Amplifier Clinical Voice Capture

Legal

Terms of Service

Last updated August 2026

This tool (the "App") is provided by Amplifier Health Inc. to authorized site staff for capturing de-identified voice recordings under a documented chain of custody, as part of the K2 Connect (LifeKey) proof-of-concept. By signing in and using the App, you agree to these terms.

1. Who may use the App

Accounts are provisioned by an Amplifier administrator for named site staff only. Your account may not be shared, and you are responsible for all activity recorded under your sign-in, since your identity is written into the chain-of-custody record for every recording you capture, view, or sign.

2. No patient identity in the App

You must never enter a patient's name, date of birth, or other direct identifier into the App. Recordings are tagged only by the coded CRIO Subject ID for the visit. Entering identifying information into any field of the App is a misuse of the tool and a violation of these terms.

3. Chain of custody is permanent

Every capture, view, note, and signature is written to an append-only, hash-chained audit trail that cannot be edited or deleted once recorded. Do not treat any action in the App as reversible.

4. Regulatory scope

Electronic-signature and Part 11 features in the App are scaffolding only and do not make this a Part 11 system of record unless and until K2's Quality & Compliance team has confirmed FDA-submission scope in writing. Do not rely on this App as a validated Part 11 system without that written confirmation.

5. Acceptable use

You may not use the App to capture or process recordings for anyone other than the study you are authorized on, attempt to access another site's or staff member's recordings, interfere with or attempt to alter the audit trail, or use the App in a way that violates your site's policies or applicable law.

6. Data handling

How the App collects, uses, and stores data is described in the Privacy Policy, which is part of these terms.

7. Availability and changes

The App is provided on an "as is" basis. We may update, modify, or temporarily suspend the App for maintenance or improvement, and may update these terms from time to time; continued use of the App after an update constitutes acceptance of the revised terms.

8. Limitation of liability

To the fullest extent permitted by law, Amplifier Health Inc. is not liable for indirect, incidental, or consequential damages arising from use of the App. Nothing in these terms limits liability for gross negligence or willful misconduct, or excludes any liability that cannot be excluded under applicable law.

9. Contact

Questions about these terms can be sent to amit@amplifierhealth.com.