HHS Agency Roles

What role will OCR have regarding the Patient Safety Rule?

OCR is responsible for the investigation and enforcement of the confidentiality provisions of the Patient Safety Rule. OCR will investigate allegations of violations of confidentiality through a complaint-driven system. To the extent practicable, OCR will seek cooperation in obtaining compliance with the confidentiality provisions, including providing technical assistance.

How does AHRQ ensure that a listed PSO is in compliance with the statutory requirements as outlined in the Patient Safety Rule?

The Patient Safety Rule establishes in Subpart B the requirements that an entity must meet to seek listing, and remain listed, as a PSO. The Patient Safety Rule relies primarily upon a system of attestations, which places a significant burden for understanding and complying with these requirements on the PSO. However, the Patient Safety Rule also authorizes AHRQ to conduct reviews (including announced or unannounced site visits) to assess PSO compliance.

Which agencies within the Department of Health and Human Services (HHS) implement the Patient Safety Act?

AHRQ is responsible for the provisions dealing with the listing of PSOs such as administering the certification processes for listing; verifying that PSOs meet their obligations under the Patient Safety Rule; working with PSOs to correct any deficiencies in their operations; and, if necessary, revoking the listing of a PSO that remains out of compliance with the requirements. The Office for Civil Rights (OCR) administers and enforces the confidentiality protections provided to PSWP.