Collapse to view only § 299b-21. Definitions
- § 299b-21. Definitions
- § 299b-22. Privilege and confidentiality protections
- § 299b-23. Network of patient safety databases
- § 299b-24. Patient safety organization certification and listing
- § 299b-24a. Activities regarding women’s health
- § 299b-25. Technical assistance
- § 299b-26. Severability
§ 299b–21. DefinitionsIn this part:
(1) HIPAA confidentiality regulations
(2) Identifiable patient safety work productThe term “identifiable patient safety work product” means patient safety work product that—
(A) is presented in a form and manner that allows the identification of any provider that is a subject of the work product, or any providers that participate in activities that are a subject of the work product;
(B) constitutes individually identifiable health information as that term is defined in the HIPAA confidentiality regulations; or
(C) is presented in a form and manner that allows the identification of an individual who reported information in the manner specified in section 299b–22(e) of this title.
(3) Nonidentifiable patient safety work product
(4) Patient safety organization
(5) Patient safety activitiesThe term “patient safety activities” means the following activities:
(A) Efforts to improve patient safety and the quality of health care delivery.
(B) The collection and analysis of patient safety work product.
(C) The development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices.
(D) The utilization of patient safety work product for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk.
(E) The maintenance of procedures to preserve confidentiality with respect to patient safety work product.
(F) The provision of appropriate security measures with respect to patient safety work product.
(G) The utilization of qualified staff.
(H) Activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system.
(6) Patient safety evaluation system
(7) Patient safety work product
(A) In generalExcept as provided in subparagraph (B), the term “patient safety work product” means any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements—
(i) which—(I) are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization; or(II) are developed by a patient safety organization for the conduct of patient safety activities;
and which could result in improved patient safety, health care quality, or health care outcomes; or
(ii) which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.
(B) Clarification
(i) Information described in subparagraph (A) does not include a patient’s medical record, billing and discharge information, or any other original patient or provider record.
(ii) Information described in subparagraph (A) does not include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system. Such separate information or a copy thereof reported to a patient safety organization shall not by reason of its reporting be considered patient safety work product.
(iii) Nothing in this part shall be construed to limit—(I) the discovery of or admissibility of information described in this subparagraph in a criminal, civil, or administrative proceeding;(II) the reporting of information described in this subparagraph to a Federal, State, or local governmental agency for public health surveillance, investigation, or other public health purposes or health oversight purposes; or(III) a provider’s recordkeeping obligation with respect to information described in this subparagraph under Federal, State, or local law.
(8) ProviderThe term “provider” means—
(A) an individual or entity licensed or otherwise authorized under State law to provide health care services, including—
(i) a hospital, nursing facility, comprehensive outpatient rehabilitation facility, home health agency, hospice program, renal dialysis facility, ambulatory surgical center, pharmacy, physician or health care practitioner’s office, long term care facility, behavior health residential treatment facility, clinical laboratory, or health center; or
(ii) a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, psychologist, certified social worker, registered dietitian or nutrition professional, physical or occupational therapist, pharmacist, or other individual health care practitioner; or
(B) any other individual or entity specified in regulations promulgated by the Secretary.
(July 1, 1944, ch. 373, title IX, § 921, as added Pub. L. 109–41, § 2(a)(5), July 29, 2005, 119 Stat. 424.)
§ 299b–22. Privilege and confidentiality protections
(a) PrivilegeNotwithstanding any other provision of Federal, State, or local law, and subject to subsection (c), patient safety work product shall be privileged and shall not be—
(1) subject to a Federal, State, or local civil, criminal, or administrative subpoena or order, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;
(2) subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative proceeding, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;
(3) subject to disclosure pursuant to section 552 of title 5 (commonly known as the Freedom of Information Act) or any other similar Federal, State, or local law;
(4) admitted as evidence in any Federal, State, or local governmental civil proceeding, criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider; or
(5) admitted in a professional disciplinary proceeding of a professional disciplinary body established or specifically authorized under State law.
(b) Confidentiality of patient safety work product
(c) ExceptionsExcept as provided in subsection (g)(3)—
(1) Exceptions from privilege and confidentialitySubsections (a) and (b) shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:
(A) Disclosure of relevant patient safety work product for use in a criminal proceeding, but only after a court makes an in camera determination that such patient safety work product contains evidence of a criminal act and that such patient safety work product is material to the proceeding and not reasonably available from any other source.
(B) Disclosure of patient safety work product to the extent required to carry out subsection (f)(4)(A).
(C) Disclosure of identifiable patient safety work product if authorized by each provider identified in such work product.
(2) Exceptions from confidentialitySubsection (b) shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:
(A) Disclosure of patient safety work product to carry out patient safety activities.
(B) Disclosure of nonidentifiable patient safety work product.
(C) Disclosure of patient safety work product to grantees, contractors, or other entities carrying out research, evaluation, or demonstration projects authorized, funded, certified, or otherwise sanctioned by rule or other means by the Secretary, for the purpose of conducting research to the extent that disclosure of protected health information would be allowed for such purpose under the HIPAA confidentiality regulations.
(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
(d) Continued protection of information after disclosure
(1) In general
(2) ExceptionNotwithstanding 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
(4) Limitations on actions
(A) Patient safety organizations
(i) In general
(ii) Nonapplication
(B) Providers
(e) Reporter protection
(1) In generalA provider may not take an adverse employment action, as described in paragraph (2), against an individual based upon the fact that the individual in good faith reported information—
(A) to the provider with the intention of having the information reported to a patient safety organization; or
(B) directly to a patient safety organization.
(2) Adverse employment actionFor purposes of this subsection, an “adverse employment action” includes—
(A) loss of employment, the failure to promote an individual, or the failure to provide any other employment-related benefit for which the individual would otherwise be eligible; or
(B) an adverse evaluation or decision made in relation to accreditation, certification, credentialing, or licensing of the individual.
(f) Enforcement
(1) Civil monetary penalty
(2) Procedure
(3) Relation to HIPAA
(4) Equitable relief
(A) In general
(B) Against State employees
(g) Rule of constructionNothing in this section shall be construed—
(1) to limit the application of other Federal, State, or local laws that provide greater privilege or confidentiality protections than the privilege and confidentiality protections provided for in this section;
(2) to limit, alter, or affect the requirements of Federal, State, or local law pertaining to information that is not privileged or confidential under this section;
(3) except as provided in subsection (i), to alter or affect the implementation of any provision of the HIPAA confidentiality regulations or section 1320d–5 of this title (or regulations promulgated under such section);
(4) to limit the authority of any provider, patient safety organization, or other entity to enter into a contract requiring greater confidentiality or delegating authority to make a disclosure or use in accordance with this section;
(5) as preempting or otherwise affecting any State law requiring a provider to report information that is not patient safety work product; or
(6) to limit, alter, or affect any requirement for reporting to the Food and Drug Administration information regarding the safety of a product or activity regulated by the Food and Drug Administration.
(h) Clarification
(i) Clarification of application of HIPAA confidentiality regulations to patient safety organizationsFor purposes of applying the HIPAA confidentiality regulations—
(1) patient safety organizations shall be treated as business associates; and
(2) patient safety activities of such organizations in relation to a provider are deemed to be health care operations (as defined in such regulations) of the provider.
(j) Reports on strategies to improve patient safety
(1) Draft report
(2) Final report
(July 1, 1944, ch. 373, title IX, § 922, as added Pub. L. 109–41, § 2(a)(5), July 29, 2005, 119 Stat. 427.)
§ 299b–23. Network of patient safety databases
(a) In general
(b) Data standards
(c) Use of information
(July 1, 1944, ch. 373, title IX, § 923, as added Pub. L. 109–41, § 2(a)(5), July 29, 2005, 119 Stat. 431.)
§ 299b–24. Patient safety organization certification and listing
(a) Certification
(1) Initial certificationAn entity that seeks to be a patient safety organization shall submit an initial certification to the Secretary that the entity—
(A) has policies and procedures in place to perform each of the patient safety activities described in section 299b–21(5) of this title; and
(B) upon being listed under subsection (d), will comply with the criteria described in subsection (b).
(2) Subsequent certificationsAn entity that is a patient safety organization shall submit every 3 years after the date of its initial listing under subsection (d) a subsequent certification to the Secretary that the entity—
(A) is performing each of the patient safety activities described in section 299b–21(5) of this title; and
(B) is complying with the criteria described in subsection (b).
(b) Criteria
(1) In generalThe following are criteria for the initial and subsequent certification of an entity as a patient safety organization:
(A) The mission and primary activity of the entity are to conduct activities that are to improve patient safety and the quality of health care delivery.
(B) The entity has appropriately qualified staff (whether directly or through contract), including licensed or certified medical professionals.
(C) The entity, within each 24-month period that begins after the date of the initial listing under subsection (d), has bona fide contracts, each of a reasonable period of time, with more than 1 provider for the purpose of receiving and reviewing patient safety work product.
(D) The entity is not, and is not a component of, a health insurance issuer (as defined in section 300gg–91(b)(2) of this title).
(E) The entity shall fully disclose—
(i) any financial, reporting, or contractual relationship between the entity and any provider that contracts with the entity; and
(ii) if applicable, the fact that the entity is not managed, controlled, and operated independently from any provider that contracts with the entity.
(F) To the extent practical and appropriate, the entity collects patient safety work product from providers in a standardized manner that permits valid comparisons of similar cases among similar providers.
(G) The utilization of patient safety work product for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk.
(2) Additional criteria for component organizationsIf an entity that seeks to be a patient safety organization is a component of another organization, the following are additional criteria for the initial and subsequent certification of the entity as a patient safety organization:
(A) The entity maintains patient safety work product separately from the rest of the organization, and establishes appropriate security measures to maintain the confidentiality of the patient safety work product.
(B) The entity does not make an unauthorized disclosure under this part of patient safety work product to the rest of the organization in breach of confidentiality.
(C) The mission of the entity does not create a conflict of interest with the rest of the organization.
(c) Review of certification
(1) In general
(A) Initial certification
(B) Subsequent certification
(2) Notice of acceptance or non-acceptanceIf the Secretary determines that—
(A) an entity’s initial certification meets requirements referred to in paragraph (1)(A), the Secretary shall notify the entity of the acceptance of such certification; or
(B) an entity’s initial certification does not meet such requirements, the Secretary shall notify the entity that such certification is not accepted and the reasons therefor.
(3) Disclosures regarding relationship to providers
(d) Listing
(e) Revocation of acceptance of certification
(1) In general
(2) Supplying confirmation of notification to providers
(3) Publication of decisionIf the Secretary revokes the certification of an organization under paragraph (1), the Secretary shall—
(A) remove the organization from the listing maintained under subsection (d); and
(B) publish notice of the revocation in the Federal Register.
(f) Status of data after removal from listing
(1) New data
(2) Protection to continue to apply
(g) Disposition of work product and dataIf the Secretary removes a patient safety organization from the listing as provided for in subsection (e)(3)(A), with respect to the patient safety work product or data described in subsection (f)(1) that the patient safety organization received from another entity, such former patient safety organization shall—
(1) with the approval of the other entity and a patient safety organization, transfer such work product or data to such patient safety organization;
(2) return such work product or data to the entity that submitted the work product or data; or
(3) if returning such work product or data to such entity is not practicable, destroy such work product or data.
(July 1, 1944, ch. 373, title IX, § 924, as added Pub. L. 109–41, § 2(a)(5), July 29, 2005, 119 Stat. 431.)
§ 299b–24a. Activities regarding women’s health
(a) Establishment
(b) Purpose
The official designated under subsection (a) shall—
(1) report to the Director on the current Agency level of activity regarding women’s health, across, where appropriate, age, biological, and sociocultural contexts, in all aspects of Agency work, including the development of evidence reports and clinical practice protocols and the conduct of research into patient outcomes, delivery of health care services, quality of care, and access to health care;
(2) establish short-range and long-range goals and objectives within the Agency for research important to women’s health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Agency that relate to health services and medical effectiveness research, for issues of particular concern to women;
(3) identify projects in women’s health that should be conducted or supported by the Agency;
(4) consult with health professionals, nongovernmental organizations, consumer organizations, women’s health professionals, and other individuals and groups, as appropriate, on Agency policy with regard to women; and
(5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 237a(b)(4) of this title).
(c) Authorization of appropriations
(July 1, 1944, ch. 373, title IX, § 925, as added Pub. L. 111–148, title III, § 3509(e)(2), Mar. 23, 2010, 124 Stat. 534.)
§ 299b–25. Technical assistance
The Secretary, acting through the Director, may provide technical assistance to patient safety organizations, including convening annual meetings for patient safety organizations to discuss methodology, communication, data collection, or privacy concerns.
(July 1, 1944, ch. 373, title IX, § 926, formerly § 925, as added Pub. L. 109–41, § 2(a)(5), July 29, 2005, 119 Stat. 434; renumbered § 926, Pub. L. 111–148, title III, § 3509(e)(1), Mar. 23, 2010, 124 Stat. 534.)
§ 299b–26. Severability
If any provision of this part is held to be unconstitutional, the remainder of this part shall not be affected.
(July 1, 1944, ch. 373, title IX, § 927, formerly § 926, as added Pub. L. 109–41, § 2(a)(5), July 29, 2005, 119 Stat. 434; renumbered § 927, Pub. L. 111–148, title III, § 3509(e)(1), Mar. 23, 2010, 124 Stat. 534.)