Medical Disclaimer and Informed Consent

Calma AI

Effective Date: November 9, 2025
Version: 1.0

⚠️ CRITICAL MEDICAL DISCLAIMER

This Service is NOT Medical Care

PLEASE READ CAREFULLY: Calma AI is an informational and educational wellness platform ONLY. It is NOT:

❌ NOT a medical device (not regulated as such under EU MDR or FDA regulations)
❌ NOT a diagnostic tool (does not diagnose medical conditions)
❌ NOT a treatment service (does not prescribe medications or treatments)
❌ NOT a replacement for healthcare professionals (doctors, nurses, specialists)
❌ NOT an emergency service (not for urgent or life-threatening situations)
❌ NOT telemedicine (no licensed healthcare providers involved)

What Calma AI IS

Calma AI is designed to:

✅ Help you organize and track your health information
✅ Provide general wellness education
✅ Assist in preparing questions for your healthcare provider
✅ Offer a personal health journal
✅ Use AI to provide general information about health topics

1. AI Limitations and Capabilities

1.1 How Our AI Works

Our AI assistant:

Uses third-party AI providers's Large Language Models (LLMs)
Analyzes text you provide
Generates responses based on general health knowledge
Provides information similar to what you might find in health education resources

1.2 What AI CANNOT Do

The AI assistant CANNOT:

❌ Examine you physically
❌ Order or interpret medical tests
❌ Make medical diagnoses
❌ Prescribe medications or treatments
❌ Provide dosage recommendations
❌ Replace professional medical judgment
❌ Provide emergency medical assistance
❌ Guarantee accuracy of information

1.3 AI Errors and "Hallucinations"

IMPORTANT: AI can make mistakes, including:

Hallucinations: Generating plausible-sounding but false information
Outdated information: Medical knowledge changes rapidly
Misunderstandings: Misinterpreting your questions or symptoms
Overgeneralizations: Applying general information inappropriately to specific cases
Incomplete information: Missing important nuances or considerations

YOU MUST: Always verify AI information with qualified healthcare professionals.

2. When You MUST Seek Professional Medical Care

2.1 Always Consult a Healthcare Professional For:

You MUST consult a qualified healthcare professional for:

✅ Any diagnosis: Only licensed professionals can diagnose medical conditions
✅ Any treatment: Including medications, procedures, or therapies
✅ Test interpretation: Lab results, imaging, biopsies, etc.
✅ Symptom evaluation: Any new, worsening, or concerning symptoms
✅ Medication changes: Starting, stopping, or adjusting medications
✅ Chronic conditions: Ongoing management of any health condition
✅ Preventive care: Screenings, vaccinations, check-ups
✅ Mental health concerns: Depression, anxiety, or psychological issues

2.2 Emergency Situations

🚨 CALL EMERGENCY SERVICES IMMEDIATELY (112 in EU, 911 in US) if you experience:

Life-Threatening Symptoms:

Chest pain or pressure
Difficulty breathing or shortness of breath
Sudden severe headache
Loss of consciousness or fainting
Severe bleeding that won't stop
Seizures
Signs of stroke: Face drooping, Arm weakness, Speech difficulty (F.A.S.T.)
Severe allergic reaction (anaphylaxis)
Suicidal or homicidal thoughts
Severe injury or trauma
Poisoning or overdose

DO NOT:

❌ Use Calma AI for emergency situations
❌ Delay emergency care to consult the AI
❌ Rely on AI responses in life-threatening situations

IF IN DOUBT, SEEK EMERGENCY CARE

2.3 Urgent Care Situations

Seek urgent medical attention (within 24 hours) for:

High fever (over 103°F/39.4°C)
Severe pain
Persistent vomiting or diarrhea
Severe abdominal pain
Difficulty urinating
Deep cuts or wounds
Signs of infection (redness, swelling, pus, fever)
Severe allergic reactions (not anaphylaxis)
Eye injuries or sudden vision changes
Severe burns

3. Your Responsibilities

3.1 As a User, You Must:

Information Accuracy:

✅ Provide accurate and complete information to the AI
✅ Update your health information regularly
✅ Do not rely solely on AI responses
⚠️ Do not upload sensitive medical documents or detailed medical records - Calma AI is a wellness journal, not a secure medical records system

Professional Consultation:

✅ Consult healthcare professionals for all medical decisions
✅ Discuss AI-generated information with your doctor
✅ Follow your doctor's advice over AI recommendations

Critical Thinking:

✅ Question and verify AI information
✅ Recognize AI limitations
✅ Use AI as a supplementary tool, not a primary source

Emergency Awareness:

✅ Know when to seek emergency care
✅ Never use Calma AI for emergencies
✅ Keep emergency numbers easily accessible

3.2 You Acknowledge That:

By using Calma AI, you acknowledge and agree that:

You understand this is not medical care
You will not use AI responses for self-diagnosis or self-treatment
You will consult healthcare professionals for all medical decisions
You understand AI can make errors
You will seek emergency care when appropriate
You bear full responsibility for health decisions
Calma AI is not liable for medical outcomes

4. Specific Medical Disclaimers

4.1 No Doctor-Patient Relationship

Using Calma AI does NOT create a doctor-patient relationship. There is:

No licensed healthcare provider involved
No medical examination
No professional medical duty of care
No medical confidentiality (beyond data privacy)

4.2 No Medical Advice

AI responses are NOT medical advice. They are:

General information only
Educational in nature
Not tailored to your specific medical situation
Not a substitute for professional medical advice

4.3 No Diagnosis or Treatment

Calma AI does NOT provide:

Medical diagnoses
Treatment plans
Medication prescriptions
Dosage recommendations
Prognosis or medical predictions

4.4 No Guarantee of Accuracy

We do NOT guarantee:

Accuracy of AI-generated information
Completeness of information
Currency of medical knowledge
Applicability to your specific situation
Absence of errors or omissions

4.5 Regional Differences

Medical practices vary by region:

Treatment guidelines differ between countries
Medication availability varies
Healthcare systems differ
Always consult local healthcare professionals

5. Special Populations

5.1 Pregnancy and Breastfeeding

If you are pregnant, trying to conceive, or breastfeeding:

ALWAYS consult your OB/GYN or healthcare provider
Do not rely on AI for pregnancy-related questions
Many medications and treatments are unsafe during pregnancy
Seek immediate care for any pregnancy complications

5.2 Children and Adolescents

If you are managing health information for children or adolescents:

ALWAYS consult a pediatrician
Children are not "small adults" - they require specialized care
Growth and development issues require professional evaluation
Pediatric dosages differ significantly from adult dosages

5.3 Elderly Users

If you are elderly or managing care for elderly individuals:

ALWAYS consult a healthcare provider
Older adults may have different symptoms and needs
Medication interactions are more common
Age-related conditions require specialized care

5.4 Chronic Conditions

If you have chronic health conditions (diabetes, heart disease, asthma, etc.):

ALWAYS follow your doctor's treatment plan
Do not adjust medications based on AI recommendations
Regular professional monitoring is essential
AI cannot replace disease management expertise

5.5 Mental Health

If you have mental health concerns:

ALWAYS consult a mental health professional
AI cannot provide psychotherapy or psychiatric care
Mental health crises require immediate professional help
Suicide Prevention Hotline: Call 988 (US) or 116 123 (UK/EU)

6. Limitation of Liability

6.1 No Medical Liability

Calma AI and its operators:

Are NOT responsible for any medical outcomes
Are NOT liable for decisions made based on AI information
Are NOT liable for errors, omissions, or inaccuracies in AI responses
Are NOT liable for delays in seeking professional medical care
Are NOT liable for misinterpretation of AI information

6.2 Maximum Liability

As stated in the Terms of Service:

Our total liability is limited to the amount you paid for the service
We are not liable for indirect, incidental, or consequential damages
This includes damages related to health outcomes

6.3 Indemnification

You agree to indemnify and hold harmless Calma AI from:

Any claims arising from your use of the service
Your reliance on AI-generated information
Your failure to seek appropriate medical care
Any health outcomes related to your use of the service

7. Informed Consent

7.1 Your Explicit Consent

By checking the consent box during registration, you explicitly consent to and acknowledge:

I understand and agree that:

✅ Calma AI is not a medical service or medical device
✅ AI responses are not medical advice, diagnosis, or treatment
✅ AI can make errors and provide inaccurate information
✅ I will consult healthcare professionals for all medical decisions
✅ I will not use Calma AI for emergency situations
✅ I am responsible for my health decisions
✅ Calma AI is not liable for medical outcomes
✅ I will seek emergency care when appropriate
✅ I have read and understood this Medical Disclaimer
✅ I voluntarily choose to use this service with full knowledge of its limitations

7.2 Ongoing Consent

Your consent is:

Ongoing: Applies to all future use of the service
Revocable: You can withdraw consent at any time by deleting your account
Informed: You have been fully informed of risks and limitations
Voluntary: You are not required to use this service

7.3 Documentation of Consent

We maintain records showing:

Date and time of your consent
Version of this disclaimer you consented to
IP address (for fraud prevention)
This is required for legal compliance

8. Additional Important Information

8.1 Medical Information Sources

AI information is based on:

General medical knowledge available in training data
Public health resources and educational materials
Not your personal medical records (unless you enter them)
Data that may be outdated or incomplete

8.2 No Continuous Monitoring

Calma AI does NOT:

Continuously monitor your health
Provide alerts for health changes
Track vital signs in real-time
Provide proactive health interventions

8.3 Data Usage in Medical Context

Your health data is:

Used to provide AI responses
Not reviewed by medical professionals (unless you report an issue)
Not used for medical decision-making by the service
Subject to the Privacy Policy

8.4 Third-Party Information

If AI responses include references to:

External websites or resources
Medical studies or research
Treatment options or medications YOU MUST: Verify this information with healthcare professionals

9. Reporting Issues

9.1 Report Concerning AI Responses

If you receive AI responses that are:

Dangerous or harmful
Clearly medically inaccurate
Encourage dangerous behaviors
Provide dosage or treatment advice

Please report to: support@calma-ai.com

We will:

Review the report within 24 hours
Take corrective action if needed
Improve AI safeguards

9.2 Report Medical Emergencies

If you experience a medical emergency while using the service:

DO NOT report it to us - call emergency services immediately
After you are safe, you may inform us for service improvement

10. Legal and Regulatory Information

10.1 Regulatory Status

Calma AI is:

NOT a medical device under EU MDR (Medical Device Regulation)
NOT a medical device under FDA regulations (US)
NOT subject to medical device regulatory approval
An informational and educational service only

10.2 Professional Licensure

Calma AI does:

NOT employ licensed healthcare providers
NOT provide services requiring medical licensure
NOT claim to provide medical care

10.3 Geographic Limitations

This service is:

Available globally (where legally permitted)
Not tailored to specific geographic medical practices
Subject to local laws and regulations
May not reflect local healthcare standards

11. Questions and Concerns

11.1 Medical Questions

For medical questions:

Consult your healthcare provider
Do not rely on Calma AI for medical guidance

11.2 Service Questions

For questions about this disclaimer:

Email: legal@calma-ai.com
Response time: Within 7 days

11.3 Safety Concerns

For safety concerns:

Email: support@calma-ai.com
Response time: Within 24 hours for urgent matters

12. Updates to This Disclaimer

12.1 Changes

We may update this Medical Disclaimer:

To reflect legal or regulatory changes
To improve clarity
To add new information

12.2 Notification

We will notify you of material changes:

By email (30 days in advance)
Through the service interface
You must re-consent to continue using the service

13. Final Acknowledgment

BY USING CALMA AI, YOU ACKNOWLEDGE THAT:

You have read this entire Medical Disclaimer
You understand the limitations of the service
You understand that AI can provide inaccurate information
You will not use this service for medical diagnosis or treatment
You will seek professional medical care when needed
You will seek emergency care for life-threatening situations
You accept full responsibility for your health decisions
You release Calma AI from medical liability

IF YOU DO NOT AGREE WITH ANY PART OF THIS DISCLAIMER, DO NOT USE CALMA AI.

Last Updated: November 9, 2025
Version: 1.0
Next Review: May 9, 2026

Emergency Numbers

Always call emergency services for life-threatening situations:

EU: 112
US: 911
UK: 999 or 112
Australia: 000
Canada: 911

Suicide Prevention:

US: 988
UK: 116 123 (Samaritans)
EU: 116 123
International Association for Suicide Prevention: https://www.iasp.info/resources/Crisis_Centres/