Regulatory Compliance
For practice managers, compliance officers, and legal advisors
For Practice Decision Makers
This page provides the regulatory and compliance information needed to evaluate PreConsult for your healthcare practice. Whether you're a practice manager conducting due diligence, a compliance officer assessing risk, or a legal advisor reviewing for your client, you'll find the key information below.
TGA Status
PreConsult operates under the TGA clinical decision support software exemption.
- Not classified as a medical device
- Decision support only, not diagnosis
- Requires practitioner review
Privacy Compliance
Full compliance with the Privacy Act 1988 and Australian Privacy Principles.
- Australian data hosting (Sydney)
- APP 8 consent for AI processing
- No AI model training on patient data
Professional Standards
Designed to support AHPRA registration requirements and professional standards.
- Clinical accountability maintained
- Audit trail for all decisions
- Documentation supports record-keeping
TGA Exemption Pathway
The Therapeutic Goods Administration (TGA) exempts clinical decision support software from medical device regulation when it meets specific criteria. PreConsult is designed to meet all exemption requirements.
Reference: TGA guidance on software-based medical devices and clinical decision support software.
Drafting Tool, Not Decision Maker
PreConsult drafts suggestions for practitioner review. It does not diagnose conditions or prescribe treatments—practitioners make all clinical decisions.
Human-in-the-Loop
Every AI suggestion requires explicit practitioner action: Accept, Edit, or Dismiss. No clinical action occurs without human review.
Non-Prescriptive Language
All AI outputs use advisory language: "commonly associated with", "consider", "may be appropriate". Never directive statements.
Practitioner-Only Access
Patients never see diagnostic suggestions or treatment considerations. All clinical assessments are visible only to healthcare practitioners.
Practitioner Responsibilities
Clear obligations when using PreConsult in clinical practice
When practitioners use PreConsult, they accept responsibility for:
Before Clinical Use
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Review all AI-generated content
Read summaries, findings, and suggestions before using them clinically. Do not accept content without review.
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Verify accuracy with the patient
Confirm patient-reported information is accurate and complete. AI summaries may contain errors or omissions.
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Exercise independent clinical judgment
Use PreConsult as one input among many. Your clinical assessment, examination, and experience remain paramount.
Documentation & Accountability
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Maintain clinical accountability
You remain responsible for all clinical decisions. PreConsult is a tool that supports your practice, not a substitute for your expertise.
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Export to your clinical system
Transfer relevant findings and notes to your practice management system to maintain complete patient records.
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Report any safety concerns
If you identify incorrect, misleading, or potentially harmful AI suggestions, report them to PreConsult immediately.
Professional Indemnity Considerations
Healthcare practitioners considering AI tools often have questions about professional indemnity insurance. Here's what you should know about using PreConsult.
We recommend discussing AI tool usage with your professional indemnity insurer.
Clinical Accountability is Clear
PreConsult's design ensures the practitioner always makes the final clinical decision. This maintains clear professional accountability—the same as using any reference material or decision support tool.
Complete Audit Trail
Every AI suggestion and practitioner action is logged with timestamps, providing documentation that supports your clinical reasoning.
Exportable Records
Clinical notes and decision logs can be exported to your practice management system, ensuring records are available if ever needed.
AI Safety Measures
Technical controls that maintain clinical safety
AI Disclosure Labels
All AI content clearly marked
Review Confirmation
Timed review before finalizing
Editable Content
All AI content can be modified
Accept/Dismiss
Explicit action required
Emergency Guidance
000 reminders for emergencies
Data Processing & Privacy
PreConsult complies with the Privacy Act 1988 and the Australian Privacy Principles (APPs). Patient data is handled with strict controls throughout its lifecycle.
For detailed technical security information, see our Security page.
Australian Data Hosting
All patient data stored in Sydney, Australia. Full data sovereignty within Australia.
AI Processing Consent
Patients consent to AI processing (including overseas providers) as part of the interview. Complies with APP 8.
No AI Training
Patient data is never used to train AI models. Zero data retention agreement with AI providers.
Configurable Retention
Configurable PII retention periods. You choose the retention settings that meet your compliance requirements.
Documentation & Agreements
Legal documents available for your review
Compliance Checklist
Quick reference for practice decision-makers
| Requirement | Status | Notes |
|---|---|---|
| TGA medical device registration | Exempt | Exempt from registration under CDSS pathway (practitioner review required) |
| Privacy Act 1988 compliance | Compliant | Full APP compliance |
| Australian data hosting | Yes | Sydney, Australia |
| Cross-border disclosure consent | Yes | Patient consent for AI processing (APP 8) |
| AI model training on patient data | No | Zero data retention with AI providers |
| Audit trail | Yes | All AI suggestions and practitioner actions logged |
| Human oversight required | Yes | Accept/Edit/Dismiss for all suggestions |
| Data Processing Agreement available | Yes | For enterprise customers |
Questions About Compliance?
If you have questions about regulatory compliance, data handling, or need documentation for your compliance review, we're here to help.
Last updated: January 2026
This page provides general compliance information. For specific legal or regulatory advice, consult your legal advisor or relevant regulatory body.