ITU-T H 845 9-2017 Conformance of ITU-T H 810 personal health system Personal Health Devices interface Part 5I Medication adherence monitor (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.845.9 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 (HR

2、N, PAN, LAN, TAN and WAN) Conformance of ITU-T H.810 personal health system: Personal Health Devices interface Part 5I: Medication adherence monitor Recommendation ITU-T H.845.9 ITU-T H-SERIES RECOMMENDATIONS AUDIOVISUAL AND MULTIMEDIA SYSTEMS CHARACTERISTICS OF VISUAL TELEPHONE SYSTEMS H.100H.199 I

3、NFRASTRUCTURE OF AUDIOVISUAL 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 service

4、s H.300H.349 Directory 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 o

5、f Mobility and Collaboration, 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 mult

6、imedia collaboration applications 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 ser

7、vices and applications 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 metadat

8、a H.750H.759 IPTV multimedia 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

9、, TAN and WAN) H.820H.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.845.9 (04/2017) i Recommendation ITU-T H.845.9 Conformance of ITU-T H.810 personal health system: Personal Health Devices interface Par

10、t 5I: Medication adherence monitor Summary Recommendation ITU-T H.845.9 provides a test suite structure (TSS) and the test purposes (TP) for medication adherence monitors in the Personal Health Devices (PHD) interface, based on the requirements defined in the Recommendations of the ITU-T H.810 sub-s

11、eries, of which Recommendation ITU-T H.810 (2016) is the base Recommendation. The objective of this test specification is to provide a high probability of interoperability at this interface. Recommendation ITU-T H.845.9 is a transposition of Continua Test Tool DG2016, Test Suite Structure Part 5I: D

12、evice Specializations. Personal Health Device (Adherence Monitor) (Version 1.6, 2016-09-20), that was developed by the Personal Connected Health Alliance. A number of versions of this specification existed before transposition. This Recommendation includes an electronic attachment with the protocol

13、implementation conformance statements (PICS) and the protocol implementation extra information for testing (PIXIT) required for the implementation of Annex A. History Edition Recommendation Approval Study Group Unique ID* 1.0 ITU-T H.845.9 2015-01-13 16 11.1002/1000/12270 2.0 ITU-T H.845.9 2016-07-1

14、4 16 11.1002/1000/12946 3.0 ITU-T H.845.9 2017-04-13 16 11.1002/1000/13227 Keywords Conformance testing, Continua Design Guidelines, e-health, IEEE 11073 device specialization, ITU-T H.810, medication adherence monitor, personal area network, personal connected health devices, Personal Health Device

15、s interface, touch area network. _ * To access the Recommendation, type the URL http:/handle.itu.int/ in 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.845.9 (04/2017) FOREWORD The Internation

16、al Telecommunication Union (ITU) is the United Nations specialized agency in the field of telecommunications, 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, operatin

17、g and tariff questions and issuing Recommendations on them with a view to standardizing telecommunications 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, produ

18、ce Recommendations on these topics. The approval of ITU-T Recommendations is covered by the procedure laid 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

19、 Recommendation, the expression “Administration“ is used for conciseness to indicate both a telecommunication administration and a recognized operating agency. Compliance with this Recommendation is voluntary. However, the Recommendation may contain certain mandatory provisions (to ensure, e.g., int

20、eroperability or applicability) and compliance with the Recommendation is achieved when all of these mandatory 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

21、that compliance with the Recommendation is required of any party. INTELLECTUAL PROPERTY RIGHTSITU draws 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,

22、 validity or applicability of claimed Intellectual Property Rights, whether asserted by ITU members or 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

23、 required to implement this Recommendation. However, implementers are cautioned that this may not represent the latest information and are therefore strongly urged to consult the TSB patent database at http:/www.itu.int/ITU-T/ipr/. ITU 2017 All rights reserved. No part of this publication may be rep

24、roduced, by any means whatsoever, without the prior written permission of ITU. Rec. ITU-T H.845.9 (04/2017) iii Table of Contents Page 1 Scope . 1 2 References . 2 3 Definitions 2 3.1 Terms defined elsewhere 2 3.2 Terms defined in this Recommendation . 2 4 Abbreviations and acronyms 2 5 Conventions

25、3 6 Test suite structure (TSS) . 5 7 Electronic attachment . 7 Annex A Test purposes . 8 A.1 TP definition conventions . 8 A.1 Subgroup 1.3.9: Adherence monitor (AM) 9 Bibliography. 38 Electronic attachment: This Recommendation includes an electronic attachment with the protocol implementation confo

26、rmance statements (PICS) and the protocol implementation extra information for testing (PIXIT) required for the implementation of Annex A. iv Rec. ITU-T H.845.9 (04/2017) Introduction This Recommendation is a transposition of Continua Test Tool DG2016, Test Suite Structure Part 5I: Device Specializa

27、tions. Personal Health Device (Adherence Monitor) (Version 1.6, 2016-09-20), that was developed by the Personal Connected Health Alliance. The table below shows the revision history of this test specification; it may contain versions that existed before transposition. Version Date Revision history 1

28、.2 2012-10-05 Initial release for Test Tool DG2011. This is the same version as “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

29、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 (2016) Recommendation ITU-T H.810 (2016), Interoperability design guidelines for personal health systems. ISO/IEEE 1

30、1073-10472 ISO/IEEE 11073-10472-2012, Health informatics Personal health device communication Part 10472: Device specialization Medication monitor. https:/www.iso.org/standard/54364.html ISO/IEEE 11073-20601-2015A ISO/IEEE 11073-20601:2010, Health informatics Personal health device communication Par

31、t 20601: Application profile Optimized exchange protocol, including ISO/IEEE 11073-20601:2010 Amd 1:2015. https:/www.iso.org/standard/54331.html with https:/www.iso.org/standard/63972.html ISO/IEEE 11073-20601-2016C ISO/IEEE 11073-20601:2016, Health informatics Personal health device communication P

32、art 20601: Application profile Optimized exchange protocol, including ISO/IEEE 11073-20601:2016/Cor.1:2016. https:/www.iso.org/standard/66717.html with https:/www.iso.org/standard/71886.html 3 Definitions 3.1 Terms defined elsewhere This Recommendation uses the following terms defined elsewhere: 3.1

33、.1 agent ISO/IEEE 11073-20601-2016C: A node that collects and transmits personal health data to an associated manager. 3.1.2 manager ISO/IEEE 11073-20601-2016C: A node receiving data from one or more agent systems. Some examples of managers include a cellular phone, health appliance, set top box, or

34、 a computer system. 3.2 Terms defined in this Recommendation None. 4 Abbreviations and acronyms This Recommendation uses the following abbreviations and acronyms: ATS Abstract Test Suite DUT Device Under Test Rec. ITU-T H.845.9 (04/2017) 3 CDG Continua Design Guidelines CGM Continuous Glucose Monito

35、r GUI Graphical User Interface INR International Normalized Ratio IP Insulin Pump IUT Implementation Under Test MDS Medical Device System NFC Near Field Communication PAN Personal Area Network PCT Protocol Conformance Testing PCO Point of Control and Observation PHD Personal Health Device PHDC Perso

36、nal Healthcare Device Class PHG Personal Health Gateway PICS Protocol Implementation Conformance Statement PIXIT Protocol Implementation extra Information for Testing SABTE Sleep Apnoea Breathing Therapy Equipment SCR Static Conformance Review SDP Service Discovery Protocol SOAP Simple Object Access

37、 Protocol TCWG Test and Certification Working Group TP Test Purpose TSS Test Suite Structure USB Universal Serial Bus WDM Windows Driver Model 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 2

38、62. 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 required that. NOT

39、E The above-mentioned key words are capitalized for illustrative purposes only and they do not appear capitalized within this Recommendation. 4 Rec. ITU-T H.845.9 (04/2017) Reference is made in the ITU-T H.800-series of Recommendations to different versions of the Continua Design Guidelines (CDG) by

40、 a specific designation. The list of terms that may be used in this Recommendation is provided in Table 1. 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

41、errata noting all ratified bugs b-CDG 2016. 2016 6.0 Release 2016 of the CDG including maintenance updates of the CDG 2015 and additional guidelines that cover new functionalities. Iris 2015 plus errata b-ITU-T H.810 (2015) 5.1 Release 2015 plus errata noting all ratified bugs b-CDG 2015. The 2013 e

42、dition of H.810 is split into eight parts in the H.810-series. 2015 5.0 Release 2015 of the CDG including maintenance updates of the CDG 2013 and additional guidelines that cover new functionalities. Genome 2013 plus errata b-ITU-T H.810 (2013) 4.1 Release 2013 plus errata noting all ratified bugs b

43、-CDG 2013. 2013 4.0 Release 2013 of the CDG including maintenance updates of the CDG 2012 and additional guidelines that cover new functionalities. Endorphin 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 upda

44、tes of the CDG 2011 and additional guidelines that cover new functionalities. Catalyst 2011 plus errata 2.1 CDG 2011 integrated with identified errata. 2011 2.0 Release 2011 of the CDG including maintenance updates of the CDG 2010 and additional guidelines that cover new functionalities b-CDG 2011.

45、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 and 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. Rec. ITU-T H.845.9 (

46、04/2017) 5 6 Test suite structure (TSS) The test purposes (TPs) for the Personal Health Devices interface have been divided into the main subgroups specified below. Annex A describes the TPs for subgroup 1.3.9 (shown in bold). Group 1: Personal Health Device (PHD) Group 1.1: Transport (TR) Subgroup

47、1.1.1: Design guidelines: Common (DGC) Subgroup 1.1.2: USB design guidelines (UDG) Subgroup 1.1.3: Bluetooth design guidelines (BDG) Subgroup 1.1.4: Pulse oximeter design guidelines (PODG) Subgroup 1.1.5: Cardiovascular design guidelines (CVDG) Subgroup 1.1.6: Activity hub design guidelines (HUBDG)

48、Subgroup 1.1.7: ZigBee design guidelines (ZDG) Subgroup 1.1.8: Glucose meter design guidelines (GLDG) Subgroup 1.1.9: Bluetooth low energy design guidelines (BLEDG) Subgroup 1.1.10: Basic electrocardiograph design guidelines (ECGDG) Subgroup 1.1.11: NFC design guidelines (NDG) Group 1.2: IEEE 20601

49、Optimized exchange protocol (OXP) Subgroup 1.2.1: PHD domain information model (DIM) Subgroup 1.2.2: PHD service model (SER) Subgroup 1.2.3: PHD communication model (COM) Group 1.3: Devices class specializations (CLASS) Subgroup 1.3.1: Weighing scales (WEG) Subgroup 1.3.2: Glucose meter (GL) Subgroup 1.3.3: Pulse oximeter (PO) Subgroup 1.3.4: Blood pressure monitor (B