Electronic Medication Management system (EMM)

National standards and specifications 

General requirements

Cyber security 

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

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. (e.g. Privacy Act 1988 (Cth), Health Records and Information Privacy Act 2002 (NSW) etc).

The software must demonstrate adherence to relevant Federal, State or Territory privacy legislation. 

Applicable Federal legislation is the Privacy Act 1988 (cth). Details of the relevant State and Territory based legislation is contained in the State requirements section.

Core requirements 

Standards for identification

The software must:  

• integrate Individual Healthcare Identifiers (IHIs) into the local patient record
• allow for the storing of Healthcare Provider Identifier-Organisation (HPI-O) in the local system and associate or link them with locally stored healthcare provider organisation details
• allow for the storing of healthcare provider identifier-individual (HPI-I) in the local system and associate or link them with locally stored healthcare provider individuals’ details.
• be capable of managing the physical medicinal products using the unique identification as specified by the Therapeutic Goods Administration in Therapeutic Goods Order(s) 91 and Therapeutic Goods Order 106.

The system should:

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

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 software should:  

• support the authoring and consumption of clinical documents in Fast Healthcare Interoperability Resources (FHIR®) formats.
• support HL7 Fast Healthcare Interoperability Resources (FHIR®)-compliant API as the base standard communication process
• support an API compliant with HL7 version 2.4.1 and the ORM specification as a minimum

Standards for terminology, code sets and classifications  

The system must:  

• be capable of capturing or storing medication related clinical information using the Australian Medicines Terminology (AMT)

National Safety and Quality Health Service (NSQHS) Standards:

The software must:

• support compliance with the Medication Safety Standard.
• support compliance to the Communicating for Safety Standard.

Note: Additional consideration of National Safety and Quality Standards is recommended to ensure systems support safety and the highest quality care.

Other National Standards 

The system must:  

• support Active Ingredient Prescribing. 

The system should: 

• support Australian Standards AS ISO/IEC 15459.4:2023 Information technology — Automatic identification and data capture techniques — Unique identification, Part 4: Individual products and product packages and AS ISO/IEC 15418:2023 Information technology — Automatic identification and data capture techniques — GS1 Application Identifiers and ASC MH10 Data Identifiers and maintenance to enable data capture related to products.

Future considerations may include requirements related to traceability of medicines as referenced in Therapeutic Goods Order 106. 

Where the system is used within a residential aged care facility, the system should: 

• support adherence to the guiding principles for medication management in residential aged care facilities 

Connections to National Systems 

HI Service:

If the software is expected to deal with healthcare identifiers (e.g. in a hospital environment) then it must: 

• be able to discover and validate Individual Healthcare Identifiers (IHI) via the Healthcare Identifier (HI) Service 

My Health Record

The software should:

• be able to access the My Health Record for the purposes of viewing a patient record
• be able to upload an electronic Prescription record
• support patient instruction not to upload 

Conformance

The software must:

• conform with the Electronic Prescribing Conformance Framework. 

Where the system is required to connect to national infrastructure, the system should: 

• have production access to the My Health Record
• have production access to the Health Identifiers Service  

State-based requirements  

 The following state-based requirements should be considered based on your location. 

All requirements must be supported based on location.