ISO/TC 215 NZ
This is our national mirror committee of the ISO/TC 215 Health informatics technical committee. Members are appointed by the Standards Approval Board of New Zealand. Our purpose is to have input to new and updated ISO standards through working groups and the ballot process. Having operated behind the scenes for a couple of years, we’re now sharing our work with the wider ehealthforum community.
Our role requires us to:
- Monitor international work items, drafts and ballots through relevant ISO online services
- Review the technical content of documents out ‘for comment’ and formulate a national perspective to International Standards development
- Inform Standards NZ of the consolidated comments reached on new ISO work proposals (NP), committee draft (CD), draft international standard (DIS) and final draft international standard (FDIS) documents
- Inform Standards NZ of the IRG vote on NP, CD, DIS and FDIS documents. With participating (P) membership there is an obligation to submit a vote on international ballots
- Provide a valid technical justification for any negative votes submitted by the mirror committee
- Inform Standards NZ of the consolidated position reached on International Standards under systematic review (each standard undergoes a 5 yearly systematic review)
- Consult with their organisation/employer/association in order to take the organisation’s position into IRG committee meetings for discussion towards a consolidated national position/vote on international matters
- Nominate a suitable expert to attend international meetings (if funding support is available to allow attendance)
- Besides contributing to international standards, ISO/TC 215 NZ makes recommendations to HISO on standards choices for national adoption.
Agenda
- Welcome
- Around the working groups
- Conference reports
- Upcoming ballots (see below)
- Any other business
Previous meeting
2026-06-08T12:00:00Z | ISO/TC 215 NZ Hui June 2026
Attending today
Actions
- All members please check your committee membership details on the new HNZ website https://www.healthnz.govt.nz/about-us/who-we-are/expert-groups-and-networks/expert-groups/isotc-215-health-informatics-national-mirror-committee
1. Welcome
2. Around the working groups
- IPS Maintenance Agency @i.hunter
- ISO/TC 215/SC 1 Genomics Informatics
- ISO/TC 215/WG 1 Architecture, Frameworks and Models @alastairk @keithduddy
- ISO/TC 215/WG 2 Systems and Device Interoperability
- ISO/TC 215/WG 3 Semantic content
- ISO/TC 215/WG 4 Security, Safety and Privacy
- ISO/TC 215/WG 6 Pharmacy and medicines business
- ISO/TC 215/WG 10 Traditional Medicine
- ISO/TC 215/WG 11 Personalized digital health @angela.pidd
- ISO/TC 215/WG 21 Telehealth and Virtual Care (TVC) Standards @i.hunter @atalagk. WG 12 picks up where TF 7 left off
@alastairk is working on HL7/ISO 21089 Trusted end-to-end information flows revision project
3. Related groups
- SNOMED International - October 2026 conference in Sydney
- Global Digital Health Partnership (GDHP) - JIC and IPS Coordinating Committee liaisonship, October 2026 conference in Sydney
- WHO Global Initiative on Digital Health (GIDH) is meeting to frame new Global Strategy for Digital Health 2028-2033
- WHO - NZ intervention at WHA79 urged faster progress from WHO on linking ICD-11 and SNOMED CT to enable seamless data use across the health data lifecycle
4. Upcoming ballots
We’ll walk through these, make a decision on the straightforward ones and allocate the rest for further investigation
| Item | Type | Reference | Title | Due Date | Outcome/Action |
|---|---|---|---|---|---|
| 1 | CIB | N5409 - TF5 Healthcare-Specific-Considerations-for-AI_Final | Healthcare considerations for AI | 2026-10-15 | |
| 2 | CIB | N5378 - IEC 62A CD2 62304 | N5378 - IEC 62A CD2 62304 Health software - Software life cycle processes | 2026-11-20 | |
| 3 | CIB | N5379 - IEC 62A CD TS 62366-3 | N5379 - IEC 62A CD TS 62366-3 Med devices - Part 3 guidance on AI-enabled medical devices | 2026-11-27 | |
| 4 | DIS | ISO/DIS 18308 (Ed 2) | Health informatics — Requirements for an electronic health record architecture | 2026-11-18 | |
| 5 | FDIS | ISO/IEEE FDIS 11073-10406 (Ed 2) | Health Informatics — Device Interoperability — Part 10406: Personal health device communication, device specialization, basic electrocardiograph (ECG) (1- to 3-lead ECG) | 2026-12-01 | |
| 6 | FDIS | ISO/IEEE FDIS 11073-10417 (Ed 4) | Health informatics — Device interoperability — Part 10417: Personal health device communication, device specialization, glucose meter | 2026-12-01 | |
| 7 | FDIS | ISO/IEEE FDIS 11073-10419 (Ed 3) | Health informatics — Device interoperability — Part 10419: Personal health device communication, device specialization, insulin pump | 2026-12-01 | |
| 8 | FDIS | ISO/IEEE FDIS 11073-10442 (Ed 2) | Health informatics — Device interoperability — Part 10442: Personal health device communication, device specialization, strength fitness equipment | 2026-12-01 | |
| 9 | FDIS | ISO/IEEE FDIS 11073-10441 (Ed 2) | Health informatics — Device interoperability — Part 10441: Device specialization — Cardiovascular fitness and activity monitor | 2027-02-01 | |
| 10 | SR | IEC 82304-1:2016 (vers 2) | Health software — Part 1: General requirements for product safety | 2026-12-02 | |
| 11 | SR | ISO 17090-2:2015 (Ed 2, vers 2) | Health informatics — Public key infrastructure — Part 2: Certificate profile | 2026-12-02 | |
| 12 | SR | ISO/TS 22773:2019 (vers 2) | Health Informatics — Categorial structures for the representation of the decocting process in traditional Chinese medicine | 2026-12-02 |
Key to the various ballot types:
- Draft Technical Report (DTR)
- Committee Internal Ballot (CIB)
- Committee Draft (CD)
- Final Draft International Standard (FDIS)
- Systematic Review (SR)
- New Proposal (NP)
5. Any other business
None
6. Next meeting
1 December 2026