What must a clinic have before letting a cloud company store its patient records?

A business associate agreement (written contract).

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  1. Each patient's signed authorization
  2. A written business associate agreement ✔
  3. Nothing, storage isn't a disclosure

Why: A covered entity may let a business associate maintain PHI only after getting satisfactory assurance it will safeguard the information. That assurance must be in a written contract or agreement.

Huh, didn't know that: The contract must spell out how the business associate is allowed to use and disclose the PHI.

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References

Answer: A written business associate agreement. A covered entity may let a business associate maintain PHI only after getting satisfactory assurance it will safeguard the information. That assurance must be in a written contract or agreement.

  1. 45 CFR 164.502 (eCFR) www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-E/section-164.502
    must be documented through a written contract or other written agreement or arrangement with the business associate
    Checked 2026-10-10.
  2. 45 CFR 164.504 (eCFR) www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-E/section-164.504
    Establish the permitted and required uses and disclosures of protected health information by the business associate.
    Checked 2026-10-10.

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