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Dr. Alpo Värri
Convener
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CEN/TC251/WG II Scope
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WG II’s own active work item
EN 1064 revision, Standard communication protocol
- Computer-assisted electrocardiography
Enquiry version submitted in December 2017
Template converted version submitted in March
2018, thanks to Paul Rubel and Jocelyne Fayn
The document is in the processing queue of CEN,
coming to Enquiry ballot within a few months, e.g.
26.7.-18.10.2018
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Review of WG II work program
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ISO/TC215 WG2, Maringa summary by Bron Kisler
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ISO/TC215 WG2, Genomics discussion piece
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ISO/TC215 WG2, Approved Maringa Resolutions
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2018-09: ISO/TC215 resolves to Approve to start a revision of ISO TS 13131:2014
Health informatics -- Telehealth services -- Quality planning guidelines. The work
item shall be registered as a WD under the timeframe of 36 months, keeping the same
scope, with Alan Taylor (Australia) as project leader, and further approves the change
in deliverable from a Technical Specification to an International Standard.
2018-10: ISO/TC215 resolves to Approve the following title change: ISO/AWI 14199
Health informatics -- Information models -- Biomedical Research Integrated Domain
Group (BRIDG) Model version 5.0 to ISO/AWI 14199 Health informatics -- Information
models -- Biomedical Research Integrated Domain Group (BRIDG) Model version 5.1
and approves the circulation of ISO/AWI 14199 Health informatics -- Information
models -- Biomedical Research Integrated Domain Group (BRIDG) Model version 5.1
for a 20 week DIS ballot
2018-11: ISO/TC215 resolves to Approve ISO/TC215 DTR 21835.2 Health informatics
-- Health-related data which a person generates daily for an 8-week second DTR
ballot by 25 June 2018
2018-12: ISO/TC215 resolves to Approve changing the time frame from 36 to 48
months for ISO/AWI 21860 Health informatics -- Reference Standards Portfolio for
Clinical Imaging (RSP-CI)
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ISO/TC215 WG2, Approved Maringa Resolutions
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2018-13: ISO/TC215 resolves to Approve the following title change: ISO/AWI TS
22077-5 Health Informatics - Medical waveform format -- Part 5:
Electroencephalography (EEG) to ISO/AWI TS 22077-5 Health Informatics - Medical
waveform format -- Part 5: Neurophysiological Signals
2018-14: ISO/TC215 resolves to Approve ISO/PWI TR 22228 Health Informatics --
Healthcare applications of blockchain technologies for an 8-week NP ballot by 25
June 2018
ISO/TC215 resolves to Approve ISO/PWI 22690 Health informatics -- Reliability
assessment criteria for high-throughput gene-expression data for an 8-week NP
ballot by 25 June 2018.
2018-16: ISO/TC215 resolves to Approve the following title change: ISO/NP TS 22691
Health informatics -- Reliability assessment criteria for token-based document sharing
to ISO/NP TS 22691 Health Informatics -- Token-based health information sharing
2018-17: ISO/TC215 resolves to Approve the following title change: ISO/AWI TS
22692 Health informatics -- Reliability assessment criteria for quality control metrics
for DNA sequencing to ISO/AWI TS 22692 Health Informatics — Quality control
metrics for DNA sequencing.
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ISO/TC215 WG2, Approved Maringa Resolutions
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2018-18: ISO/TC215 resolves to Approve the following title change: ISO/PWI 23357
Clinical genomics data sharing specification to ISO/PWI 23357 Clinical genomics
data sharing specification for next generation sequencing and approves the
circulation to ISO/PWI 23357 Clinical genomics data sharing specification for next
generation sequencing for an 8-week NP ballot by 25 June 2018
2018-19: ISO/TC215 resolves to Approve the following title change: ISO/AWI 25720
Health informatics -- Whole genome sequence markup language (WGML) to ISO/AWI
25720 Health informatics – Genomic Sequence Variation Markup Language
(GSVML)
2018-20: ISO/TC215 resolves to Approve ISO/PWI Health informatics -- Whole
genome sequence markup language (WGML) to be added to the WG2 work
program
2018-21: ISO/TC215 resolves to Approve ISO/PWI Elderly homecare system to be
added to the WG2 program. (Is there target IS, TS, TR)
2018-22: ISO/TC215, resolves to Approve Mr. Eduardo Mugnai ABNT, be appointed
liaison to ISO/TC 307 Blockchain and distributed ledger technologies.
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ISO/TC215 WG2, Other activities
The Japanese active in proposing new device standards
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ISO/TC215 WG2, Other activitiesAging in Community report, unpublished draft
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1. Abbreviations
2. Introduction
2.1. General 2.2. Survey national challenges & activities (esp. P-Members)
2.2.1. Progressive Standards project in EU
3. Catalog of representative use cases / scenarios
3.1. Identified use cases
3.1.1. Healthy Aging by building a healthy habit: write it and do it.
3.2. Requirements & Business Drivers / Inhibitors
4. Assess related (technology /) standards activities
4.1. ISO/TC 314 Aging societies (4.1.1. Present 4.1.2. Future)
4.2. IEC/SyC AAL Active Assisted Living (4.2.1. Present 4.2.2. Future)
4.3. ISO/TC 173 Assistive products (4.3.1. Present 4.3.2. Future)
4.4. IEEE 11073/Personal Health Devices (4.4.1. Present 4.4.2. Future)
4.5. ISO/TC 184, Automation systems and integration (4.5.1. Present 4.5.2. Future)
4.6. ISO/TC 43 Acoustics (4.6.1. Present 4.6.2. Future)
4.7. <Other standardisation committees> (4.7.1. Present 4.7.2. Future)
4.8. Other activities and documents
5. Conceptual Framework / Model
6. Recommendations for TC 215 (6.1. RSPs 6.2. Liaisons & Joint Work (SyC AAL, JTC1,
PCHA/Continua, 6.3. Roadmap)
7. Bibliography
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ISO/TC215 JWG7, Approved Maringa Resolutions
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2018-37: ISO/TC215 resolves to Approve a parallel ISO and IEC circulation of ISO/CD
81001-1 Heath informatics - Health software and health IT systems safety,
effectiveness and security -- Part 1: Foundational principles, concepts, and
terms for CD for 8-week comment only by 1 July 2018.
2018-38: ISO/TC215 resolves to Approve a parallel ISO/NP and IEC/NP circulation of
IEC 80001-5-1: Safety, effectiveness and security in the implementation and use of
connected medical devices or connected health software - Part 5: Security - Part 5-1:
Activities in the product lifecycle to be added to the JWG7 work program.
2018-39: ISO/TC215, noting that Mr. Todd Cooper, the current project leader for the
revision of IEC 80001-1 is stepping down from that role, resolves that Mr. Stuart
Harrison (UK) is appointed as the new ISO project co-leader for the revision of
IEC 80001-1.
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ISO/TC215 JWG7, Other activities
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ISO/TC215 JWG7, Other activities
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ISO/TC215 JWG7, Other activities
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ISO/TC215 JWG7, Other activities
81001-1 is supposed to be the standard which defines
the terms for 80001-X-X and 62304, 82304,…
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ISO/TC215 JWG7, Other activities
Bad news from ISO/IEC 62304 development
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ISO/TC215 JWG7, Other activities
A reason for ISO 62304 ed. 2 rejection
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IEEE 11073 Point of Care Devices update
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IEEE 11073 Point of Care Devices update
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IEEE 11073 Personal Health Devices updateSitges, Barcelona June 2018
Face-to-face meeting in Barcelona 1.6.2018
The core standard 11073-20601 being updated
PHD – FHIR connection being developed
Cybersecurity report of PHD being crafted14/06/2018 Alpo Värri 22
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Date and Location of next Meetings
ISO/TC215 & CEN/TC251, October 22-26, 2018,
Paestrum, Italy
CEN/TC251/WG II, not planned yet
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