Scope
Clearly enumerate the analyses to be performed, the metrics and statistical methods used, and any excluded tasks so expectations and deliverables are unambiguous.
A written agreement reduces misunderstandings about scope, protects patient privacy by specifying permitted uses of PHI, and documents legal responsibilities that support HIPAA compliance and auditability.
Typical parties include healthcare organizations, analytics vendors, payers, and authorized researchers; roles vary by use case.
Signatures and contact details should list authorized representatives and, when required by HIPAA, include a Business Associate Agreement or similar data use agreement.
Clearly enumerate the analyses to be performed, the metrics and statistical methods used, and any excluded tasks so expectations and deliverables are unambiguous.
List data elements, sources, formats, and any required deidentification or limited data set specifications; specify who retains linking keys if applicable.
State HIPAA obligations, require a signed Business Associate Agreement when applicable, and describe safeguards for transmission, storage, and access control.
Describe report formats, data extracts, visualizations, ownership of aggregate results, and acceptable file types for final delivery.
Specify encryption standards, access controls, breach notification procedures, and any audit logging or penetration testing requirements.
Set milestones, review cycles, acceptance criteria, and remedies for missed deadlines or requests for additional scope work.
| Field | Configuration |
|---|---|
| Signer Order | Sequential or parallel routing; set role-specific approvers. |
| Authentication | Email link, SMS code, or stronger MFA depending on PHI sensitivity. |
| Document Retention | Enable secure storage and export options (PDF/A recommended). |
| Audit Trail | Enable capture of IP, timestamp, and signer actions for compliance. |
Use an eSignature workflow that supports HIPAA requirements and preserves a detailed audit trail for each signing event.
Maintain copies in secured repositories and confirm that any chosen vendor can sign a Business Associate Agreement when PHI is involved.
Allow 5–10 business days for legal and privacy review for standard agreements.
Plan 7–21 business days for secure data extraction and transfer depending on complexity.
Typical reporting turnaround is 2–8 weeks depending on scope and dataset size.
Include a 5–10 business day window for stakeholder review and revisions.
Retention periods begin on the Effective Date unless otherwise specified.