Page:United States Statutes at Large Volume 119.djvu/446

 119 STAT. 428

PUBLIC LAW 109–41—JULY 29, 2005

‘‘(D) Disclosure by a provider to the Food and Drug Administration with respect to a product or activity regulated by the Food and Drug Administration. ‘‘(E) Voluntary disclosure of patient safety work product by a provider to an accrediting body that accredits that provider. ‘‘(F) Disclosures that the Secretary may determine, by rule or other means, are necessary for business operations and are consistent with the goals of this part. ‘‘(G) Disclosure of patient safety work product to law enforcement authorities relating to the commission of a crime (or to an event reasonably believed to be a crime) if the person making the disclosure believes, reasonably under the circumstances, that the patient safety work product that is disclosed is necessary for criminal law enforcement purposes. ‘‘(H) With respect to a person other than a patient safety organization, the disclosure of patient safety work product that does not include materials that— ‘‘(i) assess the quality of care of an identifiable provider; or ‘‘(ii) describe or pertain to one or more actions or failures to act by an identifiable provider. ‘‘(3) EXCEPTION FROM PRIVILEGE.—Subsection (a) shall not apply to (and shall not be construed to prohibit) voluntary disclosure of nonidentifiable patient safety work product. ‘‘(d) CONTINUED PROTECTION OF INFORMATION AFTER DISCLOSURE.— ‘‘(1) IN GENERAL.—Patient safety work product that is disclosed under subsection (c) shall continue to be privileged and confidential as provided for in subsections (a) and (b), and such disclosure shall not be treated as a waiver of privilege or confidentiality, and the privileged and confidential nature of such work product shall also apply to such work product in the possession or control of a person to whom such work product was disclosed. ‘‘(2) EXCEPTION.—Notwithstanding paragraph (1), and subject to paragraph (3)— ‘‘(A) if patient safety work product is disclosed in a criminal proceeding, the confidentiality protections provided for in subsection (b) shall no longer apply to the work product so disclosed; and ‘‘(B) if patient safety work product is disclosed as provided for in subsection (c)(2)(B) (relating to disclosure of nonidentifiable patient safety work product), the privilege and confidentiality protections provided for in subsections (a) and (b) shall no longer apply to such work product. ‘‘(3) CONSTRUCTION.—Paragraph (2) shall not be construed as terminating or limiting the privilege or confidentiality protections provided for in subsection (a) or (b) with respect to patient safety work product other than the specific patient safety work product disclosed as provided for in subsection (c). ‘‘(4) LIMITATIONS ON ACTIONS.— ‘‘(A) PATIENT SAFETY ORGANIZATIONS.— ‘‘(i) IN GENERAL.—A patient safety organization shall not be compelled to disclose information collected or developed under this part whether or not such

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