Understanding the image storage and transmission software exclusion
Guidance on when software products with the sole purpose of storing or transmitting patient images may be excluded from our regulatory requirements.
Purpose
If you are a software developer, manufacturer or product sponsor it is your responsibility to check whether your software or digital product is excluded from our regulation before you release it for supply in Australia.
There are currently 15 excluded software categories listed in Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018 (the Determination).
This guidance relates to software intended by its manufacturer to be used for the sole purpose of storing or transmitting patient images, which may be excluded from our regulation under item 14H of the Determination.
Legislation
Introduction
We regulate all software-based products in Australia that meet the definition of a medical device unless they meet one of 15 excluded software categories.
If your product meets the definition of a medical device in Section 41BD of the Therapeutic Goods Act 1989 it must be included on the Australian Register of Therapeutic Goods (ARTG) before it can be marketed or supplied in Australia unless a valid exemption is in place.
However, software used for storing and transmitting patient images might be excluded from our regulation provided it has no other functionality or intended purpose under item 14H of the Determination.
Note: Software with multiple functions
Every feature of software with multiple functionalities must meet the exclusion criteria to qualify for an excluded software category.
About this exclusion category
Exclusion 14H applies to software that is for the sole purpose of storing or transmitting patient images.
14H only applies to software intended for the electronic storage or transmission of patient images. It does not apply to software with any additional functionality like displaying images for diagnostic purposes or to screen for diseases or conditions.
Extract: Item 14H
Software that is intended by its manufacturer to be used for the sole purpose of storing or transmitting patient images.
Check if your software is excluded
This exclusion is based on 2 questions.
If you answer YES to the following question, the exclusion may apply:
- Is your software for the sole purpose of storing or transmitting patient images?
If you answer YES to the following questions, your software is not excluded:
- Does your software analyse the images?
Flowchart for determining if software is excluded by 14H
A decision flowchart for determining if software exclusion category 14H applies to a software product.
The centre of the diagram displays one question: "Does your software have any other purpose than storing or transmitting patient images?"
There are 2 possible paths depending on the answer to the question:
- If YES, the outcome is "Not excluded."
- If NO, the outcome the is "Excluded."
Examples
Excluded software
Example: Medical images database
A database that allows for images to be received, saved, and sent to other software.
The software has no other functionality.
This software would be excluded from our regulation because it is intended to function purely as a repository for images.
All this software does is receive, save, and send images.
Example: Online image storage system
An online platform that stores patient images and allows patients to access their images for information purposes only.
This software would be excluded from our regulation because it is for information purposes only and does not display patient images for the purpose of diagnosis.
Not excluded
Example: Image analysis app
An app that receives a patient image from a health record then highlights areas on the image that might be flagged for further review by a health professional.
This app would not be excluded from our regulation because it is intended for additional uses outside of the sole purpose of storing, retrieving, or transmitting patient images.
The software also analyses images and image metadata for a medical purpose.
Glossary
| Term | Definition |
|---|---|
| Sole purpose | Your software has one purpose only. It cannot be used for anything else. If your software has any other functionality (such as displaying images for diagnostic purposes) it may not be excluded. |
| Storing or transmitting patient images | The software is intended (only) for the electronic storage of digital images of a patient that relate to that patient's health or condition and/or electronically transmitting those images. If your software analyses the images for the purposes of diagnosis, screening, monitoring and/or determining treatment options, it will not be excluded. Similarly, software intended to display medical images for the purpose of the viewer making a diagnosis or to screen for a disease or condition is not excluded. |
Page history
Published using selected content previously located in guidance titled 'Understanding if your software-based medical device is excluded from our regulation.'
Published using selected content previously located in guidance titled 'Understanding if your software-based medical device is excluded from our regulation.'