§3.206. Confidentiality of patient safety work product. — Inbound Citations

(2) A written agreement (such as a memorandum of understanding or equivalent recording of mutual commitments) between a Federal, State, local, or Tribal provider and a Federal, State, local, or Tribal PSO that is executed in good faith by officials authorized to execute such agreement.

Complainant means a person who files a complaint with the Secretary pursuant to § 3.306.

Component organization means an entity that:

(a) Subject to paragraphs (b) through (e) of this section, and §§ 3.208 and 3.210 of this subpart, patient safety work product shall be confidential and shall not be disclosed.

(1) Disclosure of relevant patient safety work product for use in a criminal proceeding, subject to the conditions at § 3.206(b)(1) of this subpart.

(1) Patient safety work product disclosed for use in a criminal proceeding pursuant to section 922(c)(1)(A) of the Public Health Service Act, 42 U.S.C. 299b-22(c)(1)(A), and/or pursuant to § 3.206(b)(1) of this subpart continues to be privileged, but is no longer confidential.

(2) Disclosure to the extent required to permit equitable relief subject to the conditions at § 3.206(b)(2) of this subpart.

(3) Disclosure pursuant to provider authorizations subject to the conditions at § 3.206(b)(3) of this subpart.

(B) The identifiers at § 3.206(b)(4)(iv)(A) are removed.

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(4) Disclosure of non-identifiable patient safety work product subject to the conditions at § 3.206(b)(5) of this subpart.

(A) The direct identifiers listed at § 3.206(b)(4)(iv)(A)(1) through (13) of this subpart;

(a) Subject to paragraphs (b) through (e) of this section, and §§ 3.208 and 3.210 of this subpart, patient safety work product shall be confidential and shall not be disclosed.

The Secretary may request information or conduct announced or unannounced reviews of, or site visits to, PSOs, to assess or verify PSO compliance with the requirements of this subpart and for these purposes will be allowed to inspect the physical or virtual sites maintained or controlled by the PSO. The Secretary will be allowed to inspect and/or be given or sent copies of any PSO records deemed necessary and requested by the Secretary to implement the provisions of this subpart. Such PSO records may include patient safety work product in accordance with § 3.206(d) of this part.

(a) Subject to paragraphs (b) through (e) of this section, and §§ 3.208 and 3.210 of this subpart, patient safety work product shall be confidential and shall not be disclosed.

(1) Identifiable patient safety work product obtained by the Secretary in connection with an investigation or compliance review under this subpart will not be disclosed by the Secretary, except in accordance with § 3.206(d) of this subpart, or if otherwise permitted by this part or the Patient Safety Act.

(a) Subject to paragraphs (b) through (e) of this section, and §§ 3.208 and 3.210 of this subpart, patient safety work product shall be confidential and shall not be disclosed.