Checklist · Health & Medical Law
Business associate subcontractor assurance checklist
Checklist for satisfactory assurances when a business associate uses a subcontractor, and for the other arrangements in 45 CFR 164.504(e)(3). It is not the subcontract.
- Kind
- Checklist. Steps or checks to work through and tick off.
- Where it applies
- United States
- AI use
- Yellow You and the tool draft together, with you directing. You check every statement you rely on.
- Law stated as at
- 22 October 2026
- Status
- Maintained. Checked on 22 October 2026 against the 2 authorities it cites, for United States.
- Version
- 1
- Source
- Written for this library
When to use it
Use when a business associate is about to let another person create, receive, maintain, or transmit protected health information on its behalf. Do not use it as the subcontract or as a data use agreement.
Used for these tasks
- Review an AI clinical-tool vendor contract for privacy and TGA issues
- Review a hospital or health-services agreement
Each task page says how far AI may help with the task and what the lawyer must review.
How AI may be used
Yellow: the lawyer decides whether the writing meets 45 CFR 164.504(e) before information is shared.
AI may
- List the subcontractor assurance required by 45 CFR 164.502(e)(1)(ii) and 164.504(e)(5).
- List the other-arrangement paths in 164.504(e)(3) as questions, without completing them.
- Record a failed attempt to obtain assurances, if the lawyer supplies the facts.
AI must not
- Do not sign a subcontract or a memorandum of understanding.
- Do not restate 45 CFR 164.314 or 164.514(e). Those sections were not opened.
- Do not decide that return or destruction of information is not feasible.
- Do not treat a limited data set as compliant without a data use agreement the lawyer has read.
The lawyer checks
- Name the subcontractor and the function from the engagement.
- Read 164.314 before using a security-rule arrangement.
- Read 164.514(e) before relying on a limited data set.
- Keep any omitted termination term inside the statutory-obligation path in 164.504(e)(3)(iii).
Method: how the Green, Yellow and Red levels are decided. This is guidance for planning, not legal advice.
Read the full text
The full text is available after you log in. It is free. When you log in you can:
- read the whole precedent, with its drafting notes beside it;
- copy it, or download it as a Word file or Markdown;
- add it to your firm’s knowledge base, so colleagues can find it;
- let the AI tools you connect read it from that knowledge base.
The summary, the law it rests on and the AI-use guidance above stay public. Privacy.
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