164.308(b)(2) Subcontractor Arrangements
A business associate may permit a business associate that is a subcontractor to create, receive, maintain, or transmit electronic protected health information on its behalf only if the business associate obtains satisfactory assurances, in accordance with 164.314(a), that the subcontractor will appropriately safeguard the information.
Source: HIPAA Security Rule, 164.308(b)(2). 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
none for this control
periodic reviewEvidence produced at each review
- Evidence the assurances obtained are equivalent to those the business associate provided to the covered entity · Document repository
- Records of action taken where a subcontractor was known to have breached the assurance, including termination or reporting · HR system / LMS
governing documentDocuments that govern the control
- Inventory of subcontractors that create, receive, maintain or transmit electronic protected health information on the business associate's behalf · Policy repository / GRC workspace
- Executed written agreements with each subcontractor containing the satisfactory assurances required · Vendor register / contract repository
- Due diligence records supporting the assurance, such as security assessments or attestations, rather than the contract alone · Vendor register / contract repository
First move
Common gaps auditors find
- Assurances obtained from the immediate subcontractor while its own downstream subcontractors handling the same data are unaddressed
- Signed agreement treated as the whole control, with no due diligence or ongoing verification behind it
- Cloud and support vendors that incidentally access electronic protected health information never identified as subcontractors, so no agreement exists
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(b)(1) Business Associate Contracts and Other Arrangements (Standard) · 164.308(b)(3) Written Contract or Other Arrangement