Intended Purpose and Regulatory Status

What CAREFUL is for

CAREFUL is a clinical coordination and communication platform for healthcare teams. Its intended purpose is to help clinical teams coordinate care — to record, organise, communicate and track the tasks, handovers, referrals and messages that move a patient's care forward — within a single shared, auditable plan.

CAREFUL is intended for use by registered healthcare professionals and the care teams who support them, across settings including hospital wards, emergency departments, overnight and intensive-care teams, community and aged care, and cross-organisation pathways.

What CAREFUL does

• Handover and tasks — records clinical tasks, gives each a named owner and a due date, and carries them across shift changes.
• Referrals and coordination — structures and transmits referrals between teams and organisations.
• Secure messaging — links conversations to a patient and an owner, replacing unstructured channels.
• Ambient voice documentation — records a consultation with consent, drafts a structured clinical note from the transcript for the clinician to review, and captures the actions the clinician decides on during the consultation so they can be assigned and tracked.

In every case, CAREFUL records, organises, communicates and tracks information and decisions that originate from the clinical team. The clinical judgement — what is wrong with the patient, what should be done, and whether to do it — is made by the responsible healthcare professional, not by CAREFUL.

What CAREFUL is not, and does not do

CAREFUL is not a medical device, and is not intended to be used as one. It does not:

• diagnose, screen for, or predict any disease or condition;
• interpret physiological signals, images, or laboratory data to produce a clinical finding;
• calculate a clinical score, risk, or dose used to reach a diagnosis or treatment decision;
• recommend, select, or decide a diagnosis or treatment for an individual patient;
• control, drive, or determine the output of any other medical device;
• carry out, order, or execute any clinical action.

CAREFUL presents information that clinicians have created and decisions they have made, in a form that helps them coordinate it and not lose track of it. It does not generate clinical information of its own.

The Ambient Voice feature

The ambient voice feature's purpose is documentation and coordination. It spares clinicians the work of writing up consultations and notes and manually re-recording actions they have agreed. It does two things.

1. It produces a structured note from the consultation transcript, which the clinician reviews and edits.
2. It captures the actions the clinician states during the consultation, which the clinician reviews, edits and confirms before anything is saved.