Digital Scribes: TGA Guidance Overview 

The Therapeutic Goods Administration (TGA) has published guidance on the regulation of digital scribes, also known as AI or ambient scribes, which capture clinical conversations between patients and healthcare practitioners and generate clinical notes, summaries, or letters. When these tools employ AI (e.g., large language models or deep learning), they potentially are regulated as medical devices by the TGA. 

TGA Compliance for Digital Scribes

When TGA Digital Scribes Are Regulated as Medical Devices: 

• If they are intended to diagnose, monitor, predict, treat, or otherwise facilitate clinical decisions, they meet the medical device criteria under Section 41BD of the Therapeutic Goods Act 1989. These must be included in the Australian Register of Therapeutic Goods (ARTG) before being supplied in Australia. 
• Conversely, tools that only transcribe or translate clinical conversations—without analysis or recommendation—are not classified as medical devices. 

Domestic Compliance & Reporting: 

• Digital scribes that do analyze or interpret and are used without ARTG registration are considered non-compliant, and the TGA may take enforcement actions. 
• Users and professionals are encouraged to report suspected breaches via the TGA’s reporting form. 

Responsibilities toward Consumers and Health Professionals: 

• Healthcare professionals must: 
  • Obtain informed consent, clearly explaining how the scribe works and how it may affect patient privacy. 
  • Ensure patients understand whether any recommendations are being generated by the tool. 
  • Offer patients the option to withdraw consent or use another recording method if preferred. Patients also retain the right to review the captured information. 
• Suppliers or developers must: 
  • Continually assess whether product updates introduce features that push the tool into the medical device category. 
  • If so, either cease supply until ARTG inclusion or remove the therapeutic-use functionality. 

How MedEnvoy Can Support 

MedEnvoy assists manufacturers, software developers, and healthcare providers in determining whether their digital scribe technology should be classified as a medical device under TGA regulations. We provide: 

• Regulatory classification assessments and compliance gap analysis 

• Guidance on ARTG inclusion and preparation of required documentation 

• Support with ongoing compliance to meet both medical device and broader legal requirements in Australia 

Our expertise ensures that your digital scribe solutions meet the applicable TGA regulatory standards, enabling safe market access and ongoing compliance in Australia. We encourage you to contact our team for tailored support.