Hyfe CoughMonitor Suite Terms and Conditions

These Terms & Conditions ("Terms") govern the use of the Hyfe CoughMonitor Suite (CMS), including its software platform, wearable devices, and related services (collectively, "CMS"). By using CMS, you ("User" or "Participant") agree to comply with these Terms. If you do not agree, do not use CMS.

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1. Scope & Purpose

CMS is a research platform used in clinical trials and clinical research to monitor cough patterns via AI-driven acoustic analysis. It includes a wearable device and software platform, which collect, process, and analyze cough-related data in compliance with Good Clinical Practice (GCP), HIPAA, GDPR, and other applicable regulations.
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2. Eligibility & Use

• CMS is designed exclusively for clinical research purposes and is not intended for personal health monitoring, diagnosis, or treatment.
• Users must be 18 years or older, unless participating in an approved pediatric clinical trial with legal guardian consent.
• Participants must be enrolled in an IRB registered and approved clinical trial where CMS is used as a study tool.
• Use is subject to informed consent, provided through the trial’s governing body or principal investigator.

3. Acceptable Use

Users agree to:
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• Use CMS only for its intended clinical research purpose.
• Follow all instructions provided by the research team or Hyfe.
• Handle and maintain the wearable device responsibly.
• Report any technical issues, malfunctions, or suspected misuse promptly.

Users must not:
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• Attempt to modify, reverse-engineer, or tamper with CMS software or hardware.
• Use CMS for unauthorized medical diagnoses, treatment decisions, or non-research purposes.
• Share access credentials or use CMS outside of the clinical study.

4. Wearable Device Terms

The CMS wearable device is provided as part of the clinical trial and:
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• Must be used strictly according to study protocols.
• Remains the property of the research institution or sponsor (unless otherwise stated in trial agreements).
• Must be returned at the end of the study unless explicitly permitted for continued use.
• Limited Warranty: The device is covered for defects in materials and workmanship under normal use during the study period.
• Liability: Hyfe is not responsible for damage caused by misuse, unauthorized modifications, or negligence.

5. Data Collection & Privacy

CMS collects de-identified acoustic data for research purposes.
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• No personal identifiable data (e.g., names, addresses) is linked to CMS data.
• Data is stored securely in compliance with HIPAA, GDPR, and other applicable laws.
• Data access is restricted to authorized study personnel and regulatory authorities as required.
• Participants may withdraw consent at any time, but previously collected data may still be used in anonymized, aggregated form for scientific integrity.

For more details, refer to the CMS Privacy Policy.
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6. System Requirements & Updates

• The CMS software and wearable device require a compatible mobile device and/or network connection for data synchronization.
• Hyfe may provide updates, patches, or modifications to enhance CMS functionality.
• Users must ensure the device remains charged and operational as per study guidelines.

7. Disclaimers & Limitations of Liability

• CMS is not a medical device and does not provide real-time health alerts, diagnosis, or treatment guidance.
• Hyfe is not liable for medical decisions, adverse events, or any health outcomes related to CMS use.
• CMS is provided "as is" without warranties of performance, accuracy, or fitness for a particular purpose beyond its intended research use.
• To the maximum extent permitted by law, Hyfe is not responsible for indirect, incidental, or consequential damages arising from CMS use.

8. Intellectual Property & Ownership

• Hyfe retains all intellectual property rights over CMS software, AI models, and device technology.
• Users are granted a limited, non-transferable, revocable license to use CMS within the scope of the clinical trial.
• Any unauthorized duplication, modification, or redistribution is strictly prohibited.

9. Termination & Withdrawal

• User-Initiated Withdrawal: Participants can stop using CMS at any time, following study withdrawal protocols.
• Sponsor or Hyfe Termination: Use of CMS may be terminated if a participant violates these Terms or if the trial sponsor discontinues CMS use.
• Upon termination, Users must return the CMS wearable device and discontinue software use.

10. Governing Law & Dispute Resolution

• These Terms shall be governed by the laws of Delaware, USA, or as required by the clinical trial jurisdiction.
• Any disputes shall be resolved through arbitration or mediation, unless otherwise mandated by applicable law.

11. Modifications to These Terms

Hyfe may update these Terms to reflect changes in CMS operations or regulatory requirements. Continued use of CMS after updates constitutes acceptance of the new Terms.
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12. Contact Information

For questions or concerns regarding these Terms, contact:
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Hyfe Inc.
Email:support@coughmonitor.com
Address: 1209 Orange Street, Wilmington, Delaware 19801

Acknowledgment & Acceptance

By using CMS, you acknowledge that you have read, understood, and agreed to these Terms & Conditions.

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