ITU-T H 811-2017 Interoperability design guidelines for personal connected health systems Personal Health Devices 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.811 TELECOMMUNICATION STANDARDIZATION SECTOR OF ITU (11/2017) SERIES H: AUDIOVISUAL AND MULTIMEDIA SYSTEMS E-health multimedia services and applications Personal health systems Interoperability design guidelines for perso

2、nal connected health systems: Personal Health Devices interface Recommendation ITU-T H.811 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

3、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 architecture for audiovisual and multimedia services H.

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

5、 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 services H.540H.549 VEHICULAR GATEWAYS AND INTELL

6、IGENT TRANSPORTATION SYSTEMS (ITS) Architecture for vehicular gateways H.550H.559 Vehicular gateway interfaces 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 sen

7、sor 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 application framewo

8、rks 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 e-health da

9、ta exchange services H.860H.869 For further details, please refer to the list of ITU-T Recommendations. Rec. ITU-T H.811 (11/2017) i Recommendation ITU-T H.811 Interoperability design guidelines for personal connected health systems: Personal Health Devices interface Summary The Continua Design Guid

10、elines (CDG) defines a framework of underlying standards and criteria that ensure the interoperability of devices and data used for personal connected health services. The Continua Design Guidelines also contains design guidelines (DGs) that further clarify the underlying standards or specifications

11、 by reducing options or by adding missing features to improve interoperability. ITU-T H.811 focuses on the Personal Health Devices interface (PHD-IF). ITU-T H.811 is part of the “ITU-T H.810 interoperability design guidelines for personal connected health systems“ subseries that covers the following

12、 areas: ITU-T H.810 Interoperability design guidelines for personal connected health systems: Introduction ITU-T H.811 Interoperability design guidelines for personal connected health systems: Personal Health Devices interface (this design guidelines document) ITU-T H.812 Interoperability design gui

13、delines for personal connected health systems: Services interface ITU-T H.812.1 Interoperability design guidelines for personal connected health systems: Services interface: Observation Upload capability ITU-T H.812.2 Interoperability design guidelines for personal connected health systems: Services

14、 interface: Questionnaire capability ITU-T H.812.3 Interoperability design guidelines for personal connected health systems: Services interface: Capability Exchange capability ITU-T H.812.4 Interoperability design guidelines for personal connected health systems: Services interface: Authenticated Pe

15、rsistent Session capability ITU-T H.813 Interoperability design guidelines for personal connected health systems: Healthcare Information System interface History Edition Recommendation Approval Study Group Unique ID* 1.0 ITU-T H.811 2015-11-29 16 11.1002/1000/12652 2.0 ITU-T H.811 2016-07-14 16 11.1

16、002/1000/12912 3.0 ITU-T H.811 2017-11-29 16 11.1002/1000/13414 Keywords CDG, Continua Design Guidelines, healthcare information systems, personal connected health systems, personal health devices, services. * To access the Recommendation, type the URL http:/handle.itu.int/ in the address field of y

17、our web browser, followed by the Recommendations unique ID. For example, http:/handle.itu.int/11.1002/1000/11830-en. ii Rec. ITU-T H.811 (11/2017) FOREWORD The International Telecommunication Union (ITU) is the United Nations specialized agency in the field of telecommunications, information and com

18、munication 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 telecommunications on a worldwide basis.

19、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 laid down in WTSA Resolutio

20、n 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 telecommunication administration and

21、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 mandatory provisions are met

22、. 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 attention to the possibil

23、ity 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 others outside of the Reco

24、mmendation 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 represent the latest informatio

25、n and are therefore strongly urged to consult the TSB patent database at http:/www.itu.int/ITU-T/ipr/. ITU 2018 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.811 (11/2017) iii Table of Contents P

26、age 0 Introduction 1 0.1 Organization . 1 0.2 Guideline releases and versioning 1 0.3 Whats new? . 2 1 Scope 3 2 References 5 2.1 Equivalent IEEE and ISO specifications 5 3 Definitions 6 4 Abbreviations and acronyms 6 5 Conventions 6 6 Common X73 Personal Health Devices guidelines . 6 6.1 X73 interf

27、ace architecture (informative) 6 6.1.1 Introduction to X73 interface . 6 6.1.2 Overview of the X73 interface . 7 6.1.3 Common data/messaging layer and selected standards . 8 6.1.4 Transport protocols and selected standards . 8 6.2 Common X73 layer guidelines . 9 6.2.1 Applicable interfaces . 9 6.2.2

28、 Exchange protocol . 9 6.2.3 Standard configuration support 24 6.2.4 Sensor component communication capabilities 25 6.2.5 Sensor component multi-function devices . 25 6.3 X73 devices 26 6.3.1 Pulse oximeter 26 6.3.2 Basic 1-3 lead ECG 30 6.3.3 Heart-rate sensor 31 6.3.4 Blood pressure monitor 34 6.3

29、.5 Thermometer 34 6.3.6 Weighing scales . 35 6.3.7 Glucose meter 35 6.3.8 INR meter . 35 6.3.9 Body composition analyser 35 6.3.10 Peak expiratory flow monitor 36 6.3.11 Cardiovascular fitness 36 iv Rec. ITU-T H.811 (11/2017) Page 6.3.12 Cardiovascular step counter . 36 6.3.13 Strength fitness . 37

30、6.3.14 Activity hub . 37 6.3.15 Fall sensor 37 6.3.16 Motion sensor . 38 6.3.17 Enuresis sensor . 38 6.3.18 Contact closure sensor . 39 6.3.19 Switch sensor . 39 6.3.20 Dosage sensor 40 6.3.21 Water sensor . 40 6.3.22 Smoke sensor . 41 6.3.23 Property exit sensor 41 6.3.24 Temperature sensor 42 6.3.

31、25 Usage sensor 42 6.3.26 PERS sensor . 43 6.3.27 CO sensor . 43 6.3.28 Gas sensor 44 6.3.29 Adherence monitor . 44 6.3.30 Sleep apnoea breathing therapy equipment (SABTE) . 44 6.3.31 Continuous glucose monitor (CGM) . 44 6.3.32 Insulin pump (IP) . 45 6.3.33 Power status monitor (PSM) 45 7 NFC inter

32、face design guidelines 45 7.1 NFC interface architecture (informative) . 45 7.1.1 Overview of NFC interface 46 7.1.2 Transport protocols and selected standards . 47 7.1.3 Exchange protocols and selected standards . 47 7.1.4 Device communication styles 47 7.1.5 NFC interface security . 47 7.2 NFC int

33、erface guidelines 47 7.2.1 NFC PHD to PHG linkage . 47 7.2.2 NFC user experience 48 7.2.3 NFC Personal Health Device communication . 48 7.2.4 Multi-function devices . 48 7.2.5 NFC quality of service . 49 7.3 NFC Certified Capability Classes 49 8 USB interface design guidelines 51 8.1 USB interface a

34、rchitecture (informative) . 51 8.1.1 Overview of USB interface 51 Rec. ITU-T H.811 (11/2017) v Page 8.1.2 Exchange protocols and selected standards . 52 8.1.3 USB device communication styles 52 8.1.4 USB-IF security . 52 8.2 USB device and interface guidelines . 52 8.2.1 USB device to PHG linkage 52

35、 8.2.2 USB general requirements . 52 8.2.3 USB map to IEEE 11073-20601 53 8.2.4 Sending metadata via USB PHDC . 54 8.2.5 USB quality of service . 55 8.2.6 USB multi-function devices . 55 8.2.7 USB connectors . 56 8.2.8 USB data rates 57 8.3 USB Certified Capability Classes 57 9 Bluetooth BR/EDR inte

36、rface design guidelines . 59 9.1 Bluetooth BR/EDR interface architecture (informative) . 59 9.1.1 Overview of Bluetooth BR/EDR interface 60 9.2 Bluetooth BR/EDR interface guidelines 60 9.2.1 Bluetooth BR/EDR PHD to PHG linkage . 60 9.2.2 Bluetooth health device profile 61 9.2.3 Discovery and pairing

37、 61 9.2.4 Bluetooth BR/EDR discoverable mode . 65 9.2.5 Notifying the user 66 9.2.6 Quality of service . 67 9.2.7 Secure simple pairing debug mode 68 9.3 Bluetooth BR/EDR Certified Capability Classes . 68 10 ZigBee interface design guidelines 70 10.1 ZigBee interface architecture (informative) . 70

38、10.1.1 Introduction to the ZigBee interface 70 10.1.2 Scope of the ZigBee interface 71 10.1.3 Overview of the ZigBee interface 72 10.1.4 Transport protocol and selected standards . 72 10.1.5 Data exchange protocol and selected standards . 73 10.2 ZigBee interface guidelines 73 10.2.1 ZigBee transpor

39、t layer 73 10.2.2 ZigBee data/messaging layer . 74 10.3 ZigBee Certified Capability Classes 78 11 Bluetooth low energy (LE) design guidelines 80 11.1 Architecture of Bluetooth LE (informative). 80 vi Rec. ITU-T H.811 (11/2017) Page 11.1.1 Introduction 80 11.1.2 Overview 81 11.2 Bluetooth LE interfac

40、e guidelines 83 11.2.1 Bluetooth LE services and profiles 83 11.2.2 Device discovery, connection establishment, pairing, service discovery and bonding . 83 11.2.3 User notification . 88 11.2.4 Security, authentication and privacy 89 11.2.5 Device information requirements 91 11.2.6 Date and time requ

41、irements . 92 11.2.7 Certification and regulatory aspects . 92 11.2.8 Transcoding 93 11.3 Bluetooth LE PHDs and PHGs 94 11.3.1 Blood pressure monitor 94 11.3.2 Thermometer 95 11.3.3 Heart-rate sensor 95 11.3.4 Glucose meter 95 11.3.5 Weighing scale . 96 11.3.6 Continuous glucose monitor 96 11.3.7 Pu

42、lse oximeter 97 11.4 Bluetooth LE Certified Capability Classes 97 Appendix I Additional Bluetooth BR/EDR information . 98 I.1 Bluetooth terminology 98 I.2 Bluetooth BR/EDR pairing methods . 98 I.3 Bluetooth BR/EDR legacy pairing procedures . 99 I.4 Supporting Bluetooth OEM subsystems and components

43、99 I.5 Quality of service bins for Bluetooth 99 Appendix II Additional ZigBee information . 102 II.1 ZigBee networking 102 II.2 ZigBee pairing process/service discovery types 102 II.3 ZigBee security 103 Appendix III Recommendation for use of generic USB drivers . 104 Bibliography 105 Rec. ITU-T H.8

44、11 (11/2017) vii List of Tables Page Table 6-1 Applicable interfaces 9 Table 6-2 X73 wired/wireless general requirements . 9 Table 6-3 Minimally supported base protocol version(s) for device specializations . 11 Table 6-4 Correspondence between 11073-20601 protocol versions and specifications . 11 T

45、able 6-5 Communication capabilities General 12 Table 6-6 Communication capabilities Event reporting 12 Table 6-8 Communication capabilities Time setting . 13 Table 6-9 Device information . 15 Table 6-10 Unsupported service component 17 Table 6-12 Bidirectional transport layer: Message type/QoS bin m

46、apping . 19 Table 6-13 Regulatory / certification information 21 Table 6-14 Manager conformance 23 Table 6-15 Nomenclature codes . 23 Table 6-16 User identification 23 Table 6-17 Communication capabilities general . 24 Table 6-18 Communication capabilities association and configuration . 25 Table 6-

47、19 Multi-function devices . 25 Table 6-20 Pulse oximeter General requirements . 26 Table 6-21 Pulse Oximeter PM-Store measurement requirements 29 Table 6-22 Pulse Oximeter PM-Store object attributes guideline 29 Table 6-23 Basic 1-3 lead ECG General requirements . 30 Table 6-24 ECG PM-Store measurem

48、ent requirements . 31 Table 6-25 ECG PM-Store object attributes guidelines 31 Table 6-26 Heart-rate sensor General requirements 32 Table 6-27 Heart-rate sensor PM-Store measurement requirements . 34 Table 6-28 PM-Store object attributes guidelines 34 Table 6-29 Blood pressure monitor General require

49、ments 34 Table 6-30 Thermometer General requirements 35 Table 6-31 Weighing scales General requirements . 35 Table 6-32 Glucose meter General requirements 35 Table 6-33 INR meter General requirements 35 Table 6-34 Body composition analyzer General requirements . 35 Table 6-35 Peak flow monitor General requirements 36 Table 6-36 Cardiovascular fitness General requirements 36 Table 6-37 Cardiovascular step counter Gener