1. Purpose and term
The Site evaluates EchoReview AI for echocardiogram triage, severity grading, and report drafting for an initial term of ninety (90) days, renewable in writing. The pilot is provided at no fee unless a separate order form is signed.
2. Investigational status — not for diagnostic use
EchoReview AI is investigational research software. It is not FDA-cleared. Output is advisory only, must be reviewed by a qualified physician, and may not be used as the sole basis for any diagnosis or treatment decision. The Site retains full clinical responsibility for every interpretation.
3. Data handling
Studies are transmitted encrypted in transit and at rest, stored in an access-controlled workspace scoped to the Site, and accessible only to users the Site authorizes. Every view, edit, and sign-off is recorded in an immutable audit log available to the Site.
4. Business Associate Agreement
Where the pilot involves Protected Health Information, the attached BAA governs and controls over any conflicting term in this agreement.
5. Data Use Agreement and de-identification
Where the Site provides a limited or de-identified data set, the attached DUA governs. Site data is never used to train models and is never shared with third parties without separate written consent.
6. Site responsibilities
The Site names a clinical lead and a technical contact, provides access to the studies in scope, ensures reviewers are appropriately licensed, and completes any internal privacy, security, or IRB review required before the pilot begins.
7. Confidentiality
Each party protects the other's non-public information. EchoReview AI will not name the Site publicly without written approval.
8. Evaluation output
Agreement statistics, turnaround times, and reviewer feedback generated during the pilot may be used in aggregate, de-identified form to improve the product. Site-identifying results are shared publicly only with written approval.
9. Termination and data return
Either party may end the pilot at any time with written notice. Within thirty (30) days of termination, Site data is returned or destroyed and workspace access is revoked, except where retention is required by law.
10. Liability
The software is provided "as is" for evaluation. Neither party is liable for indirect or consequential damages arising from the pilot.
Disclaimer: This template is provided for convenience and is not legal advice. Please route it through your institution's legal and compliance review before signing.