Site notifications

Sub menu

 

 

Understanding the communications software exclusion

Guidance on when software that enables communications to support the delivery of health services may be excluded from our regulatory requirements.

Published

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 to enable communications for the purposes of supporting the delivery of health services, which may be excluded from our regulation under item 14F 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 is marketed or supplied in Australia unless a valid exemption is in place.

However, software intended to be used manufacturer to enable communications including the transmission of patient information for the purposes of supporting the delivery of health services may be excluded from our regulation under item 14F 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 14F applies to software intended to enable communications for the purposes of supporting the delivery of health services.

Extract: Item 14F

...software that is:

  1. intended by its manufacturer to enable communications, including the transmission of patient information, for the purposes of supporting the delivery of health services; and
  2. not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment, or defect.

Check if your software is excluded

This exclusion is based on 2 questions.

If you answer YES to the following question, exclusion 14F may apply to your product:

  1. Is your software intended to enable communications, including the transmission of patient information, for the purposes of supporting the delivery of health services?

However, if you answer YES to the following question, your software is not excluded:

  1. Does your software make claims about a disease, condition, ailment, or defect?

Flowchart for determining if software is excluded by 14F

Flow chart for the software category 14F from the Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018 (the Determination).

This diagram is a decision flowchart that can be used to determine whether software is excluded from our regulation.

First question: "Does your software make claims about a disease, condition, defect or ailment?"

If YES, the outcome is "Not excluded."

If NO, continue to the next question.

Second question: "Is it only for communications, including the transmission of patient information, for the purposes of supporting the delivery of health services?"

If NO, the outcome is "Not excluded."

If YES, the outcome is "Excluded."

Examples

Excluded software

Example: SMS or email distribution software

Software that runs or is used purely as a communications tool for sharing health information, like a platform that sends patients or health professionals an SMS about test results or an email with a PDF attachment containing written results. 

The software is marketed specifically for sharing health information.

The SMS or email distribution software would be excluded from our regulation because it is used only for healthcare communication. Even though a diagnosis or prognosis or some other health activity might be undertaken during the communication, the software itself does not perform that activity.

Not excluded

Example: Telehealth module to measure range of movement

A telehealth module that is one feature of a general practice (GP) management practice software system.

The module acts like a goniometer to measure the range of movement of a patient's limbs for the purpose of monitoring patient recovery or prognosis.

This general practice management software would not be excluded from our regulation because it is more than just a communication tool. The telehealth feature is making claims about a disease, condition, ailment, or defect.

Glossary

TermDefinition
Enable communications

Your software provides or helps to provide an electronic communication medium, method or channel, over which patient information (and, possibly, other information) can be transmitted and shared between individuals (patients and/or health professionals). 

This channel could be anything from an SMS to an email, or an audio call, video call or video conference, and is intended to refer to communications between people, rather than equipment or devices.

Transmission of patient information

Software intended to send and receive information related to one or more aspects of a patient's health. 

This transmission might be between health professionals and/or general consumers. 

This information could be from a patient record, for example.

Software intended to remotely display certain patient information would not be excluded if the information:

  • is being displayed to remotely monitor a patients’ condition, that is intended to alert a caregiver to take clinical action
  • is being displayed for the purposes of making a diagnosis, or screening for a disease or condition (for example, is the software is intended to display test results or medical imaging for a health professional to interpret, and/or make a diagnosis).
Supporting the delivery of health services

Software to transmit patient information with the goal of helping to deliver some sort of health service.

There are many types of health service that can be delivered remotely via a telehealth service – anything from the results of a test or scan (information only) to advice on what disease a patient might have (diagnosis), what the patient's chances are of recovery (prognosis) or step-by-step guidance to perform an emergency procedure in a remote location (treatment).

If the software only facilitates the communication, then it is excluded, even if a health professional using it might be diagnosing or treating a patient.

However, if the software makes claims about a disease, condition, ailment, or defect, it may not be excluded.

For example, if software intended to support communications also included functionality that analysed patient information (such as imaging and test results) to detect a particular condition, it would not be excluded.

Make claims about a disease, condition, ailment or defect

If your software does any of the following:

  • diagnosis
  • screening
  • prevention
  • monitoring
  • predicting
  • prognosis
  • alleviation
  • treatment
  • recommending or making decisions about treatment

…of a disease, condition, ailment, or defect, then it is not excluded.

Product types

Page history

Show all page updates (1)

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.'