Submitting UDI records using HL7 SPL

HL7 SPL overview

The Health Level 7 (HL7) Structured Product Labelling (SPL) is a document markup standard governed by HL7 International (www.hl7.org). It supports the electronic transfer of health-related data based on extensible markup language (XML).

Sponsors, manufacturers and agents can use HL7 SPL to submit data to the Australian Unique Device Identification Database (AusUDID). 

This submission method aligns with the approach used by the United States Food and Drug Administration (USFDA) for electronical submissions data to their UDI database.

We recommend this submission method for users with a high number of UDI records and are familiar with HL7 SPL.

For help or more information, contact the AusUDID Technical Support Team at AusUDIDTechnicalSupport@health.gov.au.

HL7 SPL document suite

We have developed a HL7 SPL document suite, known as the M2M HL7 SPL – Implementation Package – AusUDID. This suite provides detailed guidance on using HL7 SPL to submit UDI records to the AusUDID. 

You must review these documents before using the HL7 SPL submission method. They contain mandatory rules, technical requirements and validation guidance.

You can download the full document suite from the Supporting documents section at the bottom of this page. 

Table 1: HL7 SPL document suite

Note
The Australian UDI Data Dictionary is the reference list for AusUDID UDI data elements. 

When preparing HL7 SPL submissions, you should follow the M2M HL7 SPL -Implementation Specification. Some variations exist due to the technical nature of the submission method. 

For example, the M2M HL7 SPL submission method cannot derive system information such as UDI record Publish Date.

HL7 SPL user types

The HL7 SPL submission method can be used by:

• manufacturers
• sponsors
• third party data providers
• agents.

Some actions, such as generating a Subscription Key, can only be completed by sponsors, manufacturers and agents. These actions require a TGA Business Services (TBS) user with the system role of Submitter to complete. Third party data providers cannot perform these actions independently. 

Third party data providers may submit UDI records on behalf of a sponsor, manufacturer or agent. However, they:

• cannot obtain their own TBS account
• Must work with their client organisations to complete testing and submissions
• Require a Subscription Key generated by their client. 

Getting started

Sponsors, manufacturers and agents

Follow these steps to begin submitting UDI records using M2M HL7 SPL. 

1. Review the HL7 SPL document suite
   • understand how the M2M HL7 SPL submission method words
   • understand access roles, responsibilities and limitations
   • understand mandatory testing requirements
2. Complete the Intent to submit to the AusUDID using M2M HL7 SPL form
   • submit the form for your organisation
   • acknowledge the M2M HL7 SPL Terms of Use (available within the form)
   • if you are submitting directly, you will receive a Client ID and Secret
   • if you are using a third party data provider, they must complete the form to obtain a Client ID and Secret
3. Obtain required credentials
   • follow the M2M HL7 SPL – User Guide to generate a Subscription Key
   • if you are submitting directly, follow the M2M HL7 SPL – User Guide to obtain an Access Token
4. Prepare your data
   • collate representative test data for submission to the AusUDID Pre-Production environment
   • ensure data meets validation requirements
5. Complete testing in the AusUDID Pre-Production environment
   • complete all mandatory testing outlined in the M2M HL7 SPL – User Guide
6. Complete the Confirmation of M2M HL7 SPL Testing Completion form
   • submit the Confirmation of M2M HL7 SPL Testing Completion form
7. Submit UDI records in AusUDID Production
   • once your Confirmation of M2M HL7 SPL Testing Completion form has been reviewed, access to AusUDID Production will be granted
   • if you are submitting directly, you may begin submitting UDI records to AusUDID Production
   • if you are using a third party data provider, you may provide them with a Subscription Key for AusUDID Production.

Third party data providers

Follow these steps to begin submitting UDI records using M2M HL7 SPL. 

1. Review the HL7 SPL document suite
   • understand how the M2M HL7 SPL submission method words
   • understand access roles, responsibilities and limitations
   • understand mandatory testing requirements
2. Complete the Intent to submit to the AusUDID using M2M HL7 SPL form
   • submit the form for your organisation
   • you will receive a Client ID and Secret
3. Obtain required credentials
   • obtain a Subscription Key from your client
   • follow the M2M HL7 SPL – User Guide to obtain an Access Token
4. Obtain data from your client
   • obtain representative test data for submission to the AusUDID Pre-Production environment
   • ensure data meets validation requirements
5. Complete testing in the AusUDID Pre-Production environment
   • complete all mandatory testing outlined in the M2M HL7 SPL – User Guide
   • request your client submit the Confirmation of M2M HL7 SPL Testing Completion form
6. Submit UDI records in AusUDID Production
   • once your client’s Confirmation of M2M HL7 SPL Testing Completion form has been reviewed, access to AusUDID Production will be granted
   • obtain a Subscription Key from your client for use in the AusUDID Production environment
   • you may then begin submitting UDI records to AusUDID Production. 

Mandatory testing requirements 

All HL7 SPL users must complete testing in the AusUDID Pre-Production environment before submitting data to AusUDID production. 

Testing confirms:

• correct transmission of the HL7 SPL message
• compatibility with the AusUDID messaging services and platform
• integrity of the UDI record(s)
• acceptable system performance and load management
• correct detection and management of errors.

Sponsors, manufacturers, and agents must submit the Confirmation of M2M HL7 SPL Testing Completion form. This enables the TGA to: 

• confirm testing is complete
• grant access to AusUDID Production. 

Third party data providers that submit UDI records on behalf of multiple organisations must complete testing for each organisation in the AusUDID Pre-Production environment.

Sponsors, manufacturers, and agents must submit the Confirmation of M2M HL7 SPL Testing Completion form prior to providing the Subscription Key to them for the AusUDID Production environment.

Submitting UDI records to AusUDID Production

Once you have completed all necessary testing, you must complete the Confirmation of M2M HL7 SPL Testing Completion Form. This must be completed by the sponsor, manufacturer or agent organisation - third party data providers cannot complete this form on behalf of their client. 

Once testing is approved, the Client ID and Secret are cleared for use, you may begin submitting UDI records to AusUDID Production.

Supporting documents

• Form: Intent to submit to AusUDID using M2M HL7 SPL
• Form: Confirmation of M2M HL7 SPL testing completion