Medical Disclaimer

Biostar CMA — biostarcma.com
Effective Date: 1 February 2026
Last Updated: 11 February 2026

1. General Disclaimer

BIOSTAR CMA IS NOT A MEDICAL DEVICE, DOES NOT PROVIDE MEDICAL ADVICE, AND DOES NOT RENDER MEDICAL DIAGNOSES OR TREATMENT RECOMMENDATIONS.

The Biostar CMA platform ("Platform"), operated by Biostar Technology International ("Biostar"), is an AI-assisted software tool designed to help licensed health practitioners conduct structured patient interviews and generate analysis reports. The Platform is a professional productivity and workflow tool — not a clinical decision-making system.

Nothing on the Platform, including any AI-generated output, should be interpreted as medical advice, a medical diagnosis, a treatment recommendation, or a substitute for the professional judgment of a qualified health practitioner.

2. Regulatory Status

2.1 Not a Medical Device

Biostar CMA is not classified, registered, cleared, or approved as a medical device by any regulatory authority, including but not limited to:

United States: Not cleared or approved by the FDA under 21 CFR Part 820 or any applicable premarket pathway (510(k), PMA, De Novo)
European Union: Not certified under the EU Medical Device Regulation (MDR 2017/745) and does not bear a CE mark for medical device use
United Kingdom: Not registered with the MHRA under the UK Medical Devices Regulations 2002
Other jurisdictions: Not registered or approved as a medical device in any jurisdiction

2.2 Intended Use Classification

The Platform is intended as a general-purpose software tool for health practitioners to organise and process interview information. It is not intended to:

Diagnose any disease or medical condition
Recommend or guide treatment decisions
Monitor patient vital signs or physiological parameters
Replace any function of a regulated medical device
Serve as clinical decision support software within the meaning of MDR 2017/745

3. AI Limitations

3.1 Nature of AI-Generated Outputs

The Platform uses the Anthropic Claude API, a large language model, to process structured interview data and generate analysis reports. Users must understand the following inherent limitations:

AI-generated outputs may:

Contain inaccuracies, errors, or fabricated information ("hallucinations")
Reflect biases present in training data
Miss critical clinical information or fail to identify relevant patterns
Produce outputs that appear confident but are substantively incorrect
Generate different results for identical inputs across sessions
Fail to account for the full complexity of a patient's clinical picture

3.2 No Clinical Validation

AI-generated reports and analyses have not been clinically validated through controlled trials, peer review, or regulatory evaluation for diagnostic accuracy, sensitivity, specificity, or clinical utility.

3.3 No Substitute for Clinical Judgment

AI-generated outputs are starting points for professional analysis, not conclusions. They are designed to assist — never to replace — the clinical reasoning, experience, and professional judgment of a qualified health practitioner.

4. Practitioner Responsibilities

4.1 Professional Duty

Health practitioners using Biostar CMA retain full professional and legal responsibility for:

All clinical decisions made in the course of patient care
Independent verification and validation of all AI-generated content before use
Exercising professional judgment that meets the standard of care
Ensuring that Platform use complies with their professional regulatory requirements

4.2 Mandatory Review

Practitioners must independently review, critically evaluate, and where necessary correct all AI-generated outputs before sharing them with patients, incorporating them into clinical records, or using them to inform any clinical decision.

4.3 Professional Licensing

Practitioners are solely responsible for maintaining valid professional licensure, certification, and insurance. Use of Biostar CMA does not modify, expand, or replace any professional licensing requirement.

4.4 Scope of Practice

Practitioners must use the Platform only within their recognised scope of practice and professional competence.

5. Patient Consent

5.1 Consent Requirements

Before using the Platform to process any patient data, Practitioners must obtain appropriate informed consent, which should include:

Clear explanation that an AI-assisted platform will be used
Description of what data will be collected and how it will be processed
Information about AI involvement in generating analysis outputs
Explanation that AI outputs are assistive tools reviewed by the Practitioner
The patient's right to refuse AI-assisted processing
Information about data storage, retention, and the patient's data rights

5.2 Right to Refuse

Patients have the right to refuse AI-assisted processing of their health data. Practitioners must respect this right and, where possible, offer alternative methods of assessment.

6. No Emergency Use

BIOSTAR CMA MUST NOT BE USED IN EMERGENCY OR URGENT CARE SITUATIONS.

In any medical emergency: Call your local emergency services immediately (112 in the EU, 911 in the US, 999 in the UK, or your local equivalent). Go to the nearest emergency department. Do not rely on any software platform for emergency triage, assessment, or guidance.

The Platform does not provide real-time monitoring, alerts, or notifications related to patient health status. It is not a patient monitoring system.

7. Patient Information

If you are a patient or client whose health practitioner uses Biostar CMA:

Reports generated are tools to assist your practitioner, not independent medical assessments
Your practitioner reviews and interprets all AI-generated content using their professional expertise
You should discuss questions or concerns about your care directly with your practitioner
You have the right to ask about the role of AI tools in your care
You have the right to refuse AI-assisted processing of your data

Use of the Platform does not establish a patient-practitioner relationship between you and Biostar Technology International.

8. Limitation of Liability for Clinical Outcomes

BIOSTAR TECHNOLOGY INTERNATIONAL IS NOT LIABLE FOR ANY CLINICAL DECISIONS, HEALTH OUTCOMES, OR PATIENT HARM ARISING FROM THE USE OF THE PLATFORM, including decisions made based on AI-generated outputs, failure to identify conditions, errors or inaccuracies in AI-generated content, delays in care, or misinterpretation of outputs.

Clinical liability rests solely with the treating health practitioner.

9. Research and Educational Use

If the Platform is used for research or educational purposes:

AI-generated outputs must not be cited as authoritative medical sources
Research use must comply with applicable ethics board requirements
Educational use should clearly identify AI limitations to students and trainees

10. Jurisdictional Variations

Healthcare regulations vary by jurisdiction. This disclaimer provides general guidance and does not constitute legal advice. Practitioners are responsible for ensuring compliance with all applicable laws, regulations, and professional standards in their jurisdiction.

11. Updates to This Disclaimer

We may update this Medical Disclaimer to reflect changes in our services, applicable regulations, or AI capabilities. Material changes will be communicated to registered users via email and/or Platform notification.

12. Contact

Biostar Technology International
Email: legal@biostartechnology.com
Website: biostarcma.com

For privacy-related inquiries: privacy@biostartechnology.com

This Medical Disclaimer is provided for informational purposes and should be reviewed by qualified legal counsel to ensure compliance with all applicable laws and regulations in your jurisdiction. It does not constitute legal or medical advice.

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