HEALTHCARE DISCLAIMER

I.

TECHNOLOGY PLATFORM — NOT A HEALTHCARE PROVIDER

Moana Digital Health Pty Ltd (ACN 694 101 052 / ABN 41 694 101 052) ("Moana") is a technology company that develops and operates digital health infrastructure software. Moana is NOT a healthcare provider, medical practice, hospital, clinic, or health service of any kind.

The Moana Platform is: (a) a software tool designed to support healthcare organisations in managing health information and clinical workflows; (b) an infrastructure platform for electronic medical records and health data management; (c) an interoperability solution enabling the exchange of health data between authorised health systems; and (d) an administrative and operational tool for healthcare organisations. The Platform does NOT provide any health service within the meaning of applicable health legislation.

II.

NO MEDICAL ADVICE OR CLINICAL SERVICES

NOTHING ON THE MOANA PLATFORM OR IN ANY COMMUNICATION FROM MOANA CONSTITUTES, OR SHOULD BE CONSTRUED AS: (a) MEDICAL ADVICE; (b) MEDICAL DIAGNOSIS; (c) MEDICAL OPINION; (d) A TREATMENT RECOMMENDATION; (e) A CLINICAL PATHWAY; OR (f) A SUBSTITUTE FOR CONSULTATION WITH A QUALIFIED HEALTHCARE PROFESSIONAL.

Any clinical information displayed, generated, or accessible through the Platform reflects data entered by, or received from systems operated by, healthcare organisations and their clinicians. Such information has not been independently verified, assessed, or clinically evaluated by Moana.

III.

CLINICAL RESPONSIBILITY

ALL CLINICAL DECISIONS ARE THE SOLE RESPONSIBILITY OF THE QUALIFIED AND REGISTERED HEALTHCARE PROFESSIONAL(S) PROVIDING CARE. This includes, without limitation:

• Medical diagnoses and differential diagnoses

• Prescribing decisions and medication management

• Treatment plans, care pathways, and clinical interventions

• Interpretation of laboratory results, pathology reports, and diagnostic imaging

• Interpretation and verification of AI-assisted outputs (see Section VII)

• Assessment of patient risk, clinical urgency, and acuity

• Referral decisions, discharge decisions, and follow-up care plans

• Any clinical action taken or not taken in connection with a patient

• Documentation of clinical decisions in patient records

The healthcare organisation deploying the Platform is responsible for: (a) ensuring all clinical users are appropriately qualified, registered, and credentialed; (b) establishing clinical governance frameworks and oversight structures; (c) ensuring the Platform is configured and used in accordance with applicable clinical standards; and (d) taking institutional responsibility for the outcomes of care delivered using the Platform.

IV.

REGULATORY CLASSIFICATION

4.1 Australia — TGA Position

As at the Effective Date, Moana Digital Health is positioned as a health information technology (health IT) infrastructure platform, not as a Medical Device or Software as a Medical Device (SaMD) under: (a) the Therapeutic Goods Act 1989 (Cth); (b) the Therapeutic Goods (Medical Devices) Regulations 2002; or (c) the TGA guidance on Software as a Medical Device. The Platform provides data management and workflow facilitation rather than direct patient care functions that would trigger medical device classification.

4.2 International Classification

Moana's classification assessment also covers: (a) the United States — FDA Software as a Medical Device (SaMD) framework and the FDA's Digital Health Center of Excellence guidance; the Platform is not classified as FDA-regulated SaMD as at the Effective Date; (b) European Union — EU Medical Device Regulation 2017/745 (EU MDR); the Platform is not classified as a medical device under EU MDR as at the Effective Date; (c) Pacific Island jurisdictions — equivalent national health regulatory frameworks as applicable.

4.3 Classification Review

This classification is based on current Platform functionality. The Parties acknowledge that: (a) regulatory classifications may change as AI and clinical decision support features evolve; (b) Moana will monitor applicable regulatory guidance and notify healthcare organisation clients of any material change in classification assessment; and (c) healthcare organisations are responsible for their own regulatory compliance with respect to their use of the Platform.

V.

DATA ACCURACY DISCLAIMER

The accuracy, completeness, and timeliness of clinical information displayed on the Platform depends entirely on the quality of data entered by clinical users and received from integrated health systems. Moana does not independently verify clinical data and is not responsible for clinical decisions made on the basis of inaccurate, incomplete, or outdated data.

Clinicians must: (a) verify critical clinical information through appropriate clinical assessment before acting on it; (b) not rely solely on Platform-displayed data for high-risk clinical decisions; (c) document and correct any data discrepancies identified during clinical care; and (d) treat Platform-generated summaries as working documents subject to their own clinical review.

VI.

NO CLINICAL LIABILITY

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, MOANA EXPRESSLY DISCLAIMS ALL LIABILITY FOR:

• Any clinical outcome, adverse event, patient harm, or healthcare-related loss arising from the use of or reliance on the Platform

• Clinical errors, missed diagnoses, medication errors, contraindication failures, or treatment failures in connection with the Platform

• Any reliance on Platform-displayed information for clinical decision-making without appropriate clinical verification

• System downtime, data synchronisation delays, or technical errors affecting clinical workflows

• Errors in data received from third-party integrated systems (laboratories, radiology, pharmacies)

• Decisions made on the basis of AI-assisted outputs without clinical review and verification

• Failure of a healthcare professional to comply with their professional registration obligations in connection with their use of the Platform

Nothing in this Disclaimer limits Moana's liability for: (a) death or personal injury caused by Moana's negligence; (b) fraud or fraudulent misrepresentation; or (c) any other liability that cannot be lawfully excluded under the Australian Consumer Law, the Competition and Consumer Act 2010 (Cth), or equivalent mandatory consumer protection laws.

VII.

ARTIFICIAL INTELLIGENCE DISCLAIMER

Where AI-assisted features are enabled on the Platform (including automated clinical coding, note transcription, workflow suggestions, or data quality alerts):

• All AI outputs are informational and non-binding suggestions only

• AI outputs do not constitute diagnoses, treatment recommendations, or clinical advice

• Clinicians must independently review, verify, and take clinical responsibility for any AI-assisted output before it is recorded in a patient record

• Moana disclaims all liability for adverse outcomes arising from reliance on AI-generated outputs without appropriate clinical review

• Healthcare organisations are responsible for their own AI governance policies and ensuring compliance with any applicable AI regulation in their jurisdiction

VIII.

EMERGENCY SITUATIONS

THE MOANA PLATFORM IS NOT DESIGNED OR INTENDED AS A PRIMARY TOOL FOR MANAGING LIFE-THREATENING EMERGENCIES OR AS AN EMERGENCY RESPONSE SYSTEM. In any emergency situation, clinicians must: (a) prioritise direct patient assessment and emergency clinical response; (b) follow their institution's emergency protocols without delay; and (c) contact emergency services as appropriate. Do not delay emergency clinical action to interact with or document in the Platform.

IX.

PROFESSIONAL OBLIGATIONS

Use of the Platform does not modify or replace any professional, ethical, or legal obligations of healthcare professionals. All users must comply with: (a) their professional registration requirements and codes of conduct (including AHPRA-registered health professionals in Australia); (b) applicable health records legislation and documentation standards; (c) their employer's clinical policies and procedures; (d) standards published by relevant professional bodies; and (e) applicable mandatory reporting obligations.

X.

AMENDMENTS AND CONTACT

This Disclaimer may be updated to reflect changes in Platform capabilities, regulatory guidance, or legal requirements. The current version is available at moanadigitalhealth.com. Material changes will be communicated to healthcare organisations using the Platform.