Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Implied Repeal Analysis


When faced with the need to determine how different federal laws interact with one another, we turn to the judiciary's approach. Courts apply the implied repeal analysis to resolve tensions that appear to exist between two or more statutes. While the implication of a regulation-on-regulation conflict is unclear, courts agree that administrative rules and regulations that do not conflict with express statutory provisions have the force and effect of law. Thus, we believe courts would apply the standard rules of interpretation that apply to statutes to address questions of interpretation with regard to regulatory conflicts.

When faced with two potentially conflicting statutes, courts attempt to construe them so that both are given effect. If this construction is not possible, courts will look for express language in the later statute, or an intent in its legislative history, indicating that Congress intended the later statute to repeal the earlier one. If there is no expressed intent to repeal the earlier statute, courts will characterize the statutes as either general or specific. Ordinarily, later, general statutes will not repeal the special provisions of an earlier, specific statute. In some cases, when a later, general statute creates an irreconcilable conflict or is manifestly inconsistent with the earlier, specific statute in a manner that indicates a clear and manifest Congressional intent to repeal the earlier statute, courts will find that the later statute repeals the earlier statute by implication. In these cases, the latest legislative action may prevail and repeal the prior law, but only to the extent of the conflict.

There should be few instances in which conflicts exist between a statute or regulation and the rules below. For example, if a statute permits a covered entity to disclose protected health information and the rules below permit such a disclosure, no conflict arises; the covered entity could comply with both and choose whether or not to disclose the information. In instances in which a potential conflict appears, we would attempt to resolve it so that both laws applied. For example, if a statute or regulation permits dissemination of protected health information, but the rules below prohibit the use or disclosure without an authorization, we believe a covered entity would be able to comply with both because it could obtain an authorization under § 164.508 before disseminating the information under the other law.

Many apparent conflicts will not be true conflicts. For example, if a conflict appears to exist because a previous statute or regulation requires a specific use or disclosure of protected health information that the rules below appear to prohibit, the use or disclosure pursuant to that statute or regulation would not be a violation of the privacy regulation because § 164.512(a) permits covered entities to use or disclose protected health information as required by law.

If a statute or regulation prohibits dissemination of protected health information, but the privacy regulation requires that an individual have access to that information, the earlier, more specific statute would apply. The interaction between the Clinical Laboratory Improvement Amendments regulation is an example of this type of conflict. From our review of several federal laws, it appears that Congress did not intend for the privacy regulation to overrule existing statutory requirements in these instances.