H.812.1 (11/2015) vii List of Tables Page Table 8-1 Certified device classes 15 Table 8-2 Guidelines for certified device classes . 16 Table 9-1 Simplified PCD-01 table 29 Table 10-1 MDS-OBX attributes 43 Table A-1 Guidelines for all CDC classes 4

42、7 Table A-2 Observation upload guidelines for an AHD application 47 Table A-3 Observation upload guidelines for a WAN application . 47 Table B-1 Observation upload guidelines for an AHD application using hData 48 Table B-2 Observation upload guidelines for a WAN application using hData . 49 Table C-

43、1 Common observation upload guidelines using SOAP . 50 Table C-2 Observation upload guidelines for an AHD using SOAP 51 Table C-3 Observation upload guidelines for a WAN device using SOAP . 51 Table D-1 Observation upload general data payload guidelines 52 Table D-2 Continua WAN regulation nomenclat

44、ure codes 55 Table D-3 Continua WAN AHD production specification nomenclature codes 62 Table D-4 Continua WAN sensor production specification nomenclature codes 65 Table D-5 Primary observational metric attributes . 76 Table D-6 Time stamp cases . 82 Table D-7 OBX-8 Status Values . 87 Table D-8 Meas

45、urement status values 88 Table D-9 Special data types 89 Table D-10 Example blood pressure . 91 Table D-11 Example AMM feedback . 91 Table D-12 BTLE temperature location codes . 94 Table D-13 Qualified time timestamp examples 97 Table D-14 AHD time elements . 98 Table D-15 Sensor time elements . 99

46、Table D-16 AHD and sensor timestamps . 101 Table D-17 AHD time behaviours 101 Table D-18 HL7 user table for OBX-18-2 103 Table D-19 Time synchronization nomenclature codes . 104 Table D-20 Generic metric attributes 107 Table D-21 Numeric (subclass of metric) . 107 Table D-22 RT-SA (subclass of metri

47、c) . 108 Table D-23 Enumeration (subclass of metric) 108 viii Rec. ITU-T H.812.1 (11/2015) Page Table E-1 Continua-defined MDC codes that are not part of IEEE 20601 PAN/LAN/TAN data exchanges . 109 Table E-2 AHD containment tree . 110 Table E-3 MDS containment tree . 111 Table E-4 Pulse oximeter con

48、tainment tree 113 Table E-5 Pulse oximeter OBX encoding part 1 114 Table E-6 Pulse oximeter OBX encoding part 2 117 Table E-7 Blood pressure monitor containment tree 118 Table E-8 Blood pressure monitor encoding part 1 . 119 Table E-9 Blood pressure monitor encoding part 2 . 120 Table E-10 Thermomet

49、er containment tree 121 Table E-11 Thermometer encoding part 1 . 122 Table E-12 Thermometer encoding part 2 . 122 Table E-13 Weighing scale containment tree . 123 Table E-14 Weighing scale encoding part 1 124 Table E-15 Weighing scale encoding part 2 124 Table E-16 Glucose meter containment tree . 125 Table E-17 Glucose meter encoding part 1 128 Table E-18 Glucose meter encoding part 2 132 Table E-19 INR m

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