TGA & medical device risk

Documentation scribes are not the same as tools that suggest diagnoses, treatments or triage. TGA scrutiny increased in 2026.

Why GPs care: You remain responsible for the record. Products with clinical decision support features need extra procurement checks.

Ranking chart

Rankings reflect documented criteria and vendor-published information. See our methodology.

Ranking criteria

Documentation-only positioning with clear public statements ranks favourably. Features that resemble clinical decision support or diagnosis suggestions are flagged for extra TGA and procurement review.

Full rankings

Tap a vendor for cited facts, pricing and product screenshots.

Lyrebird Health

85%

strong

Published documentation-only / non-device framing
Positioned as documentation aid; non-device framing in privacy materials

Grounded Scribe

85%

strong

Published documentation-only / non-device framing
States not a medical device

AI Notes

85%

strong

Published documentation-only / non-device framing
Documentation aid; not diagnostic/CDS

Heidi Health

60%

suitable

Published documentation-only / non-device framing
Clinical decision support features — verify TGA classification per function

MedicalDirector Smart Scribe

30%

weak

TGA/device status not published

PatientNotes

30%

weak

TGA/device status not published

Medow Health

30%

weak

TGA/device status not published

i-scribe

30%

weak

TGA/device status not published

Coviu AI Scribe

30%

weak

TGA/device status not published

#10

EvidenceMD

insufficient data

Clinical decision support features — verify TGA classification per function
Combines scribe with clinical reasoning/CDI/CDS features
Diagnosis or treatment suggestion features need ARTG/exemption check

Vendor	Score	Tier	Why
Lyrebird Health	85%	strong	Published documentation-only / non-device framing Positioned as documentation aid; non-device framing in privacy materials
Grounded Scribe	85%	strong	Published documentation-only / non-device framing States not a medical device
AI Notes	85%	strong	Published documentation-only / non-device framing Documentation aid; not diagnostic/CDS
Heidi Health	60%	suitable	Published documentation-only / non-device framing Clinical decision support features — verify TGA classification per function
MedicalDirector Smart Scribe	30%	weak	TGA/device status not published
PatientNotes	30%	weak	TGA/device status not published
Medow Health	30%	weak	TGA/device status not published
i-scribe	30%	weak	TGA/device status not published
Coviu AI Scribe	30%	weak	TGA/device status not published
EvidenceMD	0%	insufficient data	Clinical decision support features — verify TGA classification per function Combines scribe with clinical reasoning/CDI/CDS features Diagnosis or treatment suggestion features need ARTG/exemption check