Supply Chain Systems

 

Standards and specifications

General requirements

Cyber security

The software must demonstrate adherence to the ‘Essential 8’ cyber security principles.  

Core requirements

Standards for identification

The software must:

• Content will be updated following consultation feedback

Australian Core Data for Interoperability (AUCDI)

The software should support the use of AUCDI Release 1.

Note: The focus of the AUCDI Release 1 is the representation of the clinical content necessary for each of the data groups identified within the Release 1 scope.

Development is continuing to enhance AUCDI.

Standards for data sharing

The software should:

• support the authoring and consumption of clinical documents in Fast Healthcare Interoperability Resources (FHIR®) formats.

Standards for terminology, code sets and classifications

If the system is managing prostheses, the system must:

• support the use of the Private Health Insurance (prostheses) rules and the current versions of the prosthesis list including the drafted Prescribed List Guide

If the system is managing medications, the system must:

• support Australian Medicines Terminology (AMT)

The system should:

• support person and provider identification in healthcare National Best Practice Data Set

If the system is managing medical devices or medicines, the system should:

• support the inclusion and identification of items listed on the Australian Register of Therapeutic Goods (ARTG)

National Safety and Quality Health Service (NSQHS) Standards

Implementation of NSQHS is mandated in all hospitals, day procedure services and public dental services across Australia.

Other Standards

International

The system must support:

• ISO/IEC 17360:2023 standard: Automatic identification and data capture techniques - Supply chain applications of RFID - Product tagging, product packaging, transport units, returnable transport units and returnable packaging items
• ISO/IEC 27036-3:2023 standard for Cybersecurity - supplier relationships - Part 3: Guidelines for hardware, software, and services supply chain security.

National

• comply with the relevant legislation for medicines, poisons and therapeutic goods  
• comply with the handling and destruction of drugs standard.

The system should support:

Connections to National Systems

HI Service

If the system is managing medical devices or medicines, the system should:

• support linkage to the Pharmaceutical Benefits Scheme (PBS) online-claiming system.

Conformance

The software must:

• have production access to the Health Identifiers Service.

State and territory requirements

The following state and territory requirements must be upheld based on location.