Code of federal regulations title 45 parts 160 and 164

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The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and code of federal regulations title 45 parts 160 and 164 of the Federal Government produced by the Office of the Federal Register (OFR) and aprts Government Publishing Office. View past updates to the e-CFR.Click here to learn more.e-CFR data is current as of September 15, 2016Title 45 > Subtitle A > Subchapter C > Part 164TITLE 45�Public WelfareSubtitle A�DEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER C�ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTSPART 164�SECURITY AND PRIVACYSubpart A�GENERAL PROVISIONS �164.102Statutory basis.�164.103Definitions.�164.104Applicability.�164.105Organizational requirements.�164.106Relationship to other parts.Subpart B�[RESERVED]Subpart C�SECURITY STANDARDS FOR THE PROTECTION OF Og PROTECTED HEALTH INFORMATION �164.302Applicability.�164.304Definitions.�164.306Security standards: General rules.�164.308Administrative safeguards.�164.310Physical safeguards.�164.312Technical safeguards.�164.314Organizational requirements.�164.316Policies and procedures and documentation requirements.�164.318Compliance dates for the initial implementation of the security standards.AppendixAppendix A to Subpart C of Cdoe 164�Security Standards: MatrixSubpart D�NOTIFICATION IN THE CASE OF BREACH OF UNSECURED PROTECTED HEALTH INFORMATION �164.400Applicability.�164.402Definitions.�164.404Notification to individuals.�164.406Notification to the media.�164.408Notification to the Secretary.�164.410Notification by a business associate.�164.412Law enforcement delay.�164.414Administrative requirements and burden of proof.Subpart E�PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION �164.500Applicability.�164.501Definitions.�164.502Uses and disclosures of protected health information: General rules.�164.504Uses and disclosures: Organizational requirements.�164.506Uses and disclosures to carry out treatment, payment, or health care operations.�164.508Uses and disclosures for which an authorization is required.�164.510Uses and disclosures requiring an opportunity for the individual to agree or to object.�164.512Uses and disclosures for which an authorization or opportunity to agree or object is not required.�164.514Other requirements relating to uses and disclosures of protected health information.�164.520Notice of privacy practices for protected health information.�164.522Rights to request privacy protection for protected health information.�164.524Access of individuals to protected health information.�164.526Amendment of protected health information.�164.528Accounting of disclosures of protected health information.�164.530Administrative requirements.�164.532Transition provisions.�164.534Compliance dates for initial implementation of the privacy standards.Need assistance? � About LII� Who We Are� What We Do� Who Pays For This� Contact Us� Get the law� Constitution� Supreme Court� U.S.

Code� CFR� Federal Rules� Federal Rules of Appellate Procedure� Federal Rules of Civil Procedure� Federal Rules of Criminal Procedure� Federal Rules of Evidence� Federal Rules of Bankruptcy Procedure� U.C.C.� Law by jurisdiction� State oc Uniform laws� Federal law� World law� Lawyer directory� Legal encyclopedia� Business law� Constitutional law� Criminal law� Family law� Employment law� Money and Finances� More.� Help out� Give� Sponsor� Advertise� Create� Promote� Join Lawyer Directory� � SUBPART A � General Provisions (�� 160.101 - 160.105)� SUBPART B � Preemption of State Law (�� 160.201 - 160.205)� SUBPART C � Compliance and Investigations (�� 160.300 - 160.316)� SUBPART D � Imposition of Civil Money Penalties (�� 160.400 - 160.426)� SUBPART E � Procedures for Hearings (�� 160.500 - 160.552) 42 U.S.C.

1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, Pub. 104-191, 110 Stat. 2033-2034 ( 42 U.S.C. 1320d-2 (note)); 5 U.S.C. 552; secs. 13400-13424, Pub. 111-5, 123 Stat. 258-279; and sec. 1104 ofPub. 111-148, 124 Stat. 146-154. This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, titlw provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly.

More limitations on accuracy are described at the GPO site.United States Code � About LII� Who We Are� What We Do� Who Pays For This� Federak Us� Get the law� Constitution� Supreme Court� U.S.

Code� CFR� Federal Rules� Federal Rules of Appellate Procedure� Federal Rules of Civil Procedure� Rgulations Rules of Criminal Procedure� Federal Rules of Evidence� Federal Rules of Bankruptcy Procedure� U.C.C.� Law by jurisdiction� State law� Uniform laws� Federal law� World law� Lawyer directory� Legal encyclopedia� Business law� Constitutional law� Criminal law� Family law� Employment law� Money and Finances� More.� Help out� Give� Sponsor� Advertise� Create� Promote� Join Lawyer Directory� � � 164.500 � Applicability.� � 164.501 � Definitions.� � 164.502 � Uses and disclosures of protected health information: General rules.� � 164.504 � Uses and disclosures: Organizational requirements.� � 164.506 � Uses and disclosures to carry out treatment, payment, or health care operations.� � 164.508 � Uses and disclosures for which an authorization is required.� � 164.510 � Uses and disclosures requiring an opportunity for the individual to agree or to object.� � 164.512 � Uses and disclosures for which an authorization or opportunity federwl agree or object is not required.� � 164.514 � Other requirements relating to uses and disclosures xode protected health information.� � 164.520 � Notice of privacy practices for protected health information.� � 164.522 � Rights to request privacy protection for protected health information.� � 164.524 � Access of individuals to protected health information.� � 164.526 � Amendment of protected health information.� � 164.528 � Accounting of disclosures of protected health information.� � 164.530 � Administrative requirements.� � 164.532 larts Transition provisions.� � 164.534 � Compliance tile for initial implementation of the privacy standards. � About LII� Who We Are� What We Do� Who Pays For This� Contact Us� Get the law� Constitution� Supreme Court� U.S.

Code� CFR� Federal Rules� Federal Rules of Appellate Procedure� Federal Rules of Civil Procedure� Federal Rules of Criminal Procedure� Federal Dederal of Evidence� Federal Rules of Bankruptcy Procedure� U.C.C.� Law by jurisdiction� State law� Uniform laws� Federal law� World law� Lawyer directory� Legal encyclopedia� Business law� Constitutional law� Criminal law� Family law� Employment law� Money and Finances� More.� Help out� Give� Sponsor� Advertise� Create� Promote� Join Lawyer Directory� � SUBPART A � General Provisions (�� 164.102 - 164.106)� SUBPART B � [Reserved]� SUBPART C � Security Standards for the Protection of Electronic Protected Ccode Information (�� 164.302 - 164.318)� SUBPART D � Notification in the Case of Breach of Unsecured Protected Health Information (�� 164.400 - 164.414)� SUBPART E � Privacy of Individually Identifiable Health Information (�� 164.500 - 164.534) � About LII� Who We Are� What We Do� Who Pays For This� Contact Us� Get the law� Constitution� Supreme Court� U.S.

Code� CFR� Federal Rules� Federal Rules of Appellate Procedure� Federal Rules of Civil Procedure� Federal Rules of Criminal Procedure� 146 Rules of Evidence� Federal Rules of Bankruptcy Procedure� U.C.C.� Law by jurisdiction� State law� Uniform laws� Federal law� World law� Lawyer directory� Legal encyclopedia� Business law� Constitutional law� Criminal law� Family law� Employment law� Money and Finances� More.� Help out� Give� Sponsor� Advertise� Create� Promote� Join Lawyer Fedefal 403.812 HIPAA privacy, security, administrative data standards, and national identifiers.(a) HIPAA covered entities.

An endorsed sponsor is a HIPAA feseral entity and must comply with the standards, implementation specifications, and rrgulations in 45 CFR parts 160, 162, and 164 as set forth in this section.

Those functions reyulations an endorsed sponsor the performance of which are necessary or directly related to the operations of the endorsed discount card program are covered functions for titlw of applying to endorsed sponsors the standards, regulatkons specifications, and requirements in 45 CFR parts 160, 162, and 164.(b) HIPAA privacy requirements.

An endorsed sponsor must comply with the standards, implementation specifications, and requirements in the Standards for Privacy of Individually Fexeral Health Information, 45 CFR coode 160 and 164, subparts A and E, in the same manner as a health plan, except to the extent such requirements are temporarily waived by the 10 Security requirements znd Standard. An endorsed sponsor must comply with the applicable standards, regulafions specifications, and requirements in the HIPAA Security Rule, 45 CFR parts 160 and 164, subparts A and C, in the same manner as other covered entities as of the compliance date of such Rule.(2) Attestation.

An applicant in its application shall -(i) Attest that, as of the initial enrollment date, it will have in place appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information fedral accordance with 45 CFR 164.530(c); and(ii) Attest that its information security measures will meet the standards, implementation specifications, and requirements of 45 CFR part 164 subparts A ttle C as of the initial enrollment date, or, if unable to make this attestation, provide a plan for coming into compliance with these requirements by the compliance date of the Security Rule set forth in 45 CFR part 164, subpart C.(d) Administrative data standards.

An endorsed sponsor must comply with any applicable standards, implementation specifications, and requirements in the Standards for Electronic Transactions under 45 CFR parts 160 and 162 subparts I through R.(e) Unique identifiers.

An endorsed sponsor must comply with any applicable titke, implementation specifications, and requirements regarding standard unique identifiers under 45 CFR parts 160 and 162 as of the compliance date of any final rule for standard unique identifiers.(f) Applicability of other regulations. Nothing in this paragraph or in � 403.813 shall be deemed a modification of parts 160, 162 and 164 of title 45, Code of Federal Regulations or otherwise modify the applicability of such regulations to other organizations or covered entities independently subject to the mandates of HIPAA.

If an endorsed sponsor is also a health plan, health care provider, or health care clearinghouse, nothing is this paragraph shall impair or otherwise affect the application of HIPAA or parts 160, 162 and 164 of title 45, Code of Federal Regulations to ittle entity and its performance of those functions which make such entity a health plan, health care provider, or health care clearinghouse. This is a list 4 United Parys Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly.

More limitations on accuracy are described at the GPO site.United States Code HIPAA For Professionals Menu� HIPAA for Professionals� Privacy plus� Summary of the Privacy Rule� Guidance� Combined Text of All Rules� Security plus� Summary of the Security Rule� Guidance� Combined Text of All Federxl Breach Notification plus� Breach Reporting� Guidance� Reports 1600 Congress� Regulation History� Compliance & Enforcement plus� Enforcement Rule� Enforcement Process� Enforcement Data� Resolution Agreements� Case Examples� Audit� Reports to Congress� State Attorneys General� Special Topics plus� De-Identification Methods� Research� Public Health� Emergency Response� Health Information Technology� Genetic Information (GINA)� HIV and HIPAA� National Instant Criminal Background Check System (NICS)� Clinical Laboratory Improvement Amendments of 1988 (CLIA)� Defense of Marriage Act (DOMA)� Developer Portal� HIPAA Related Links� Patient Safety plus� Statute & Rule� PSQIA Statute� Patient Safety Frderal Enforcement� Guidance� Covered Entities & Business Associates plus� Business Associates� Business Fode Contracts� Training & Resources� FAQs for Professionals� Other Administrative Simplification Rules The HIPAA Privacy Rule establishes national standards to protect individuals� medical records and other personal health padts and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically.

The Rule requires appropriate safeguards to protect the privacy of personal health information, and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization.

The Rule also gives patients rights over their health information, including rights to examine and obtain a copy of their health records, and to request corrections.The Privacy Rule is located at 45 CFR Part 160 and Subparts A and E of Part 164.Click here to view the combined regulation text of all HIPAA Administrative Simplification Regulations found at 45 CFR 160, 162, and 164.

Privacy Rule History� August 14, 2002 - Modifications to the HIPAA Privacy Pzrts � Final Rule ( PDF)� March 27, 2002 - Modifications to the HIPAA Privacy Rule 14 Proposed Rule ( PDF)� February 28, 2001 regulattions Request for Comments on Regulationx 28, 2000, Final HIPAA Privacy Rule ( PDF)� February 26, 2001 - Correction of Effective and Compliance Dates of the Final HIPAA Privacy Rule ( PDF)� December 29, 2000 - Technical Corrections to the Final Titlle Privacy Rule ( PDF)� December 28, 2000 - HIPAA Privacy Rule � Final Rule ( PDF)� November 3, 1999 - HIPAA Privacy Rule � Proposed Rule ( PDF)� Learn about the Rulemaking History of the HIPAA Enforcement Rule, 45 CFR Part 160, Subparts C, D, and E.Other Privacy Rule Notices� March 20, 2003 - Notice of Addresses for Submission of HIPAA Health Information Privacy Complaints ( PDF)� March 11, 2003 - Notice of Address for Submission of Requests for Preemption Exception Determinations ( PDF)� December 28, 2000 - Statement of Delegation of Authority to the Office for Civil Rights ( PDF) Frequently Asked Questions for Professionals - Please see the HIPAA FAQs for additional guidance on health information privacy topics.

Content created by Office for Civil Rights (OCR)Content last reviewed on April 16, 2015 Expresso�The Fasted Way to Perform aHIPAA Risk Assessment HIPAA Compliance Plan & Tools*� HIPAA Privacy Rule Checklist� HIPAA Security Rule Checklist� HIPAA Social Media Checklist� Breach Notification Framework� Business Associate Agreement� Guide for Efderal Associates� Expresso Risk Assessment� HIPAA Audit Preparation� and many more tools.� Or rrgulations them all with ourHIPAA Compliance Subscription� *All products updated with the 2013HIPAA Omnibus Rule changes.HSG Home Page HIPAA Survival Guide� Table of Contents� HIPAA Compliance� HIPAA Rules� HIPAA Requirements� HIPAA Privacy Rule� HIPAA Security Rule� HITECH Act Summary� SummaryDownload the PDF for FREE!� Receive a FREE copy of the HIPAA Survival Guide (4th Edition) when you Sign-Up for our Newsletter.�HIPAA Compliance Training� Tiitle Omnibus Rule� HIPAA Breach Notifications� Privacy Rule Training� Security Rule Rederal HITECH Act Training� Business Associate Code of federal regulations title 45 parts 160 and 164 and Regulations� HIPAA Regulations� HIPAA Definition Index� HITECH Act� HITECH Regulations� Meaningful Use Final Rule� HIT StandardsKey Topics� HIPAA Omnibus Rule� HIPAA Checklist� Meaningful Use� Business Associates� HIPAA Compliance Software� Agile ComplianceAdditional Resources� HITECH Resources� Meaningful Use Resources� Regional Extension Centers� Health Information Exchanges� HITECH Effective Dates� Business Associate Agreement� HIPAA Talk RadioCarlos Leyva� Internet Lawyer� About Carlos� Contact Carlos� HITECH Impact� Silicon Stories� LinkedInDeborah Leyva� About Deborah� Healthcare Technology� LinkedInHSG Community� Previous Titlf Facebook� LinkedIn� Advertise on HSG� HIPAA Survival Guide Testimonials� Leave Feedback� Copyright Notice� Terms of Use� Privacy Policy� About PART 164 � SECURITY AND PRIVACYSubpart A � General Provisions� 164.102 Statutory basis� 164.103 DefinitionsCommon Control Common Ownership Covered Functions Health Care Component Hybrid Entity Plan Sponsor Law Enforcement Official Required by Law� 164.104 Applicability� 164.105 Organizational Requirements� 164.106 Relationship to other partsSubpart B � aprts C � Security Partx for the Protection of Electronic Protected Health Information� 164.302 Applicability� 164.304 DefinitionsAccess Administrative Safeguards Authentication Availability Confidentiality Encryption Facility Information System Integrity Malicious Software Password Physical Safeguards Security or Security Measures Security Incident Technical Safeguards User Workstation� 164.306 Security standards: General rules� 164.308 Administrative safeguards(a)(1)(i) Standard: Security management process(ii) Implementation specifications(A) Risk analysis(B) Risk management(C) Sanction policy(D) Information system activity review(2) Standard: Assigned security responsibility(3) (i) Standard: Workforce security(ii) Implementation specifications(A) Authorization and/or supervision(B) Workforce clearance procedure(C) Termination procedures(4) (i) Standard: Information access management(ii) Implementation specifications(A) Isolating regulatins care clearinghouse functions(B) Access authorization(C) Access establishment and modification(5) (i) Standard: Security awareness and training(ii) Implementation specifications(A) Security 1164 Protection from malicious software(C) Log-in monitoring(D) Password management(6) (i) Standard: Security incident procedures(ii) Implementation specification: Response and reporting(7) parrts Standard: Contingency plan(ii) Implementation specifications(A) Data backup plan(B) Disaster recovery plan(C) Emergency mode operation plan(D) Testing and revision procedures(E) Applications and data criticality analysis(8) Standard: Evaluation(b) (1) Business prats contracts and other arrangements(3) Implementation specifications: Written contract or other arrangement� 164.310 Physical safeguards(a) (1) Standard: Facility access controls(2) Implementation specifications:(i) Contingency operations(ii) Facility security plan(iii) Access control and validation procedures(iv) Maintenance records(b) Standard: Workstation use(c) Standard: Workstation security(d) (1) Standard: Device and media controls(2) Implementation specifications(i) Disposal(ii) Media re-use(iii) Accountability(iv) Data backup and storage� 164.312 Technical safeguards(a) (1) Standard: Access control(2) Implementation specifications(i) Unique user identification(ii) Emergency access procedure(iii) Automatic logoff(iv) Encryption and decryption(b) Standard: Audit controls(c) (1) Standard: Integrity(2) Implementation specification: Mechanism to authenticate electronic protected health information(d) Standard: Person or entity authentication(e) (1) Standard: Transmission security(2) Implementation specifications(i) Integrity controls(ii) Encryption� 164.314 Organizational requirements� 164.316 Policies and procedures and documentation requirements� 164.318 Compliance dates for initial implementation of security standardsSubpart D � Notification in the Case oExpresso�The Fasted Way to Perform aHIPAA Risk Assessment HIPAA Compliance Plan & Tools*� HIPAA Privacy Rule Checklist� HIPAA Security Rule Checklist� HIPAA Social Media Checklist� Breach Notification Framework� Business Associate Agreement� Guide for Business Federa Expresso Risk Assessment� HIPAA Audit Preparation� and many more tools.� Or get them all with ourHIPAA Compliance Subscription� *All products updated with the 2013HIPAA Omnibus Rule changes.HSG Psrts Page HIPAA Survival Guide� Table of Contents� HIPAA Compliance� HIPAA Rules� HIPAA Requirements� HIPAA Privacy Rule� HIPAA Security Rule� HITECH Act Fedetal SummaryDownload the PDF for FREE!� Receive a FREE copy of the HIPAA Survival Guide (4th Edition) when you Sign-Up for our Codw Compliance Training� HIPAA Omnibus Rule� HIPAA Breach Notifications� Privacy Rule Training� Security Rule Training� HITECH Act Training� Business Associate TrainingLaws and Regulstions HIPAA Regulations� HIPAA Definition Index� HITECH Act� HITECH Regulations� Meaningful Use Final Rule� HIT StandardsKey Topics� HIPAA Omnibus Rule� HIPAA Checklist� Meaningful Use� Business Associates� HIPAA Compliance Software� Agile ComplianceAdditional Resources� HITECH Resources� Meaningful Use Resources� Regional Extension Centers� Health Information Exchanges� HITECH Effective Dates� Business Associate Agreement� HIPAA Talk RadioCarlos Leyva� Internet Lawyer� About Carlos� Contact Carlos� HITECH Impact� Silicon Stories� Code of federal regulations title 45 parts 160 and 164 Leyva� About Deborah� Healthcare Technology� LinkedInHSG Community� Previous Articles� Facebook� LinkedIn� Advertise on HSG� HIPAA Survival Guide Testimonials� Leave Feedback� Copyright Notice� Terms of Use� Privacy Policy� About HIPAA RegulationsAdministrative Simplification Regulation TextU.S Department of Health and Human ServicesOffice for Civil RightsHIPAA Tiyle Simplification Regulation Text45 CFR Parts 160, 162, and 164(Unofficial Version, as amended through February 16, 2006)HIPAA Administrative SimplificationHIPAA Administrative Simplification Regulation TextMarch 2006These regulations include the HIPAA OMNIBUS FINAL RULEreleased by HHS on January 17, 2013 Table of ContentsCFR 45 PART 160 � GENERAL ADMINISTRATIVE REQUIREMENTSCFR 45 PART 162 regulaitons ADMINISTRATIVE REQUIREMENTSCFR 45 PART 164 � SECURITY Fededal PRIVACYQuestions about HIPAA Compliance in this post HITECH/Omnibus Final Rule world?Get up to speed fast with the HIPAA Survival Guide Fourth Edition(Get the HSG 4th Ed.

FREE when you sign up for our newsletter)and our O mnibus R ule R eady? HIPAA Compliance Tools.PART 160 � GENERAL ADMINISTRATIVE REQUIREMENTSSubpart A � General Provisions� 160.101 Statutory basis and parys 160.102 Applicability� 160.103 Definitions� 160.104 Modifications� federwl Compliance dates for implementation of new or modified standards and implementation specificationsSubpart B � Preemption of State Law� 160.201 Statutory basis� 160.202 Definitions� 160.203 General rule and exceptions� 160.204 Process for requesting exception determinations� 160.205 Duration of effectiveness of exception determinationsSubpart C � Compliance and Enforcement� 160.300 Applicability� 160.302 [Removed and Reserved]� 160.304 Principles for achieving compliance� 160.306 Complaints to the Secretary� 160.308 Compliance reviews� 160.310 Responsibilities of covered entities� 160.312 Secretarial action regarding complaints and compliance reviews� 160.314 Investigational subpoenas rehulations inquiries� 160.316 Refraining from intimidation or retaliationSubpart D - Imposition of Civil Money Penalties� 160.400 Applicability� 160.401 Definitions� 160.402 Basis for a civil money penalty� 160.404 Amount of a civil money penalty� 160.406 Violations of an identical requirement or prohibition� 160.408 Factors considered in determining the amount of a civil money penalty� 160.410 Affirmative defenses� 160.412 Waiver� 160.414 Limitations� 160.416 Authority to settle� 160.418 Penalty not exclusive� 160.420 Notice of proposed determination� 160.422 Failure to request a hearing� 160.424 Collection of penalty� 160.426 Notification of the public and other agenciesSubpart E � Procedures for Hearings� 160.500 Applicability� 160.502 Definitions� 160.504 Hearing before an ALJ� 160.506 Rights of the parties� 160.508 Authority of the ALJ� 160.510 Ex parte contacts� 160.512 Prehearing conferences� 160.514 Authority to settle� 160.516 Discovery� 160.518 Exchange of witness lists, witness statements, and exhibits� 160.520 Subpoenas for attendance at hearing� 160.522 Fees� 160.524 Form, filing, and service of papers� andd Computation of time� 160.528 Motions� 160.530 Sanctions� 160.532 Collateral estoppel� 160.534 The hearing� 160.536 Statistical sampling� 160.538 Witnesses� 160.540 Evidence� 160.542 The record� 160.544 Post hearing briefs� 160.546 ALJ's decision� 160.548 Appeal of the ALJ's decision� regulatiins Stay of the Secretary's decision� 160.552 Harmless errorPART 162 � ADMINISTRATIVE REQUIRE