ISO/TC 215 NZ March 2025

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. Welcome to new member @vinay.nair
  2. International Patient Summary (IPS)
  3. Health NZ standards library
  4. Around the other working groups (if you have an update) @amyc @SamuelWong @angela.pidd @atalagk @nathanb
  5. Upcoming ballots (see below)
  6. Any other business

Previous meeting

2024-11-03T11:00:00Z | ISO/TC 215 NZ Hui November 2024

Actions

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 @amyc
  • 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

Upcoming ballots

We’ll walk through these, make a decision on the no-brainers and allocate the rest for further investigation

Item Type Reference Due date Title Outcome/Action
1 DIS ISO/DIS 16843-1 07 Mar 2025 Health informatics — Categorial structures for representation of acupuncture — Part 1: Acupuncture points Abstain - no expert opinion
2 CIB N4774 - IEC 62A CD 62304 07 Mar 2025 N4774 - IEC 62A CD 62304 Health software – Software life cycle processes @vinay.nair
3 NP ISO/PWI TS 16599-2 11 Mar 2025 Health informatics — Health data and governance — Part 2: Data design (DataQual2) @kishan
4 NP ISO/PWI TS 22039 11 Mar 2025 Health informatics — Generic model for bridging healthcare and prescribed care processes @kishan
5 CD ISO/CD 20737 12 Mar 2025 Health informatics --Interoperability of personal health decision support services We support, no comments to make
6 CIB N4799 - SBS application for Category A liaison to ISO TC 215 19 Mar 2025 SBS Cat A liaison application @nathanb
7 CD ISO/CD TR 4419 21 Mar 2025 Health informatics — Reducing clinicians burden Draft has potential but needs a lot more work. Where is a discussion of AI?
8 CIB N4800 - IEC 81001-5-1 Draft Interpretation Sheet 21 Mar 2025 N4800 - IEC 81001-5-1 Draft Interpretation Sheet @vinay.nair
9 CD ISO/CD TS 6268-3 01 Apr 2025 Health informatics — Cybersecurity framework for telehealth environments — Part 3: Cybersecurity requirements of telehealth @nathanb @SamuelWong hnz-ciso-team
10 CD ISO/CD 11238 02 Apr 2025 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances TL
11 CD ISO/CD TS 19844-1 02 Apr 2025 Health informatics – Identification of medicinal products (IDMP) — Part 1: Implementation guidelines for ISO 11238: General TL
12 CD ISO/CD TS 19844-2 02 Apr 2025 Health informatics – Identification of medicinal products (IDMP) — Part 2: Implementation guidelines for ISO 11238: Chemical substances TL
13 DIS ISO/DIS 27799 (Ed 3) 14 Apr 2025 Health informatics — Information security management in health using ISO/IEC 27002 hnz-ciso-team
14 CD ISO/CD TS 20451 16 Apr 2025 Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information TL
15 CD ISO/CD TS 22220 16 Apr 2025 Health informatics — Identification of persons, providers and organizations @SamuelWong
16 CD ISO/CD TS 27790 16 Apr 2025 Health informatics — Document registry framework @alastairk
17 CD ISO/CD 11615 17 Apr 2025 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information TL
18 DTS ISO/DTS 6226 17 Apr 2025 Health informatics — Reference architecture for syndromic surveillance systems for infectious diseases @alastairk
19 DIS ISO/DIS 17090-4 (Ed 3) 21 Apr 2025 Health informatics — Public key infrastructure — Part 4: Digital signatures for healthcare documents @SamuelWong
20 DTS ISO/DTS 6268-2 25 Apr 2025 Health informatics — Cybersecurity framework for telehealth environments — Part 2: Cybersecurity reference model of telehealth hnz-ciso-team
21 DTS ISO/DTS 9166 28 Apr 2025 Health informatics — Guidelines for self-assessment questionnaire systems Not much interest
22 SR ISO/IEEE 11073-20701:2020 04 Jun 2025 Health informatics — Device interoperability — Part 20701: Point-of-care medical device communication — Service oriented medical device exchange architecture and protocol binding @vinay.nair
23 SR ISO/TS 17117-2:2022 04 Jun 2025 Health informatics — Terminological resources — Part 2: Implementation Capability (TIC) @alastairk @evan.li
24 SR ISO/TS 20405:2018 (vers 2) 04 Jun 2025 Health informatics — Framework of event data and reporting definitions for the safety of health software
25 SR ISO/TS 21089:2018 (vers 2) 04 Jun 2025 Health informatics — Trusted end-to-end information flows
26 SR ISO/TS 21547:2010 (vers 4) 04 Jun 2025 Health informatics — Security requirements for archiving of electronic health records — Principles
27 SR ISO/TS 22835:2018 (vers 2) 04 Jun 2025 Health informatics — Information model of combination of decoction pieces in Chinese medicines
28 SR ISO/TS 23535:2022 04 Jun 2025 Health informatics — Requirements for customer-oriented health cloud service agreements
29 DIS ISO/DIS 16791 (Ed 3) 04 Jul 2025 Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers

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)

Any other business