ISO/TC 215 NZ August 2025

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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

  1. International Patient Summary (IPS) news @i.hunter @alastairk @keithduddy
  2. Around the other working groups (if you have an update) @SamuelWong @angela.pidd @atalagk @nathanb
  3. Global Digital Health Partnership (GDHP) conference report @alastairk
  4. Upcoming ballots (see below)
  5. Any other business

Previous meeting

2025-05-27T12:00:00Z | ISO/TC 215 NZ Hui May 2025

Attending today

Actions

1. International Patient Summary (IPS) news

ISO 27269 International Patient Summary (IPS) final ballot - 26/26 countries in favour (10 abstentions)

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 @SamuelWong
  • ISO/TC 215/TF 7 Task Force on Telehealth and Virtual Care (TVC) Standards @i.hunter @atalagk @nathanb

3. International news

  • Global Digital Health Partnership (GDHP) July 2025 conference (data governance topic)
  • SNOMED International 2025 meetings

4. Contsys: A system of concepts for the continuity of care

5. 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 N4935 - IEC CD 60601-1 Frag 10 Ionizing radiation hazards 30/08/2025 Abstain
2 CIB N4936 - IEC CD 60601-1 Frag 12 Electromagnetic disturbances 30/08/2025 Abstain
3 SR ISO/TS 5346:2022 Health informatics — Categorial structure for representation of traditional Chinese medicine clinical decision support system 2/09/2025 Abstain
4 SR ISO/IEEE 11073-10201:2020 (Ed 2) Health informatics — Device interoperability — Part 10201: Point-of-care medical device communication — Domain information model 2/09/2025 @kishan
5 SR ISO 11240:2012 (vers 2) Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement 2/09/2025 Refer to HNZ meds group
6 SR ISO/TS 16843-6:2022 Health informatics — Categorial structures for representation of acupuncture — Part 6: Acupuncture effects 2/09/2025 Abstain
7 SR ISO 17115:2020 (Ed 2) Health informatics — Representation of categorial structures of terminology (CatStructure) 2/09/2025 @alastair @evan
8 SR ISO/HL7 21731:2014 (Ed 2, vers 2) Health informatics — HL7 version 3 — Reference information model — Release 4 2/09/2025 Check with HL7NZ to confirm vote to withdraw
9 NP ISO/NP 25979 Health informatics — Semantic Machine-Readable Data Standards for Clinical Trial Business and Operations 2/09/2025 HNZ research
10 CIB N4943 - IEC 60601-1 Frag 5 CD 1 PEMS related hazards 5/09/2025 Abstain
11 CIB N4944 - IEC 60601-1 Frag 6 CD 1 Electrical hazards 5/09/2025 HNZ clinical engineering
12 CIB N4945 - IEC 60601-1 Frag 7 CD 1 Mechanical hazards 5/09/2025 HNZ clinical engineering
13 CIB N4946 - IEC 60601-1 Frag 8 CD 1 Thermal and fire hazards 5/09/2025 HNZ clinical engineering
14 CD ISO/CD TS 20443 Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information 6/09/2025 HNZ meds group
15 CD ISO/CD TR 24936 Health Informatics — Endoscopic video and related clinical information 12/09/2025 Abstain
16 NP ISO/PWI TS 24939 Health Informatics — Selection criteria and terminology linkage for graphical content 12/09/2025 @alastairk @evan
17 CD ISO/CD 24973 Health informatics — Digital therapeutics — Product requirements 13/09/2025 HNZ meds group
18 CD ISO/CD TR 6203 Personalized digital health informatics – Standard data set for frailty assessment 13/09/2025 Abstain
19 CD ISO/CD 25237 Health informatics — Pseudonymization 17/09/2025 @nathanb @alastairk
20 CD ISO/CD TS 22220.2 Health informatics — Identification of persons, care providers and organizations 17/09/2025 @SamuelWong
21 CIB N4991 - IEEE 11073-10101b-2023 N4991 - IEEE 11073-10101b-2023 Device interoperability - Part 10101 Foundational - Nomenclature AMD 1 Additional defn 20/09/2025 Abstain
22 CD ISO/CD 25664-1 Health Informatics-Categorial structure for semantic representation in TCM informatics — Part 1: Framework 25/09/2025 @evan
23 NP ISO/NP 26060 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of Manufacturing Process & Controls Information of products and substances for pharmaceutical industry 1/10/2025 HNZ meds group
24 DTR ISO/DTR 4419 Health informatics — Pathways for human-computer interaction in electronic health information record systems to reduce clinician burden 3/10/2025 TBD
25 NP ISO/PWI TS 18729 Health informatics ㅡ Personalized surveillance framework for artificial eye use and care 8/10/2025 Abstain
26 DIS ISO/DIS 13940 (Ed 2) Health informatics — System of concepts to support continuity of care 13/10/2025 HNZ data standards
27 SR ISO/TS 5118:2022 Health informatics — Categorial structure of representation for evaluation of clinical practice guidelines of traditional Chinese medicine 2/12/2025 Abstain
28 SR ISO/IEEE 11073-10101:2020 (Ed 2) Health informatics — Device interoperability — Part 10101: Point-of-care medical device communication — Nomenclature 2/12/2025 Abstain
29 SR ISO/TS 16277-1:2015 (vers 3) Health informatics — Categorial structures of clinical findings in traditional medicine — Part 1: Traditional Chinese, Japanese and Korean medicine 2/12/2025 Abstain
30 SR ISO/TS 18790-1:2015 (vers 3) Health informatics — Profiling framework and classification for Traditional Medicine informatics standards development — Part 1: Traditional Chinese Medicine 2/12/2025 Abstain
31 SR ISO 22600-1:2014 (vers 2) Health informatics — Privilege management and access control — Part 1: Overview and policy management 2/12/2025 @SamuelWong
32 SR ISO 22600-2:2014 (vers 2) Health informatics — Privilege management and access control — Part 2: Formal models 2/12/2025 @SamuelWong
33 SR ISO 22600-3:2014 (vers 2) Health informatics — Privilege management and access control — Part 3: Implementations 2/12/2025 @SamuelWong

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

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@alastairk people like you and the rest of the committee amaze me with your level of technical knowledge! Let’s see how well AI did in writing this for me in plain language that I could understand - value your feedback :slight_smile: Plain Language Summary – What ISO/TC 215 NZ Does and Why It Matters

Who are we?
We’re a small group of New Zealanders who help make sure our country has a say in the international rules for how health information is shared and used—things like digital health records, privacy, and telehealth. These rules are made by a big international organisation called ISO (International Organization for Standardization), and our group is called ISO/TC 215 NZ.

What do we actually do?

  • We read and review draft international standards (basically, detailed instructions or guidelines) before they’re finalised.
  • We send New Zealand’s feedback and vote on whether or not to support each one.
  • If we don’t agree with something, we explain why, and work to improve it.
  • We talk to NZ experts and organisations to make sure we’re representing local views, not just our own.
  • When possible, we send a Kiwi expert to international meetings to represent NZ in person.
  • We also advise New Zealand’s health IT leadership (through a group called HISO) on which international standards are good for local use.

Why should you care?
The decisions we help shape affect how your health information is kept safe, shared between providers, and used for your care—both here and around the world. Being at the table means NZ doesn’t just follow global decisions—we help make them.

What We Talked About in Our Latest Meeting – July 2025

  1. Patient Summaries That Work Worldwide
    We’re supporting a global standard that helps health providers instantly access a summary of a patient’s key medical info—no matter where they’re from.
  2. Updates from Working Groups
    Our members are involved in lots of areas like:
  • Genetic testing
  • Virtual doctor visits
  • Safe use of medicines
  • Data privacy and security
    Each group gave updates on what’s happening internationally.
  1. Global Conference Report
    One member attended a worldwide digital health meeting (Global Digital Health Partnership) and shared what they learned.
  2. Upcoming Votes
    There are several new standards coming up for review. Some are straightforward; others need more time to discuss.
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