Understanding the health facility management software exclusion

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.

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:

1. 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
2. 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.

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?

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.