Office for Civil Rights

Enforcement of Confidentiality Provisions of the Patient Safety and Quality Improvement Act of 2005

On April 3, 2006, Secretary Leavitt delegated to OCR's Director the authority to enforce the privilege and confidentiality protections of Section 922, Title IX of the Public Health Service Act, as amended by the Patient Safety and Quality Improvement Act of 2005 (the Act). Click here to view the Delegation of Authority. The Act establishes a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and quality issues. To encourage the reporting and analysis of medical errors and health care systems, the Act provides Federal privilege and confidentiality protections for "patient safety work product" -- including patient, provider and reporter identifying information -- that is collected, created or used for patient safety activities and imposes civil money penalties (CMPs) for impermissible disclosures of this information. Although patient safety work product may contain the Health Insurance Portability and Accountability Act of 1996's (HIPAA) Privacy Rule "protected health information," the statute prohibits dual penalties under both the Act and HIPAA.

With this delegation, OCR will be taking a lead role in fulfilling the Department's mandate to improve patient safety and reduce the incidence of events that adversely effect patient safety. The Agency for Healthcare Research and Quality (AHRQ) has been delegated all other authorities under the Act, except for those retained by the Secretary. See AHRQ's overview of the Patient Safety and Quality Improvement Act of 2005.

Working in close coordination with AHRQ, OCR will develop and operate the Act's enforcement program, drawing upon its enforcement experience with the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996. OCR's activities will include:

Administering an enforcement program regarding the Act's privilege and confidentiality protections, (the Enforcement Program), including conducting investigations, taking compliance actions, and making penalty determinations;
Developing, for issuance by the Secretary, regulations regarding such Enforcement Program;
Imposing civil monetary penalties for confidentiality violations;
Interpreting standards for enforcement and for guidance to Patient Safety Organizations and providers; and
Providing technical assistance and public information in the administration of the Enforcement Program.

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Last revised: May 19, 2006

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