Understanding when health alert software systems qualify for 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 that provides alerts to health professionals may be excluded from our regulation under item 14I 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 14I applies to software that is for the sole purpose of providing alerts to health professionals in relation to patient care.

Extract: Item 14I

Software that is:

1. intended by its manufacturer to be used for the sole purpose of providing alerts to health professionals in relation to patient care; and
2. not intended by its manufacturer to:
   1. replace the clinical judgement of a health professional; or
   2. diagnose, screen for, prevent, alleviate, treat, or make a decision about the treatment of, a disease, condition, ailment or defect.

Note: Alarms versus alerts

Exclusion 14I does not apply to software that provides alarms to health professionals that must be actioned urgently.

For example, an alarm on a ventilator that requires an intensive care unit (ICU) nurse to take immediate action would not be excluded by 14I.

This exclusion is based on 3 questions.

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

1. Is your software for sole purpose of providing alerts to health professionals in relation to patient care?

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

2. Is your software intended to replace clinical judgment?
3. Does the software diagnose, screen for, prevent, alleviate, treat, or make recommendations or decisions about treatment of a disease, condition, defect or ailment?

Excluded software

Example: Adverse drug interactions checker

Software that uses information from MIMS Australia to check potential prescriptions for any known adverse drug interactions before sending an information-only alert to a health professional.

After receiving the alert, the health professional decides whether to proceed with prescribing the medication queried.

The adverse drug interactions checker would be excluded from our regulation because:

• it is for the sole purpose of providing alerts to health professionals in relation to patient care
• it is not intended to replace clinical judgment and does not diagnose, screen for, prevent, alleviate, treat, or make recommendations or decisions about treatment of a disease, condition, defect, or ailment.

Example: Antibiotics prescription checker

Software that checks hospital prescriptions for antibiotics before sending an information-only alert to a health professional informing them of the hospital’s antimicrobial stewardship policy for the selected antibiotic. 

After receiving the alert, the health professional decides whether to proceed with prescribing the antibiotics queried.

The antibiotics prescription checker would be excluded from our regulation because:

• it is for the sole purpose of providing alerts to health professionals in relation to patient care
• it is not intended to replace clinical judgment and does not diagnose, screen for, prevent, alleviate, treat, or make recommendations or decisions about treatment of a disease, condition, defect, or ailment.

Not excluded

Example: Adverse drug interactions prevention tool

Software that uses information from MIMS Australia to check potential prescriptions for any known adverse drug interactions before sending an alert to a health professional.

If the software finds details of any known adverse drug interactions for a medicine queried, the software will not allow the medicine queried to be prescribed.

Instead, it recommends alternative prescription medicines that return no details of known adverse drug interactions.

The adverse drug interactions prevention tool would not be excluded from our regulation because it intends to replace clinical judgment.

The software prevents health professionals from proceeding with their original prescription choice. The health professional must prescribe an alternative medicine based on the options presented by the software.

This software does not have a sole purpose of providing alerts to health professionals in relation to patient care.

The software is not excluded because:

• it intends to replace clinical judgment
• it makes recommendations or decisions about treatment of a disease, condition, defect, or ailment by recommending alternative medications.

Example: Heart rhythm data collection and screening tool

Software that collects and screens a patient’s heart rhythm data before sending an alert to a health professional to notify them if an arrythmia has been detected.

If the health professional needs to take immediate action, the software includes this in the alert.

The heart rhythm tool would not be excluded from our regulation because:

• the software does not solely provide alerts related to patient care, it also monitors and screens for arrythmias and provides alerts about required clinical actions
• a health professional could rely on this information to determine whether a clinical action is required.