Regulatory Information

Regulatory Status Statement

Grounded Scribe transcribes and translates clinical conversations into written records. It does not analyse or interpret clinical conversations to generate diagnoses, differential diagnoses, or treatment recommendations not explicitly stated by the healthcare practitioner.

This classification aligns with the Therapeutic Goods Administration (TGA) guidance on digital scribes published on 30 January 2026. Under the TGA guidance, a digital scribe that transcribes and structures clinical conversations without generating clinical interpretations, diagnoses, or treatment recommendations is not considered a medical device.

TGA guidance: Digital scribes — when they are and are not regulated as medical devices

What Grounded Scribe Does and Does Not Do

Grounded Scribe does:

• Transcribe audio recordings of clinical sessions using healthcare-optimised speech recognition
• Structure clinical notes using practitioner-selected templates appropriate to their profession and documentation requirements
• Flag keywords for practitioner review using automated keyword-based detection (not clinical interpretation)
• Calculate standardised assessment scores using published, validated psychometric formulas (e.g., PHQ-9, GAD-7, DASS-21)
• Extract administrative follow-up items mentioned by the practitioner during sessions (e.g., “I’ll send the referral letter”)
• Provide an administrative AI receptionist that handles incoming calls, answers practice enquiries, and diverts crisis calls to emergency services

Grounded Scribe does not:

• Generate diagnoses or differential diagnoses
• Provide treatment recommendations not explicitly stated by the treating practitioner
• Make clinical decisions or replace professional clinical judgement
• Analyse or interpret clinical conversations to provide clinical decision support
• Predict clinical outcomes or recommend changes to treatment plans
• Triage patients based on clinical data

Applicable Regulatory Frameworks

While Grounded Scribe is not a medical device, it operates within a broader regulatory environment. The following frameworks apply to the use of AI-enabled clinical documentation tools in Australia, as referenced in TGA guidance:

For Consumers

If your healthcare practitioner uses Grounded Scribe during your consultation, you should be aware of the following rights, consistent with TGA guidance for consumers:

• Informed consent: Your practitioner should inform you that they are using an AI documentation tool and obtain your consent before recording any part of your session.
• No treatment recommendations: Grounded Scribe does not make any recommendations about your treatment or care. It only documents what is discussed during your session.
• Right to withdraw consent: You may withdraw your consent at any time. Your practitioner will continue your care without AI-assisted documentation. Withdrawal will not affect any information already collected.
• Right to view your records: You have the right to request access to the personal information collected about you, as provided by the Australian Privacy Principles.
• Raising concerns: If you have concerns about how an AI tool has been used in your care, you may raise a concern with AHPRA or contact us directly at support@groundedscribe.com.

For Health Professionals

When using Grounded Scribe, practitioners should be aware of the following obligations, consistent with TGA guidance and professional registration requirements:

Practitioner Obligations

• Informed consent: Obtain informed consent from your clients before using AI-assisted documentation in sessions. A consent template is available.
• Accuracy verification: Review and verify all AI-generated clinical notes before incorporating them into clinical records. AI-generated notes are drafts and may contain errors.
• Regular compliance assessment: Regularly assess whether the tool remains appropriate and compliant with your professional obligations, registration standards, and the needs of your clients.
• Professional standards: Comply with your registration board's codes of conduct and guidelines regarding the use of AI in healthcare practice.

Relevant Professional Guidance

• AHPRA guidelines for AI in healthcare
• ACSQHC AI Clinical Use Guide and Ambient Scribe Safety Scenario

Our Commitment

Grounded Scribe Pty Ltd is committed to ensuring that our product remains within the scope of a clinical documentation tool and does not function as a medical device. We undertake the following:

• Regular assessment of product functionality to ensure features remain within documentation-only scope
• Change management processes that evaluate whether new or modified features could change the regulatory classification of the product
• Monitoring of TGA guidance and regulatory developments to ensure ongoing compliance
• Transparent communication with users about the capabilities and limitations of the Service

If you believe the Service is being used in a manner inconsistent with this classification, please contact us immediately at support@groundedscribe.com.

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