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Quick Intro

The following steps will assist prescribing and dispensing Clinical Information System (CIS) software developers connect to an open Prescription Delivery Service (PDS) and declare software conformance with the Agency’s Electronic Prescribing technical framework.

If your product will support Electronic Prescribing, please be familiar with the conformance process:

Step 1: Connect to an Open Prescription Delivery Service (PDS)

To connect your product to an Open PDS, please contact your preferred, conformant, Open PDS provider. Your provider will make available, specifications and test environment access, to enable you to develop and test your product. Contact details for conformant, PDS providers are available below.

Delivery Services

 

 

Open PDS

eRX Script Exchange

E: [email protected]

Open PDS

MediSecure

P: Monday – Friday (0800 – 1900): 1800 472 747 
P: Saturday – Sunday (0900 – 1700): 1800 472 747 or 
E: [email protected]
Active Script List Register Medication Knowledge E: [email protected]

Step 2: Develop Your Product

Review the Electronic Prescribing Conformance Profile here:

Identify the applicable requirements/conformance points that apply to your product. Each requirement identifies if it is applicable to an Open PDS model. Applicable requirements have a “yes” in the “open PDS” column. Where “No” appears in the “Open PDS” column, it means the requirement is not applicable.

If your product is connecting to an open medication chart PDS, the applicable conformance requirements are marked with “yes” in the “Med charts Open PDS” column.

Conformance Test Specifications and test data are available to assist your development and testing here: 

Using the specifications and test environment access provided by your PDS provider commence developing your product.

Note:
Please ensure you check the specific requirements of the states and/or territories in which you intend to release your product. Some states and territories have established approval criteria software developers must meet prior to deployment. Details available here: 

Step 3: Conduct Internal Testing

Conduct a self assessment against the applicable requirements/conformance points and your own internal testing.

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.

Step 4: Complete the Conformance Test Specification

Complete the Electronic Prescribing Conformance Test Specification (CTS) and submit to your Open PDS Provider unless your product is owned (fully or partially) by the Open PDS (or vice versa) listed, in that case submit to the Australian Digital Health Agency.

Please ensure the CTS for your product, completed in full, with:

  • the relevant test outcomes (pass, fail, N/A) recorded against each test case
  • a corresponding reason documented for any test marked as N/A
  • completed Test Summary Report (TSR) worksheet
  • relevant evidence for each test outcome including screenshots, recordings, documentation or other.

*If you have previously declared conformance to an older version of the conformance profile, please ensure the CTS for your product is complete in full, with:

  • delta tests marked and passed in the CTS with evidence provided (please see the note in step 4 to access the delta)
  • all other tests marked as passed in the CTS – include a comment no change from previous conformance (if applicable)
  • the relevant test outcomes (pass, fail, N/A) recorded against each test case 
  • a corresponding reason documented for any test marked as N/A
  • completed Test Summary Report (TSR) worksheet
  • relevant evidence for each test outcome including screenshots, recordings, documentation or other.

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

test-summary-report-screenshot

Test Summary Report (TSR) worksheet (screenshot below)

test-summary-report-worksheet-screenshot

Step 5: Conduct Conformance Assessment

Your Open PDS Provider will conduct your Conformance Assessment observation session unless your product is owned (fully or partially) by the Open PDS (or vice versa) listed, in that case the Australian Digital Health Agency will conduct your observed tests.

The purpose of the observed Conformance Assessment is to verify and confirm the results recorded in your submitted Conformance Test Specification (CTS) and validate any further information requested by your Open PDS provider.

Your PDS provider will inform you if you are ready to undergo observation and will schedule the session at a mutually agreeable time.

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

Step 6: Declare Conformance

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 available here:  

and submit your completed form to [email protected]

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-screenshot

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

  • Invalid conformance ID
  • 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

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

Your product conformance ID is added to the Register of Conformance. This register is communicated by the Agency to Services Australia and PDS providers for operationalisation.

Step 7: Deploy Updated Product

Once you have received a notification that your product has been included on the list of conformant products you may commence deploying electronic prescribing functionality into production and conduct associated training to your end users.

Conclusion

You should now be able to gain product conformance with the Agency’s Electronic Prescribing Technical Framework for your CIS product/s connecting to an Open PDS. If you need any further assistance please contact [email protected].

Back to: Electronic Prescribing Conformance Process