There are two types of testing required to validate your software product for connection to the My Health Record system. These are:
- Conformance and compliance testing. Your own internal self-assessment testing in preparation for Conformance, Compliance and Declaration (CCD); and
- Notice of Connection (NOC) testing. Testing your software using test cases and test data, provided by the System Operator, and observed by the National Infrastructure Operator (NIO).
All software products must successfully pass these testing requirements before gaining access to the My Health Record production system.
Conformance and compliance testing
Conformance and compliance testing supports the safe and secure implementation and use of the My Health Record system as part of the CCD process. The CCD process requires that your software conforms to all applicable conformance profiles and the specifications they reference, and the conformance requirements for My Health Record Connecting Systems (Specifications), prior to your software being granted connection to the My Health Record system. Furthermore, you are required to maintain compliance following connection of your product to the production environment.
All technical specifications are available on the Agency website: https://www.digitalhealth.gov.au/implementation-resources.
You verify conformance of your software product by conducting self-assessment testing using the conformance test specifications that are also available from the Agency website, in conjunction with the Clinical Package Validator tool. You are required to retain evidence of the tests performed during self-assessment testing.
My Health Record Notice of Connection (NOC)
All software products need to pass NOC testing. NOC testing confirms that your software product performs according to the specified standards and conformance points defined in the technical and logical service specification documents. These documents are referenced within each implementation guide available on the Agency website: https://www.digitalhealth.gov.au/implementation-resources.
Once you have submitted the Software Vendor Product Details Form to OTS, the NIO will send you a test plan, which includes the services nominated for use during the NOC process. You will be required to submit self-assessment of all relevant test cases, and the NIO will also conduct an observed NOC session. When this process is completed successfully, the NIO will issue you with a My Health Record Declaration of Notice of Connection for the specific version of your product that has been tested.
My Health Record Conformance Vendor Declaration Form
Upon completion of both NOC and conformance testing, you must complete the Conformance Vendor Declaration Form (for instructions, see: Instructions for completing the Conformance Vendor Declaration Form). By completing the Conformance Vendor Declaration Form, you are declaring conformance against the conformance profiles and specifications. Both documents are available in the My Health Record Welcome Pack.
Vendor Deed Poll
Attached to the My Health Record Conformance Vendor Declaration Form is a Vendor Deed Poll that outlines a number of operational obligations to which you must agree when connecting a software product to the My Health Record system. The deed poll requires a signature from an authorised delegate of your organisation. The signature on the deed poll must be witnessed.
The System Operator has a responsibility to perform regular quality assurance analysis of the data and transactions submitted by products that connect to the My Health Record system (Operative Provision 9 in deed poll). If required, your organisation may be requested to assist with any product-specific analysis undertaken. The System Operator will keep your organisation informed of any findings related to your product(s).
Please email the completed Conformance Vendor Declaration Form to: [email protected].
When a software vendor makes changes to their products which adds/removes or updates My Health Record system functionality or materially changes the interaction with the system, the software vendor is required to re-complete the NOC and CCD process with an incremented version number for the software.
Triggers for subsequent registration may be:
- The development of new functionality;
- Upgrading conformance to a newer version of specifications; or,
- Development in response to an identified software error.
In all cases the software version in the SOAP header must be updated, and the product version declared.
My Health Record NOC testing may be required prior to the version being whitelisted in the system.