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

12/28/2000

In the final rule, we permit a covered health care provider to condition the provision of treatment on the receipt of the individual's consent for the covered provider to use and disclose protected health information to carry out treatment, payment, and health care operations. Covered providers may refuse to treat individuals who do not consent to uses and disclosures for these purposes. See § 164.506(b)(1). We note that there are exceptions to the consent requirements for covered health care providers that are required by law to treat individuals. See § 164.506(a)(3), described above.

Similarly, in the final rule, we permit health plans to condition an individual's enrollment in the health plan on the receipt of the individual's consent for the health plan to use and disclose protected health information to carry out treatment, payment, and health care operations, if the consent is sought in conjunction with the enrollment process. If the health plan seeks the individual's consent outside of the enrollment process, the health plan may not condition any services on obtaining such consent.

Under § 164.520, covered entities must produce a notice of privacy practices. A consent may not be combined in a single document with the notice of privacy practices. See § 164.506(b)(3).

Under § 164.506(b)(4), consents for uses and disclosures of protected health information to carry out treatment, payment, and health care operations may be combined in a single document covering all three types of activities and may be combined with other types of legal permission from the individual. For example, a consent to use or disclose protected health information under this rule may be combined with an informed consent to receive treatment, a consent to assign payment of benefits to a provider, or narrowly tailored consents required under state law for the use or disclosure of specific types of protected health information (e.g., state laws requiring specific consent for any sharing of information related to HIV/AIDS).

Within a single consent document, the consent for use and disclosure of protected health information required or permitted under this rule must be visually and organizationally separate from the other consents or authorizations and must be separately signed by the individual and dated.

Where research includes treatment of the individual, a consent under this rule may be combined with the authorization for the use or disclosure of protected health information created for the research, in accordance with § 164.508(f). (This is the only case in which an authorization under § 164.508 of this rule may be combined with a consent under § 164.506 of this rule. See § 164.508(b)(3).) The covered entity that is creating protected health information for the research may elect to combine the consent required under this section with the research-related authorization required under § 164.508(f). For example, a covered health care provider that provides health care to an individual for research purposes and for non-research purposes must obtain a consent under this section for all of the protected health information it maintains. In addition, it must obtain an authorization in accordance with § 164.508(f) which describes how it will use and disclose the protected health information it creates for the research for purposes of treatment, payment, and health care operations. Section 164.506(b)(4) permits the covered entity to satisfy these two requirements with a single document. See § 164.508(f) and the corresponding preamble discussion for a more detailed description of research authorization requirements.

Under § 164.506(b)(5), individuals may revoke a consent in writing at any time, except to the extent that the covered entity has taken action in reliance on the consent. Upon receipt of the written revocation, the covered entity must stop processing the information for use or disclosure, except to the extent that it has taken action in reliance on the consent. A covered health care provider may refuse, under this rule, to continue to treat an individual that revokes his or her consent. A health plan may disenroll an individual that revokes a consent that was sought in conjunction with the individual's enrollment in the health plan.

Covered entities must document and retain any signed consent as required by § 164.530(j).