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Enforcement of the Confidentiality Provisions of the Patient Safety Act

This is an overview of OCR's enforcement of the Confidentiality Provisions of the Patient Safety Act. The information is for covered entities and other stakeholders.


Issued by: Office for Civil Rights (OCR)

Issue Date: June 30, 1905

Enforcement of the Confidentiality Provisions of the Patient Safety Act

Health care professional looks at X-rayEnforcement of the confidentiality of patient safety work product is crucial to maintaining an environment for providers to discuss and analyze patient safety events, identify causes and improve future outcomes. The enforcement provisions are found at Subpart D of the Patient Safety Rule.

OCR seeks voluntary compliance with the confidentiality provisions by providers, patient safety organizations (PSOs) and responsible persons that hold patient safety work product.  OCR may conduct compliance reviews and investigate complaints alleging that patient safety work product has been disclosed in violation of the confidentiality provisions.  If OCR determines that a violation has occurred, OCR may impose a civil money penalty of up to $11,000 per violation.

OCR provides technical assistance to persons seeking to comply with the confidentiality provisions and public information regarding the administration of the enforcement program.

Learn more about the Patient Safety Rule Penalty Inflation Adjustment. - PDF

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DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.