{"abstract":"The Secretary of Health and Human Services is adopting rules to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005, Pub. L. 109-41, 42 U.S.C. 299b-21--b-26 (Patient Safety Act). The final rule establishes 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 the aggregation and analysis of patient safety events. The final rule outlines the requirements that entities must meet to become PSOs and the processes by which the Secretary will review and accept certifications and list PSOs. It also describes the privilege and confidentiality protections for the information that is assembled and developed by providers and PSOs, the exceptions to these privilege and confidentiality protections, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2008/11/21/E8-27475.html","cfr_references":[{"chapter":null,"citation_url":null,"part":3,"title":42}],"citation":"73 FR 70732","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The final rule is effective on January 19, 2009.","disposition_notes":null,"docket_ids":[],"dockets":[],"document_number":"E8-27475","effective_on":"2009-01-19","end_page":70814,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2008/11/21/E8-27475.xml","html_url":"https://www.federalregister.gov/documents/2008/11/21/E8-27475/patient-safety-and-quality-improvement","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E8-27475?publication_date=2008-11-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2008-11-21/E8-27475/mods.xml","not_received_for_publication":null,"page_length":83,"page_views":{"count":1708,"last_updated":"2026-07-27 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2008-11-21/pdf/E8-27475.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2008-11-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2008/11/21/E8-27475.txt","regulation_id_number_info":{"0919-AA01":{"issue":"200810","html_url":"https://www.federalregister.gov/regulations/0919-AA01/patient-safety-and-quality-improvement-act-of-2005-rules","title":"Patient Safety and Quality Improvement Act of 2005 Rules","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200810&RIN=0919-AA01&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0919-AA01"],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"HHS","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=HHS-OS-2022-0008","supporting_documents_count":0,"docket_id":"HHS-OS-2022-0008","document_id":"HHS-OS-2022-0008-0008","regulation_id_number":null,"title":"HHS 2022 Archive","checked_regulationsdotgov_at":"2022-05-28T03:30:05Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":70732,"subtype":null,"title":"Patient Safety and Quality Improvement","toc_doc":"Patient Safety and Quality Improvement","toc_subject":null,"topics":["Administrative practice and procedure","Courts","Freedom of information","Health","Health care","Health facilities","Health insurance","Health professions","Health records","Hospitals","Investigations","Law enforcement","Medical research","Privacy","Public health","Reporting and recordkeeping requirements","Safety","State and local governments","Technical assistance"],"type":"Rule","volume":73}