HHS has proposed a new Part 3 to Title 42 of the Code of Federal Regulations to implement the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) (PubLNo. 109-41). The proposed regulations establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for analysis of patient safety events.
The proposed regulations also outline the requirements that entities must meet to become PSOs and the processes for the Secretary to review and accept certifications and list PSOs. In addition, the proposed regulation establishes confidentiality protections for the information that is assembled and developed by providers and PSOs, termed "patient safety work product" by the Patient Safety Act, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.
Under the proposal, a variety of organizations—public, private, for-profit, and not-for-profit—can become PSOs and offer their consultative expertise to providers regarding patient safety events and quality improvement initiatives. To encourage providers to undertake patient safety activities, the regulation specifies that patient safety work product is subject to confidentiality and privilege protections, and persons who breach the confidentiality provisions may be subject to a $10,000 civil money penalty to be enforced by the Office for Civil Rights.
The opportunity for a provider to report identifiable patient safety work product to a PSO does not relieve a HIPAA-covered entity of its obligations under the HIPAA Privacy Rule. In fact, the Patient Safety Act indicates that PSOs are deemed to be business associates of providers that are HIPAA covered entities.
Source: Proposed rule, 73 FR 8111, Feb. 12, 2008.
For more information on this and related topics, consult the CCH® Medicare and Medicaid Guide.
Visit our News Library to read more news stories.
