Its length is set by your institution's review process, and in our experience it moves fastest when a senior sponsor asks for it to be prioritized. The answers a reviewer asks for first are published at burna.ai/it: protected health information isolated in a dedicated data plane, complete audit trails, 21 CFR Part 11 electronic signatures, SSO and SAML sign-in, role-based access and SMART on FHIR integration. Burna AI is built for HIPAA and 21 CFR Part 11, signs a business associate agreement with customers, and lists its subprocessors at burna.ai/subprocessors. Our SOC 2 Type 2 audit is in progress. For security questionnaires and documentation, write to [email protected]. Standalone capture works from day one while the review proceeds.
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