HIPAA (45 CFR Part 164)·§ 164.520(b)(1)·medium·Component: Privacy Rule

What this control requires

Right to notice. Except as provided by paragraph (a)(2) or (3) of this section, an individual has a right to adequate notice of the uses and disclosures of protected health information that may be made by the covered entity, and of the individual's rights and the covered entity's legal duties with respect to protected health information. 164.520(b)(1) Required elements. The covered entity must provide a notice that is written in plain language and that contains the elements required by this paragraph. (i) Header. The notice must contain the following statement as a header or otherwise prominently displayed: "THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY." (ii) Uses and disclosures. The notice must contain: (A) A description, including at least one example, of the types of uses and disclosures that the covered entity is permitted by this subpart to make for each of the following purposes: treatment, payment, and health care operations. (B) A description of each of the other purposes for which the covered entity is permitted or required by this subpart to use or disclose protected health information without the individual's written authorization. (C) If a use or disclosure for any purpose described in paragraphs (b)(1)(ii)(A) or (B) of this section is prohibited or materially limited by other applicable law, the description of such use or disclosure must reflect the more stringent law as defined in 160.202 of this subchapter. (D) For each purpose described in paragraph (b)(1)(ii)(A) or (B) of this section, the description must include sufficient detail to place the individual on notice of the uses and disclosures that are permitted or required by this subpart and other applicable law. (E) A description of the types of uses and disclosures that require an authorization under 164.508(a)(2) (a)(4), a statement that other uses and disclosures not described in the notice will be made only with the individuals written authorization, and a statement that the individual may revoke an authorization as provided by 164.508(b)(5). (iii) Separate statements for certain uses or disclosures. If the covered entity intends to engage in any of the following activities, the description required by paragraph (b)(1)(ii)(A) of this section must include a separate statement informing the individual of such activities, as applicable: (A) In accordance with 164.514(f)(1), the covered entity may contact the individual to raise funds for the covered entity and the individual has a right to opt out of receiving such communications; (B) In accordance with 164.504(f), the group health plan, or a health insurance issuer or HMO with respect to a group health plan, may disclose protected health information to the sponsor of the plan; or (C) If a covered entity that is a health plan, excluding an issuer of a long-term care policy falling within paragraph (1)(viii) of the definition of health plan, intends to use or disclose protected health information for underwriting purposes, a statement that the covered entity is prohibited from using or disclosing protected health information that is genetic information of an individual for such purposes. (iv) Individual rights. The notice must contain a statement of the individual's rights with respect to protected health information and a brief description of how the individual may exercise these rights, as follows: (A) The right to request restrictions on certain uses and disclosures of protected health information as provided by 164.522(a), including a statement that the covered entity is not required to agree to a requested restriction, except in case of a disclosure restricted under 164.522(a)(1)(vi); (B) The right to receive confidential communications of protected health information as provided by 164.522(b), as applicable; (C) The right to inspect and copy protected health information as provided by 164.524; (D) The right to amend protected health information as provided by 164.526; (E) The right to receive an accounting of disclosures of protected health information as provided by 164.528; and (F) The right of an individual, including an individual who has agreed to receive the notice electronically in accordance with paragraph (c)(3) of this section, to obtain a paper copy of the notice from the covered entity upon request. (v) Covered entity's duties. The notice must contain: (A) A statement that the covered entity is required by law to maintain the privacy of protected health information, to provide individuals with notice of its legal duties and privacy practices with respect to protected health information, and to notify affected individuals following a breach of unsecured protected health information; (B) A statement that the covered entity is required to abide by the terms of the notice currently in effect; and (C) For the covered entity to apply a change in a privacy practice that is described in the notice to protected health information that the covered entity created or received prior to issuing a revised notice, in accordance with 164.530(i)(2)(ii), a statement that it reserves the right to change the terms of its notice and to make the new notice provisions effective for all protected health information that it maintains. The statement must also describe how it will provide individuals with a revised notice. (vi) Complaints. The notice must contain a statement that individuals may complain to the covered entity and to the Secretary if they believe their privacy rights have been violated, a brief description of how the individual may file a complaint with the covered entity, and a statement that the individual will not be retaliated against for filing a complaint. (vii) Contact. The notice must contain the name, or title, and telephone number of a person or office to contact for further information as required by 164.530(a)(1)(ii). (viii) Effective date. The notice must contain the date on which the notice is first in effect, which may not be earlier than the date on which the notice is printed or otherwise published.
— HIPAA (45 CFR Part 164), § 164.520(b)(1)

In plain English

Right to notice. In practice, this means you can prove you information management-level controls on a defined cadence.

Why it matters

HIPAA non-compliance is a strict-liability matter: OCR civil monetary penalties are assessed per-record per-violation (up to USD 1.9 million per identical-violation calendar year as of 2024), and willful neglect can trigger criminal referral.

What an auditor looks for

HHS OCR investigators and SOC-2+HIPAA auditors look for the specific 45 CFR § citation, whether the safeguard is required vs addressable (and if addressable, the documented decision), the implementation specification, the workforce member responsible, and the records that show it runs.

Within Privacy Rule, the assessor will trace your implementation back to the catalogue reference (§ 164.520(b)(1)) and look for objective evidence on the latest two assessment cycles.

How to implement

Policy Management

Docs. Keep each policy in version-controlled Markdown alongside the code that implements it; ship a signed PDF snapshot at each annual review and link the SHA into the SoA.

Operational checklist

  • Information. Document the trigger, the owner and the cadence.
  • Person. Document the trigger, the owner and the cadence.
  • Other. Document the trigger, the owner and the cadence.
  • Group. Document the trigger, the owner and the cadence.
  • Policy. Document the trigger, the owner and the cadence.
  • Scope: management, individuals, secretary, notice, policy, genetic information, i, obtain.

Evidence to collect

  • Policy Document. A signed and version-controlled policy / standard / procedure document.

Signed policy or standard documents the safeguard. Focus: Notice of Privacy Practices.

Common pitfalls

  • Policies that no engineer has read; the version in Confluence drifts from the version that's actually being enforced.

Related controls in HIPAA (45 CFR Part 164)

References

Topics: governance riskpolicy management