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Quick intro

This process is an overview of the steps software developers take declare electronic prescribing software conformant with the Agency’s technical framework.  

The Agency offers a range of support services throughout the conformance process including consultative support and scheduled information sessions.

Please contact [email protected] if you require further assistance. 

Step One: Review the Technical Framework

Access the technical framework documents and welcome pack from the Electronic Prescribing homepage

These technical framework documents are provided to software vendors and demonstrate what is required to enable electronic prescribing. These technical documents are:

  • A Solution Architecture to provide an overview of the architectural components of the end-to-end national electronic prescribing system;
  • A Conformance Assessment Scheme which describes the scheme for assessing the conformance of software against the Conformance Profile involved in the electronic prescribing process; and
  • A Conformance Profile to summarise the functional and non-functional requirements for software that supports participation in electronic prescribing.

Step Two: Access Integration Specifications

If your product intends to operate as part of an “open model” of electronic prescribing, please contact your preferred Open Prescription Delivery Service provider(s) and Active Script List Registry provider(s) to get access to test environments and technical specifications (if applicable).

If your product intends to operate as part of a “direct model” of electronic prescribing, please contact any systems involved in your direct model to access or establish test environments and technical specifications (if applicable).

If your product is intended to integrate with any PBS related services, please contact Services Australia.

You can find contact information for these PDS and ASLR providers, and Services Australia by accessing the Contact List for Software Developers; part of the Developer Welcome Pack from the Electronic Prescribing homepage

Step Three: Develop Your Product

  1. Identify which conformance points are relevant i.e. Prescribing Systems, Dispensing Systems, Mobile Application, etc. Open PDS or Direct PDS.
  2. Commence your development cycle(s).
  3. If you require support to understand the Agency’s conformance requirements, please contact [email protected] ensuring you reference the Conformance Profile version.

Step Four: Prepare for Observed Testing

1. Conduct internal testing and self-assessment against the relevant Electronic Prescribing Conformance Test Specifications (CTS) downloadable from the Electronic Prescribing homepage.  

Note: If you have previously declared conformance to an older version of the conformance profile, please contact [email protected] for support to identify the delta testing applicable to your product.

2. Notify your observed test provider of your intention to enter into an observed test.

3. When you have completed your self-assessment, please submit your self-assessment documentation to your observed testing provider.

4. Your self-assessment documentation should include*:

- Relevant CTS for your product, completed in full, with: 

- The relevant test outcomes (pass, fail, N/A) recorded against each test case. 
Please note, any test marked as N/A requires a corresponding reason for that selection 

- Completed Test Summary Report (TSR) worksheet

- Relevant evidence for each test outcome including screenshots, recordings, documentation or other. Please ensure you accurately reference the evidence provided against each test case. This will assist your observed test provider for a more streamlined process. 

*Note: If you have previously declared conformance to an older version of the conformance profile, please complete the CTS with the accompanying evidence documentation to submit to your observed testing provider:

- Relevant CTS for your product, completed in full, with:

- Delta tests marked and passed in the CTS with evidence provided (please see note to understand how to access the delta)

- All other tests marked as passed in the CTS – comment that there has been no change from previous conformance (if applicable).

- The relevant test outcomes (pass, fail, N/A) recorded against each test case. 
Please note, any test marked as N/A requires a corresponding reason for that selection

- Completed Test Summary Report (TSR) worksheet

Conformance Test Specification –test result and test evidence cells (screenshot below)

Test Summary Report (TSR) worksheet

Test Summary Report (TSR) worksheet (screenshot below)

Conformance Test Specification –test result and test evidence cells

Step Five: Undergo Observed Testing

The observed test will verify and confirm the results recorded in your submitted Conformance Test Specification (CTS) and validate any further information requested by your observed testing organisation.

1. Complete Step Four - complete your self-assessment, please submit your self-assessment documentation to your observed testing provider.

2. Your observed test provider will inform you if you are ready to undergo observation. Your observed test provider will work with you to schedule a mutually agreeable time. 

3. During and following your observed test, your observed test provider may request further evidence for specific test cases to ensure the record of the test is full and accurate.

Observed testing providers:

Your product is a…

Your observed test provider will be…

Prescribing CIS*

Your open PDS provider

Dispensing CIS*

Your open PDS provider

Mobile Intermediary* 

Your open PDS provider

Mobile Application* 

Your Mobile Intermediary provider

Direct Model Product 

Australian Digital Health Agency

* If your product is owned (fully or partially) by the observed test provider (or vice versa) listed, the Australian Digital Health Agency will conduct your observed tests.

Step Six: Finalise Observed Testing Outcomes

Your observed test provider will finalise the outcome of your observed test. You observed test provider shall:

1. Complete the Conformance Observed Test Completion Form with the outcomes of your observed test. This form will be distributed to your organisation for verification and endorsement.

2. Complete the final Conformance Test Specification (CTS) file relevant to your product including:

a. All mandatory tests are to reflect the outcome of the observed test session (e.g. Pass, N/A, Fail) recorded against the test result.

i. Any tests marked as N/A have an appropriate agreed reason stipulated in the test result column.

b. Test Summary Report (TSR) Worksheet - Software details fully filled and include:

i. All contact details.

ii. Software component names of all software used in the system. E.g. adapter(s), workflow engine(s), API gateway(s), etc.

iii. Software version number and conformance ID.

iv. Those States and Territories applicable to your product.

3. Your observed test provider will send the Conformance Observed Test Completion Form and final, completed CTS to the Agency for processing.  Your observed test provider will send copy of final completed CTS to you for your records.

If your observed test provider is the Agency, we will retain a copy of the Conformance Observed Test Completion Form and final, completed CTS for processing.

Test Summary Report (TSR) worksheet (screenshot below)

Test Summary Report (TSR) worksheet

Note:  the information recorded in the Test Summary Report (TSR) tab must match those specified in your Conformance Vendor Declaration Form.

Step Seven: Declare Conformance

1. Upon successful completion of previous steps, you may now declare your product’s conformance to the Australian Digital Health Agency by completing the Electronic Prescribing Conformance Vendor Declaration Form and submit your completed form to [email protected]

2. When completing the Conformance Vendor Declaration Form, please ensure you have completed all relevant information such as: 
- Inclusion of companion software details in section 1.3. Companion software may include: PDS adaptor(s), workflow engine(s), mobile gateway(s) etc.

Please ensure that the information in the Conformance Vendor Declaration Form matches that of the Test Summary Report (TSR) tab in the final Conformance Test Specification (CTS).

Note: The Conformance ID is a text string of no more than 36 printable characters containing a text string representing the Product Name, a single character delimiter (“|”) and an alpha-numeric string representing the Software Product Version.  Noting that the Conformance ID may assist with issue identification and is used to manage participation, declaration of accurate version information is strongly advised. It is, however, recognised that some software products update version information on a regular basis and in response to changes which do not impact electronic prescribing functionality. For this reason, software vendors may ascertain for themselves the granularity of version information declared in the Conformance ID and the occasions at which it is declared.

Electronic Prescribing Conformance Vendor Declaration Form

Electronic Prescribing Conformance Vendor Declaration Form

Step Eight: Conformance Declaration Processed

1. The Agency will process your declaration upon receipt of all relevant documentation including – Conformance Vendor Declaration Form, Conformance Observed Test Completion Form (from your observed test provider), final observed Conformance Test Specification (CTS) (from your observed test provider).

2. If the Agency identify any errata in your submission, you will be informed directly. Common errata include:

- Invalid conformance ID (please see step 7)
- Incorrect “reason for this declaration” 
- Failure to include companion software components
- Information mismatch between the final CTS Test Summary Report (TSR) worksheet and the Conformance Vendor Declaration Form

3. Upon successful processing, you will be notified by the Agency directly.

4. You product conformance ID is added to the Register of Conformance.

5. This register is communicated by the Agency to Services Australia and PDS providers for operationalisation. 

Step Nine: Deploy Your Product

1. You are now able to commence deploying electronic prescribing functionality and associated training to your end users.

The Agency recommends your product end user training to include (but not be limited to) the following topics:

- General system guidance
- Local system settings and configuration(s) (e.g. firewalls, printer drivers, certificates etc.) 
- How to access previous records of electronic prescriptions 
- How to generate and interpret reports (e.g. for a regulator) 
- Legislative requirements or processes 
- How to access support