Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Nondelegation Doctrine


Comment: Some commenters objected to the manner by which Congress provided the Secretary authority to promulgate this regulation. These comments asserted that Congress violated the nondelegation doctrine by (1) not providing an "intelligible principle" to guide the agency, (2) not establishing "ascertainable standards," and (3) improperly permitting the Secretary to make social policy decisions.

Response: We disagree. HIPAA clearly delineates Congress' general policy to establish strict privacy protections for individually identifiable health information to encourage electronic transactions. Congress also established boundaries limiting the Secretary's authority. Congress established these limitations in several ways, including by calling for privacy standards for "individually identifiable health information"; specifying that privacy standards must address individuals' rights regarding their individually identifiable health information, the procedures for exercising those rights, and the particular uses and disclosures to be authorized or required; restricting the direct application of the privacy standards to "covered entities," which Congress defined; requiring consultation with the National Committee on Vital and Health Statistics and the Attorney General; specifying the circumstances under which the federal requirements would supersede state laws; and specifying the civil and criminal penalties the Secretary could impose for violations of the regulation. These limitations also serve as "ascertainable standards" upon which reviewing courts can rely to determine the validity of the exercise of authority.

Although Congress could have chosen to impose expressly an exhaustive list of specifications that must be met in order to achieve the protective purposes of the HIPAA, it was entirely permissible for Congress to entrust to the Secretary the task of providing these specifications based on her experience and expertise in dealing with these complex and technical matters.

We disagree with the comments that Congress improperly delegated Congressional policy choices to her. Congress clearly decided to create federal standards protecting the privacy of "individually identifiable health information" and not to preempt state laws that are more stringent. Congress also determined over whom the Secretary would have authority, the type of information protected, and the minimum level of regulation.