NRPM: Standards for Privacy of Individually Identifiable Health Information. § 164.522 Compliance and Enforcement.


An individual who believes that a covered entity is not complying with the requirements of this subpart may file a complaint with the Secretary within 180 days from the date of the alleged non-compliance, unless the time for filing is extended by the Secretary. The complaint would describe in detail the acts or omissions believed to be in violation of the requirements of this subpart.

The burden associated with these requirements is the time and effort necessary for an individual to prepare and submit a written complaint to the Secretary. On an annual basis it is estimated that 10,000 complaints will be filed on an annual basis. We further estimate that it will take an average of 15 minutes per individual to submit a complaint. Therefore, the total estimated annual burden associated with this requirement is 2,500 hours.

A covered entity would need to maintain documentation necessary for the Secretary to ascertain whether the covered entity has complied or is complying with the requirements of this subpart. While this section is subject to the PRA, the burden associated with this requirement is addressed under sections referenced above, which discuss specific record keeping requirements.

We have submitted a copy of this proposed rule to OMB for its review of the information collection requirements in §§160.204, 164.506, 164.508, 164.510, 164.512, 164.514, 164.515, 164.516, 164.520, and §164.522. These requirements are not effective until they have been approved by OMB.

If you comment on any of these information collection and record keeping requirements, please mail copies directly to the following:

Health Care Financing Administration,
Office of Information Services,
Information Technology Investment Management Group,
Division of HCFA Enterprise Standards,
Room C2-26-17, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
ATTN: John Burke HIPAA Privacy-P

Office of Information and Regulatory Affairs,
Office of Management and Budget
Room 10235, New Executive Office Building
Washington, DC 20503
ATTN: Allison Herron Eydt, HCFA Desk Officer.