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Understanding the middleware for health systems exclusion

Guidance on when software that is middleware intended to connect or interface applications 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 that is middleware intended to connect or interface applications to an underlying operating system or another application, which may be excluded from our regulation under item 14K 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, middleware may be excluded from our regulation under item 14K of the Determination.

About this exclusion category

Exclusion 14K applies to software that is middleware intended to connect or interface applications to an underlying operating system or another application, including by communicating or transmitting information.

Extract: Item 14K

Software that is middleware and is:

  1. intended by its manufacturer to connect or interface applications to an underlying operating system or another application, including by communicating or transmitting information; and
  2. not intended by its manufacturer to:
    1. control medical devices; or
    2. perform analysis, computation or logic that relates to the intended purpose of a medical device; or
    3. be used for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making 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 4 questions.

If you answer YES to the following question, the exclusion may apply:

  1. Is your software middleware that is intended to connect or interface applications to an underlying operating system or another application, including by communicating or transmitting information?

If you answer YES to any of the following questions, your software is not excluded:

  1. Does your software also control medical devices?
  2. Does your software perform analysis, computation or logic that relates to the intended purpose of a medical device?
  3. Does the software make claims about a disease, condition, ailment, or defect?

Flowchart for determining if software is excluded by 14K

Flowchart for determining if software is excluded by 14K

A left-to-right decision flowchart for determining whether exclusion 14K applies to middleware.

This image explains when software is excluded or not excluded from our regulation, based on a series of yes‑or‑no questions.

Each decision point is presented as a question followed by 2 possible outcomes: YES or NO.

The flow ends with a final determination of either "Excluded" or "Not excluded."

First decision question: "Does your software control a medical device?"

If the answer is YES, the software is not excluded, and the decision process ends.

If the answer is NO, the flow continues to the next question.

Second decision question: "Does it perform analysis, computation or logic that relates to the intended purpose of a medical device?"

If the answer is YES, the software is not excluded, and the decision process ends.

If the answer is NO, the flow continues to the next question.

Third decision question: "Does it make claims about a disease, condition, defect or ailment?"

If the answer is YES, the software is not excluded, and the decision process ends.

If the answer is NO, the flow continues to the next question.

Fourth decision question: "Is it middleware that only enables communications between these different software layers or components?"

If the answer is YES, the software is excluded.

If the answer is NO, the software is not excluded.

The diagram communicates that software is generally not excluded unless it solely functions as middleware for communication between software components and does not control a medical device, perform medical‑related analysis, or make medical claims.

Examples

Excluded software

Example: Hospital integration middleware 

Middleware software used in a hospital that communicates and integrates between user-facing software and the hospital's mainframe.

The middleware does nothing else, for example it does not analyse medical test results.

The middleware would be excluded from our regulation because it is generic and not designed specifically for a healthcare or medical purpose.

It is not a medical device, it does it control medical devices, and it is not intended for diagnosis, screening for, prevention, monitoring, predicting, prognosis, alleviation, treatment or making recommendations or decisions about treatment.

Example: Medicare payments API

An application programming interface (API) that enables secure access to patient bank details to facilitate the payment of Medicare benefits.

The API would be excluded from our regulation because it is not used to control a medical device or perform logic related to the intended purpose of a medical device or for the diagnosis, screening for, prevention, monitoring, predicting, prognosis, alleviation, treatment or making recommendations or decisions about treatment.

Not excluded

Example: Web portal for medical device content

A web server that supports the delivery of content for a software-based medical device that requires information be uploaded through a web-based portal.

The web server would not be excluded from our regulation because it is required for a medical device to achieve its intended purpose.

Example: Pathology middleware for IVD analyser

Pathology middleware software used to influence, control, or drive an analyser.

Because the analyser is an in-vitro diagnostic medical device (IVD) and the software drives or influences it, the software must be classified with the medical device, and it is not excluded.

Example: Pathology middleware to analyse biopsy samples

Pathology middleware software used to analyse biopsy samples and provide a diagnostic output.

Because the software performs or helps to perform a diagnosis or prognosis on a patient's disease, condition, ailment, or defect, it is not excluded.

Glossary

TermDefinition
Middleware

Middleware in a healthcare context usually means the same as in information technology (IT).

It is software that sits between software applications such as user-facing software and an operating system.

Middleware enables communications between these different software layers or components.

Middleware software is excluded from our regulations. It is not a medical device even if it is used in a healthcare context such as hospital.

Pathology middleware

Middleware has a slightly different meaning in pathology.

Pathology middleware commonly sits between laboratory instruments and laboratory information systems (LIS) to manage laboratory data collected from laboratory instruments.

Pathology middleware can also perform a variety of other functions including to:

  • verify and analyse the results of medical tests, for example a biopsy
  • help in diagnosis and/or prognosis. 

If the middleware includes these functions, it is a medical device. It is not excluded from our regulations.

Control medical devicesSometimes middleware can control medical devices, for example by passing instructions from another software application to a medical device.
Analysis, computation or logic that relates to the intended purpose of a medical deviceThis means, is your middleware software required by a medical device for it to perform as intended? If it does this, then it is an accessory to a medical device, and is not excluded.
Make claims about a disease, condition, ailment or defect

If your software does any of the following:

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

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

Product types

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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.'