Clinical Package Validator (Template Package Libraries & IQ Rules)

Product

Context

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Clinical Package Validator & IQ Rules

The Clinical Package Validator is a tool to automate some of the tests needed to assess conformance of clinical documents and clinical packages with the eHealth Specifications.

The Validator does not test conformance against all specifications. The product data sheet for the Validator lists the tests that are supported, tests partially supported, and a general description of the types of tests not supported.

Results from the Validator must not be relied upon to determine software conformity when declaring conformity to the My Health Record System Operator. Software developers will need to supplement results from the Validator with their own testing before declaring conformity.

Version 2.7 of the Clinical Package Validator can be found here: Clinical Package Validator v2.7

Please refer to the currently available documentation for the Clinical Package Validator 2.7:

Template package libraries

In order to validate a specific document type using the Clinical Package Validator, you will be required to load in the relevant template package.

Note: HPI-I relaxed template packages are only applicable to organisations which have been granted an exemption for HPI-Is.

IQ Rules v1.5.1

The Information Quality Rules (IQ Rules) is a tool that helps developers, testers and analysts determine the conformance of clinical documents to the My Health Record system conformance requirements. It should be used in addition to the Clinical Package Validator tests.

Use of the IQ Rules commenced within the Australian Digital Health Agency (the ‘Agency’) in January 2017. The IQ Rules are now being made available to developers of healthcare software systems to reduce the time and effort needed to test for conformance to the My Health Record system conformance requirements.

The IQ Rules are currently being published here so that feedback from software developers may be used to improve the IQ Rules. Please provide any feedback to [email protected].

Version 1.5.1 of the IQ rules can be found here: IQ Rules v1.5.1

Documentation for the installation and usage of the IQ Rules can be found here;

 

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Clinical Package Validator

The Clinical Package Validator (the Validator) is a tool to automate some of the tests needed to assess conformance of clinical documents and clinical packages with eHealth specifications.
The Validator tests a CDA document for:

  • package validation (tests the package it is enclosed in);
  • schema validation (tests its structure);
  • Schematron validation (set of rules that partially meet the CDA implementation guide, structured content specification and My Health Record system conformance profile) to a conformance level chosen by the user. The Validator does not test all requirements in these specifications; its use is strictly limited, as described in the release note. Clinical packaging zips can also be validated;
  • use of SNOMED CT-AU, AMT or PBS codes as specified in the CDA implementation guide (partial testing only);
  • use of other terminologies (partial testing only).

The Validator does not test conformance against all specifications. The product data sheet lists the tests that are supported, tests partially supported, and a general description of the types of tests not supported.
Results from the Validator must not be relied upon to determine software conformity when declaring conformity to the My Health Record System Operator. A vendor will need to supplement results from the Validator with their own testing before declaring conformity.

Template Package Libraries

In order to validate a specific document type using the Clinical Package Validator, you will be required to load in the relevant template package.

Document type

Template package

eHealth Pathology Report - Template Package Library v1.1.2

https://developer.digitalhealth.gov.au/specifications/clinical-documents/ep-2454-2017/dh-2457-2017

eHealth Diagnostic Imaging Report - Template Package Library v1.1.21

https://developer.digitalhealth.gov.au/specifications/clinical-documents/ep-2455-2016/dh-2459-2017 

Note: HPI-I relaxed template packages are only applicable to organisations which have been granted an exemption for HPI-Is.

Information Quality Rules (IQ Rules)

The Information Quality (IQ) rules is a tool that helps developers, testers and analysts determine the conformance of clinical documents to the My Health Record system conformance requirements.

The IQ rules are machine readable instructions applied by the Clinical Package Validator in addition to the instructions provided by the My Health Record template packages. The IQ rules may be used to assess individual clinical documents and collections of clinical documents.

The IQ rules compares in a collection of clinical documents to determine if there may be issues with the source of the clinical documents.

My Health Record template packages are also applied by the My Health Record system when a clinical document is uploaded to it and the system rejects a document if the template package reports any error in that document.

Constraints apply to My Health Record template packages which means there are conformance requirements that are out of scope for testing by My Health Record template packages. In contrast the IQ rules are used only in test environments so is able to apply tests that My Health Record template packages cannot, such as a test that information in the clinical document structured data is also in the narrative.

The IQ rules supplements the assessments of clinical documents performed by the My Health Record template packages.

Conformance test specifications have been created by the Australian Digital Health Agency to assist software developers to test the conformance of healthcare software systems to the My Health Record system conformance requirements.

Manual application of the conformance tests is time consuming and requires subject matter expertise that is not readily available. The IQ rules were developed to automate conformance test cases wherever possible.

Software developers should be aware that some conformance test cases cannot be automated and must be manually added in addition to the tests applied by the IQ rules and My Health Record template packages.

Access to the IQ rules may be obtained by contacting the Agency Help Centre on 1300 901 001 or [email protected].

Specifications

The Australian Digital Health Agency has provided the following specifications:

Current Specifications: 
Identifier: 
EP-2684:2018

Version 2.7 of the Clinical Package Validator (Validator) provides software developers with enhanced capabilities to achieve a greater degree of automation and depth of their conformance tests of clinical documents.

Identifier: 
EP-2454:2017

eHealth pathology reports can be used to share information about pathology tests via an individual's digital health record. The Pathology Report PDF may contain one or more tests that are uploaded by the pathology provider to the individual's digital health record.

By operation of the Public Governance, Performance and Accountability (Establishing the Australian Digital Health Agency) Rule 2016, on 1 July 2016, all the assets and liabilities of NEHTA will vest in the Australian Digital Health Agency. In this website, on and from 1 July 2016, all references to "National E-Health Transition Authority" or "NEHTA" will be deemed to be references to the Australian Digital Health Agency. PCEHR means the My Health Record, formerly the "Personally Controlled Electronic Health Record", within the meaning of the My Health Records Act 2012 (Cth), formerly called the Personally Controlled Electronic Health Records Act 2012 (Cth).

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