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


In § 164.518(e) of the NPRM, we proposed to require all covered entities to develop, and apply when appropriate, sanctions against members of its workforce who failed to comply with privacy policies or procedures of the covered entity or with the requirements of the rule. Covered entities would be required to develop and impose sanctions appropriate to the nature of the violation. The preamble stated that the type of sanction applied would vary depending on factors such as the severity of the violation, whether the violation was intentional or unintentional, and whether the violation indicated a pattern or practice of improper use or disclosure of protected health information. Sanctions could range from a warning to termination. The NPRM preamble language also stated that covered entities would be required to apply sanctions against business associates that violated the proposed rule.

In the final rule, we retain the requirement for sanctions against members of a covered entity's workforce. We also require a covered entity to have written policies and procedures for the application of appropriate sanctions for violations of this subpart and to document those sanctions. These sanctions do not apply to whistleblower activities that meet the provisions of § 164.502(j) or complaints, investigations, or opposition that meet the provisions of § 164.530(g)(2). We eliminate language regarding business associates from this section. Requirements with respect to business associates are stated in § 164.504.