Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Core Elements and Requirements


Comment: Many commenters raised concerns about the required elements for a valid authorization. They argued that the requirements were overly burdensome and that covered entities should have greater flexibility to craft authorizations that meet their business needs. Other commenters supported the required elements as proposed because the elements help to ensure that individuals make meaningful, informed choices about the use and disclosure of protected health information about them.

Response: As in the proposed rule, we define specific elements that must be included in any authorization. We draw on established laws and guidelines for these requirements. For example, the July 1977 Report of the Privacy Protection Study Commission recommended that authorizations obtained by insurance institutions include plain language, the date of authorization, and identification of the entities authorized to disclose information, the nature of the information to be disclosed, the entities authorized to receive information, the purpose(s) for which the information may be used by the recipients, and an expiration date. 13 The Commission made similar recommendations concerning the content of authorizations obtained by health care providers. 14 The National Association of Insurance Commissioners' Health Information Privacy Model Act requires authorizations to be in writing and include a description of the types of protected health information to be used or disclosed, the name and address of the person to whom the information is to be disclosed, the purpose of the authorization, the signature of the individual or the individual's representative, and a statement that the individual may revoke the authorization at any time, subject to the rights of any person that acted in reliance on the authorization prior to revocation and provided the revocation is in writing, dated, and signed. Standards of the American Society for Testing and Materials recommend that authorizations identify the subject of the protected health information to be disclosed; the name of the person or institution that is to release the information; the name of each individual or institution that is to receive the information; the purpose or need for the information; the information to be disclosed; the specific date, event, or condition upon which the authorization will expire, unless revoked earlier; and the signature and date signed. They also recommend the authorization include a statement that the authorization can be revoked or amended, but not retroactive to a release made in reliance on the authorization. 15

Comment: Some commenters requested clarification that authorizations "initiated by the individual" include authorizations initiated by the individual's representative.

Response: In the final rule, we do not classify authorizations as those initiated by the individual versus those initiated by a covered entity. Instead, we establish a core set of elements and requirements that apply to all authorizations and require certain additional elements for particular types of authorizations initiated by covered entities.

Comment: Some commenters urged us to permit authorizations that designate a class of entities, rather than specifically named entities, that are authorized to use or disclose protected health information. Commenters made similar recommendations with respect to the authorized recipients. Commenters suggested these changes to prevent covered entities from having to seek, and individuals from having to sign, multiple authorizations for the same purpose.

Response: We agree. Under § 164.508(c)(1), we require authorizations to identify both the person(s) authorized to use or disclose the protected health information and the person(s) authorized to receive protected health information. In both cases, we permit the authorization to identify either a specific person a class of persons.

Comment: Many commenters requested clarification that covered entities may rely on electronic authorizations, including electronic signatures.

Response: All authorizations must be in writing and signed. We intend e-mail and electronic documents to qualify as written documents. Electronic signatures are sufficient, provided they meet standards to be adopted under HIPAA. In addition, we do not intend to interfere with the application of the Electronic Signature in Global and National Commerce Act.

Comment: Some commenters requested that we permit covered entities to use and disclose protected health information pursuant to verbal authorizations.

Response: To ensure compliance and mutual understanding between covered entities and individuals, we require all authorizations to be in writing.

Comment: Some commenters asked whether covered entities can rely on copies of authorizations rather than the original. Other comments asked whether covered entities can rely on the assurances of a third party, such as a government entity, that a valid authorization has been obtained to use or disclose protected health information. These commenters suggested that such procedures would promote the timely provision of benefits for programs that require the collection of protected health information from multiple sources, such as determinations of eligibility for disability benefits.

Response: Covered entities must obtain the individual's authorization to use or disclose protected health information for any purpose not otherwise permitted or required under this rule. They may obtain this authorization directly from the individual or from a third party, such as a government agency, on the individual's behalf. In accordance with the requirements of § 164.530(j), the covered entity must retain a written record of authorization forms signed by the individual. Covered entities must, therefore, obtain the authorization in writing. They may not rely on assurances from others that a proper authorization exists. They may, however, rely on copies of authorizations if doing so is consistent with other law.

Comment: We requested comments on reasonable steps that a covered entity could take to be assured that the individual who requests the disclosure is whom she or he purports to be. Some commenters stated that it would be extremely difficult to verify the identity of the person signing the authorization, particularly when the authorization is not obtained in person. Other comments recommended requiring authorizations to be notarized.

Response: To reduce burden on covered entities, we are not requiring verification of the identities of individuals signing authorization forms or notarization of the forms.

Comment: A few commenters asked for clarification regarding the circumstances in which a covered entity may consider a non-response as an authorization.

Response: Non-responses to requests for authorizations cannot be considered authorizations. Authorizations must be signed and have the other elements of a valid authorization described above.

Comment: Most commenters generally supported the requirement for an expiration date on the authorization. Commenters recommended expiration dates from 6 months to 3 years and/or proposed that the expiration be tied to an event such as duration of enrollment or when an individual changes health plans. Others requested no expiration requirement for some or all authorizations.

Response: We have clarified that an authorization may include an expiration date in the form of a specific date, a specific time period, or an event directly related to the individual or the purpose of the authorization. For example, a valid authorization could expire upon the individual's disenrollment from a health plan or upon termination of a research project. We prohibit an authorization from having an indeterminate expiration date.

These changes were intended to address situations in which a specific date for the termination of the purpose for the authorization is difficult to determine. An example may be a research study where it may be difficult to predetermine the length of the project.

Comment: A few commenters requested that the named insured be permitted to sign an authorization on behalf of dependents.

Response: We disagree with the commenter that a named insured should always be able to authorize uses and disclosures for other individuals in the family. Many dependents under group health plans have their own rights under this rule, and we do not assume that one member of a family has the authority to authorize uses or disclosures of the protected health information of other family members.

A named insured may sign a valid authorization for an individual if the named insured is a personal representative for the individual in accordance with § 164.502(g). The determination of whether an individual is a personal representative under this rule is based on other applicable law that determines when a person can act on behalf of an individual in making decisions related to health care. This rule limits a person's rights and authorities as a personal representative to only the protected health information relevant to the matter for which he or she is a personal representative under other law. For example, a parent may be a personal representative of a child for most health care treatment and payment decisions under state law. In that case, a parent, who is a named insured for her minor child, would be able to provide authorization with respect to most protected health information about her dependent child. However, a wife who is the named insured for her husband who is a dependent under a health insurance policy may not be a personal representative for her husband under other law or may be a personal representative only for limited purposes, such as for making decisions regarding payment of disputed claims. In this case, she may have limited authority to access protected health information related to the payment of disputed claims, but would not have the authority to authorize that her husband's information be used for marketing purposes, absent any other authority to act for her husband. See § 164.502(g) for more information regarding personal representatives.

Comment: One commenter suggested that authorizations should be dated on the day they are signed.

Response: We agree and have retained this requirement in the final rule.