164.308(b)(1) Business Associate Contracts and Other Arrangements (Standard)
A covered entity may permit a business associate to handle ePHI only after obtaining satisfactory assurances via written contract. NIST recommends due diligence, security questionnaires, and ongoing monitoring of BAs.
Source: HIPAA Security Rule, 164.308(b)(1). The statement above is our statement of the clause, read from the published text and cited so you can check it against the official text, not the instrument verbatim. Open HIPAA Security Rule in the compliance library.
Applies to covered entities and business associates. An addressable specification can be met by a documented, reasonable alternative.
These are the artefacts auditors commonly ask for on this requirement, our guidance rather than text from the standard. Your assessor decides what is sufficient in your context, and asks for samples across the period when a report covers one.
system holds itEvidence a system already holds
- Ongoing monitoring records · SIEM / log platform
periodic reviewEvidence produced at each review
- Vendor risk assessments · Vendor register / contract repository
governing documentDocuments that govern the control
- BA inventory · Vendor register / contract repository
- Executed BAAs · Vendor register / contract repository
First move
Common gaps auditors find
- BA inventory incomplete
- BAAs missing for cloud vendors
- No ongoing monitoring after onboarding
Do this for your whole sheet
Paste the rows you run your controls from and get this mapping for every control at once, with the periodic-review ones flagged and a first move per row. No account for the first run.
Build my evidence sheet164.308(a)(8) Evaluation (Standard) · 164.308(b)(2) Subcontractor Arrangements