{"description":"Documents affecting 45 CFR 164","count":43,"total_pages":3,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bcfr%5D%5Bpart%5D=164&conditions%5Bcfr%5D%5Btitle%5D=45&format=json&page=2&search_after_cursor=WzEzNTkwNzIwMDAwMDAsIjIwMTMtMDEwNzMiXQ","results":[{"title":"Tribal Consultation on Proposed Modifications to the HIPAA Privacy Rule","type":"Proposed Rule","abstract":"The U.S. Department of Health and Human Services will conduct a virtual Tribal consultation on the proposed rule \"Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement.\"","document_number":"2026-00561","html_url":"https://www.federalregister.gov/documents/2026/01/14/2026-00561/tribal-consultation-on-proposed-modifications-to-the-hipaa-privacy-rule","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-14/pdf/2026-00561.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-00561.pdf?1768252509","publication_date":"2026-01-14","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"}],"excerpts":"The U.S. Department of Health and Human Services will conduct a virtual Tribal consultation on the proposed rule \"Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement.\""},{"title":"HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information","type":"Proposed Rule","abstract":"The Department of Health and Human Services (HHS or \"Department\") is issuing this notice of proposed rulemaking (NPRM) to solicit comment on its proposal to modify the Security Standards for the Protection of Electronic Protected Health Information (\"Security Rule\") under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The proposed modifications would revise existing standards to better protect the confidentiality, integrity, and availability of electronic protected health information (ePHI). The proposals in this NPRM would increase the cybersecurity for ePHI by revising the Security Rule to address: changes in the environment in which health care is provided; significant increases in breaches and cyberattacks; common deficiencies the Office for Civil Rights has observed in investigations into Security Rule compliance by covered entities and their business associates (collectively, \"regulated entities\"); other cybersecurity guidelines, best practices, methodologies, procedures, and processes; and court decisions that affect enforcement of the Security Rule.","document_number":"2024-30983","html_url":"https://www.federalregister.gov/documents/2025/01/06/2024-30983/hipaa-security-rule-to-strengthen-the-cybersecurity-of-electronic-protected-health-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-06/pdf/2024-30983.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-30983.pdf?1735334119","publication_date":"2025-01-06","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"The Department of Health and Human Services (HHS or \"Department\") is issuing this notice of proposed rulemaking (NPRM) to solicit comment on its proposal to modify the Security Standards for the Protection of Electronic Protected Health Information..."},{"title":"HIPAA Privacy Rule To Support Reproductive Health Care Privacy","type":"Rule","abstract":"The Department of Health and Human Services (HHS or \"Department\") is issuing this final rule to modify the Standards for Privacy of Individually Identifiable Health Information (\"Privacy Rule\") under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The Department is issuing this final rule after careful consideration of all public comments received in response to the notice of proposed rulemaking (NPRM) for the HIPAA Privacy Rule to Support Reproductive Health Care Privacy (\"2023 Privacy Rule NPRM\") and public comments received on proposals to revise provisions of the HIPAA Privacy Rule in the NPRM for the Confidentiality of Substance Use Disorder (SUD) Patient Records (\"2022 Part 2 NPRM\").","document_number":"2024-08503","html_url":"https://www.federalregister.gov/documents/2024/04/26/2024-08503/hipaa-privacy-rule-to-support-reproductive-health-care-privacy","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-26/pdf/2024-08503.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08503.pdf?1713816919","publication_date":"2024-04-26","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"The Department of Health and Human Services (HHS or \"Department\") is issuing this final rule to modify the Standards for Privacy of Individually Identifiable Health Information (\"Privacy Rule\") under the Health Insurance Portability and Accountability..."},{"title":"HIPAA Privacy Rule To Support Reproductive Health Care Privacy","type":"Proposed Rule","abstract":"The Department of Health and Human Services (HHS or \"Department\") is issuing this notice of proposed rulemaking (NPRM) to solicit comment on its proposal to modify the Standards for Privacy of Individually Identifiable Health Information (\"Privacy Rule\") under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The proposal would modify existing standards permitting uses and disclosures of protected health information (PHI) by limiting uses and disclosures of PHI for certain purposes where the use or disclosure of information is about reproductive health care that is lawful under the circumstances in which such health care is provided. The proposal would modify existing standards by prohibiting uses and disclosures of PHI for criminal, civil, or administrative investigations or proceedings against individuals, covered entities or their business associates (collectively, \"regulated entities\"), or other persons for seeking, obtaining, providing, or facilitating reproductive health care that is lawful under the circumstances in which it is provided.","document_number":"2023-07517","html_url":"https://www.federalregister.gov/documents/2023/04/17/2023-07517/hipaa-privacy-rule-to-support-reproductive-health-care-privacy","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-04-17/pdf/2023-07517.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-07517.pdf?1681328717","publication_date":"2023-04-17","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"The Department of Health and Human Services (HHS or \"Department\") is issuing this notice of proposed rulemaking (NPRM) to solicit comment on its proposal to modify the Standards for Privacy of Individually Identifiable Health Information (\"Privacy..."},{"title":"Notice of Expiration of Certain Notifications of Enforcement Discretion Issued in Response to the COVID-19 Nationwide Public Health Emergency","type":"Rule","abstract":"This document is to inform the public that four Notifications of Enforcement Discretion (\"Notifications\") issued by the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) regarding how the Privacy, Security, and Breach Notification Rules (\"HIPAA Rules\") promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act will be applied to certain violations during the COVID-19 nationwide public health emergency (\"COVID-19 PHE\"), will expire upon expiration of the COVID-19 PHE, which is currently scheduled for 11:59 p.m. on May 11, 2023. Accordingly, upon expiration of the COVID-19 PHE, the Notifications will not provide a basis for OCR to exercise enforcement discretion with respect to imposing penalties for violations of the HIPAA Rules. OCR will continue to exercise enforcement discretion consistent with the Notifications for violations of the HIPAA Rules that occurred during the period that each Notification was in effect. In addition, OCR is affording covered health care providers a 90- calendar day transition period to come into compliance with the HIPAA Rules with respect to their provision of telehealth using non-public facing remote communication technologies.","document_number":"2023-07824","html_url":"https://www.federalregister.gov/documents/2023/04/13/2023-07824/notice-of-expiration-of-certain-notifications-of-enforcement-discretion-issued-in-response-to-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-04-13/pdf/2023-07824.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-07824.pdf?1681217135","publication_date":"2023-04-13","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"This document is to inform the public that four Notifications of Enforcement Discretion (\"Notifications\") issued by the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) regarding how the Privacy, Security, and Breach..."},{"title":"Confidentiality of Substance Use Disorder (SUD) Patient Records","type":"Proposed Rule","abstract":"The Department of Health and Human Services (HHS or \"the Department\") is issuing this notice of proposed rulemaking (NPRM) to solicit public comment on its proposal to modify its regulations to implement section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.","document_number":"2022-25784","html_url":"https://www.federalregister.gov/documents/2022/12/02/2022-25784/confidentiality-of-substance-use-disorder-sud-patient-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-12-02/pdf/2022-25784.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-25784.pdf?1669650491","publication_date":"2022-12-02","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"The Department of Health and Human Services (HHS or \"the Department\") is issuing this notice of proposed rulemaking (NPRM) to solicit public comment on its proposal to modify its regulations to implement section 3221 of the Coronavirus Aid, Relief, and..."},{"title":"Considerations for Implementing the Health Information Technology for Economic and Clinical Health (HITECH) Act, as Amended","type":"Proposed Rule","abstract":"The Office for Civil Rights (OCR) at the United States Department of Health and Human Services (HHS or the Department) is issuing this Request for Information (RFI) to solicit public comment on certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act, namely: The consideration of recognized security practices of covered entities and business associates when OCR makes determinations regarding fines, audits, and remedies to resolve potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule; and the distribution to harmed individuals of a percentage of civil money penalties (CMPs) or monetary settlements collected pursuant to the HITECH Act, which requires the Secretary of HHS (Secretary) to establish by regulation, and based upon recommendations from the Government Accountability Office (GAO), a methodology under which an individual who is harmed by an act that constitutes an offense under certain provisions of the HITECH Act or the Social Security Act relating to privacy or security may receive a percentage of any CMP or monetary settlement collected by OCR with respect to such offense.","document_number":"2022-07210","html_url":"https://www.federalregister.gov/documents/2022/04/06/2022-07210/considerations-for-implementing-the-health-information-technology-for-economic-and-clinical-health","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-04-06/pdf/2022-07210.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-07210.pdf?1649162723","publication_date":"2022-04-06","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"The Office for Civil Rights (OCR) at the United States Department of Health and Human Services (HHS or the Department) is issuing this Request for Information (RFI) to solicit public comment on certain provisions of the Health Information Technology..."},{"title":"Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement","type":"Proposed Rule","abstract":"The Department of Health and Human Services (the Department) is extending the comment period for the proposed rule entitled \"Proposed Rulemaking (NPRM) to modify the Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act),\" published in the Federal Register on January 21, 2021. The comment period for the proposed rule, which would end March 22, 2021, is extended to May 6, 2021.","document_number":"2021-05021","html_url":"https://www.federalregister.gov/documents/2021/03/10/2021-05021/modifications-to-the-hipaa-privacy-rule-to-support-and-remove-barriers-to-coordinated-care-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-03-10/pdf/2021-05021.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-05021.pdf?1615297543","publication_date":"2021-03-10","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"The Department of Health and Human Services (the Department) is extending the comment period for the proposed rule entitled \"Proposed Rulemaking (NPRM) to modify the Standards for the Privacy of Individually Identifiable Health Information (Privacy..."},{"title":"Enforcement Discretion Regarding Online or Web-Based Scheduling Applications for the Scheduling of Individual Appointments for COVID-19 Vaccination During the COVID-19 Nationwide Public Health Emergency","type":"Rule","abstract":"This Notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy, Security, and Breach Notification Rules promulgated under the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health (HITECH) Act (\"HIPAA Rules\"). As a matter of enforcement discretion, the HHS Office for Civil Rights (OCR) will not impose penalties for noncompliance with regulatory requirements under the HIPAA Rules against covered health care providers or their business associates in connection with the good faith use of online or web-based scheduling applications for the scheduling of individual appointments for COVID-19 vaccinations during the COVID-19 nationwide public health emergency.","document_number":"2021-03348","html_url":"https://www.federalregister.gov/documents/2021/02/24/2021-03348/enforcement-discretion-regarding-online-or-web-based-scheduling-applications-for-the-scheduling-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-02-24/pdf/2021-03348.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-03348.pdf?1614087919","publication_date":"2021-02-24","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"}],"excerpts":"This Notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy, Security, and Breach Notification Rules promulgated under the Health Insurance Portability and..."},{"title":"Proposed Modifications to the HIPAA Privacy Rule To Support, and Remove Barriers to, Coordinated Care and Individual Engagement","type":"Proposed Rule","abstract":"The United States Department of Health and Human Services (HHS or \"the Department\") is issuing this Notice of Proposed Rulemaking (NPRM) to modify the Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). These modifications address standards that may impede the transition to value-based health care by limiting or discouraging care coordination and case management communications among individuals and covered entities (including hospitals, physicians, and other health care providers, payors, and insurers) or posing other unnecessary burdens. The proposals in this NPRM address these burdens while continuing to protect the privacy and security of individuals' protected health information.","document_number":"2020-27157","html_url":"https://www.federalregister.gov/documents/2021/01/21/2020-27157/proposed-modifications-to-the-hipaa-privacy-rule-to-support-and-remove-barriers-to-coordinated-care","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-01-21/pdf/2020-27157.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-27157.pdf?1611063916","publication_date":"2021-01-21","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"}],"excerpts":"The United States Department of Health and Human Services (HHS or \"the Department\") is issuing this Notice of Proposed Rulemaking (NPRM) to modify the Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule) under the..."},{"title":"Enforcement Discretion Regarding COVID-19 Community-Based Testing Sites (CBTS) During the COVID-19 Nationwide Public Health Emergency","type":"Rule","abstract":"This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy, Security, and Breach Notification Rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). As a matter of enforcement discretion, the HHS Office for Civil Rights (OCR) will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered health care providers or their business associates in connection with the good faith participation in the operation of a COVID-19 Community-Based Testing Site (CBTS) during the COVID-19 nationwide public health emergency.","document_number":"2020-09099","html_url":"https://www.federalregister.gov/documents/2020/05/18/2020-09099/enforcement-discretion-regarding-covid-19-community-based-testing-sites-cbts-during-the-covid-19","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-05-18/pdf/2020-09099.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-09099.pdf?1589546733","publication_date":"2020-05-18","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"}],"excerpts":"This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy, Security, and Breach Notification Rules under the Health Insurance Portability and..."},{"title":"Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency","type":"Rule","abstract":"This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy, Security, and Breach Notification Rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). As a matter of enforcement discretion, the HHS Office for Civil Rights (OCR) will not impose penalties for noncompliance with the regulatory requirements under the HIPAA rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency.","document_number":"2020-08416","html_url":"https://www.federalregister.gov/documents/2020/04/21/2020-08416/notification-of-enforcement-discretion-for-telehealth-remote-communications-during-the-covid-19","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-04-21/pdf/2020-08416.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-08416.pdf?1587386739","publication_date":"2020-04-21","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"}],"excerpts":"This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy, Security, and Breach Notification Rules under the Health Insurance Portability and..."},{"title":"Enforcement Discretion Under HIPAA To Allow Uses and Disclosures of Protected Health Information by Business Associates for Public Health and Health Oversight Activities in Response to COVID-19","type":"Rule","abstract":"This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Current regulations allow a HIPAA business associate to use and disclose protected health information for public health and health oversight purposes only if expressly permitted by its business associate agreement with a HIPAA covered entity. As a matter of enforcement discretion, effective immediately, the HHS Office for Civil Rights (OCR) will exercise its enforcement discretion and will not impose potential penalties for violations of certain provisions of the HIPAA Privacy Rule against covered health care providers or their business associates for uses and disclosures of protected health information by business associates for public health and health oversight activities during the COVID-19 nationwide public health emergency.","document_number":"2020-07268","html_url":"https://www.federalregister.gov/documents/2020/04/07/2020-07268/enforcement-discretion-under-hipaa-to-allow-uses-and-disclosures-of-protected-health-information-by","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-04-07/pdf/2020-07268.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-07268.pdf?1585858534","publication_date":"2020-04-07","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"}],"excerpts":"This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Current..."},{"title":"Request for Information on Modifying HIPAA Rules To Improve Coordinated Care","type":"Proposed Rule","abstract":"The Office for Civil Rights (OCR) is issuing this Request for Information (RFI) to assist OCR in identifying provisions of the Health Insurance Portability and Accountability Act privacy and security regulations that may impede the transformation to value-based health care or that limit or discourage coordinated care among individuals and covered entities (including hospitals, physicians, and other providers, payors, and insurers), without meaningfully contributing to the protection of the privacy or security of individuals' protected health information. This RFI requests information on whether and how the rules could be revised to promote these goals, while preserving and protecting the privacy and security of such information and individuals' rights with respect to it.","document_number":"2018-27162","html_url":"https://www.federalregister.gov/documents/2018/12/14/2018-27162/request-for-information-on-modifying-hipaa-rules-to-improve-coordinated-care","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-12-14/pdf/2018-27162.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-27162.pdf?1544631319","publication_date":"2018-12-14","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"}],"excerpts":"The Office for Civil Rights (OCR) is issuing this Request for Information (RFI) to assist OCR in identifying provisions of the Health Insurance Portability and Accountability Act privacy and security regulations that may impede the transformation to..."},{"title":"Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the National Instant Criminal Background Check System (NICS)","type":"Rule","abstract":"The Department of Health and Human Services (HHS or \"the Department\") is issuing this final rule to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to expressly permit certain HIPAA covered entities to disclose to the National Instant Criminal Background Check System (NICS) the identities of individuals who are subject to a Federal \"mental health prohibitor\" that disqualifies them from shipping, transporting, possessing, or receiving a firearm. The NICS is a national system maintained by the Federal Bureau of Investigation (FBI) to conduct background checks on persons who may be disqualified from receiving firearms based on Federally prohibited categories or State law. Among the persons subject to the Federal mental health prohibitor established under the Gun Control Act of 1968 and implementing regulations issued by the Department of Justice (DOJ) are individuals who have been involuntarily committed to a mental institution; found incompetent to stand trial or not guilty by reason of insanity; or otherwise have been determined by a court, board, commission, or other lawful authority to be a danger to themselves or others or to lack the mental capacity to contract or manage their own affairs, as a result of marked subnormal intelligence or mental illness, incompetency, condition, or disease. Under this final rule, only covered entities with lawful authority to make the adjudications or commitment decisions that make individuals subject to the Federal mental health prohibitor, or that serve as repositories of information for NICS reporting purposes, are permitted to disclose the information needed for these purposes. The disclosure is restricted to limited demographic and certain other information needed for NICS purposes. The rule specifically prohibits the disclosure of diagnostic or clinical information, from medical records or other sources, and any mental health information beyond the indication that the individual is subject to the Federal mental health prohibitor.","document_number":"2015-33181","html_url":"https://www.federalregister.gov/documents/2016/01/06/2015-33181/health-insurance-portability-and-accountability-act-hipaa-privacy-rule-and-the-national-instant","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-01-06/pdf/2015-33181.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-33181.pdf?1451942122","publication_date":"2016-01-06","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"The Department of Health and Human Services (HHS or \"the Department\") is issuing this final rule to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to expressly permit certain HIPAA covered entities to..."},{"title":"CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports","type":"Rule","abstract":"This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon the request of a patient (or the patient's personal representative), laboratories subject to CLIA may provide the patient, the patient's personal representative, or a person designated by the patient, as applicable, with copies of completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. Subject to conforming amendments, the final rule retains the existing provisions that require release of test reports only to authorized persons and, if applicable, to the persons responsible for using the test reports and to the laboratory that initially requested the test. In addition, this final rule amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals (or their personal representatives) with the right to access test reports directly from laboratories subject to HIPAA (and to direct that copies of those test reports be transmitted to persons or entities designated by the individual) by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information. These changes to the CLIA regulations and the HIPAA Privacy Rule provide individuals with a greater ability to access their health information, empowering them to take a more active role in managing their health and health care.","document_number":"2014-02280","html_url":"https://www.federalregister.gov/documents/2014/02/06/2014-02280/clia-program-and-hipaa-privacy-rule-patients-access-to-test-reports","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-02-06/pdf/2014-02280.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-02280.pdf?1391444529","publication_date":"2014-02-06","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"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon the request of a patient (or the patient's personal representative), laboratories subject to CLIA may provide the patient, the..."},{"title":"Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the National Instant Criminal Background Check System (NICS)","type":"Proposed Rule","abstract":"The Department of Health and Human Services (HHS or \"the Department\") is issuing this notice of proposed rulemaking to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to expressly permit certain HIPAA covered entities to disclose to the National Instant Criminal Background Check System (NICS) the identities of individuals who are subject to a Federal \"mental health prohibitor\" that disqualifies them from shipping, transporting, possessing, or receiving a firearm. The NICS is a national system maintained by the Federal Bureau of Investigation (FBI) to conduct background checks on persons who may be disqualified from receiving firearms based on federally prohibited categories or State law. Among the persons subject to the Federal mental health prohibitor are individuals who have been involuntarily committed to a mental institution; found incompetent to stand trial or not guilty by reason of insanity; or otherwise have been determined by a court, board, commission, or other lawful authority to be a danger to themselves or others or to lack the mental capacity to contract or manage their own affairs, as a result of marked subnormal intelligence or mental illness, incompetency, condition, or disease. Under this proposal, only covered entities with lawful authority to make adjudication or commitment decisions that make individuals subject to the Federal mental health prohibitor, or that serve as repositories of information for NICS reporting purposes, would be permitted to disclose the information needed for these purposes. This disclosure would be restricted to limited demographic and certain other information and would not include medical records, or any mental health information beyond the indication that the individual is subject to the Federal mental health prohibitor. HHS notes that the Department of Justice (DOJ) has proposed clarifications to the regulatory definitions relevant to the Federal mental health prohibitor. The DOJ proposal is published elsewhere in this issue of the Federal Register. While commenters should consider this proposed regulation in light of the clarifications proposed in DOJ's proposal, we note that those clarifications would not change how this proposed HIPAA permission would operate.","document_number":"2014-00055","html_url":"https://www.federalregister.gov/documents/2014/01/07/2014-00055/health-insurance-portability-and-accountability-act-hipaa-privacy-rule-and-the-national-instant","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-01-07/pdf/2014-00055.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-00055.pdf?1388783833","publication_date":"2014-01-07","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"The Department of Health and Human Services (HHS or \"the Department\") is issuing this notice of proposed rulemaking to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to expressly permit certain HIPAA covered..."},{"title":"Technical Corrections to the HIPAA Privacy, Security, and Enforcement Rules","type":"Rule","abstract":"These technical corrections address certain inadvertent errors and omissions in the HIPAA Privacy, Security, and Enforcement Rules that are located at 45 CFR parts 160 and 164.","document_number":"2013-13472","html_url":"https://www.federalregister.gov/documents/2013/06/07/2013-13472/technical-corrections-to-the-hipaa-privacy-security-and-enforcement-rules","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-06-07/pdf/2013-13472.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-13472.pdf?1370523019","publication_date":"2013-06-07","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"These technical corrections address certain inadvertent errors and omissions in the HIPAA Privacy, Security, and Enforcement Rules that are located at 45 CFR parts 160 and 164."},{"title":"HIPAA Privacy Rule and the National Instant Criminal Background Check System (NICS)","type":"Proposed Rule","abstract":"On January 16, 2013, President Barack Obama announced a series of Executive Actions to reduce gun violence in the United States, including efforts to improve the Federal government's background check system for the sale or transfer of firearms by licensed dealers, called the National Instant Criminal Background Check System (NICS). Among those persons disqualified from possessing or receiving firearms under Federal law are individuals who have been involuntarily committed to a mental institution; found incompetent to stand trial or not guilty by reason of insanity; or otherwise have been determined, through a formal adjudication process, to have a severe mental condition that results in the individuals presenting a danger to themselves or others or being incapable of managing their own affairs (referred to below as the \"mental health prohibitor\"). Concerns have been raised that, in certain states, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule may be a barrier to States' reporting the identities of individuals subject to the mental health prohibitor to the NICS. The Department of Health and Human Services (HHS or \"the Department\"), which administers the HIPAA regulations, is issuing this Advance Notice of Proposed Rulemaking (ANPRM) to solicit public comments on such barriers to reporting and ways in which these barriers can be addressed. In particular, we are considering creating an express permission in the HIPAA rules for reporting the relevant information to the NICS by those HIPAA covered entities responsible for involuntary commitments or the formal adjudications that would subject individuals to the mental health prohibitor, or that are otherwise designated by the States to report to the NICS. In addition, we are soliciting comments on the best methods to disseminate information on relevant HIPAA policies to State level entities that originate or maintain information that may be reported to NICS. Finally, we are soliciting public input on whether there are ways to mitigate any unintended adverse consequences for individuals seeking needed mental health services that may be caused by creating express regulatory permission to report relevant information to NICS. The Department will use the information it receives to determine how best to address these issues.","document_number":"2013-09602","html_url":"https://www.federalregister.gov/documents/2013/04/23/2013-09602/hipaa-privacy-rule-and-the-national-instant-criminal-background-check-system-nics","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-04-23/pdf/2013-09602.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-09602.pdf?1366402629","publication_date":"2013-04-23","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"On January 16, 2013, President Barack Obama announced a series of Executive Actions to reduce gun violence in the United States, including efforts to improve the Federal government's background check system for the sale or transfer of firearms by..."},{"title":"Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules","type":"Rule","abstract":"The Department of Health and Human Services (HHS or \"the Department\") is issuing this final rule to: Modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Enforcement Rules to implement statutory amendments under the Health Information Technology for Economic and Clinical Health Act (\"the HITECH Act\" or \"the Act\") to strengthen the privacy and security protection for individuals' health information; modify the rule for Breach Notification for Unsecured Protected Health Information (Breach Notification Rule) under the HITECH Act to address public comment received on the interim final rule; modify the HIPAA Privacy Rule to strengthen the privacy protections for genetic information by implementing section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA); and make certain other modifications to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (the HIPAA Rules) to improve their workability and effectiveness and to increase flexibility for and decrease burden on the regulated entities.","document_number":"2013-01073","html_url":"https://www.federalregister.gov/documents/2013/01/25/2013-01073/modifications-to-the-hipaa-privacy-security-enforcement-and-breach-notification-rules-under-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-01-25/pdf/2013-01073.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-01073.pdf?1358457430","publication_date":"2013-01-25","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"},{"raw_name":"Office of the Secretary"}],"excerpts":"The Department of Health and Human Services (HHS or \"the Department\") is issuing this final rule to: Modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Enforcement Rules to implement statutory amendments under..."}]}