Understanding the health facility management software exclusion
Guidance on when software used for the administration or management of health processes or facilities 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 to be administration or management of health processes or facilities, which may be excluded from our regulation under item 14G 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 for the administration or management of health processes or facilities may be excluded from our regulation under item 14G 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 14G applies to software intended to be used for the administration or management of health processes or facilities, including for:
- financial records
- claims
- billing
- appointments
- operating theatre management
- hospital bed management
- schedules
- business analytics
- admissions
- inventory workflow.
This exclusion category does not apply to software intended to manage individual patient care or to software intended for general consumer use.
Extract: Item 14G
…software that is:
- intended by its manufacturer to be used for the administration or management of health processes or facilities (including financial records, claims, billing, appointments, operating theatre management, hospital bed management, schedules, business analytics, admissions, inventory, and workflow); and
- not intended by its manufacturer to 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 2 questions.
If you answer YES to the following question, this exclusion may apply:
- Is your software for the administration or management of health processes or facilities?
If you answer YES to the following questions, your software is not excluded:
- Does your software make claims about a disease, condition, ailment, or defect?
Flowchart for determining if software is excluded by 14B
A flowchart for determining whether a medical device software product used for the administration or management of health processes or facilities is excluded under category 14G.
The flowchart begins with the question: "Does your software make claims about a disease, condition, defect or ailment?"
If YES, the path leads to a blue box labelled "Not excluded."
If NO, the path continues to the next question.
The second question asks: "Is it only for the administration or management of health processes or facilities?"
If NO, the path leads to a blue box labelled "Not excluded."
If YES, the path leads to a purple box labelled "Excluded."
The flowchart shows that software is only excluded if it does not make clinical claims and is solely for administrative or management purposes.
Examples
Excluded software
Example: Medicare claim software
Software that organises and processes Medicare claims for a general practice (GP) clinic.
The Medicare claim software would be excluded from our regulation because it is not used for diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment or for making decisions about treatment of a disease, condition, ailment, or defect.
Not excluded
Example: Hospital admissions software with patient screening module
A software module that is used by hospital staff to screen patients for health conditions and forms part of a larger system that manages hospital admissions.
The hospital admissions software would not be excluded from our regulation because it includes a module that is intended to be used for screening for a disease, condition, ailment, or defect.
Glossary
| Term | Definition |
|---|---|
| Administration or management of health processes or facilities | Software intended for things such as (but not limited to):
Your software is not intended for patient clinical use cases but is nonetheless important for the health and wellbeing of a patient as they go through the health process and/or a facility. This exclusion does not apply to software intended to manage individual patient use cases. This includes matters such as managing financial records, claims, billing, appointments, operating theatre management, hospital bed management, schedules, business analytics, admissions and/or inventory and workflow. |
| Make claims about a disease, condition, ailment or defect | If your software does any of the following:
…of a disease, condition, ailment, or defect, then it 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.'