Compliance & Regulatory Notice
AICA HEALTH Regulatory Disclaimer
Important information regarding the regulatory status, validation, and intended use of the AICA HEALTH Platform.
Compliance & Regulatory Notice
Certain AICA HEALTH Platform features, systems, models, outputs, or workflows may:
- Remain investigational.
- Be pilot-stage.
- Undergo validation.
- Be calibration-dependent.
- Evolve over time.
Unless expressly stated otherwise, the regulatory status and clinical applicability of individual Platform features may vary by feature, deployment, jurisdiction, and stage of validation.
Regulatory Status
Unless expressly stated otherwise:
- The Platform may not constitute a regulated medical device.
- The Platform may not possess regulatory approvals in all jurisdictions.
- Outputs may not be clinically validated across all populations or conditions.
No Implied Regulatory Approval
Nothing on the Platform shall be interpreted as:
- FDA approval.
- CDSCO approval.
- Diagnostic certification.
- Medical certification.
- Guaranteed clinical efficacy.
Any specific regulatory approval, certification, or authorization will only be represented where expressly stated in writing by AICA.
Intended Role of the Platform
The AICA HEALTH Platform is intended as an assistive preventive and proactive healthcare support system.
It is not intended to function as an autonomous clinical decision-making system.
Platform outputs should therefore be understood within the stated limitations of the applicable feature, system, model, workflow, validation status, and regulatory environment.