work group 1: data structure preliminary work items … · 1 iso / cd 13606-3 iso/np 13606-part...

WG ISO # ISO Title PLs Current Stage Stage desc at time of this report As of this date If currently in ballot: date

open

If currently in ballot: date

closes

Other key info Other key info SKMT Status Resolutions

1 ISO/DTR 13054-2

Knowledge management of health information standards-Part 2

00.00 2012/11/25

1

1 ISO / CD 13606-1

ISO/NP 13606-Part 1: Reference Model, Health informatics – Electronic Health Record Communication Part 1 Reference Model

BSI; Dipak Kalra

20.20 2012-09-04: NP Ballot N1051 closed, passed, NP results w/form 6 posted as N1131.

2013/01/08 Vancouver 5

1 ISO / CD 13606-2

ISO/NP 13606-Part 2: Archetype Specification, Health informatics – Electronic Health Record Communication Part 2: Archetype Specification

BSI; Dipak Kalra



1 ISO / CD 13606-3

ISO/NP 13606-Part 3:Health informatics – Electronic Health Record Communication Part 3: Reference Archetypes and Term Lists

BSI; Dipak Kalra

20.20 2012-09-04: NP BallotN1053 closed, passed, NP results w/form 6 posted as N1133.


1 ISO / CD 13606-4

ISO/NP 13606- Part 4: Security, Health informatics – Electronic Health Record Communication Part 4: Security

BSI; Dipak Kalra

20.20 2012-09-04: NP BallotN1054 closed, passed, NP results w/form 6 posted as N1134.


1 ISO / CD 13606-5

ISO/NP 13606 – Part 5, Health informatics – Electronic Health Record Communication Part 5: Interface Specification

BSI; Dipak Kalra



1 ISO / DTS 18530

TS - Health informatics – Automatic identification and data capture marking and labeling - Subject of care and individual provider identification

Mr. Christian Hay

30.20 NP Passed. Results & form 6 posted as N1116. In DTS ballot - launched 2012-11-10, closes 2013-02-10.

2013/01/08 2012/11/10 2013/02/10 JIC 2012-09-04: NP Ballot closed, item passed, results N1049. Form 6 posted as N1116.

Vancouver 10; Vienna 6

1 ISO/ DTS 13972 Pts 1 & 2 merged - new name: HI, TS, Detailed clinical models-detailed clinical models, charateristics and processes

Mr. W Goosen

30.20 Vienna R5. CD ballot initiated opened 2012-10-31, closes 2013-01-31.

2013/01/08 2012/10/31 2013/01/31 JIC; HL7 (1) Name changed. (2)Vancouver R4: Parts 1 & 2 publish as single TS w/content of the former parts placed in new document, and normative and informative sections clearly identified.


1 ISO / NP 17537 Electronic Health Records [EHR-CR] Clinical Research Functional Profile

Mr Peter Knight (BSI); Mathias Pogensen

10.60 Per WG1 Vienna minutes: Project has been delayed for many reasons; decision made to continue.

2013/01/08 Proposed JIC project 2011-09-27: N855, passed NP | Schedule next for DTR FDIS

Rotterdam 4

1 ISO / NP/ TS 18528

TS - Health informatics, Functional classification health informatics standards

Mr. Andrew Grant (CAN)

10.20 NP ballot N1089 closed 2012-12-14, passed results w/form 6 posted as N1110.

2013/01/08 NP results N1110 Vancouver 48

1 ISO /HL7 / DIS 10781-2

Electronic Health Record-System Functional Model, Release 2 (EHR FM)

Mr. G. Dickinson (CentriHealth)

40.99 Completed DIS 2012-09-26, passed. Project team is reviewing comments, preparing FDIS. Lisa S to meet w/PL @ HL7 in Jan 2013 to discuss next steps.

2013/01/08 HL7, JIC; Revision of ISO/HL7 10781:2009

1 ISO /HL7 / DIS 16527

Personal Health Record System Functional Model, Release 1 (PHRS FM):

Mr. G. Dickinson (CentriHealth)

40.20 DIS ballot opened 2012-11-05, closes 2013-02-06. Lisa S to meet w/PL @ HL7 in Jan 2013 to discuss next steps.

2013/01/08 2012/11/05 2013/02/06 Vancouver R#49: Task for secretary to request extension completed 13 June 2012 - 15 days ahead of schedule. ISO approved, is moved to track 3.

Vancouver 49 & 50

WORK GROUP 1: DATA STRUCTURE Preliminary work items

Active work items

WG ISO # ISO Title PLs Current Stage Stage desc at time of this report As of this date If currently in ballot: date

open


closes


1 ISO/NP TR 14639-2

TR - Health informatics - eHealth Enterprise Architecture for emerging and developing countries -- Part 2: Business Requirements

Mr. P. Whitaker (WHO)

10.60 Project was delayed. Updated in Vienna R4: DTS text expected 15 January 2013.

2013/01/08 -

1 ISO / DIS 13940 System of concepts to support continuity of care [ContSys]

40.20 DIS ballot expected to open 2012-12-13 2013/01/08 2012/12/13 2012/05/13 Chicago 12

1 ISO/ TR 14639-1

Health informatics, Capacity-based eHealth architecture roadmap part 1: Overview of national initatives [eHealth Enterprise] Architecture for emerging and developing countries -- Part 1: Environmental Scan - TR

Mr. P. Whitaker (WHO)

60.60 Published 2012-08-08 - congratulations! 2012/08/01 - Kuopio 84Chicago 31 Vancouver 51

1 ISO/PRF TR 14292

Health informatics, Personal health records, Definition, scope and context

- 60.00 Published 2012-03-09 - congratulations! 2012/08/01 - Kuopio 85

1 ISO/DTR 13054-1

Knowledge management of health information standards, Part 1

- 60.60 Published standard. Congratulations! Next review is in 2016.

2012/08/01 - Chicago 30

1 ISO 13606-1:2008 (Ed. 1)

HER communication - Part 1: Reference model

- 90.60 Published standard. Next review is in 2016. 2012/08/01 Kuopio 13

1 ISO/NP TS 16555

Framework for National Health Information Systems

Mr. R. Krishnarmurthy (WHO)

10.99 Vienna R2: To withdraw 16555 from work program. 2012/11/21 Vienna 2

1 ISO/HL7 NP 13972

Health informatics - Quality Requirements and Methodology for Detailed Clinical Models [DCM] - Note: Splitinto two parts - see below

Dr. W. Goosen (NEN)

10.99 New project approved - split into two parts VA: ISO LeadWI: 00251248CEN/TC 251Vote in parallelCritical: DIS limit date exceeded; risk of automatic cancellation if no action taken (development track rules)

N724 - voting results (2009-07-29) | approved as WD | 2011-11-14: Final version of ISO 13972-2 DCM received

Chicago 2

1 13972-1 HI- Detailed Clinical Models [DCM]- Part 1: Quality processes regarding detailed clinical model development, governance, publishing and maintenance

W Goosen 30.20 Vancouver: (a)Approves WG1 recc that 13972 be re-targeted for pub as a TS (b) Approves recc hat 13972 Parts 1 & 2 be published as a single TS Technical Specification, with the content of the former parts appropriately placed within the new document, and normative and informative sections be clearly identified.

2012/04/10 - 2012-03-03: CD ballot closed, results circulated. N958

Kuopio 14Kuopio 15Chicago 2

1 13972-2 HI- Detailed Clinical Models - [DCM]- Part 2: Quality attributes of DCMs

W Goosen 30.20 2012/04/10 - 2012-03-03: CD ballot closed, results circulated. N959

Kuopio 16Kuopio 17Kuopio 18Chicago 3

Recently Published Standards

WG ISO # ISO Title PLs Current Stage

Stage desc at time of this report As of this date If currently in ballot: date

open


closes

Other Key Info Other Key Info SKMT Status

Resolutions

2 PWI PWI - Clinical trials - Registration and reporting [CTR&R]

Bron Kisler, CDISC

00.00 This project will start once BRIDG [14119] is underway

2012/11/25 Rotterdam 6 Kuopio 20

2 ISO CD 14199 HI-The BRIDG Domain Analysis Model for Protocol-driven biomedical Research

Bron Kisler, CDISC

00.00 Prior verison deleted; new NP [which will go NP to DIS] before mid - Aug 2012. Lead: Bron Kisler - CDISC

2012/11/25 - Vancouver 13 & 14

2 ISO / HL7 / DIS 21731-2

Health informatics, HL7 v3 3 - Reference information model [RIM] - R 1 -2

W Beeler 40.20 DIS closed 2013-01-07. Passed; DIS results N 1124

2013/01/10 Chicago 5 Vancouver 12

2 ISO / CD 17583 Health informatics, Terminology constraints [Binding] for coded data elements expressed in ISO harmonized data types used in healthcare information interchange

Beeler, Klein, Glickman

30.99 2012-09-14: CD ballot approved; closed, results N1058.

2013/01/10 Vancouver 11

2 ISO / DTR 28380-1

Health informatics, Messages & communication - IHE Global Standards Adoption Process -- Part 1: Process

Michael Nusbaum (CAN)

TBD Previous version has been updated. IHE is updating graphics and then will be submited for TR ballot

2013/01/10 Vienna 10

2 ISO/ DTR 28380-2

Health informatics, Messages & communication - IHE Global Standards Adoption Process -- Part 2: Integration and Content Profiles [TR]


30.99 Updating previous version. 2013/01/10 - CIB ballot closed 2008-09-14 - approved DTR to proceed to publication.

Chicago 6

2 ISO/ DTR 28380-3

Health informatics, Messages & communication - IHE Global Standards Adoption Process -- Part 3: Deployment [TR]


10.99 Discussed in Vienna; draft expected in early 2013.

2013/01/10 - NP ballot closed 2012-04-27, approved to move to next level committee draft

Chicago 6

2 ISO / NP 12974 Health informatics, Web access to DICOM persistent objects by means of web services extension of the retrieve service [WADO web service]

- 10.60 2013-01-10: See note from Cor L on next step. To be discussed at HL7-DICOM mtg 18 Jan 2013.

2013/01/03 - WG2: Please provide update. NP ballot closed 2008-10-13; results N653; Is this Chicago Res 7? Text was due 29 Feb 2012. Will be cancelled if status not provided soon.

Chicago 7 ?

2 ISO / NP / TR 17522

Health informatics, Provisions for Health Applications on Mobile / Smart Devices [TR]

Mr. I. Kim (Chungbuk University)

10.60 From WG2 Vienna presentation: ISO/TR 17522 Reviewed a CD of the TR from Korea; PL will revise to extend it to include devices used in lower, middle-income countries and to provide a framework for further standards to address the issues raised in the DTR; Submit revised DTR to WG vote, including a vote on whether to seek approval from TC for a DTR ballot

2013/01/03 - 2011-10-10: N872 NP voting results;

WORKING GROUP 2: DATA INTERCHANGE Preliminary work items

Active work items



open


closes

Other Key Info Other Key Info SKMT Status

Resolutions

2 ISO / NP / DTS 13131

Health informatics, Quality criteria for services and systems for telehealth [DTS]

- 30.99 CD approved for DIS. Notes from Vienna WG2 report: ISO/DTS 13131 HI-Quality criteria for services and systems for Telehealth; Discussed work plan with PL Revise and submit to Expert review; Then to WG 30-day review and ballot with consideration of approval for a second DTS ballot

2012/11/25 - CD ballot, approved; closed 2012-03-09 - vote results N878

Kuopio 23

2 ISO / HL7 / DIS 13449

Health informatics, Clinical genomics pedigree topic

Amon Shabo, IBM

40.60 This project has passed critical FDIS limit date and will likley be cancelled. Lisa S to meet w/PL at HL7 in Jan 2013 to get info

2012/11/25 Last reults N878 Kuopio 21

2 ISO TR 13128 Health Informatics, Clinical document registry federation [DTR]

- 60.60 TR published in June 2012 - congratulations!

2012/07/16 - Kuopio 22

2 ISO/PRF 10159 Health informatics -- Messages and communication -- Web access reference manifest

- 60.00 International Standard Published

2 ISO/HL7 21731:2006

(Ed. 1)

Health informatic, ISO/HL7 v3 - Reference information model [RIM] -R1

Gary Dickenson 90.60 Published. Next SI is 2014 External reference: HL7 RIM R1-2003

Chicago 5



Stage desc at time of this report As of this date

If currently in ballot: date open

If currently in ballot: date closes

Other key info Other key info SKMT Status

Resolutions

3 ISO PWI Conceptual framework for representation of sites in body surface non-chemical stimulation

PWI 2012/11/25 Vancouver 19

3 ISO / PWI Conceptual framework for representation of treatment and diagnostic non-chemical stimulation methods

PWI 2012/11/25 Vancouver 20

3 ISO / PWI Principles and guidelines for the measurement of conformance in the implementation of terminological resources

PWI 2012/11/25

ISO / PWI New project based on EN12264 Vienna R17. [WG3-R6] 2012/11/25 Vienna R17. [WG3-R6] an NP based on EN12264 Categorial Structures for Systems of Concepts be added to the TC 215 work program as a PWI which will include relevant content from ISO 17115 which will subsequently be withdrawn

3 ISO 17115 : 2007

Vocabulary for terminological systems for systematic review

PWI Vienna R17. [WG3-R6] 2012/11/25 Vancouver 17.) Revision of ISO 17115:2007, Vocabulary for terminological systems – Resolved that ISO/TC 215 - Approves the WG 3 recommendation that the above mentioned project be added to the TC 215 Program of Work as a Preliminary Work Item as per the results of the 2011Systematic Review; and Instructs the TC 215 Secretary to inform ISO Central Secretariat of this decision and add the project to the TC 215 Program of Work.


3 ISO/NP TS 17117-1

Health informatics, Terminological resources --- Part 1: Characteristics

T. Imai (JISC Experts)

10.60 Project was delayed but has resumed. WG3 Dec 2012 conf call: PL said draft was sent to WG3 to be circulated and reviewed.

2013/01/07 Revision of ISO/TS 17117:2002 |

2011-05-13: NWIP results posted-N842. |

Kuopio 40

Work Group 3: Semantic content Preliminary work items

Active work items






Resolutions

3 ISO/DTS 13582

Health informatics, Sharing of OID Registry information [Shared w/WG2]

- 50.00 Vienna 12. [WG3-R1] | TC215 secretary sent TS draft 2012-12-04 for final ISOCS review and posting.

2013/01/07 Former name: Communication model and XML-interface specification for OID Registries Name change

N711 - voting results (2009-06-18); Project approved; but is now past FDIS. | 2012-02-09: Requested ISO to move from track 2 [36 months] to track 3 [ 48 months].

Istanbul 21 Vancouver24; Vienna 12

3 ISO/NP TR 14668

Health informatics, Guidelines for principles and desirable features of clinical decision support systems

H. Grain (SA Experts)

10.60 2013/01/07 - 2012-01-31: NP ballot closed 2009 - N746 results. Need update from WG3 or it will get cancelled.

Kuopio 31Kuopio 32Kuopio 33Kuopio 34Kuopio 35Kuopio 36

3 ISO/NP TS 16843-1

TS - Health informatics, Categorial structures for representation of acupuncture, Part 1: Acupuncture points

T. Togo (JISC_249)

10.60 Project was delayed, work is to have re-started. Might transfer to new JWG1.

2013/01/07 NP voting closed 2011-02-12: Results - N835 | May 2012: Proposed as probable for new JWG10 [Traditional Chinese Medicine] work program which is TBD until co-conveners elected. JWG10 to meet in Vienna so expect update at that time.

Kuopio 40

3 ISO/NP TS 16843-2

TS - Health informatics, Categorial structures for representation of acupuncture -- Part 2: Needling

T. Togo (JISC_249)

10.60 Project was delayed, work is to have re-started. Might transfer to new JWG1.

2013/01/07 NP voting closed 2011-02-12: Results - N836 | May 2012: Proposed as probable for new JWG10 [Traditional Chinese Medicine] work program which is TBD until co-conveners elected. JWG10 to meet in Vienna so expect update at that time.

Kuopio 40

3 ISO/NP TS 17439

TS - Health informatics, Structure and maintenance of the health informatics glossary

Ms. H. Grain (SA Experts)

20.00 2013/01/07 - 2011-10-10: NP passed; N871 results posted N871. | 2012-01-30: Need status update.






Resolutions

3 ISO / CD 17583

Terminology constraints for coded data elements expressed in ISO Harmonized Data Types used in healthcare information interchange [Binding] [Note: this item is shared w/WG2]

G. Beeler (ANSI Experts)W. Klein (ANSI Experts)

30.99 CD approved for DIS; results posted as N1058. Next stage text in preparation.

2013/01/07 2011-07-08: NP results posted N857. CD results N1058.

Kuopio 24

3 ISO / DTS 17938

TS, Semantic network framework and coding of Traditional Chinese Medicine language system

- 20.00 Vienna 19. [WG3-R8] Lisa posted draft text from PL for WG 3 review. Text was due to secretary 2013-12-15.

2013/01/07 NP ROV published as N1003. CD text is on WG3 site on eCommittee as N0011

NP ballot closed 2012-02-23. Passed- Results N924; May 2012: Proposed as probable for new JWG10 [TCM] work program which is TBD until co-conveners elected. JWG10 to meet in Vienna so expect update at that time. 2012-05-18: NP passed, approved for DTS/FDIS.

Chicago 13; Vienna 19

3 ISO / DTS 17948

TS - Health Informatics -- Traditional Chinese medicine literature metadata

- 20.00 Vienna 19. [WG3-R8] Lisa posted draft text from PL for WG 3 review. Text was due to secretary 2013-12-15.

2013/01/07 NP ROV published as N1002. CD text is on WG3 site on eCommittee as N0013

NP ballot closed 2012-02-26 - Passed N928. May 2012: Proposed as probable for new JWG10 [Traditional Chinese Medicine] work program which is TBD until co-conveners elected. JWG10 to meet in Vienna so expect update at that time.

Chicago 10, Vienna 18

3 ISO / TS 18062 TS - HI- Categorical structure for representation of herbal medicaments in terminological systems

- 20.00 2013/01/07 Was delayed due to past admin issues which have been resolved. N1020 replaces N1018 - has been updated w/corrected info regarding experts & been formally registered in TC/215 work programme with a new start date of 2012-10-22.

NP ballot closed 2012-03-20, results N934. May 2012: Proposed as probable for new JWG10 [TCM] work program which is TBD until co-conveners elected. JWG10 to meet in Vienna so expect update at that time.

Chicago 9






Resolutions

3 ISO / NP / TS 16277-1

Health informatics, Categorial structures of clinical findings in Traditional Medicine: Part 1: Traditional East Asian Medicine

Dr Park, Korea 10.99 Is behind schedule and at risk w/ISOCS. CD draft is supposed to be circulating per WG3 Dec 2012 Mtg notes.

2013/01/07 NOTE: FDIS limit date is 2012-11-08; May 2012: Proposed as probable for new JWG10 [TCM] work program which is TBD until co-conveners elected. JWG10 to meet in Vienna so expect update at that time.

NP approved in 2010 - NP results N779| / 2012-01-23: Notes from WG3 mtg; CD due Feb 2012. Past name: TS HI- Structure of representation of clinical findings in traditional medicine - Part 1: Traditional East Asian Medicine | Name change:


3 ISO / DTR 12300

TR, Principles of mapping between terminological systems[DTR]

Heather Grain (AUS)

30.60 Vienna 14. [WG3-R3] - Draft still in development post-Vienna - is behind schedule.

2013/01/07 N804-2010-10-06:

2011-01-10: N820 - voting results | 2012-01-31: DTR ballot complete and posted as N820. CD ballot closed 2011-11-22 - results N820

Kuopio 29Kuopio 30; Vienna 14

3 ISO / CD 16278

IS, Identification of the status of structures for representation of human anatomy within healthcare terminological systems

M. J. Rodrigues (AFNOR Experts)

30.60 2013/01/07 - N780 - voting results (2010-05-26); approved as WD. | NP closed 2012-03-02, approved N950.

Kuopio 28

3 ISO / DIS 18104

Health informatics, Categorial structure for representation of nursing diagnosis and nursing actions in terminological systems

- 40.20 In DIS ballot, opended 2012-08-23, closes 2013-01-23 so NXXX.

2013/01/07 2012/08/23 2013/01/23 VA: ISO LeadWI: 00251257CEN/TC 251Vote in parallelRevision of ISO 18104:2003

2011-05-19: N843 - voting results | 2

Kuopio 38 Vancouver 22

3 ISO / FDIS 13120

Health informatics, Syntax to represent the content of healthcare classification systems, Classification Markup Language (ClaML)

Ronald Cornet,

50.00 In DIS ballot through 2013/02/14 2013/01/07 2012/12/13 2013/02/14 VA: ISO LeadWI: 00251237CEN/TC 251Vote in parallel

2011-10-13: Vote results reported N881; approved on balloting portal (2011-09-23) |

Vienna 15

3 ISO/DIS 13940 Health informatics, System of concepts to support continuity of care [ContSYS]

- 40.00 DIS ballot opens 2012-12-13, closes 2013-05-14.

2013/01/07 2012/12/13 2013/05/14 Merged from ISO/CD 13940-1 and ISO/CD 13940-2

N838 - voting results (2011-06-02); approved as WD;

Kuopio 37Chicago 12 Vancouver 21; Vienna 21

3 ISO/DIS 1828 Categorial Structure for Terminological Systems of Surgical Procedures

- 60.60 IS published 2012-09-12! Kuopio 39

3 ISO/FDIS 13119

Health informatics -- Clinical knowledge resources -- Metadata

- 60.60 IS published 2012-10-26. Congratulations! VA: CEN LeadWI: 00251236CEN/TC 251Vote in parallel

2011-10-13: DIS vote results N880.







Resolutions

13940-1 & 2 Note: 13940 1 & 2 were merged into 13940

3 ISO / NP TR 12310 HI- Principles and guidelines for the measurement of conformance in the implementation of terminological systems

- 10.98 NP ballot closed 2008-02-29 - N622…. 2012-01-31: Cancelled and moved to PWI per Vancouver R16.

2012/04/10 - 2008-06-16-Passed - N622 NP first draft expected by 2008-10 | 2012-01-31: No movement since 2008 - still in process?

3 ISO/NP TR 12975 HI- Guidelines for the maintenance of terminological systems

- 10.98 NP ballot closed 2008-02-29-N622. No activity since 2008 - project cancelled.

2012/04/10 - N659 - voting results (2008-11-11)

3 ISO/NP TR 13581 Health informatics, Guidance for maintenance of object identifiers OID

- 10.98 Cancelled by committee May 2012. NWIP voting closed 2009-06-11. WG3 indicated that this is delayed. When expected to get started again? No activity since 2009 - project cancelled.

2012/04/10 2012-010-31: Update from WG 3 - work is delayed see notes from WG tele-conferece 2012-01-23.

3 ISO/DTS 13582 Health Informatics - Communication model and XML-interface specification for OID Registries

- 30.20? 2012-05-21: New DTS text NXXX provided for DTS ballot.

2012/05/25 Warning: Six months or less until FDIS limit date (dev track rules) - FDIS was to have been completed by 2012-08-03

N711 - voting results (2009-06-18); Project approved; but is now past FDIS. | 2012-02-09: Requested ISO to move from track 2 [36 months] to track 3 [ 48 months].

Istanbul 21 Vancouver24




open



4

4

4 ISO / TR 18638 Components of education to ensure health information privacy

Mee Jeong Lee 20.00 Passed NP ballot ROV 1078. Draft should be in development

2013/01/08 N1040: NP ballot. N1078: NP ROV

Vancouver 27

4 ISO 17090-1 Health informatics - Public Key Infrastructure - Part 1: Overview of digital certificate services

50.00 2012-11-12: (1) TC secretary uploaded documents to ISO/CS for FDIS | Vienna R24. [WG4-R2]

2013/01/08 Will enter dates when I receive from

ISO-CS

Will enter dates when I receive from ISO-CS


4 ISO 17090-2 Health informatics - Public Key Infrastructure - Part 2: Certificate profile

30.20 2012-11-14: CD ballot N1076, opened, closes 2012-01-14 . Vienna 25. [WG4-R3]

2013/01/08 2012/11/14 2013/01/14 CD ballot N1076 Vienna 25

4 17090-4 Health informatics, Public key infrastructure-Part 4: Digital signatures for healthcare documents

- 20.00 Was discussed in Vienna, work is ongoing.

2013/01/08 N532 Draft 17090-4 2012-07-30 PKI Part 4:Digital signatures for healthcare documents

Chicago 24

Vienna 26

ISO / TR 17791 TR - Health informatics, Guidance on Standards for Enabling Safety in Health Software [working w/JWG7 [TC215 WG7 & IEC62A]

Mr. D. Newsham (SCC Experts)

20.00 Vienna 26. [WG4-R4] - Text was due to TC secretary 15 December 2012. Lisa S checking status

2013/01/08 Associated committee: IEC/TC 62

2011-22-02: N909 NP vote results; approved; working w/JWG7. || Note: Ballot for JWG w//IEC 62A is out for ballot in IEC -NP in IEC 62A is out for ballot, closing 2012-04-06. -

Kuopio 47, Vienna 26

Vienna 27

New - NP coming ISO/TS Pseudonymization 25237:2008 | New work item -

10.00 Vienna R27 [WG4-R5 : Text not yet delivered - was due Oct 1

2013/01/08 Vienna 27

Working Group 4: Privacy, Safety, and Security

Preliminary work items [PWI]

Active work items




open



4 & 1 ISO / NP 13606-4 Health informatics, EHR Communication Part 4 - Security [Doing jointly w/WG1]

20.20 NP N1054 passed, results w/form 6 posted as N1134; Text should be in development & disp comments.

2013/01/08 NP ballot closed 2012-09-04; passed, results N1054; Updated w/form 6 as 1134

4 ISO/NP 21549-2 Health informatics, Patient healthcard data -- Part 2: Common objects

Mr. I. Emelin (GOST R Experts)

40.20 DIS closed 2012-11-28; Passed, DIS ROV is N1139. |Text should be in development & disp comments.

2013/01/08 Revision of ISO 21549-2:2004

2011-11-02: N906 NP vote results; approved as CD

Kuopio 48Chicago 16

4 ISO/NP 21549-3 Health informatics,, Patient healthcard data -- Part 3: Limited clinical data


40.20 DIS closed 2012-11-28; Passed, DIS ROV is 1140

2013/01/08 Revision of ISO 21549-3:2004


Kuopio 49Chicago 17

4 ISO/NP 21549-4 Health informatics, Patient healthcard data -- Part 4: Extended clinical data


40.20 DIS closed 2012-11-28; Passed, DIS ROV is 1141

2013/01/08 Revision of ISO 21549-3:2006


Kuopio 50Chicago 18

4 ISO / NP 21549-5 revises ISO 21549-

5:2008

Health informatics, Patient healthcard data-Part 5: Identification data - NP for the revision of 21529-5:2008

10.60 NP not pass, short an expert; asked WG for feedback - find expert or fail item. 2013-01-08: Austria provided expert, but still one short.

2013/01/08 Vancouver 28

4 ISO 21549-7 Health informatics, Patient healthcard data-Part 7: Medication

10.20 Vancouver R30: NP due 6 Aug 2012 - text not yet delivered; Sent inquiry to WG; 2013-01-08:

2013/01/08 Vancouver 30

4 ISO / DTS 17975 Health informatics, Principles and data structures for consent in the collection, use or disclosure of PHI [TS]

E Sawatsky (scc) 20.00 2012-06-15: NP approved for DTS-FDIS From WG4 Vienna report: Discussed in Vienna, text expected before May 2013

2013/01/08 NP form 6 N975

4 ISO/NP 16864 Health Informatics, Data protection in trans-border flows of personal health information

Mr. L. Posthumus (NEN Experts)

10.60 2012-08-01: ISO 16864 to replace ISO 22857. Migration path discussed in Vienna

2013/01/08 - 2011-03-24: N833NP vote results - N903 - revised voting results (2011-11-02); approved as WD

Kuopio 43




open



4 ISO / DIS 20301 Health informatics -- Health cards -- General characteristics

Mr. M. Yachida (JISC_JTC1)

40.60 Passed - approved for FDIS, results posted as N1136. | Sent question to WG4-- proceed to publication or go through FDIS?

2013/01/08 Revision of ISO 20301:2006

2011-11-02: N904 NP vote results; approved as a CD; DIS ROV 1136

Chicago 20

4 ISO/NP TS 14441 HI-- Security and privacy requirements for compliance testing of EHR systems -- Part 1: Foundation

- 30.99 In DTS ballot, will close 2013-03-07

2013/01/08 2012/11/26 2013/03/07 VA: ISO LeadWI: 00251258CEN/TC 251Vote in parallel

2009010-07: N741 - voting results; approved as WD

Chicago 27

4 ISO/NP TS 14441-1 Health informatics -- Security and privacy requirements for compliance testing of

- 30.20 In CD / Study ballot Changed to 14441 when 14441 2 withdrawn

2012/02/02 2012/01/14 2012/04/14 VA: ISO LeadWI: 00251258

2009010-07: N741 - voting results; approved

Chicago 27

4 ISO/NP TS 14441-2 Health informatics -- Security and privacy requirements for compliance testing of

- 10.99 New project approved Wthdrawn from work programme

2009/10/01 VA: ISO LeadWI: 00251259

N742 - voting results (2009 10 07) 2011 10

Chicago 26

4 ISO/DIS 22857 (Ed 2)

Guidelines on data protection to facilitate trans-border flows of personal health data

40.60 ISO 16864 replace ISO 22857. Migration path discussed in Vienna - ongoing work.

2013/01/08 Secretary filed an extension - extended to 2013-10-30;

DIS opened by ISO/CS: 2011-06-28; closed 2011-11-28 -Passed 17/18 - post results

Vancouver 33

4 ISO TR 21298:2008

Revision of ISO 21298, Health informatics, Functional structure and roles

TBD Text not yet delivered, discussed in Vienna, ongoing work

2012/11/25

Vienna 30

ISO / DIS / SR 21549-1

Health informatics, Patient healthcard data part 1: General structures

L Fourquet 50.00 In FDIS proofing w/ISOCSFDIS ballot opens 2013-01-31 and close 2013-04-01 - on Mexico agenda only if questions.

2013/01/08 2013/01/31 2013/04/01 Vienna 30;

4 ISO/DIS 27789 Health informatics -- Audit trails for electronic health records

- 50.20 In FDIS ballot 2012/11/25 2012/11/15 2013/01/16 VA: ISO LeadWI: 00251215CEN/TC 251Vote in parallel

Opened by ISO/CS on 2011-11-03; End date: 2012-01-03 - Passed 17/19 - post results.

Kuopio 42

4 ISO/FDIS 21091 HI- Directory services for healthcare providers, subjects of care and other entities

- 50.60 FDIS ballot started 2012-11-01 thru 2013-01-02

2012/11/25 2012/11/01 2013/01/02 VA: ISO LeadWI: 00251234CEN/TC 251Vote in parallelWarning: Six months or less until FDIS limit

2011-10-17: DIS voting results - N890; approved on balloting portal (2011-09-16) |

Chicago 15

Vienna 23

ISO 16114 ISO 16114-Health Informatics – Security aspects of EHR migration - to be withdrawn

Vienna 23. [WG4-R1] ISO 16114 be withdrawn from the TC 215 Program of Work and the intent that an NP with a broader scope will be submitted in the future...

Vienna 23

4 ISO 25238 Classification of safety risks 90.60 SR review completed 2010

Recently Published Standards / Completed Work




open



4 ISO 17090-1:2008 (Ed. 1)

HI- Public key infrastructure -- Part 1: Overview of digital

- 90.60 SR review outcomes submitted; must progress to new NWIP

2012/09/11 Revision of ISO/TS 17090-1:2002

N - ?

Chicago 21

4 ISO 17090-2:2008 (Ed. 1)

HI-- Public key infrastructure -- Part 2: Certificate profile

- 90.60 SR review outcomes submitted; must progress to new NWIP


N - ?

Chicago 22

4 ISO 17090-3:2008 (Ed. 1)

HI -- Public key infrastructure -- Part 3: Policy management of

- 90.60 No revisions required. To be submitted to ISO/CS


N - ?

Chicago 23

4 ISO 27799:2008 (Ed. 1)

HI-- Information security management in health using

- 90.60 Close of review 2011/09/17 VA: ISO LeadWI: 00251184

/ N - ?

4 ISO 21549-7 (Ed. 1)

Health informatics -- Patient healthcard data -- Part 7:

- 90.60 Close of review 2010/09/17 VA: ISO LeadWI: 00251176

/

N - ?

Chicago 19

4 ISO/TS 22600-1:2006 (Ed. 1)

Health informatics -- Privilege management and access

- 90.60 2012-08-02: SR documents received & submitted to ISO/CS

2012/08/02 Will enter dates when ISO

Will enter dates when ISO opens

-N - ?

Kuopio 44

4 ISO/TS 22600-2:2006 (Ed. 1)

Health informatics -- Privilege management and access




-N - ?

Kuopio 45

4 ISO/TS 22600-3:2009 (Ed. 1)

HI-Privilege management and access control -- Part 3:




- - Kuopio 46

4 ISO/NP TR 16114 Health informatics, Security aspects of Electronic Health

P. Ruotsalainen (SFS)

10.60 Withdrawn from work program per Vienna 23.

2012/11/21 - 2010-05-25: N774 NP results; approved as

Vienna 23

4 ISO 21549-6:2008 Health informatics, Patient healthcard data-Part 6:

90.93 IS confirmed 2012/08/08 2012/11/21 Vancouver 29



open


closes


6 PWI Per Vienna agenda: Discussion of possible New Work Item Proposal – Dispense record

Work expected to commence in 2013

6 PWI Per Vienna agenda: Discussion of possible New Work Item Proposal – Compound medicine


6 PWI Per Vienna agenda: Discussion of possible New Work Item Proposal – Drug dictionaries


Vienna 33

ISO / NP TR 14872

Health informatics, Requirements for the implementation of the standards for the identification of medicinal products for the exchange of regulated medicinal product information [TR]

T. Buxton (EMEA) 10.60 Work had been delayed but has resumed. DTR text is expected by 15 Dec 2012 per Vienna R 33. [WG6-R2] - not yet received by TC secretary.

2013/01/08 - - Kuopio 68, Vienna 33

6 prEN / ISO/NP TS

17251

Health informatics, Business requirements for a syntax to exchange structured dose information for medicinal products [TS]

J. Goulding (BSI Experts)

10.60 Discussed in Vienna; Draft in process? 2013/01/08 2011-06-15: N851 NWIP 17251 vote results.

Kuopio 54

6 prEN /ISO/NP 17523

Health informatics, Requirement for electronic prescriptions

F. Elferink (NEN)Mr. I. Shepherd (BSI Experts)

20.00 Discussed in Vienna; CD draft in process

2013/01/08 VA w/ISO lead 2011-10-10: N874-vote results;

Kuopio 53

Vienna 32

ISO AWI TS 16791

Health informatics, Requirements for international machine-readable coding of medicinal product package identifiers

G. Hartley (GS 1 - NZ)

30.20 In FDIS/TS through 2013-03-19 2013/01/08 2012/12/19 2013/03/19 One year extension request filed by secretary 2012-06-14 per Vancouver R#37.

Rotterdam 38 Kuopio 55; Vienna 32

6 ISO/FDIS 11238

HI- Identification of medicinal products -[IDMP] - Data elements and structures for the unique identification and exchange of regulated information on substances

L. Callahan (ANSI Experts)

60.00 Congratulations - International Standard was published 2012-10-26!

2012/11/21 JIC project VA: ISO LeadWI: 00251227CEN/TC 251Vote in parallel

Kuopio 58Kuopio 59

6 ISO/FDIS 11239

HI- Identification of medicinal products -[IDMP] - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

R. Granados Martin (AENOR ISO Experts)



Kuopio 66Kuopio 67

6 ISO/FDIS 11240

HI- Identification of medicinal products -[IDMP] Data elements and structures for unique identification and exchange of units of measurement

C. Gessner (DIN Experts)



Kuopio 62Kuopio 63

Work Group 6: Pharmacy & Medicines Preliminary work items [PWI]

Active work items




open


closes


6 ISO/FDIS 11615

HI- Identification of medicinal products -[IDMP] - Data elements and structures for the unique identification and exchange of regulated medicinal product information

T. Buxton (EMEA) 60.00 Congratulations - International Standard was published 2012-10-26!


Kuopio 64Kuopio 65

6 ISO/FDIS 11616

HI- Identification of medicinal products -[IDMP] - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information

L. Grandia (IH SDO) 60.00 Congratulations - International Standard was published 2012-10-26!


Kuopio 60Kuopio 61

6 ISO/HL7 27953-1

Health informatics -- Individual case safety reports (ICSRs) in pharmacovigilance -- Part 1: Framework for adverse event reporting

- 60.60 Congratulations - International Standard published 2011-11-21!

VA: ISO LeadWI: 00251238CEN/TC 251Vote in parallelSplit from ISO/HL7 NP 27953

International Standard published 2011-11-21

Kuopio 56

6 ISO/HL7 27953-2

Health informatics -- Individual case safety reports (ICSRs) in pharmacovigilance -- Part 2: Human pharmaceutical reporting requirements for ICSR

- 60.60 Congratulations - International Standard published 2011-11-21!

VA: ISO LeadWI: 00251239CEN/TC 251Vote in parallelSplit from ISO/HL7 NP 27953

International Standard published 2011-11-21

Kuopio 57

Note: Per WG6 Vienna report: WG6 is preparing a plan for the ongoing maintenance of the IDMP standards.

WG ISO # ISO Title PLs Stage # at time of report


open


closes

Other key info Other key info Entered in SKMT?

Resolutions

ISO/PWI TR 11073-92205 Health informatics -- Medical waveform format -- Part 92205: Physiological report, HL7 CDA R2

00.60 Withdrawn per Vienna R37 [WG7-R2] 2012-08-07 Unknown-please update

ISO/PWI TR 11073-92206 Health informatics -- Medical waveform format -- Part 92206: Conversion from SCP-ECG format

00.60 Withdrawn per Vienna R37 [WG7-R2] 2012-08-07 Unknown-please update

Vienna 36

11073-10422 Health informatics -- Personal health device communication -- Part 10422: Device specialization -- Urine analyzer

- 10.60 Vienna R36. [WG7-R1] Regarding the Correction of ISO/IEEE Projects in the TC215 Program of Work, Resolved that ISO/TC215, Noting that the following work item was accidentally included in the list of work items to be removed from the work program in Resolution 40-Vancouver 2012 - ISO/IEEE NP 11073-10422 Health informatics — Personal health device communication — Device specialization — Urine analyzer — Part 10422 ISO/TC 215 agrees with the WG 7 recommendation that this work item be restored to the work program of ISO/TC 215 as a preliminary work item; and Reiterates that IEEE has been invited to submit this revised standard for Fast Track ballot and adoption by ISO/TC 215 in accordance with the ISO–IEEE Partner Standards Development Organization agreement

2012-11-21 - Vancouver Resolution 40 to remove was an error-remains on program

Unknown-please update

Kuopio 74; Vienna 36

Vienna 38

ISO / IEEE / NP / TR 11073-00103

Health informatics -- Personal health device communication -- Part 00103: Technical report -- Overview [NP TR]

- 10.60 Vienna R38. [WG7-R2] Regarding the cancellation of ISO/IEEE Projects as to the TC215 Program of Work, resolved that ISO/TC215, Noting that the following items are not on the work program of IEEE and are not active projects within WG 7 ISO/PWI TR 11073-92205 Health informatics ―Medical waveform format ― Part 92205: Physiological report, HL7 CDA R2, ISO/PWI TR 11073-92206 Health informatics ― Medical waveform format ― Part 92206: Conversion from SCP-ECG format. ISO/TC 215 agrees with the WG 7 recommendation th t th k it h ld b ithd f th ISO TC 215 P f W k d I t t th TC 215

2012-11-21 VA document 2012-02-29-See email MLP:


Kuopio 75; Vienna 38

Vienn 39

ISO/IEEE 11073-20601:2010

Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol

10.00 Vienna R39 [WG7-R4] Regarding the addition of ISO/IEEE 11073-20601:2010 to the TC215 Program of Work, Resolved that ISO/TC215 Noting that IEEE has published an amendment to the following ISO/IEEE standard - ISO/IEEE 11073-20601:2010 Health informatics – Personal health device communication – Part 20601: Application profile – Optimized Exchange Protocol - ISO/TC 215 agrees with the WG7 recommendation that this amendment be added to the work program as a revision of the 2010 standard; and Invites IEEE to submit the amended standard for Fast Track ballot and adoption by ISO/TC 215 in accordance with the ISO–IEEE Partner Standards Development Organization agreement. Abstain: China, Singapore

2012-11-21 Vancouver R45: Added to 215 work program, IEEE invited to submit for Fast Track ballot - see V-R45 |

Vancouver 45; Vienna 39; Vienna 40

Vienna 40

ISO/IEEE WD 11073-10101

Health informatics -- Point-of-care medical device communications -- Nomenclature -- Part 10101: 2004

Stage - TBD Vienna R40 [WG7-R5] Regarding the Addition of Five IEEE Documents as Listed to the TC215 Program of Work, Noting that Resolution 41-Vancouver 2012 agreed to add the following revisions to the work program of ISO/TC 215 and invited IEEE to submit these documents for Fast Track ballot upon their completion:ISO/IEEE 11073-10101 Health informatics -- Point-of-care medical device communication -- Part 10101: NomenclatureISO/IEEE 11073-10201 Health informatics -- Point-of-care medical device communication -- Part 10201:

2012-11-21 Vancouver R41: Added to 215 work program, IEEE invited to submit for Fast Track ballot etc see V-R41

Vienna 40

Vienna 40

ISO/IEEE NP 11073-10201 Health informatics — Point-of-care medical device communication — Part 10201: Domain information model

Stage - TBD Vienna R40 [WG7-R5] Regarding the Addition of Five IEEE Documents as Listed to the TC215 Program of Work, Noting that Resolution 41-Vancouver 2012 agreed to add the following revisions to the work program of ISO/TC 215 and invited IEEE to submit these documents for Fast Track ballot upon their completion:ISO/IEEE 11073-10101 Health informatics -- Point-of-care medical device communication -- Part 10101:

2012-11-21 Vancouver R41: Added to 215 work program, IEEE invited to submit for Fast Track ballot etc see V-R41 |


Vienna 40

ISO/IEEE 11073-10404 Health informatics — Personal health device communication — Part 10404: Device specialization — Pulse oximeter

Stage - TBD Vienna R40. [WG7-R5] Regarding the Addition of Five IEEE Documents as Listed to the TC215 Program of Work, Noting that Resolution 41-Vancouver 2012 agreed to add the following revisions to the work program of ISO/TC 215 and invited IEEE to submit these documents for Fast Track ballot upon their completion:ISO/IEEE 11073-10101 Health informatics -- Point-of-care medical device communication -- Part 10101:



Vienna 40

ISO/IEEE 11073-20101 Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard

Stage - TBD Vienna R 40. [WG7-R5] Regarding the Addition of Five IEEE Documents as Listed to the TC215 Program of Work, Noting that Resolution 41-Vancouver 2012 agreed to add the following revisions to the work program of ISO/TC 215 and invited IEEE to submit these documents for Fast Track ballot upon their completion:ISO/IEEE 11073-10101 Health informatics -- Point-of-care medical device communication -- Part 10101:



Vienna 40

IEEE 11073-20601 Health informatics — Personal health device communication - Application profile - Optimized Exchange prtocol

Stage - TBD Vienna R 40. [WG7-R5] Regarding the Addition of Five IEEE Documents as Listed to the TC215 Program of Work, Noting that Resolution 41-Vancouver 2012 agreed to add the following revisions to the work program of ISO/TC 215 and invited IEEE to submit these documents for Fast Track ballot upon their completion:ISO/IEEE 11073-10101 Health informatics -- Point-of-care medical device communication -- Part 10101:

2012-11-21 Vienna 40

Vienna 41

ISO/IEEE DIS 11073-10417 Health informatics, Personal health device communication, Part 10417: Device specialization -- Glucose meter

40.99 Vienna R41. [WG7-R6] Regarding the Addition of ISO/IEEE DIS 11073-10417 to the TC215 Program of Work, Resolved that ISO/TC215 -- Noting that Resolution 42-Vancouver 2012 approved the circulation of the following work item for Fast Track ballot and that a ballot document was provided to the ISO Central Secretariat on 5 April 2012 - ISO/IEEE DIS 11073-10417 Health informatics — Personal health device communication — Part 10417: Device specialization — Glucose meter

2012-11-21 Unknown-please update

Vienna 41

Vienna 42

ISO/IEEE WD 11073-10101:2004

Health informatics -- Point-of-care medical device communications -- Nomenclature -- Part 10101: 2004

SR complete stage

Vienna 42. [WG7-R7] Regarding the 2008 Systematic Review of ISO/IEEE Projects, Resolved that ISO/TC215 Noting that the Periodic Review of the following documents closed in 2008ISO/IEEE 11073-10101:2004 Health informatics -- Point-of-care medical device communication -- Part 10101: Nomenclature

2012-11-21 Vienna 42

Vienna 42

ISO/IEEE NP 11073-10201:2004

Health informatics — Point-of-care medical device communication — Part 10201: Domain information model

SR complete stage

Vienna R42. [WG7-R7] Regarding the 2008 Systematic Review of ISO/IEEE Projects—Resolved that ISO/TC215 Noting that the Periodic Review of the following documents closed in 2008ISO/IEEE 11073-10101:2004 Health informatics -- Point-of-care medical device communication -- Part 10101: Nomenclature



Vienna 42

ISO/IEEE 11073-20101:2004

Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard

SR complete stage

Vienna R42. [WG7-R7] Regarding the 2008 Systematic Review of ISO/IEEE Projects, Resolved that ISO/TC215 Noting that the Periodic Review of the following documents closed in 2008 ISO/IEEE 11073-10101:2004 Health informatics -- Point-of-care medical device communication -- Part 10101: Nomenclature ISO/IEEE 11073-10201:2004 Health informatics -- Point-of-care medical device communication -- Part 10201: Domain



Working Group 7: Devices [Note: now merged back into WG2Note: Action items from Berlin meeting Feb 2012: Eight (8) WG7 items were cancelled from the program of work: 10073-0000, 10073-00101, 11073-10316, 11073-10400, 11073-20102, 11073-20200, 11073-30503, 11073-60101

Note: Action items from Berlin meeting Feb 2012: Items added as PWIs: 11073.00101, 11073-10202, 11073-10406

PRELIMINARY WORK ITEMS [PWI]

ACTIVE WORK ITEMS [AWI]



open


closes


Resolutions

Vienna 42

ISO/IEEE 11073-30200:2004

Health informatics — Point-of-care medical device communication — Part 30200: Transport profile - cable connected

SR complete stage

Vienna 42. [WG7-R7] Regarding the 2008 Systematic Review of ISO/IEEE Projects, Resolved that ISO/TC215 Noting that the Periodic Review of the following documents closed in 2008 ISO/IEEE 11073-10101:2004 Health informatics -- Point-of-care medical device communication -- Part 10101: NomenclatureISO/IEEE 11073-10201:2004 Health informatics -- Point-of-care medical device communication -- Part 10201:

2012-11-21 Vienna 42

Vienna 43

ISO/IEEE 11073-30200:2004

Health informatics — Point-of-care medical device communication — Part 30200: Transport profile - cable connected

Stage? Vienna 43. [WG7-R8] Regarding the Addition of ISO/IEEE 11073-30200 to the TC215 Program of Work, Resolved that Noting that that an amendment of this standard has been published by IEEE, ISO/IEEE 11073-30200:2004 Health informatics — Point-of-care medical device communication — Part 30200: Transport profile — Cable connected

2012-11-21 Vienna 43

Vienna 44

IEEE NP 11073:10413 Health informatics — Personal health device communication — Device specialization — Respiration rate monitor

Stage? 20.00? Vienna 44. [WG7-R9] Regarding the Addition of Four Projects to the TC 215 Program of Work—Resolved that Noting that Resolution 45-Vancouver 2012 agreed to add the following new IEEE work items to the work program of the TC and invited IEEE to submit these documents for Fast Track ballot upon their completion:IEEE 11073-10413 Health informatics – Personal health device communication – Device specialization – Respiration rate monitorIEEE 11073-10419 Health informatics – Personal health device communication – Device specialization – Insulin pumpIEEE 11073-10441 Health informatics – Personal health device communication – Device specialization – C di l Fit d A ti it M it

2012-11-21 See Vancouver R45: IEEE working on 5 new parts ISO 11073, resolved to add to TC215 work program & then IEEE invited to submit under ISO-IEEE PSDO.


Vienna 44

IEEE NP 11073-10419 Health informatics — Personal health device communication — Device specialization — Insulin pump

Stage? 20.00? Vienna 44. [WG7-R9] Regarding the Addition of Four Projects to the TC 215 Program of Work—Resolved that Noting that Resolution 45-Vancouver 2012 agreed to add the following new IEEE work items to the work program of the TC and invited IEEE to submit these documents for Fast Track ballot upon their completion:IEEE 11073-10413 Health informatics – Personal health device communication – Device specialization – Respiration rate monitorIEEE 11073-10419 Health informatics – Personal health device communication – Device specialization – Insulin pumpIEEE 11073-10441 Health informatics – Personal health device communication – Device specialization – Cardiovascular Fitness and Activity MonitorIEEE 11073 10442 H lth i f ti P l h lth d i i ti D i i li ti


Vienna 44

Vienna 44

IEEE NP 11073-10441 Health informatics — Personal health device communication — Device specialization — Cardiovascular fitness and activity monitor

Stage? 20.00? Vienna 44. [WG7-R9] Regarding the Addition of Four Projects to the TC 215 Program of Work—Resolved that Noting that Resolution 45-Vancouver 2012 agreed to add the following new IEEE work items to the work program of the TC and invited IEEE to submit these documents for Fast Track ballot upon their completion:IEEE 11073-10413 Health informatics – Personal health device communication – Device specialization – Respiration rate monitorIEEE 11073-10419 Health informatics – Personal health device communication – Device specialization – Insulin pumpIEEE 11073-10441 Health informatics – Personal health device communication – Device specialization – Cardiovascular Fitness and Activity MonitorIEEE 11073-10442 Health informatics – Personal health device communication – Device specialization –



Vienna 44

IEEE NP 11073-10442 Health informatics — Personal health device communication — Device specialization — Strength fitness equipment

Stage? 20.00? Vienna 44. [WG7-R9] Regarding the Addition of Four Projects to the TC 215 Program of Work—Resolved that Noting that Resolution 45-Vancouver 2012 agreed to add the following new IEEE work items to the work program of the TC and invited IEEE to submit these documents for Fast Track ballot upon their completion:IEEE 11073-10413 Health informatics – Personal health device communication – Device specialization – Respiration rate monitorIEEE 11073-10419 Health informatics – Personal health device communication – Device specialization – Insulin pumpIEEE 11073-10441 Health informatics – Personal health device communication – Device specialization –

d l d



Vienna 46

ISO/IEEE 11073-10471:2010

Health informatics – Personal health device communication – Device specialization – Independent Living Activity Hub

Stage? 20.00? Vienna R 46. [WG7-R11] Regarding the Addition of ISO/IEEE 11073-10471 to the TC215 Program of Work, Resolved that ISO/TC215, Noting that IEEE has begun work on an amendment to the following standard ISO/IEEE 11073-10471:2010 Health informatics – Personal health device communication – Device specialization – Independent Living Activity Hub, ISO/TC 215 agrees with the WG 7 recommendation that a revision of ISO/IEEE 11073-10471 be added to the work program of the technical committee; and Invites IEEE, upon completion of the amendment, to submit the amended standard for Fast Track ballot and adoption by TC 215 as a revision

f h 2010 d d i d i h h ISO IEEE P S d d D l O i i Ab i Chi

2012-11-21 Vienna 46

Vienna 47

IEEE 11073-10423 EEE 11073-10423 Health informatics – Personal health device communication – Device specialization – Sleep Quality Monitor

Stage? 20.00? Vienna 47. [WG7-R12] Regarding the Addition of Three IEEE Work Items to the TC215 Program of Work, Resolved that ISO/TC215 , Noting that IEEE has begun work on the following work itemsIEEE 11073-10423 Health informatics – Personal health device communication – Device specialization – Sleep Quality MonitorIEEE 11073-10424 Health informatics – Personal health device communication – Device specialization – Sleep apnea breathing therapy equipment

2012-11-21 Vienna 47

Vienna 47

IEEE 11073-10424 IEEE 11073-10424 Health informatics – Personal health device communication – Device specialization – Sleep apnea breathing therapy equipment

Stage? 20.00? Vienna 47. [WG7-R12] Regarding the Addition of Three IEEE Work Items to the TC215 Program of Work, Resolved that ISO/TC215 , Noting that IEEE has begun work on the following work itemsIEEE 11073-10423 Health informatics – Personal health device communication – Device specialization – Sleep Quality MonitorIEEE 11073-10424 Health informatics – Personal health device communication – Device specialization – Sleep apnea breathing therapy equipment

2012-11-21 Vienna 47

Vienna 47

IEEE 11073-10425 IEEE 11073-10425 Health informatics – Personal health device communication – Device specialization – Continuous Glucose Monitor (CGM)

Stage? 20.00? Vienna 47. [WG7-R12] Regarding the Addition of Three IEEE Work Items to the TC215 Program of Work, Resolved that ISO/TC215 , Noting that IEEE has begun work on the following work items - IEEE 11073-10423 Health informatics – Personal health device communication – Device specialization – Sleep Quality MonitorIEEE 11073-10424 Health informatics – Personal health device communication – Device specialization – Sleep apnea breathing therapy equipment

2012-11-21 Vienna 47

Vienna

48IEEE 11073-10301 11073-10301-1 Health informatics – Point-of-care medical device

communication – Part 10301-1: Device specialization – Infusion pump – General

Stage TBD - IEE to add 1st

Vienna R48. [WG7-R13] Regarding the Addition of Seven Specific IEEE Work Items to the TC215 Program of Work—Resolved that ISO/TC215Noting that IEEE 11073 have the following projects in the submission process:11073-10301-1 Health informatics – Point-of-care medical device communication – Part 10301-1: Device specialization – Infusion pump – General

2012-11-21 Vienna 48

Vienna 48

IEEE 11073-10302-1 11073-10302-1 Health informatics – Point-of-care medical device communication – Part 10302-1: Device specialization – Physiologic monitor – General



2012-11-21 Vienna 48



open


closes


Resolutions

Vienna 48

IEEE 11073-10303-1 11073-10303-1 Health informatics – Point-of-care medical device communication – Part 10303-1: Device specialization – Ventilator – General



2012-11-21 Vienna 48

Vienna 48

IEEE 11073-20201 11073-20201 Health informatics – Point-of-care medical device communication – Part 20201: Application profile – Polling mode


Vienna R48. [WG7-R13] Regarding the Addition of Seven Specific IEEE Work Items to the TC215 Program of Work—Resolved that ISO/TC215Noting that IEEE 11073 have the following projects in the submission process:11073-10301-1 Health informatics – Point-of-care medical device communication – Part 10301-1: Device specialization – Infusion

2012-11-21 Vienna 48

Vienna 48

IEEE 11073-20202 11073-20202 Health informatics – Point-of-care medical device communication – Part 20202: Application profile – Baseline asynchronous mode



l h f f d l d l h l

2012-11-21 Vienna 48

Vienna 48

IEEE 11073-20301 11073-20301 Health informatics – Point-of-care medical device communication – Part 20301: Application profile – Optional package, remote control


Vienna R48. [WG7-R13] Regarding the Addition of Seven Specific IEEE Work Items to the TC215 Program of Work—Resolved that ISO/TC215Noting that IEEE 11073 have the following projects in the submission process:11073-10301-1 Health informatics – Point-of-care medical device communication – Part 10301-1: Device specialization – Infusion pump – General 11073-10302-1 Health informatics – Point-of-care medical device communication – Part 10302-1: Device specialization – Physiologic

2012-11-21 Vienna 48

Vienna 48

IEEE 11073-20401 11073-20401 Health informatics – Point-of-care medical device communication – Part 20401: Application profile – Common networking services


Vienna R48. [WG7-R13] Regarding the Addition of Seven Specific IEEE Work Items to the TC215 Program of Work—Resolved that ISO/TC215Noting that IEEE 11073 have the following projects in the submission process:11073-10301-1 Health informatics – Point-of-care medical device communication – Part 10301-1: Device specialization – Infusion pump – General 11073-10302-1 Health informatics – Point-of-care medical device communication – Part 10302-1: Device specialization – Physiologic

2012-11-21 Vienna 48

Vienna 49

NP Spirometry - expected 15 Dec 2012 10.00 Vienna R49. [WG7-R14] Regarding a New Project on Spirometry, Resolved that ISO/TC215, TC 215 agrees with the WG 7 recommendation that an ISO/HL7 New Work Item Proposal for the development of a standard for spirometry test reports go forward under the Vienna Agreement with an ISO lead. This NP is to be submitted for consideration by ISO/TC 215 and CEN/TC 251 no later than 15 December 2012 and upon approval of the new work the Joint Initiative Council will be asked to facilitate the coordination

2012-11-21 JIC Vienna 49

Vienna 50

N/R IEEE Project Manager Vienna 50. [WG7-R15] Regarding the Appointment of an IEEE-Sponsored Project Manager to Manage Joint ISO-IEEE Work Items—Resolved that ISO/TC215 Noting that the proposed reorganization plan for ISO/TC 215 envisions the disbanding of ISO/TC 215/WG 7

2012-11-21 Vienna 50

Vienna 51

ISO 11073-91064:2009 (Ed.1)

Health informatics, Standard communication protocol -- Part 91064: Computer-assisted electrocardiography, (EN 1064:2005+A1:2007)

20.00 Vienna R51. [WG7-R16] Regarding a Revision of ISO 11073-91064:2009 (Ed.1), Health informatics -- Standard communication protocol -- Part 91064: Computer-assisted electrocardiography, (EN 1064:2005+A1:2007) —Resolved that ISO/TC215TC 215 resolves that a New Work Item Proposal to initiate a revision of ISO 11073-91064:2009 (Ed. 1) under the Vienna Agreement with a CEN lead be prepared and submitted to the TC 215 and CEN/TC 251 Secretariats

2012-11-21 Vienna 51

End of Vienna Resolutions

ISO/IEEE 11073-10418 Health informatics, Personal health device communication, Part 10418: Device specialization--International Normalized Ratio (INR) monitor \\

40.99 Is this still an active item? 2012-11-21 Unknown-please update

ISO/CD 22077-1 Medical waveform format - Part 1: Encoding rules - review of 2007 [Note: was renumbered after the Kupio previous was ISO/CD 11073-92001 (a revision of ISO 11073-92001:2007).

30.99 Vancouver R46: Document has been reviewed and will be circulated as an Enquiry DIS - PL is currently finishing final draft

2012-11-21 Vancouver 46

ISO 22077-2 Health informatics ― Medicalwaveform format ― Part 2

10.60 From WG7 Vancouver notes: Wking drafts near complete - to be circulated to WG7 prior to Vienna Mtg 2012-11-21

ISO 22077-3 Health informatics ― Medicalwaveform format ― Part 3: Long-term electrocardiogram

10.60 From WG7 Vancouver notes: Wking drafts near complete - to be circulated to WG7 prior to Vienna Mtg 2012-11-21

ISO/TR 21730:2007 Health informatics – Use of mobile wireless communication and computing technology in healthcare facilities – Recommendation for electromagnetic compatibility (management of unintentional electromagneticinterference) with medical devices

Vancouver: Published 2007, WG plans to review to ensure its still current & consistent w/existing International Standards. Was agreed to ask the TC215 Secretary to circulate this document to WG7, JWG 7 & IEC/SC 62A Secretariat for review prior to Vienna.

2012-08-07 Vancouver 47

ISO/IEEE 11073-10406:2012

Health informatics -- Personal health device communication -- Part 10406: Device specialization -- Basic Electrocardiograph (ECG) (I to 3-lead ECG)

- 60.60 Congratulations - IS published 2012-11-16! Kuopio 74

11073-10420:2012 Health informatics -- Personal health device communication -- Part 10420: Device specialization -- Body composition analyzer

- 60.60 Congratulations - IS published 2012-10-26! - Kuopio 75

11073-10421:2012 Health informatics- Personal health device communication -- Part 10421: Device specialization -- Peak expiratory flow monitor (peak flow)


7 ISO/IEEE NP 11073-10472:2012

Health Informatics -- Personal health device communication - Device specialization -- Part 10472: Medication monitor

D. Bogia (Intel)

60.60 Congratulations - IS published 2012-10-26! Kuopio 75

Newly published standards in 2012!

Start of other items on exisiting work program



open


closes


Resolutions

7 11073-30400:2012 Health informatics -- Point-of-care medical device communication -- Part 30400: Transport profile -- Cabled ethernet


ISO/IEEE 11073-10415:2010

Health informatics — Personal health device communication — Part 10415: Device specialization — Weighing scale

60.60

ISO/IEEE 11073-10407:2010

Health informatics — Personal health device communication — Part 10407: Device specialization — Blood pressure monitor

60.60

ISO/IEEE 11073-10408:2010

Health informatics — Personal health device communication — Part 10408: Device specialization — Thermometer

60.60

ISO/IEEE 11073-10415:2010

Health informatics — Personal health device communication — Part 10415: Device specialization — Weighing scale

60.60

7 ISO/TS 11073-92001:2007 (Ed. 1)

Health informatics -- Medical waveform format -- Part 92001: Encoding rules

- 90.60 Published in 2007. Close of review - Next SI 2015 VA: ISOWI: 00251206

- Unknown-please update

Kuopio 76

TR 21730 2007 Health informatics-Use of mobile wireless communication and computing technology in healthcare facilities - Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices

Status: WG7 is reviewing per Vancouver R47

7 ISO PWI / TR 11073-92205

Health informatics, Medical waveform format - Part 92205: Physiological report, HL7 CDA R2

Withdrawn Vienna R37

7 ISO /PWI TS 11073-92206 Health informatics, Medical waveform format - Part 92206: Conversion from SCP-ECG format

Withdrawn Vienna R37

IEEE NP 11073-10443 Health informatics — Personal health device communication — Device specialization — Physical activity monitor

Vienna R45: Should not be added to program of work 2012-08-07 Vancouver 45

7 ISO/IEEE NP 11073-00000 Health Informatics -- Point-of-care medical device communication -- P 00000 F k d i

- 10.98 Project cancelled by committee 2012/02/07 VA: ISO LeadWI 00251158

- Kuopio 73

7 11073-00101 Health Informatics -- Point-of-care medical device communication -- P 00101 T h i l G id li f h f RF i l

- - - - - pNWIP - not registered i ISO t

Kuopio 73

7 PWI 11073-10202 Health informatics -- Point-of-care medical device communication -- P 10202 D i i f i d l (DIM) XML h f

Patty Krantz 10.98 Added as PWI per Berlin and as currently on ISO Project Portal 2012/03/01 - Kuopio 74

D ISO/IEEE NP 11073-20102 Health informatics -- Point-of-care medical device communication -- P 20102 A li i fil MIB l

10.98 15 ISO/TC 215/WG 2D ISO/IEEE NP 11073-20200 Health informatics -- Point-of-care medical device communication --

P 20200 A li i fil A i i l i 10.98 15 ISO/TC

215/WG 2ISO/IEEE NP 11073-20201 Health informatics -- Point-of-care medical device communication -- P 20201 A li i fil P lli dISO/IEEE NP 11073-20201 Health informatics -- Point-of-care medical device communication -- P 20201 A li i fil P lli dD ISO/IEEE NP 11073-10300 Health informatics -- Point-of-care medical device communication -- P 10300 D i i li i F k d i


P 10301 D i i li i I f i d i 10.98 7 Aug 2012: This is on the project portal but was not on my tracking spreadsheet ISO/TC

215/WG 2D ISO/IEEE NP Health informatics -- Point-of-care medical device communication -- P 10302 D i i li i Vi l i i

10.98 15 ISO/TC 215

D ISO/IEEE NP 11073-10303 Health informatics -- Point-of-care medical device communication -- P 10303 D i i li i V il


P 10304 D i i li i P l i 10.98 15 ISO/TC 215

D ISO/IEEE NP 11073-10305 Health informatics -- Point-of-care medical device communication -- P 10305 D i i li i D fib ill

10.98 15 ISO/TC 215

D ISO/IEEE NP 11073-10306 Health informatics -- Point-of-care medical device communication -- l

10.98 15 ISO/TC 215

D ISO/IEEE NP 11073-10307 Health informatics -- Point-of-care medical device communication -- l l d

10.98 15 ISO/TC 215

D ISO/IEEE NP 11073-10308 Health informatics -- Point-of-care medical device communication -- l

10.98 15 ISO/TC 215

7 11073-10316 Health Informatics -- Point-of-care medical device communication -- l l d

- - - - - pNWIP - not registered i ISO t

Kuopio 73

7 11073-10400 Health Informatics -- Personal health device communication -- Part l f k

- - - - - not registered in ISO t

Kuopio 73

7 11073-10406 Health Informatics -- Personal health device communication -- Part l

- - 2012/02/29 - 2012-02-29: Berlin: See h K i

Kuopio 74

7 ISO/PWI TS 11073-92301

Health informatics -- Medical waveform format -- Part 92301: l d h

M. Hirai (NIFTY

40.00 Numbering change: 11073.92301 to 22077-1. To go for DIS vote once updated revised text received from

2012/02/29 - Email MLP 29 Feb 2012 U d d t

Kuopio 76

7 ISO/IEEE NP 11073-20102 Health informatics -- Point-of-care medical device communication -- l f l l

- 10.60 Close of voting 2005/10/02 - - Kuopio 73

7 ISO/IEEE NP 11073-20200 Health informatics -- Point-of-care medical device communication -- l f l l


D ISO/IEEE NP 11073-20201 Health informatics -- Point-of-care medical device communication -- l f l ll d

10.98 15 ISO/TC 215/WG 2D ISO/IEEE NP 11073-20202 Health informatics -- Point-of-care medical device communications --

l f l l h d2012-06-12 10.98 15 ISO/TC

215/WG 2D ISO/IEEE NP 11073-20301 Health informatics -- Point-of-care medical device communication -- l f l l k l

10.98 15 ISO/TC 215/WG 2ISO /PWI TS 11073-92302 Health informatics -- Medical waveform format encoding rules -- Part

92302 L l di00.98 Cancelled

7 11073-30503 Health Informatics -- Point-of-care medical device communication -- P 30503 T fil RF i l L l k

- - - - - not registered in ISO t

Kuopio 73

7 ISO/IEEE NP 11073-60101 Health informatics -- Point-of-care medical device communication -- P 60101 A li i HL7 b i i i f


D ISO/DIS 11073-92001 Health informatics -- Medical waveform format -- Part 92001: Encoding l

2014-09-01 (C ll i d 2015 03 01)

36 ISO/TC 215

Published standards

ALL BELOW CANCELLED / Withdrawn / Not added BY COMMITTEE

WG ISO # ISO # Sort JIC ISO Title PLs Stage # at time of this report

Stage desc at time of this report

As of this date If currently in ballot: date

open


closes

Other ISO Info Status/Notes/Actions Entered in SKMT?

Resolutions

There are no PWIs listed at this time as of 2012-08-01IEC 80001-2-x,"Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1”

0.00 Preliminary research work being done at the Regulated Software Research Group, Dundalk Institute of Technology, Ireland

2012/08/16 Resolved that ISO/TC215 approves the ISO/TC215-IEC/SC62A Joint Working Group 7 (JWG7) recommendation that IEC 80001-2-x,"Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1” be added to the work program of ISO/TC 215 as a new preliminary work item to be jointly developed between ISO/TC 215 and IEC/ SC62A within JWG7. And be it further resolved that, upon the future receipt from JWG7 of a Form 4 and initial working draft for this project, the ISO/TC 215 Secretariat shall circulate the NWIP for approval as a new work item targeting a technical report.

NO? Kuopio 94 (IEC Seattle 4)

IEC 80001-2-x "Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance on how IEC 80001-1 and ISO/IEC 20000-2:2005, Information technology – Service management – Part 2: Code of practice

0.00 Preliminary work waiting on revision of ISO/IEC 20000

2012/08/16 Resolved that ISO/TC215 approves the ISO/TC215-IEC/SC62A Joint Working Group 7 (JWG7) recommendation that IEC 80001-2-x "Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance on how IEC 80001-1 and ISO/IEC 20000-2:2005, Information technology – Service management – Part 2: Code of practice, be added to the work program of ISO/TC 215 as a new preliminary work item to be jointly developed between ISO/TC 215 and IEC/ SC62A within JWG7.

No? Kuopio 95 (IEC Seattle 4)

JWG7 ISO 82304-1 82304-1 No Healthcare software systems - Part 1: General requirements [General implementation guidance for healthcare delivery organizations]

10.99 20.00

JWG working on comment resolution in Vienna and next draft text. Also may meet w/WG4 in Vienna to discuss.

2012/08/08 2011-10-04: NP passed closed

V#3:Regarding ISO/NP 82304, Healthcare software systems–Part 1: General requirements – Resolved 215-Notes the positive results of the NP ballot and instructs the ISO/TC215 Secretary to add to the TC work program and assign the project to JWG7.


Vancouver 3

JWG7 IS 80001-2-x 80001-2-x No Application of risk management

for IT-networks incorporating medical devices – Part 2-x: Guidance on distributed alarm systems

Mr Oliver Christ

10.00 2012-05-25: NP ballot opened each in ISO & IEC. Ballot will close before Vienna and is on Vienna agenda for review and comment disposition

2012/08/08 2012-05-24 2012-08-26 N1008: DTR NP text


Vancouver 1 (IEC Seattle 5)

JWG7 IEC/CD TR 80001-2-1

80001-2-1 No Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples

Ms. K. Delvecchio (GE)Mr. M. Janssen (NEN Experts)

30.99 60.60

Published 2012-07-10 2012/08/08 Unknown-please update

Kuopio 89


80001-2-2 No Part 2-2: Guidance for the communication of medical device security needs, risks and controls


30.99 60.60


Kuopio 88Kuopio 90

JWG7 TC215 WG7 & IEC62A: Application risk management for IT networks incorp medical devices Preliminary work items

Active work items

WG ISO # ISO # Sort JIC ISO Title PLs Stage # at time of this report

Stage desc at time of this report

As of this date If currently in ballot: date

open


closes

Other ISO Info Status/Notes/Actions Entered in SKMT?

Resolutions


80001-2-3 No Part 2-3: Guidance for wireless networks

30.99 60.60


Kuopio 88Kuopio 90

JWG7 DTR 80001-2-4

80001-2-4 No Application risk mngment for IT-networks incorp med devices-Part 2-4: General implementation guidance for healthcare delivery organizations

Dr. Maureen Baker (UK NHS)

40.20 2012-05-25: NP balllot opened each in ISO & IEC. Ballot will close before Vienna & is on Vienna agenda for review and comment disposition

2012/08/08 2012-05-24 2012-08-26 Approves the disposition of NP ballot comments agreed to at the JWG 7 meeting and that the project should proceed to DTR ballot; Instructs the PL/WG convener to provide the updated text of the DTR and the final disposition of NP comments to the IEC/SC62A and ISO/TC 215 Secretaries no later than 1 June 2012; Instructs the ISO/TC 215 Secretary to coordinate with the IEC/SC62A Secretary to circulate a DTR ballot no later than 15 June 2012


Kuopio 92 & 93, Vancouver 2

WG ISO # ISO Title PLs Stage # at time of this report




closes

Other ISO Info Other key info Entered in SKMT?

Resolutions

JWG7 ISO / IEC / PWI 80001-2-X

80001-2-x, Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance for technical information exchange for component suppliers

0.00 Vienna 59. [JWG7-R7] Regarding 80001-2-x, Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance for technical information exchange for component suppliers – Resolved that Approves the JWG 7 recommendation that the above mentioned project be added to the TC 215 Program of Work as a Preliminary Work Item; and Instructs the TC 215 Secretary to inform ISO Central Secretariat of this decision and add the project to the TC 215 Program of Work.

2012/11/25

JWG7 ISO / IEC / PWI 80001-2-x

IEC 80001-2-x "Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance on how IEC 80001-1 and ISO/IEC 20000-2:2005, Information technology – Service management – Part 2: Code of practice

0.00 2012/08/16 Resolved that ISO/TC215 approves the ISO/TC215-IEC/SC62A Joint Working Group 7 (JWG7) recommendation that IEC 80001-2-x "Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance on how IEC 80001-1 and ISO/IEC 20000-2:2005, Information technology – Service management – Part 2: Code of practice, be added to the work program of ISO/TC 215 as a new preliminary work item to be jointly developed between ISO/TC 215 and IEC/ SC62A within JWG7.

No? Kuopio 95 (IEC Seattle 4)

Vienna 58

ISO / NP 80001-2-x

Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

10.00 Vienna 58. [JWG7-R6] Regarding 80001-2-x, Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1 – Resolved that ISO/TC 215, Approves the JWG 7 recommendation to issue a Joint NP ballot targeting a technical report to be developed with ISO/TC215 lead; Instructs the PL/WG convener to provide a draft document to the TC 215 Secretary no later than 30 Nov 2012; Instructs the ISO/TC 215 Secretary to coordinate with the IEC/SC 62A Sec to circulate a Joint NP ballot with an attached draft, with ISO/TC215 lead no later than 15 December 2012

2012/11/25 Joint NP text expected 30 Nov 2012

Vienna 58

Vienna 55

IEC DTR 80001-2-4 - TR

Application risk mngment for IT-networks incorp med devices-Part 2-4: General implementation guidance for healthcare delivery organizations - IEC lead

Dr. Maureen Baker (UK NHS)

30.99 CD closed, approved, results N1057. Registered for DIS. | Vienna 55. [JWG7-R3] Regarding 80001-2-4, Application of risk management for IT-networks incorporating medical devices – Part 2-4: General implementation guidance for healthcare delivery organizations – Resolved that Notes that IEC has the lead;Approves the disposition of DTR ballot comments agreed to at the JWG7 Vienna meeting and that the project should proceed to final TR publication; Instructs the PL/WG convener to provide the updated text of the TR and the final disposition of DTR comments to the IEC/SC62A and ISO/TC 215 Secretaries no later than 31 October 2012; Instructs the ISO/TC 215 Secretary to coordinate with the IEC/SC62A Secretary on the publication of the TR no later than 15 November 2012

2012/11/25 N1017: Combined IEC & ISO ROV N1026 DTR ballot. N1057 DTR results N1057: CD results


Kuopio 92 & 93, Vancouver 2; Vienna 55

JWG7 TC215 WG7 & IEC62A: Application risk management for IT networks incorp medical devices Preliminary work items

Active work items

WG ISO # ISO Title PLs Stage # at time of this report




closes

Other ISO Info Other key info Entered in SKMT?

Resolutions

Vienna 56

ISO / IEC 80001-2-5 / TR

Application risk managment for IT-networks incorp med devices- Guidance for responsibility agreements

10.20 Vienna 56. [JWG7-R4] Regarding 80001-2-x, Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance for responsibility agreements – Resolved that ISO/TC 215, Approves the JWG 7 recommendation to issue a Joint NP ballot targeting a technical report to be developed with ISO/TC215 lead; Instructs the PL/WG convener to provide the updated working draft text of the TR to the IEC/SC62A and ISO/TC 215 Secretaries no later than 31 October 2012;Instructs the ISO/TC 215 Secretary to coordinate with the IEC/SC 62A Secretary to circulate a Joint NP ballot with ISO/TC215 lead no later than 15 November 2012

2012/11/25 2012/11/10 2013/02/15 Vienna 56

JWG7 ISO / CD 82304-1

Healthcare software systems - Part 1: General requirements - General implementation guidance for healthcare delivery organizations

30.20 In CD ballot through 2013/01/12 | Vienna R 57. [JWG7-R5] Regarding IEC ISO CD 82304-1, Healthcare software systems–Part 1: General requirements – Resolved that ISO/TC 215, Approves the disposition of NP ballot comments as agreed by the project team and that the project should proceed to CD ballot; Instructs the PL/WG convener to provide the updated text of IEC/ISO CD 82304-1 and final disposition of comments document to the TC 215 Secretary no later than 30 November 2012;Instructs the TC 215 Secretary to coordinate with the IEC/SC 62A Secretary to circulate the text for a three month CD ballot immediately upon receipt, but no later than 15 December 2012.

2012/11/25 2012/10/27 2013/01/12 Unknown-please update

Vancouver 3

JWG7 IEC / NP 80001-2-x

Application of risk management for IT-networks incorporating medical devices – Part 2-x: Guidance on distributed alarm systems

Mr Oliver Christ

20.00 N1079: Updated with form 6 results w/IEC to be posted when IEC CD info available

2012/11/25 N1047: Initial NP ballot results N1079: Combined ISO & IEC to be posted


Vancouver 1 (IEC Seattle 5)


Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples


60.60 Published 2012-07-10 2012/08/08 Unknown-please update

Kuopio 89


Part 2-2: Guidance for the communication of medical device security needs, risks and controls


60.60 Published 2012-07-10 2012/08/08 Unknown-please update

Kuopio 88Kuopio 90


Part 2-3: Guidance for wireless networks 60.60 Published 2012-07-10 2012/08/08 Unknown-please update

Kuopio 88Kuopio 90

Published Standards