Regulatory Disclaimer
Last updated: December 2025
Threadline Health Pty Ltd (ABN 69 692 845 391) (“Threadline”, “we”, “us”, or “our”) is engaged in research, development, and early-stage innovation in the field of mental health, diagnostics, and artificial intelligence.
This Regulatory Disclaimer applies to all content made available on the Threadline website and through related communications.
Development and Research Status
Threadline’s technologies, systems, and concepts are:
- In development or evaluation
- Intended for research, design, and exploratory purposes only
- Subject to change as development progresses
They are not approved medical devices, clinical tools, or therapeutic products.
No Clinical or Therapeutic Use
Threadline products and materials are not intended for clinical use and must not be used:
- To diagnose mental health conditions
- To guide or replace clinical judgement
- To determine treatment decisions
- In live or operational healthcare settings
Any future clinical use will occur only after appropriate validation, regulatory approval, and governance processes are completed.
No Medical Advice
Nothing on the Threadline website:
- Constitutes medical, clinical, or professional advice
- Should be relied upon for healthcare decisions
- Creates a clinician–patient relationship
Users should always seek advice from a qualified healthcare professional for medical or mental health concerns.
Demonstrations, Prototypes, and Outputs
Any demonstrations, prototypes, models, visualisations, or descriptions presented:
- Are provided for information and discussion purposes only
- May not reflect final or deployed systems
- May be incomplete, experimental, or subject to error
No reliance should be placed on such materials for clinical, regulatory, or operational decision-making.
Regulatory Approvals
Threadline does not represent that any product, system, or service has received approval or clearance from:
- The Australian Therapeutic Goods Administration (TGA)
- Any international medical device regulator
- Any clinical, ethical, or research governance body
Where regulatory approvals are obtained in the future, this will be explicitly stated.
Compliance Intent
Threadline intends to design and develop its technologies in alignment with applicable legal, ethical, and regulatory frameworks, which may include:
- Australian therapeutic goods legislation
- Medical device and software-as-a-medical-device (SaMD) frameworks
- Research ethics and governance requirements
- Data protection and privacy laws
No assurance is given that regulatory approval will be obtained.
Limitation of Responsibility
To the maximum extent permitted by law, Threadline:
- Disclaims responsibility for reliance on any content or materials provided
- Makes no warranties regarding accuracy, completeness, or suitability
- Accepts no liability for outcomes arising from use or interpretation of information on the website
Contact Us
For regulatory or compliance enquiries, please contact us via the form on our website at www.threadline.com.au