NRPM: Standards for Privacy of Individually Identifiable Health Information. d. Internal complaint process. (§ 164.518(d))

11/03/1999

In proposed § 164.518(d), we would require covered plans and providers to have some mechanism for receiving complaints from individuals regarding the covered plan’s or provider’s compliance with the requirements of this proposed rule. The covered plan or provider would be required to accept complaints about any aspect of their practices regarding protected health information. We would not require that the entity develop a formal appeals mechanism, nor that “due process” or any similar standard be applied. We would not require that covered entities respond in any particular manner or time frame. We are proposing two basic requirements for the complaint process. First, the covered plan or provider would be required to identify a contact person or office in the notice of information practices for receiving complaints. This person or office could either be responsible for handling the complaints or could put the individual in touch with the appropriate person within the entity to handle the particular complaint. See proposed § 164.512. This person could, but would not have to be, the entity’s privacy official. See proposed §164.518(a)(2). Second, the covered plan or provider would be required to maintain a record of the complaints that are filed and a brief explanation of the resolution, if any.

We considered requiring covered plans and providers to provide a formal internal appeal mechanism, but rejected that option as too costly and burdensome for some entities. We also considered eliminating this requirement entirely, but rejected that option because a complaint process would give covered plans or providers a way to learn about potential problems with privacy policies or practices, or training issues. We also hope that providing an avenue for covered plans or providers to address complaints would lead to increased consumer satisfaction. We believe this approach strikes a reasonable balance between allowing covered plans or providers flexibility and accomplishing the goal of promoting attention to improvement in privacy practices. If an individual and a covered plan or provider are able to resolve the individual’s complaint, there could be no need for the individual to file a complaint with the Secretary under proposed § 164.522(b). However, an individual has the right to file a complaint with the Secretary at any time. An individual could file a complaint with the Secretary before, during, after, or concurrent with filing a complaint with the covered plan or provider or without filing a complaint with the covered plan or provider.

We are considering whether modifications of these complaint procedures for intelligence community agencies could be necessary to address the handling of classified information and solicit comment on the issue.