1. Acceptance of Terms
By accessing or using M2 ("the Platform"), you agree to be bound by these Terms of Use ("Terms"). If you do not agree, you may not access or use the Platform.
2. Authorized Users
M2 is intended solely for licensed healthcare professionals acting within the scope of their professional licensure and clinical privileges.
By using M2, you represent and warrant that:
- You are a licensed healthcare professional
- You are authorized to practice in your applicable jurisdiction
- You are using M2 solely for professional clinical support purposes
M2 is not intended for patients, consumers, or the general public.
3. Intended Use and Clinical Scope
M2 is a physician-facing clinical decision support (CDS) tool intended to assist licensed clinicians in reviewing, synthesizing, and considering medical information.
M2:
- Does not provide medical advice
- Does not diagnose conditions
- Does not recommend or select treatments
- Does not prescribe medications
- Does not interpret diagnostic tests independently
- Does not replace clinical judgment
- Does not operate autonomously
All clinical decisions remain the sole responsibility of the licensed clinician.
4. FDA Clinical Decision Support Positioning
M2 is designed to meet the criteria for Non-Device Clinical Decision Support Software as described under Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act.
M2:
- Does not acquire or analyze medical images or signals
- Provides information supportive of clinician decision-making
- Allows clinicians to independently review and assess the basis for outputs
Accordingly, M2 is not intended to function as a regulated medical device.
5. Physician-in-the-Loop Requirement
M2 is a physician-in-the-loop system by design.
- All outputs require clinician review
- No output may be relied upon without independent professional judgment
- No clinical action is initiated by the Platform
Use of M2 does not delegate, transfer, or reduce professional responsibility.
6. No Emergency or Sole Reliance Use
M2 is not intended for sole reliance in:
- Medical emergencies
- Time-critical clinical situations
Clinicians must rely on their training, institutional protocols, and professional judgment.
7. No Standard of Care Creation
Use of M2:
- Does not establish a standard of care
- Does not define required clinical actions
- Does not replace institutional or specialty guidelines
Failure to use M2, or choosing not to follow its outputs, does not constitute negligence.
8. Prohibition on PHI and Identifiable Patient Data
You must not enter, upload, transmit, or disclose any Protected Health Information (PHI) or identifiable patient data when using M2.
This includes, but is not limited to:
- Names or initials
- Dates of birth
- Medical record numbers
- Contact information
- Images, audio, or text that could identify a patient
M2 is intended for de-identified, hypothetical, or abstracted clinical scenarios only.
9. No Business Associate Relationship
Because PHI must not be entered:
- M2 is not acting as a Business Associate under HIPAA
- No Business Associate Agreement (BAA) is formed
- Entry of PHI constitutes unauthorized use outside the intended scope
10. Data Accuracy and Input Responsibility
You are solely responsible for:
- Accuracy and completeness of data entered
- Proper de-identification of all information
- Verifying outputs before clinical use
Outputs may be inaccurate or incomplete and must be independently validated.
11. Disclaimer of Warranties
M2 is provided "as is" and "as available."
To the maximum extent permitted by law, the Platform disclaims all warranties, express or implied, including accuracy, completeness, fitness for a particular purpose, and non-infringement.
12. Limitation of Liability
To the maximum extent permitted by law:
- M2 assumes no responsibility for clinical decisions or patient outcomes
- Clinical responsibility remains exclusively with the licensed clinician
- Use of M2 does not create a physician-patient relationship with the Platform
13. Regulatory and Institutional Compliance
You remain responsible for compliance with:
- State and federal laws
- Medical board regulations
- Institutional policies
- Documentation and malpractice requirements
14. User Acknowledgment
By using M2, you acknowledge that:
- You understand the Platform's limitations
- You will not enter PHI
- You retain full clinical responsibility at all times