Checklist · Health & Medical Law

HIPAA business associate agreement checklist

Checklist for the written terms in a HIPAA business associate contract under 45 CFR 164.504(e) and 164.502(e). It is a review list. It is not the contract.

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 covered entity or business associate is reviewing a written contract before protected health information is shared. Do not use it as the signed contract, and do not use it to decide who is a business associate.

Used for these tasks

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 checks every term against the contract and the current regulation before anyone signs.

AI may

  • List the contract terms described in 45 CFR 164.504(e)(2) as questions against the draft.
  • Record the names of the parties and the function as blanks for the lawyer to complete.
  • Note that 164.504(e)(5) applies the same contract requirements between a business associate and a subcontractor.

AI must not

  • Do not complete or sign a business associate agreement.
  • Do not define business associate, covered entity, or protected health information. Section 160.103 was not opened.
  • Do not restate 45 CFR 164.410, 164.524, 164.526, 164.528, or 164.314. Those sections were not opened.
  • Do not decide that a person is a business associate, or that a breach must be notified.

The lawyer checks

  • Confirm the parties and the function from the engagement, not from this list.
  • Read 45 CFR 164.410 before describing what a breach report must contain.
  • Read 164.524, 164.526, and 164.528 before writing the access, amendment, and accounting mechanics.
  • Read 164.314 before relying on a security-rule term that this checklist only cites.

Method: how the Green, Yellow and Red levels are decided. This is guidance for planning, not legal advice.

Authorities

Read the full text

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