What evidence do auditors commonly ask for on 164.308(b)(3) Written Contract or Other Arrangement?

Standard BAA template aligned to 164.314(a); Executed BAAs stored in contract repository; Alternative arrangement documentation where BA is a government entity; Contract version history; Legal review records for BAA negotiations; Mapping of contract clauses to 164.314(a) requirements.

What is the most common gap auditors find on 164.308(b)(3)?

BAAs missing required Security Rule clauses

HIPAA Security Rule · Administrative

`164.308(b)(3)` Written Contract or Other Arrangement

Document the satisfactory assurances required by paragraph (b)(1) of this section through a written contract or other arrangement with the business associate that meets the applicable requirements of 164.314(a).

Source: HIPAA Security Rule, 164.308(b)(3). 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.

artefacts

held by a system

at each review

hard

to go live

Document repository

where the evidence lives

teal = a system already holds it · olive = produced at each review. To go live: easy when half or more of the artefacts are already held by a system, moderate from a quarter to a half, hard below a quarter.

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

Contract version history · Vendor register / contract repository

periodic reviewEvidence produced at each review

Legal review records for BAA negotiations · Document repository

governing documentDocuments that govern the control

Standard BAA template aligned to 164.314(a) · Policy repository / GRC workspace
Executed BAAs stored in contract repository · Policy repository / GRC workspace
Alternative arrangement documentation where BA is a government entity · Document repository
Mapping of contract clauses to 164.314(a) requirements · Vendor register / contract repository
Retention of BAAs for 6 years post-termination · HR system / LMS
Subcontractor BAAs · Document repository

First move

Mostly documents and reviews. Pull the 1 system-held artefact from your Vendor register / contract repository on a schedule; put the documents under version control with an owner and review date, and log each review as a dated record with a named reviewer.

Common gaps auditors find

BAAs missing required Security Rule clauses
Verbal or implied arrangements without writing
Legacy BAAs from pre-Omnibus Rule never updated
Government arrangement alternatives undocumented
BAA records not retained after termination
Templates not updated when Rule changes

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 sheet

164.308(b)(2) Subcontractor Arrangements · 164.310(a)(1) Facility Access Controls (Standard)