Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Basis for Violation Findings and Enforcement


Comment: A number of commenters asked that covered entities not be liable for violations of the rule if they have acted in good faith. One commenter indicated that enforcement actions should not be pursued against covered entities that make legitimate business decisions about how to comply with the privacy standards.

Response: The commenters seemed to argue that even if a covered entity does not comply with a requirement of the rule, the covered entity should not be liable if there was an honest and sincere intention or attempt to fulfill its obligations. The final rule, however, does not take this approach but instead draws careful distinctions between what a covered entity must do unconditionally, and what a covered entity must make certain reasonable efforts to do. In addition, the final rule is clear as to the specific provisions where "good faith" is a consideration. For example, a covered entity is permitted to use and disclose protected health information without authorization based on criteria that includes a good faith belief that such use or disclosure is necessary to avert an imminent threat to health or safety (§ 164.512(j)(1)(i)). Therefore, covered entities need to pay careful attention to the specific language in each requirement. However, we note that many of these provisions can be implemented in a variety of ways; e.g, covered entities can exercise business judgement regarding how to conduct staff training.

As to enforcement, a covered entity will not necessarily suffer a penalty solely because an act or omission violates the rule. As we discuss elsewhere, the Department will exercise discretion to consider not only the harm done, but the willingness of the covered entity to achieve voluntary compliance. Further, the Administrative Simplification provisions of HIPAA provide that whether a violation was known or not is relevant in determining whether civil or criminal penalties apply. In addition, if a civil penalty applies, HIPAA allows the Secretary, where the failure to comply was due to reasonable cause and not to willful neglect, to delay the imposition of the penalty to allow the covered entity to comply. The Department will develop and release for public comment an enforcement regulation applicable to all the administrative simplification regulations that will address these issues.

Comment: One commenter asked whether hospitals will be vicariously liable for the violations of their employees and expressed concern that hospitals and other providers will be the ones paying large fines.

Response: The enforcement regulation will address this issue. However, we note that section 1128A(1) of the Social Security Act, which applies to the imposition of civil monetary penalties under HIPAA, provides that a principal is liable for penalties for the actions of its agent acting within the scope of the agency. Therefore, a covered entity will generally be responsible for the actions of its employees such as where the employee discloses protected health information in violation of the regulation.

Comment: A commenter expressed the concern that if a covered entity acquires a non-compliant health plan, it would be liable for financial penalties. This commenter suggested that, at a minimum, the covered entity be given a grace period of at least a year, but not less than six months to bring any acquisition up to standard. The commenter stated that the Secretary should encourage, not discourage, compliant companies to acquire non-compliant ones. Another commenter expressed a general concern about resolution of enforcement if an entity faced with a HIPAA complaint acquires or merges with an entity not covered by HIPAA.

Response: As discussed above, the Secretary will encourage voluntary efforts to cure violations of the rule, and will consider that fact in determining whether to bring a compliance action. We do not agree, however, that we should limit our authority to pursue violations of the rule if the situation warrants it.

Comment: One commenter was concerned about the "undue risk" of liability on originators of information, stemming from the fact that "the number of covered entities is limited and they are unable to restrict how a recipient of information may use or re-disclose information..."

Response: Under this rule, we do not hold covered entities responsible for the actions of recipients of protected health information, unless the recipient is a business associate of the covered entity. We agree that it is not fair to hold covered entities responsible for the actions of persons with whom they have no on-going relationship, but believe it is fair to expect covered entities to hold their business associates to appropriate standards of behavior with respect to health information.