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ISBT 128 Standard - Labeling of Reproductive Tissue and Cell Products v1.0.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-019
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
Nov-22
This document provides guidance for facilities, hospitals, software developers and label vendors on the design of ISBT 128 labels for reproductive tissue and cell products.
Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information
Category
Standard
Organisation
ISO
ID
ISO 11615:2017
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
Oct-17
This standard defines the data elements and structural relationships required for the unique identification and detailed description of medicinal products.
Health informatics – Identification of medicinal products – Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
Category
Standard
Organisation
ISO
ID
ISO 11616:2017
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
Oct-17
This standard defines the data elements, structures and relationships required for the exchange of regulated information to uniquely identify pharmaceutical products.
Resources
This page is a gateway into discovering resources that have been provided to guide software developers who are wanting to achieve conformance and connectivity for digital health solutions supported by the Australian Digital Health Agency.
… This page is a gateway into discovering resources that have been provided to … Australian Digital Health Agency. These resources consist of guides, tools, code, …
Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information – Amendment 1
Category
Standard
Organisation
ISO
ID
ISO 11615:2017/Amd 1:2022
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
Aug-22
This document adds an additional annex to ISO 11615:2017. The annex specifies class name and attribute translations and synonyms for the identification of medicinal products.
Implementation guide – Encoding Product Information [Data Structures 003, 032, 033, and 034] – Tissues v2.0.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-020
Type
Standard
Version
2.0.0
Access
Open
Status
Active
Created
Apr-15
This document provides detailed information about ISBT 128 product coding for tissue products (Product Description Codes that begin with the letter “T”).
Implementation guide – Product Coding [Data Structures 003 and 032] – Cellular Therapy v1.3.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-022
Type
Standard
Version
1.3.0
Access
Open
Status
Active
Created
Jun-23
This document provides guidance for cellular therapy facilities in the use of the Product Code [Data Structure 003], Product Divisions [Data Structure 032], and the supporting database in the coding of cellular therapy products.
HIPS - Product Data Sheet v8.3
Product Data Sheet
ID
DH-3603:2022
Type
Component
Version
8.3
Status
Active
Created date
Updated date
The HIPS product enables the seamless integration of digital health systems with national digital health infrastructure services, such as the Healthcare Identifiers Service, the My Health Record system. The product data sheet provides information for implementers about the capabilities of the HIPS end product and its product components.
Trade product reference set
Category
Reference Sets
Organisation
SNOMED
ID
929360021000036102
Type
Standard
Version
20241231
Access
Open
Status
Active
This reference set contains terminology to describe, in a health record, the product (medication) brand name or the grouping of products into a "family", for either single component products or components of multicomponent products.
Implementation Guide - Use of Product Divisions [Data Structure 032] v1.2.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-023
Type
Standard
Version
1.2.0
Access
Open
Status
Active
Created
Nov-18
This document provides guidance to users and software developers on the use of the Product Divisions [Data Structure 032] for cellular therapy and regenerated tissue products, when used with the Product Code [Data Structure 003].
Implementation guide – Use of Product Code [Data Structure 003] – Ocular Tissue v1.2.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-032
Type
Standard
Version
1.2.0
Access
Open
Status
Active
Created
Nov-16
This document provides detailed guidance for eye banks about ISBT 128 product coding for ocular tissue using the Product Code [Data Structure 003].
ISBT 128 Standard - Standard terminology for medical products of human origin v7.72
For use with product description code database
Category
Specification
Organisation
ICCBBA
ID
ICCBBA ST-002
Type
Standard
Version
7.72
Access
Open
Status
Active
Created
Jan-24
This document provides a standard terminology for describing transfusion and transplantation products. It helps users distinguish between products when required for safety, clinical practice, or inventory management.
FHIR® Resources
… on how to connect your software to these products via FHIR®. … FHIR® is an … on how to connect your software to these products via FHIR®. …
SNOMED CT Medicinal Product Model Specification v4.0
Category
Specification
Organisation
SNOMED
Type
Standard
Version
4
Access
Open
Status
Active
Updated
Nov-21
SNOMED CT is a standard for data elements used in the electronic exchange of clinical information. This document specifies the concept model for representation of pharmaceutical and biological products in the international edition of SNOMED CT.
HIPS Mobile - Product Data Sheet v3.1
Product Data Sheet
ID
DH-3829:2023
Type
Component
Version
3.1
Status
Active
Created date
Updated date
HIPS Mobile is a mobile web application that may be added to an existing HIPS v7.1 or higher instance operated by a HIPS site, enabling users to list, download and display CDA™ documents and views from a patient’s My Health Record on their mobile or tablet device. The product data sheet provides information for implementers about the…
Health Viewer - Product Data Sheet v1.0
Product Data Sheet
ID
DH-3909:2024
Type
Component
Version
1.0
Status
Active
Created date
Updated date
The Health Viewer product enables the viewing of the My Health Record on various devices, including desktop, tablet and phone form-factors. Health Viewer is an optional add-on to HIPS and will be the eventual replacement for HIPS UI. HIPS is a middleware product offering standards-based interfaces for seamless integration with systems like patient…
Health informatics — Terminological resources — Part 2: Implementation Capability (TIC)
Category
Specification
Organisation
ISO
ID
ISO/TS 17117-2:2022
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
Mar-22
This specification defines the components (benchmarks) of capability of terminological resources implementation in healthcare software products, including electronic health record systems.
My Health Record - Managing Your B2B Software In Production v1.6
Managing Your B2B Software In Production
Services
ID
DH-3849:2023
Type
Component
Version
1.6
Status
Active
Created date
Updated date
A guide for vendors already in production. It covers topics such as incident management and software changes and upgrades. This document outlines the process for liaising with the My Health Record System Operator (SO) about production incidents and events requiring notification to the SO, such as changes and upgrades to software that connects to the My…
Implementation guide – Use of Product Code [Data Structure 003] – Blood v1.2.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-021
Type
Standard
Version
1.2.0
Access
Open
Status
Active
Created
Sep-22
This document provides guidance for blood facilities in the use of the Product Code [Data Structure 003] and its supporting database in the coding of blood components.
Clinical Document Packaging Library - Product Data Sheet v1.2
Product Data Sheet
ID
NEHTA-2131:2015
Type
Component
Version
1.2
Status
Active
Created date
Updated date
The Clinical Document Packaging Library provides a sample implementation of how to package CDA documents (and any attachments) following the Agency specifications. This product component was previously called CDA Packaging Library - Product Data Sheet.
NASH - Obtaining Identity From a Production or Test NASH Certificate v1.0
Obtaining Identity From a Production or Test NASH Certificate
ID
NEHTA-1281:2013
Type
Component
Version
1.0
Status
Active
Created date
Updated date
This FAQ answers: What identity information contained in a production or test NASH certificate should I use when validating a signature And What will be the impact on the CCA status of any SMD product that was tested with code that used the URI in the test NASH certificates issued before June 2012
HIPS Core APIs - Product Data Sheet v2.0
Product Data Sheet
ID
DH-3914:2024
Type
Component
Version
2.0
Status
Active
Created date
Updated date
The HIPS Core APIs provide a set of APIs that are dependencies for various HIPS products. As of this release, the following HIPS products are compatible with HIPS Core APIs v2.0: Document Authoring Adapter v1.0 Health Viewer v1.0 Structured Pathology Adapter v1.0
Clinical Document Data Extractor Library - Product Data Sheet v1.1
Product Data Sheet
ID
NEHTA-2130:2015
Type
Component
Version
1.1
Status
Active
Created date
Updated date
The Clinical Document Data Extractor Library simplifies the development process by providing vendors with a simple interface for extracting data from a range of CDA documents. The library uses the information from Agency-developed CDA implementation guides. This product component was previously called CDA Data Extractor Library - Product Data…
My Health Record - Managing Your B2B Software In Production v1.6
My Health Record - Managing Your B2B Software In Production
Services
ID
EP-3850:2023
Type
Product
Version
1.6
Access
Open access
Status
Active
Created date
Updated date
A guide for vendors already in production. It covers topics such as incident management and software changes and upgrades. This document outlines the process for liaising with the My Health Record System Operator (SO) about production incidents and events requiring notification to the SO, such as changes and upgrades to software that connects to the My…