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The CISO Decision Brief

Section § 164.308(b)(1)Business associate contracts and other arrangements

What it says

(b)(1) Business associate contracts and other arrangements. A covered entity may permit a business associate to create, receive, maintain, or transmit electronic protected health information on the covered entity's behalf only if the covered entity obtains satisfactory assurances, in accordance with § 164.314(a), that the business associate will appropriately safeguard the information. A covered entity is not required to obtain such satisfactory assurances from a business associate that is a subcontractor.

(2) 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.

(3) Implementation specifications: Written contract or other arrangement (Required). Document the satisfactory assurances required by paragraph (b)(1) or (b)(2) of this section through a written contract or other arrangement with the business associate that meets the applicable requirements of § 164.314(a).

HIPAA, the United States rules protecting health information, § 164.308(b)(1)

What is in the packs for this

From HIPAA Security Rule Readiness. Each one helps with this requirement.

  • Excel

    Security Rule Safeguard Register

    Its Framework References cite this section. Lists the 22 Security Rule standards and their 41 implementation specifications in plain words, required or addressable, with an owner and the evidence to keep.
  • Word

    Business Associate Agreement Security Terms

    Its Framework References cite this section. Gives the security team the terms to check in a business associate agreement, each with its source and a pointer to the supplier clause library. It is not a legal template.

Text: 45 CFR Part 164, from the Electronic Code of Federal Regulations (eCFR) as it stood on 6 October 2026.