The ICR Sixth Edition changes Standard 4 to accept an Australian-approved messaging standard, with HL7 Version 2.4 as the minimum and flexibility for HL7 FHIR. The in-house IVD Sixth Edition adds software quality standards and changes the companion diagnostics wording.
The Explanatory Statement describes the ICR change as a move away from a Standard 4 that restricted providers to HL7 Version 2.4 as localised for Australia. The Sixth Edition allows conformance with an Australian-approved electronic messaging standard, with a minimum of HL7 Version 2.4 as localised for Australia and flexibility to adopt HL7 FHIR. On the in-house IVD side, the Sixth Edition revises the companion diagnostics standard to refer to a corresponding medicine rather than a specific medicine, a minor clarification, and introduces quality standards for laboratories that manufacture or develop in-house IVD software. Those standards apply to embedded and integrated software, software that drives or influences other devices, and standalone software or software as a medical device, with or without machine learning or artificial intelligence.
Is the ICR change only about FHIR?
No. The Explanatory Statement frames it as a move to an Australian-approved messaging standard, with HL7 Version 2.4 as the minimum and FHIR as an option.
Is the in-house IVD change only about software?
No. It also changes the companion diagnostics wording. The software standards are the larger operational change.
Where this comes from
The register states each provision in our own words and cites the section or item. The dates page separates the two commencements. The official text is F2026L00927 on the Federal Register.
Not legal advice; does not certify. The standards themselves are separate documents and are not reproduced here.