1. National standards and specifications

Adherence to standards and specifications is essential for healthcare systems to ensure seamless data exchange and interoperability across all systems. Prioritising standards-based solutions that integrate with national systems like the Healthcare Identifier (HI) Service allows accurate identification of individuals and healthcare providers during information exchange.

National standards and specifications and examples are outlined below. They are applicable to healthcare systems and technologies and should be reviewed during procurement processes.

General requirements

All systems and technologies in Australia must adhere to these requirements:

Cyber security

They must demonstrate ability to effectively achieve mitigation strategies in line with ‘Essential 8’.

Privacy

Data collected about an individual by medical software is likely to constitute health information (which is sensitive information, a category of personal information that generally has a higher degree of privacy protection than other personal information) under relevant federal, state and territory privacy legislation. Systems must demonstrate adherence to the Privacy Act 1988. State based requirements also apply based on location. Further details are provided within the individual system content.

Core requirements

All healthcare systems and technologies must adhere to these requirements:

Standards for identification

the Healthcare Identifiers Act 2010 is a legislation that specifies the use of healthcare identifiers for healthcare and related management purposes. Identification standards such as Healthcare Identifiers, GS1 and ICCBBA ensure accurate and consistent identification within all processes and systems.

Australian Core Data for Interoperability (AUCDI)

The system should support the use of AUCDI Release 2.

Note: Development is continuing to enhance AUCDI to include further elements to support clinical data and will continue to be published over time.

Standards for data sharing

the use of HL7 frameworks and implementation guides are defined as the relevant standards for the electronic exchange of healthcare information. HL7 CDA has been used historically, however there is increasing use of HL7 Fast Healthcare Interoperability Resources (FHIR) Release 5 being defined.

Standards for terminology, code sets and classifications

most communication between health information systems relies on terminologies, code sets and classification systems to represent health concepts. Terminology standards like SNOMED CT-AU, Logical Observation Identifiers Names and Codes (LOINC), and the metadata standards defined by the Australian Institute of Health and Welfare’s METEOR Online Registry enable the communication of medical concepts

National Safety and Quality Health Service (NSQHS) Standards

these standards have been developed by the Australian Commission on Safety & Quality in Health Care to provide a nationally consistent statement of the level of care consumers can expect from health service organisations

Standards to enable meaningful information and statistics

the collection, use and reporting of datasets and resources managed by the Australian Institute of Health and Welfare, accessible via METEOR, are critical for improving evidence-based decision making on healthcare systems.  

Standards to support efficient, evidence-based funding for health and aged care

the collection of data and reporting of classifications, data specifications and code sets defined by the Independent Health and Aged Care Pricing Authority enable evidence-based price determinations and advice, ensuring fairer access and better outcomes in the Australian health and aged care sectors.

Regulatory Standards

many technologies and products in Australia’s health and aged care sectors are regulated by the Therapeutic Goods Administration as ‘therapeutic goods’ to ensure patient and consumer safety. It is important to consider relevant regulations, therapeutic goods orders, and reporting requirements.

Other Standards

healthcare systems/technologies may also be subject to other requirements like the Digital Imaging and Communications in Medicine (DICOM) Standard - a global standard for the communication and management of medical imaging and health care information. Consumer data standards may also apply.

Next: 2. Connections to national systems