Terms of Use

1. Acceptance of Terms

These Terms of Use ("Terms") constitute a legally binding agreement between you ("User", "you") and BreasyMed Ltd. ("BreasyMed", "we", "us", "our"), governing your access to and use of:

• The BREASY mobile application (iOS and Android)
• The BREASY website and associated web pages
• Any related services, platforms, or tools provided by BreasyMed

By downloading, installing, accessing, or using BREASY, you confirm that you have read, understood, and agree to be bound by these Terms. If you do not agree, do not use BREASY.

2. Eligibility and Intended Users

BREASY is intended for use by:

• Licensed healthcare professionals (physicians, nurses, paramedics, and allied health professionals)
• Caregivers of young children, used alongside professional medical guidance
• Researchers and clinical investigators operating under appropriate ethical approvals
• Health system administrators and institutional partners

You must be at least 18 years of age to use BREASY. BREASY is not intended for direct use by minors.

By using BREASY, you represent that you understand the tool's intended purpose as a decision-support aid and will not rely on it as a standalone diagnostic instrument.

3. Nature of the Service — Medical Device Status

BREASY is currently under development and is NOT cleared, approved, or authorized as a medical device by any regulatory authority, including but not limited to the U.S. FDA, Health Canada, the European CE mark process, the Israeli Ministry of Health, or any other national or regional regulatory body.

BREASY is designed to:

• Support respiratory assessment and triage-related decision-making
• Provide objective respiratory motion analysis as a supplementary tool
• Assist clinicians and caregivers in identifying children who may warrant further evaluation

BREASY is not designed to:

• Diagnose any medical condition
• Recommend specific treatments or medications
• Replace clinical examination or standard-of-care assessment
• Function as an autonomous or sole decision-making system in any clinical context

4. Permitted Use

Subject to these Terms, BreasyMed grants you a limited, non-exclusive, non-transferable, revocable license to use BREASY for its intended purpose.

You agree to use BREASY only:

• For lawful purposes and in accordance with these Terms
• In a manner consistent with BREASY's intended use as a decision-support tool
• With appropriate informed consent from individuals whose data is collected (where required)
• In compliance with applicable laws, professional standards, and institutional policies

5. Prohibited Uses

You agree NOT to:

• Use BREASY as a substitute for emergency medical care or professional clinical judgment
• Use BREASY for autonomous clinical diagnosis or treatment decisions without professional oversight
• Reproduce, distribute, modify, reverse engineer, or create derivative works of BREASY without written authorization
• Use BREASY in violation of any applicable law, regulation, or professional code of conduct
• Attempt to circumvent security features or access unauthorized areas of the platform
• Use BREASY to collect or process data without appropriate legal basis and consent
• Misrepresent BREASY's capabilities, regulatory status, or clinical evidence to any party
• Use BREASY in connection with any activity that poses a risk to user safety

6. Health Data and Consent

When using BREASY to capture video of a child:

• You are solely responsible for obtaining all necessary consents, including parental/guardian consent where required
• You must comply with all applicable data protection and health privacy laws in your jurisdiction
• You must not capture video of individuals without their knowledge or appropriate authorization
• You acknowledge that video data constitutes sensitive health information and must be handled accordingly

Refer to our Privacy Policy for details on how we handle health data.

7. Disclaimer of Medical Advice

BREASY does not provide medical advice. All outputs, analyses, and information provided by BREASY are for informational and decision-support purposes only and should be interpreted by qualified healthcare professionals in the context of each patient's full clinical picture.

BreasyMed expressly disclaims any liability for:

• Clinical decisions made based on BREASY outputs
• Any adverse patient outcomes associated with the use or misuse of BREASY
• Reliance on BREASY in lieu of appropriate medical evaluation

8. Intellectual Property

All content, technology, algorithms, software, trademarks, and materials associated with BREASY are the exclusive intellectual property of BreasyMed Ltd. or its licensors.

These Terms do not transfer any intellectual property rights to you. You may not use BreasyMed's name, logo, or trademarks without prior written permission.

9. Disclaimer of Warranties

BREASY is provided "as is" and "as available" without warranty of any kind, express or implied. To the fullest extent permitted by applicable law, BreasyMed disclaims all warranties, including but not limited to:

• Implied warranties of merchantability, fitness for a particular purpose, and non-infringement
• Warranties that BREASY will be uninterrupted, error-free, or free of viruses
• Warranties regarding the accuracy, completeness, or clinical reliability of any output

10. Limitation of Liability

To the maximum extent permitted by applicable law, BreasyMed shall not be liable for any:

• Indirect, incidental, special, consequential, or punitive damages
• Loss of life, personal injury, or health-related harm arising from use or misuse of BREASY
• Data loss or unauthorized access to data
• Clinical or patient outcomes associated with BREASY use

This limitation applies regardless of the legal theory of liability and even if BreasyMed has been advised of the possibility of such damages.

11. Regulatory Compliance

You are solely responsible for ensuring that your use of BREASY complies with all applicable laws, regulations, and professional standards in your jurisdiction, including but not limited to:

• Medical device regulations (where applicable)
• Health data privacy laws (GDPR, HIPAA, PIPEDA, etc.)
• Professional licensing and scope-of-practice requirements
• Institutional review board or ethics committee requirements for research use
• Applicable clinical governance frameworks

12. Updates and Modifications

BreasyMed reserves the right to modify these Terms at any time. We will provide notice of material changes by:

• Updating the 'Last Updated' date at the top of this page
• Posting a notice within the BREASY app or website
• Sending email notification where appropriate

Continued use of BREASY after changes to these Terms constitutes acceptance of the revised Terms.

BreasyMed also reserves the right to modify, suspend, or discontinue BREASY (or any part thereof) at any time with or without notice.

13. Termination

We may suspend or terminate your access to BREASY at any time if you violate these Terms or if required by applicable law. Upon termination, all rights granted to you under these Terms will immediately cease.

14. Governing Law

These Terms shall be governed by and construed in accordance with the laws of the State of Israel, without regard to its conflict of law provisions. Any disputes arising from these Terms shall be subject to the exclusive jurisdiction of the courts of Israel.

15. Support and Contact

For support, questions about these Terms, or to report concerns:

BreasyMed Ltd.
Legal & Support Inquiries
Email: [email protected]

These Terms of Use are publicly accessible and maintained as a live web page in compliance with Apple App Store and Google Play developer requirements.