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Acceptance of Terms
By accessing or using InsightRay, you agree to these Terms of Service and any additional terms referenced herein. If you do not agree, you may not use InsightRay.
Description of Service
InsightRay is an AI-powered clinical decision support system (CDSS) designed to assist healthcare professionals (HCPs) in reviewing and organizing radiological images and diagnostic data, facilitating the medical decision-making process but not performing autonomous analysis or interpretation. It enhances workflows by providing imaging assistance and insights but does not autonomously diagnose or treat patients. InsightRay operates under a “human-in-the-loop” framework, ensuring that all outputs are reviewed, confirmed, and approved by licensed HCPs before clinical use. InsightRay is a supplementary tool that supports, but does not replace, professional medical judgment.
FDA Compliance
InsightRay aligns with the FDA’s Human-in-the-Loop requirement for Clinical Decision Support Systems (CDSS). It operates as an advisory tool that provides insights requiring review, interpretation, and finalization by licensed healthcare professionals before any clinical decisions are made. Key compliance features include:
HIPAA Compliance
InsightRay adheres to all applicable HIPAA requirements to protect patient health information. This includes administrative, physical, and technical safeguards to maintain confidentiality, integrity, and availability of patient data.
Business Associate Agreement (BAA)
InsightRay will sign a Business Associate Agreement (BAA) with healthcare providers to ensure HIPAA compliance when handling Protected Health Information (PHI).
Use of Service
InsightRay is a decision-support tool designed to assist medical professionals. Final responsibility for all clinical decisions lies with the healthcare professional. InsightRay is not intended to replace professional medical judgment or independently diagnose, treat, mitigate, cure, or prevent any disease.
User Responsibilities
Users are required to:
Prohibited Conduct
Users are prohibited from:
Intellectual Property Rights
All intellectual property rights related to InsightRay, including software, content, and branding, are owned by InsightRay or its licensors. Users receive a limited license to use the service in accordance with these Terms of Service.
Third-Party Services
InsightRay may utilize third-party services or content. Users agree to comply with applicable terms for such services.
Service Availability
InsightRay does not guarantee uninterrupted access. The service may be subject to maintenance or downtime. Reasonable efforts will be made to minimize disruptions.
No Warranty
InsightRay is provided “as-is” without warranties, expressed or implied, including warranties of merchantability, fitness for a particular purpose, and non-infringement. AI-generated insights are advisory and must always be validated and interpreted by healthcare professionals before being used in clinical workflows. InsightRay does not provide conclusive findings or independently influence patient care decisions.
Disclaimer
InsightRay supports healthcare workflows by assisting professionals in reviewing imaging data, but it does not perform diagnostic functions or guarantee accuracy or completeness of insights provided. Healthcare professionals remain solely responsible for final diagnostic and treatment decisions.
Limitations of Liability
InsightRay and its partners are not liable for damages arising from service use or inability to use the service. AI-generated insights may contain errors or biases. HCPs are responsible for verifying all outputs.
Indemnification
Users agree to indemnify InsightRay against claims arising from their use of the service or violations of these terms.
Generative AI Considerations
Generative AI models may produce preliminary insights that could contain inaccuracies or biases. Users must implement safeguards such as:
Mitigating Biases and Inequities
AI performance may vary across populations. Users are encouraged to:
Privacy and Data Security
InsightRay protects user data and complies with data protection regulations. Users retain ownership of patient data. InsightRay will not use data for purposes beyond service provision.
Data Breach Notification
InsightRay will notify users of data breaches involving PHI in compliance with HIPAA.
Security Measures
InsightRay employs encryption, access controls, and audit trails to protect patient information.
Audit and Monitoring
InsightRay conducts regular audits to ensure HIPAA compliance and data security.
Usage Statistics and Monitoring
InsightRay may collect anonymized usage data to improve services. Data collection complies with HIPAA standards.
Training and Support
Training materials and support are available to ensure safe and effective use of InsightRay.
Modifications to Service and Terms
InsightRay may modify services or terms at any time. Continued use constitutes acceptance of changes.
Termination
InsightRay may suspend or terminate user access for violations of these terms.
Beta Features
Features marked “(Beta)” are experimental, intended strictly for research and evaluation. They are not designed for use in clinical decision-making or direct patient care and must not be relied upon in any medical context. Users accept associated risks.
Force Majeure
InsightRay is not liable for delays or failures due to causes beyond its control.
Jurisdiction and Dispute Resolution
Disputes are governed by Wyoming law. Parties agree to resolve disputes through negotiation or mediation before litigation.
Severability
Invalid provisions do not affect the validity of remaining terms.
Entire Agreement
These Terms constitute the entire agreement between InsightRay and the user.
Contact Information
For support, contact: support@insightray.com.