Medical Disclaimer

1. Nature of the Service

CardioHelper synthesizes published guideline content from recognized medical societies (ESC, ACC/AHA, and others) to provide structured clinical information. It is designed to assist licensed healthcare professionals in evidence lookup — not to replace their professional judgment, training, or clinical experience.

2. Not a Medical Device

CardioHelper is not classified as a medical device under:

• EU Medical Device Regulation (MDR 2017/745)
• US FDA medical device regulations (21 CFR)
• Any other national medical device regulatory framework

No CE marking, FDA 510(k) clearance, or equivalent regulatory approval is required or claimed. The Service falls outside the scope of medical device regulation as it provides general guideline information, not patient-specific diagnostic or therapeutic recommendations.

3. Not Patient-Specific

CardioHelper provides general guideline synthesis. It does not:

• Account for individual patient comorbidities, allergies, or clinical context
• Integrate with electronic health records or patient data systems
• Provide personalized treatment plans or dosing adjustments
• Consider local formulary, institutional protocols, or regional drug availability

The treating physician must interpret all information in the context of the individual patient.

4. Drug Information

Drug names, dosing ranges, and contraindications presented by CardioHelper are extracted from published guidelines using International Nonproprietary Names (INN). However:

• Always verify dosing against the current local Summary of Product Characteristics (SmPC)
• Regional variations in approved indications, dose ranges, and formulations exist
• Off-label uses may be referenced in guidelines but not approved in all jurisdictions
• Drug-drug interactions require independent verification beyond guideline content

5. Guideline Currency

We update guideline content within 4 weeks of new ESC/ACC/AHA publications. Each response displays the source document and publication year. However, guidelines are living documents and interim updates, errata, or focused updates may occur between our refresh cycles. Physicians should verify critical recommendations against the latest published guideline text.

6. Safety Validation

CardioHelper includes automated safety checks including Class III (harm) flagging, dose range validation, and contraindication detection. These are supplementary safety measures — they do not eliminate the need for independent clinical assessment. No automated system can detect all potential safety issues for every clinical scenario.

7. Epistemic Honesty

When CardioHelper cannot find sufficient guideline consensus for a clinical question, it returns a "NO CONSENSUS" response with suggested next steps. We believe it is safer to acknowledge the limits of available evidence than to generate a potentially inaccurate recommendation. Approximately 3% of queries receive this response.

8. Professional Liability

Use of CardioHelper does not transfer, modify, or diminish the professional liability of the treating physician. Clinical decisions made after consulting CardioHelper remain the full responsibility of the healthcare professional making those decisions. CardioHelper output should be documented as one of multiple sources consulted, not as the sole basis for clinical action.

9. Affiliation Disclaimer

CardioHelper is not affiliated with, endorsed by, or sponsored by the European Society of Cardiology (ESC), the American College of Cardiology (ACC), the American Heart Association (AHA), or any other guideline-publishing organization. All guideline content is attributed to its original source.

10. Contact

Questions about this disclaimer or the clinical governance of CardioHelper: governance@cardiohelper.com