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 Page 1007 - Shaping smarter and more sustainable cities - Striving for sustainable development goals           Basic HTML Version Table of Contents View Full Version Page 1007 - Shaping smarter and more sustainable cities - Striving for sustainable development goals P. 1007 Work FG‐SSC SDO work‐ Document Corresponding Standardization Future needs area deliverable(s) ing on this number document title gap in this area and suggestions related to this area released by to SG5 work area this SDO ITU‐T H.844 Conformance for ITU‐T H.810 personal health devices: PAN/LAN/TAN interface Part 4: Continua Design Guidelines: Manager ITU‐T Conformance for ITU‐T H.810 H.845.1 personal health devices: PAN/LAN/TAN interface Part 5A: Weighing scales: Agent ITU‐T Conformance for ITU‐T H.810 H.845.2 personal health devices: PAN/LAN/TAN interface Part 5B: Glucose meter: Agent ITU‐T Conformance for ITU‐T H.810 H.845.3 personal health devices: PAN/LAN/TAN interface Part 5C: Pulse oximeter: Agent ITU‐T Conformance for ITU‐T H.810 H.845.4 personal health devices: PAN/LAN/TAN interface Part 5D: Blood pressure monitor: Agent ITU‐T Conformance for ITU‐T H.810 H.845.5 personal health devices: PAN/LAN/TAN interface Part 5E: Thermometer: Agent ITU‐T Conformance for ITU‐T H.810 H.845.6 personal health devices: PAN/LAN/TAN interface Part 5F: Cardiovascular fitness and activity monitor: Agent ITU‐T Conformance for ITU‐T H.810 H.845.7 personal health devices: PAN/LAN/TAN interface Part 5G: Strength fitness equipment: Agent ITU‐T Conformance for ITU‐T H.810 H.845.8 personal health devices: PAN/LAN/TAN interface Part 5H: Independent living activity hub: Agent ITU‐T Conformance for ITU‐T H.810 H.845.9 personal health devices: PAN/LAN/TAN interface Part 5I: Medication adherence monitor: Agent ITU‐T Conformance for ITU‐T H.810 H.845.11 personal health devices: PAN/LAN/TAN interface Part 5K: Peak expiratory flow monitor: Agent ITU‐T's Technical Reports and Specifications 997     1002     1003     1004     1005     1006     1007     1008     1009     1010     1011     1012          
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Score: 926322.9 - https://www.itu.int/en/publica...files/basic-html/page1007.html
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ITU-T & ACADEMIA ITU standards for technologies enabling e-health Chaesub LEE Director of ITU Telecommunication Standardization Bureau ITU Regional Workshop for Europe and CIS on e-Health 17 – 19 October 2018, Odessa, Ukraine Technology areas • Personal health devices • Safe listening devices and systems • Data exchange and supporting services • Telemedicine and remote monitoring • AI for health 2 Personal health devices • Promising growing sector • Enabled by ICTs • Recommendations in the ITU-T H.810 sub-series – Transposition of the Personal Connected Health Alliance “Continua Design Guidelines” • Cooperation with IEEE PHD WG • Consultation with WHO – Joint meetings and workshops 3 ITU-T H.810 • Ensures interoperability of devices used for applications monitoring personal health. • Defines the interfaces between: – Personal health devices and a gateway (application hosting device) – Gateways and wide-area network entities providing health & fitness services – Connection of health & fitness services to health information systems (such as a Health Record Network) – Based on industry-accepted standards such as IEEE 11073 devices; Bluetooth, USB, and Zigbee transports; HL7 protocols; and IHE profiles • Test suites completed – 50 specs covering 2000+ test cases • Latest edition: 2017 – Transposition of the “Keratin” edition of the Continua Design Guidelines (CDG) – New edition expected in 2019 4 https://www.itu.int/en/ITU-T/studygroups/2017-2020/16/Pages/rm/ehealth.aspx ITU-T H.820-H.850 sub-series • Conformance testing of H.810 (2017) implementations – Master conformance testing plan: ITU-T H.820 – Health Information System block (H.821-series) – Health & Fitness wide-area network block (H.830-series) – Personal Health Device block (H.820~H.850 series) • Compliance and interoperability testing programme run by PCHA – Continua-compliant (self-certification) – Continua-certified (certification by a 3rd-party laboratory) • Compliant devices list: “E-health devices” tab at https://itu.int/net/itu- t/cdb/ConformityDB.aspx 5 https://itu.int/net/itu-t/cdb/ConformityDB.aspx Safe listening • Developed in close collaboration with WHO and its experts • Addresses the risk of early onset of hearing loss due to unsafe use of personal music devices – Totally preventable however irreversible once occurred • ITU-T H.870 (ex ITU-T F.SLD) Specification for safe music listening devices – Specifies features for music player devices & systems that promote safe use by and education of users – It does not set a rigid volume limit (as previous regulations mandated in Europe), but rather advises a user what to do to minimize hearing risk when the safe sound dose is exceeded (e.g. for a given day). Users have the choice of continuing with the listening after acknowledging the risks. – Messaging guidelines are provided for device manufacturers to be effective in communicating risk • H.870 is aligned with existing standards; however, it expands them with a “child mode” as well as in providing end-user messaging guidelines to be implemented in music player devices & systems • Next steps: – WHO is developing a reference implementation – Specification for conformance testing and profiles for safe listening devices 6 https://itu.int/rec/T-REC-H.870 Data exchange schema and supporting services • Recommendation ITU-T H.860 (April 2014) – Multimedia e-health data exchange services: data schema and supporting services • Features: – Common Health Data Schema (using relevant data standards • E.g. (...) lang=en&parent=T-REC-Y.2075 E-health app using ITU-T IPTV standards 10 IPTV widget Hub working as gateway ScalePedometer Blood pressure meter Normal programme Server Widget implemented with LIME (ITU-T H.762) for e-health information collected from the user site, consolidated in the server backend and displayed on users’ IPTV terminal device as a widget.
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Score: 925255.3 - https://www.itu.int/en/ITU-D/R...0.2018%20-%20Chaesub%20LEE.pdf
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 Page 1008 - Shaping smarter and more sustainable cities - Striving for sustainable development goals           Basic HTML Version Table of Contents View Full Version Page 1008 - Shaping smarter and more sustainable cities - Striving for sustainable development goals P. 1008 Work FG‐SSC SDO work‐ Document Corresponding Standardization Future needs area deliverable(s) ing on this number document title gap in this area and suggestions related to this area released by to SG5 work area this SDO ITU‐T Conformance for ITU‐T H.810 H.845.12 personal health devices: PAN/LAN/TAN interface Part 5L: Body composition analyser: Agent ITU‐T Conformance for ITU‐T H.810 H.845.13 personal health devices: PAN/LAN/TAN interface Part 5M: Basic electrocardiograph: Agent ITU‐T Conformance for ITU‐T H.810 H.845.14 personal health devices: PAN/LAN/TAN interface Part 5N: International normalized ratio: Agent ITU‐T H.846 Conformance for ITU‐T H.810 personal health devices: PAN/LAN/TAN interface Part 6: Device specializations: Manager ITU‐T H.847 Conformance for ITU‐T H.810 personal health devices: PAN/LAN/TAN interface Part 7: Bluetooth low energy: Agent ITU‐T H.848 Conformance for ITU‐T H.810 personal health devices: PAN/LAN/TAN interface Part 8: Bluetooth low energy: Manager ITU‐T H.849 Conformance for ITU‐T H.810 personal health devices: PAN/LAN/TAN interface Part 9: Transcoding for Bluetooth low energy: Agent ITU‐T H.850 Conformance for ITU‐T H.810 personal health devices: PAN/LAN/TAN Interface Part 10: Transcoding for Bluetooth low energy: Manager ITU‐T E‐health application for H.OPVQ on‐flight and post‐flight virtual quarantine CEN/TC 251 EN 1068 Health informatics – Registra‐ (Health tion of coding systems informatics) EN 12264 Health informatics – Categori‐ al structures for systems of concepts EN 12435 Health informatics – Expres‐ sion of results of measure‐ ments in health sciences 998 ITU‐T's Technical Reports and Specifications     1003     1004     1005     1006     1007     1008     1009     1010     1011     1012     1013          
Language:English
Score: 925127.8 - https://www.itu.int/en/publica...files/basic-html/page1008.html
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However, in a remote setting, they are increasingly exposed to excessive cognitive stress and, as a consequence, possible health hazards. Good, clear audio quality is the most important element for interpreters to provide their service. (...) The best way to guarantee audio quality is to observe the following requirements: ▫ Connect from a computer or laptop only. ▫ Avoid using hand-held devices or tablet computers such as smartphones or iPads. ▫ Use Chrome or Firefox (Safari for Macs). ▫ The internet connection must be strong and stable: min download/upload: 10Mbps. ▫ Connecting the broadcasting device via an Ethernet cable ensures maximum stability. ▫ In the absence of a cabled connection, the Wi-Fi signal must be excellent. ▫ Log in early to test the connection. ▫ Please use high quality microphones: ◦ lapel microphone; or ◦ unidirectional table microphone; or ◦ wired headset with a built-in microphone. ▫ Ensure that the broadcasting platform recognizes the microphone. ▫ Speaking from a quiet environment is of utmost importance. ▫ Avoid sitting in a large empty room to minimize echo. ▫ Avoid using the computer’s built-in microphone. ▫ Omnidirectional microphones pick up ambient noise and should be avoided. ▫ Avoid smartphone-style earbuds/earphones with in-line microphones and other Bluetooth devices. (...) When taking the floor, all other devices and notifications should be muted. mailto:estatements@un.org mailto:is-unhq@un.org Annex 1.
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Score: 924730.6 - https://sdgs.un.org/sites/defa...MeetingswithInterpretation.pdf
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Page 316 - 2015 Security in Telecommunications and Information Technology           Basic HTML Version Table of Contents View Full Version Page 316 - 2015 Security in Telecommunications and Information Technology P. 316 3 Unleashing the potential of the Internet of Things 3.2 Terms defined in this Recommendation This Recommendation defines the following terms: 3.2.1 e-health monitoring (EHM) service: A service which consists of observing and recording information based on a customer's physiological data, environmental data and other data, with the aim of monitoring the customer's state of health through the use of information and communication technologies. 3.2.2 e-health monitoring healthcare (EHMH) service: A class of EHM services providing the customer with health monitoring services for a 'healthy' state. 3.2.3 e-health monitoring rehabilitation (EHMR) service: A class of EHM services providing the customer with health monitoring services for a 'not fully healthy' or 'in recovery' state of health. 3.2.4 e-health monitoring treatment (EHMT) service: A class of EHM services providing the customer with health monitoring services for an 'illness' state of health. 3.2.5 EHM system: A set of hardware and software components which constitute as a whole the technical chain of e-health monitoring (EHM) service provisioning. NOTE – EHM systems include EHM devices, gateways, networks, service support platforms and EHM applications. 3.2.6 EHM device: A device, as defined in [ITU-T Y.2060], which has sufficient qualification for e-health monitoring (EHM) service provisioning. NOTE – Examples include EHM devices for EHMH (i.e., EHM devices which have sufficient qualification for EHMH), EHM devices for EHMT and EHM devices for EHMR. 3.2.7 EHM terminal: An e-health monitoring (EHM) device directly connected to the communication network. 3.2.8 EHM end point: An e-health monitoring (EHM) device connected to the communication network through gateway(s). 4 Abbreviations and acronyms This Recommendation uses the following abbreviations and acronyms: CT Computed Tomography ECG Electrocardiogram EHM e-health Monitoring EHMH e-health Monitoring Healthcare EHMR e-health Monitoring Rehabilitation EHMT e-health Monitoring Treatment EMR Electronic Medical Record EMSS Emergency Medical Service System GPRS General Packet Radio Service GPS Global Positioning System GSM Global System for Mobile communications ICT Information and Communication Technology IP Internet Protocol IoT Internet of Things 302 Rec.
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Score: 923177.6 - https://www.itu.int/wftp3/Publ.../files/basic-html/page316.html
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The current list complements the WHO List of priority medical devices for COVID-19 published in 2020, the WHO list of priority medical devices for cancer management published in 2017 and the Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health published in 2015. Objectives of this publication were to: determine and select the medical devices required for priority interventions to manage cardiovascular diseases and diabetes aligned with WHO guidance, policies and evidence-based guidelines; expand the WHO Priority Medical Devices lists, these now include reproductive, maternal, new born and child health, the ones for cancer management and the most recent ones for COVID-19, to those for cardiovascular diseases and diabetes, which will become global guidances that Member States can use as a reference to define their national medical devices lists; provide guidance to countries, national and regional health departments, and health facilities to prioritize medical devices for procurement or reimbursement to manage NCDs in their settings.   (...) It serves to inform  policy-makers and technical decision-makers on the selection of medical devices required for the package of  benefits and interventions for a target population in the context of universal health coverage.  
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Score: 922592.3 - https://www.who.int/publicatio...-detail-redirect/9789240027978
Data Source: un
H.845.2 : Conformance of ITU-T H.810 personal health system: Personal Health Devices interface Part 5B: Glucose meter   Français   Español     Home : ITU-T : Publications : Recommendations : H Series : H.845.2 Recently posted  -  Search Recommendations     H.845.2 : Conformance of ITU-T H.810 personal health system: Personal Health Devices interface Part 5B: Glucose meter Recommendation H.845.2 In force components Number Title Status H.845.2 (08/18)   Conformance of ITU-T H.810 personal health system: Personal Health Devices interface Part 5B: Glucose meter   In force     Superseded and Withdrawn components Number Title Status H.845.2 (01/15)   Conformance of ITU-T H.810 personal health devices: PAN/LAN/TAN interface Part 5B: Glucose meter: Agent   Superseded H.845.2 (07/16)   Conformance of ITU-T H.810 personal health devices: PAN/LAN/TAN interface Part 5B: Glucose meter: Agent   Superseded H.845.2 (04/17)   Conformance of ITU-T H.810 personal health system: Personal Health Devices interface Part 5B: Glucose meter   Superseded   Top  -  Feedback  -  Contact us  -  Copyright © ITU  2008 All Rights Reserved Contact for this page :  ITU-T Publications Updated : 2018-11-15  
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Score: 922550.1 - https://www.itu.int/rec/T-REC-H.845.2
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The team also has developed an evidence- based methodology to select the WHO Priority Medical Devices List (including 1500+ devices). Such list is in continuous expansion to address different health conditions and has been adapted to an online database “ MeDevIS ”. (...) The Strategic and Technical Advisory Group on Medical Devices (STAG-MEDEV), will be multidisciplinary, with members who have a range of technical knowledge, skills and experience relevant to medical devices and related health technologies. (...) Access to appropriate, affordable, acceptable, safe and good quality medical technologies for low resource settings; Access to medical devices for: diagnostics (including imaging, and specialized diagnostics), surgery and other devices for treatment, monitoring and intensive and palliative care for all health care disciplines; Access to medical devices for emergencies and outbreaks; Access to priority medical devices lists for procurement and reimbursement; Access to personal protective equipment (PPE); Development, assessment  and use of innovative medical technologies; Development of policies on medical devices and related health technologies; Ethics, equity, human rights and gender in public health; Health systems and programme delivery;   Health technology assessment; Health technology management; Human resources for medical devices; Nomenclature, classification, and coding of medical devices and unique device identifier; Pricing, needs estimation  and facility assessment of medical devices; Regulation of medical devices; Standards (International and national); Technology transfer and local production.
Language:English
Score: 922399.1 - https://www.who.int/news-room/...ll-for-experts-STAG-MEDEV-2022
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Diagnostic devices, including in vitro diagnostics (IVDs) and imaging devices are a key driver of patient, financial and health systems impact, and a critical enabler of universal health coverage. (...) Medical devices are used to diagnose illness, to enable treatment of illnesses and injuries, to monitor treatments, to assist people with disabilities, and to protect health care workers and patients.  (...) Technical links Guidelines Access to Medicines and Health Products (who.int)    Health product policy standards   In vitro diagnostics - Global (who.int)   Prequalified In Vitro Diagnostics | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)   Medical devices (who.int)   Health technology assessment - Global (who.int)   Universal Health Coverage (who.int)    Antimicrobial resistance (who.int) - Our work Regional Workshop on Essential Diagnostics Ensuring the availability, accessibility, affordability, and quality of diagnostics is essential to delivering universal health coverage (UHC).
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Score: 921900.6 - https://www.who.int/southeasta.../health-topics/medical-devices
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PowerPoint Presentation Canada’s Experience in Regulatory Cooperation in the Medical Devices Sector February 25, 2019 Nancy Shadeed Manager, International Programs Division Office of Policy and International Programs Medical Devices Directorate, Health Canada Global Context and Drivers • Rising health care costs and budget constraints • Fast paced technological development – R&D generates competitive edge for device companies, as in other industries – Rate of innovation, shorter review timelines and greater diversity/complexity of technologies pose increasing regulatory challenges • International regulatory cooperation 2 International Collaboration Key international activities for the Medical Devices Program: • Participation in the International Medical Device Regulators Forum (IMDRF) • Medical Device Single Audit Program (MDSAP) 3 International Medical Devices Regulator Forum (IMDRF) • Goals are to: – Accelerate international medical device regulatory harmonization and convergence building on the work of the Global Harmonization Task Force (GHTF) – Address common public health regulatory challenges to convergence due to the globalization of medical device production and the emergence of new technologies – Accelerate innovation by clear and practical regulatory expectations 4 Current IMDRF Working Groups • Adverse Event Terminology – Develop harmonized terminology and systems being used to code information relating to medical device adverse events • Good Regulatory Review Practices – Develop harmonized requirements for assessing conformity to safety and performance regulatory requirements for new medical devices • Regulated Product Submission (RPS) – Develop standard system for the electronic exchange of information related to premarket medical device submissions and a common ‘Table of Contents’ for medical device regulatory submissions 5 Current IMDRF Working Groups • Standards – Improve the utility of standards for regulatory use • Unique Device Identification (UDI) – Establish guidance for the positive identification of medical devices • Patient Specific Devices – Develop a harmonized approach to defining medical devices that are manufactured for a particular individual • Clinical Evaluation – Develop a harmonized approach and requirements for leveraging and evaluating clinical evidence • Cybersecurity – Develop a globally harmonized approach to medical device cybersecurity that ensures the safety and performance of medical devices while encouraging innovation 6 Implementation of Guidance Documents Leads to Regulatory Convergence • Common Table of Contents for Medical Device Regulatory Submissions – Health Canada published guidance in 2019 to accept the IMDRF Table of Contents as a preferred format. Other countries have since announced their implementation of this format to lead to efficiencies in re-using submission content for multi-jurisdictions. • Software as a Medical Device (SaMD) – Health Canada recently published guidance in 2020 that used definitions and risk categorization criteria developed by IMDRF. Other countries such as US FDA, Australia’s TGA, Singapore have published similar guidances. 7 Implementation of Guidance Documents Leads to Regulatory Convergence • Adverse Event Terminology – Health Canada will be using the IMDRF code information relating to medical device adverse events.
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Score: 921557.4 - https://www.wto.org/english/tr...ada_shadeed_grp_25022020_e.pdf
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