Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Section 164.506(c) - Consent Content Requirements


Under § 164.506(c), the consent must be written in plain language. See the preamble discussion regarding notice of privacy practices for a description of plain language requirements. We do not provide a model consent in this rule. We will provide further guidance on drafting consent documents prior to the compliance date.

Under § 164.506(c)(1), the consent must inform the individual that protected health information may be used and disclosed by the covered entity to carry out treatment, payment, or health care operations. The covered entity must determine which of these elements (use and/or disclosure; treatment, payment, and/or health care operations) to include in the consent document, as appropriate for the covered entity's practices.

For covered health care providers that are required to obtain consent, the requirement applies only to the extent the covered provider uses or discloses protected health information. For example, if all of a covered provider's health care operations are conducted by members of the covered provider's own workforce, the covered provider may choose to obtain consent only for uses, not disclosures, of protected health information to carry out health care operations. If an individual pays out of pocket for all services received from the covered provider and the provider will not disclose any information about the patient to a third party payor, the provider may choose not to obtain the individual's consent to disclose information for payment purposes. In order for a covered provider to be able to use and disclose information for all three purposes, however, all three purposes must be included in the consent.

Under §§ 164.506(c)(2) and (3), the consent must refer the individual to the covered entity's notice for additional information about the uses and disclosures of information described in the consent. The consent must also indicate that the individual has the right to review the notice prior to signing the consent. If the covered entity has reserved the right to change its privacy practices in accordance with § 164.520(b)(1)(v)(C), the consent must indicate that the terms of the notice may change and must describe how the individual may obtain a revised notice. See § 164.520 and the corresponding preamble discussion regarding notice requirements.

Under § 164.506(c)(4), the consent must inform individuals that they have the right to request restrictions on uses and disclosures of protected health information for treatment, payment, and health care operations purposes. It must also state that the covered entity is not required to agree to an individual's request, but that if the covered entity does agree to the request, the restriction is binding on the covered entity. See § 164.522(a) regarding the right to request restrictions.

Under § 164.506(c)(5), the consent must indicate that the individual has the right to revoke the consent in writing, except to the extent that the covered entity has taken action in reliance on the consent.

Under § 164.506(c)(6), the consent must include the individual's signature and the date of signature. Once we adopt the standards for electronic signature, another of the required administrative simplification standards we are required to adopt under HIPAA, an electronic signature that meets those standards will be sufficient under this rule. We do not require any verification of the individual's identity or authentication of the individual's signature. We expect covered health care providers that are required to obtain consent to employ the same level of scrutiny to these signatures as they do to the signature obtained on a document regarding the individual's consent to undergo treatment by the provider.