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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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