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Title 45
Volume 2 CHAPTER A SUBCHAP C
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Title 45
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Volume 2
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Chapter A
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Subchapter C
Subchapter C - Administrative Data Standards And Related Requirements
45:2.0.1.2.18
PART 160
PART 160 - GENERAL ADMINISTRATIVE REQUIREMENTS
45:2.0.1.2.18.1
SUBPART A
Subpart A - General Provisions
45:2.0.1.2.18.1.1.1
SECTION 160.101
160.101 Statutory basis and purpose.
45:2.0.1.2.18.1.1.2
SECTION 160.102
160.102 Applicability.
45:2.0.1.2.18.1.1.3
SECTION 160.103
160.103 Definitions.
45:2.0.1.2.18.1.1.4
SECTION 160.104
160.104 Modifications.
45:2.0.1.2.18.1.1.5
SECTION 160.105
160.105 Compliance dates for implementation of new or modified standards and implementation specifications.
45:2.0.1.2.18.2
SUBPART B
Subpart B - Preemption of State Law
45:2.0.1.2.18.2.1.1
SECTION 160.201
160.201 Statutory basis.
45:2.0.1.2.18.2.1.2
SECTION 160.202
160.202 Definitions.
45:2.0.1.2.18.2.1.3
SECTION 160.203
160.203 General rule and exceptions.
45:2.0.1.2.18.2.1.4
SECTION 160.204
160.204 Process for requesting exception determinations.
45:2.0.1.2.18.2.1.5
SECTION 160.205
160.205 Duration of effectiveness of exception determinations.
45:2.0.1.2.18.3
SUBPART C
Subpart C - Compliance and Investigations
45:2.0.1.2.18.3.1.1
SECTION 160.300
160.300 Applicability.
45:2.0.1.2.18.3.1.2
SECTION 160.302
160.302 [Reserved]
45:2.0.1.2.18.3.1.3
SECTION 160.304
160.304 Principles for achieving compliance.
45:2.0.1.2.18.3.1.4
SECTION 160.306
160.306 Complaints to the Secretary.
45:2.0.1.2.18.3.1.5
SECTION 160.308
160.308 Compliance reviews.
45:2.0.1.2.18.3.1.6
SECTION 160.310
160.310 Responsibilities of covered entities and business associates.
45:2.0.1.2.18.3.1.7
SECTION 160.312
160.312 Secretarial action regarding complaints and compliance reviews.
45:2.0.1.2.18.3.1.8
SECTION 160.314
160.314 Investigational subpoenas and inquiries.
45:2.0.1.2.18.3.1.9
SECTION 160.316
160.316 Refraining from intimidation or retaliation.
45:2.0.1.2.18.4
SUBPART D
Subpart D - Imposition of Civil Money Penalties
45:2.0.1.2.18.4.1.1
SECTION 160.400
160.400 Applicability.
45:2.0.1.2.18.4.1.2
SECTION 160.401
160.401 Definitions.
45:2.0.1.2.18.4.1.3
SECTION 160.402
160.402 Basis for a civil money penalty.
45:2.0.1.2.18.4.1.4
SECTION 160.404
160.404 Amount of a civil money penalty.
45:2.0.1.2.18.4.1.5
SECTION 160.406
160.406 Violations of an identical requirement or prohibition.
45:2.0.1.2.18.4.1.6
SECTION 160.408
160.408 Factors considered in determining the amount of a civil money penalty.
45:2.0.1.2.18.4.1.7
SECTION 160.410
160.410 Affirmative defenses.
45:2.0.1.2.18.4.1.8
SECTION 160.412
160.412 Waiver.
45:2.0.1.2.18.4.1.9
SECTION 160.414
160.414 Limitations.
45:2.0.1.2.18.4.1.10
SECTION 160.416
160.416 Authority to settle.
45:2.0.1.2.18.4.1.11
SECTION 160.418
160.418 Penalty not exclusive.
45:2.0.1.2.18.4.1.12
SECTION 160.420
160.420 Notice of proposed determination.
45:2.0.1.2.18.4.1.13
SECTION 160.422
160.422 Failure to request a hearing.
45:2.0.1.2.18.4.1.14
SECTION 160.424
160.424 Collection of penalty.
45:2.0.1.2.18.4.1.15
SECTION 160.426
160.426 Notification of the public and other agencies.
45:2.0.1.2.18.5
SUBPART E
Subpart E - Procedures for Hearings
45:2.0.1.2.18.5.1.1
SECTION 160.500
160.500 Applicability.
45:2.0.1.2.18.5.1.2
SECTION 160.502
160.502 Definitions.
45:2.0.1.2.18.5.1.3
SECTION 160.504
160.504 Hearing before an ALJ.
45:2.0.1.2.18.5.1.4
SECTION 160.506
160.506 Rights of the parties.
45:2.0.1.2.18.5.1.5
SECTION 160.508
160.508 Authority of the ALJ.
45:2.0.1.2.18.5.1.6
SECTION 160.510
160.510 Ex parte contacts.
45:2.0.1.2.18.5.1.7
SECTION 160.512
160.512 Prehearing conferences.
45:2.0.1.2.18.5.1.8
SECTION 160.514
160.514 Authority to settle.
45:2.0.1.2.18.5.1.9
SECTION 160.516
160.516 Discovery.
45:2.0.1.2.18.5.1.10
SECTION 160.518
160.518 Exchange of witness lists, witness statements, and exhibits.
45:2.0.1.2.18.5.1.11
SECTION 160.520
160.520 Subpoenas for attendance at hearing.
45:2.0.1.2.18.5.1.12
SECTION 160.522
160.522 Fees.
45:2.0.1.2.18.5.1.13
SECTION 160.524
160.524 Form, filing, and service of papers.
45:2.0.1.2.18.5.1.14
SECTION 160.526
160.526 Computation of time.
45:2.0.1.2.18.5.1.15
SECTION 160.528
160.528 Motions.
45:2.0.1.2.18.5.1.16
SECTION 160.530
160.530 Sanctions.
45:2.0.1.2.18.5.1.17
SECTION 160.532
160.532 Collateral estoppel.
45:2.0.1.2.18.5.1.18
SECTION 160.534
160.534 The hearing.
45:2.0.1.2.18.5.1.19
SECTION 160.536
160.536 Statistical sampling.
45:2.0.1.2.18.5.1.20
SECTION 160.538
160.538 Witnesses.
45:2.0.1.2.18.5.1.21
SECTION 160.540
160.540 Evidence.
45:2.0.1.2.18.5.1.22
SECTION 160.542
160.542 The record.
45:2.0.1.2.18.5.1.23
SECTION 160.544
160.544 Post hearing briefs.
45:2.0.1.2.18.5.1.24
SECTION 160.546
160.546 ALJ's decision.
45:2.0.1.2.18.5.1.25
SECTION 160.548
160.548 Appeal of the ALJ's decision.
45:2.0.1.2.18.5.1.26
SECTION 160.550
160.550 Stay of the Secretary's decision.
45:2.0.1.2.18.5.1.27
SECTION 160.552
160.552 Harmless error.
45:2.0.1.2.19
PART 162
PART 162 - ADMINISTRATIVE REQUIREMENTS
45:2.0.1.2.19.1
SUBPART A
Subpart A - General Provisions
45:2.0.1.2.19.1.1.1
SECTION 162.100
162.100 Applicability.
45:2.0.1.2.19.1.1.2
SECTION 162.103
162.103 Definitions.
45:2.0.1.2.19.2
SUBPART B
Subparts B-C [Reserved]
45:2.0.1.2.19.3
SUBPART D
Subpart D - Standard Unique Health Identifier for Health Care Providers
45:2.0.1.2.19.3.1.1
SECTION 162.402
162.402 [Reserved]
45:2.0.1.2.19.3.1.2
SECTION 162.404
162.404 Compliance dates of the implementation of the standard unique health identifier for health care providers.
45:2.0.1.2.19.3.1.3
SECTION 162.406
162.406 Standard unique health identifier for health care providers.
45:2.0.1.2.19.3.1.4
SECTION 162.408
162.408 National Provider System.
45:2.0.1.2.19.3.1.5
SECTION 162.410
162.410 Implementation specifications: Health care providers.
45:2.0.1.2.19.3.1.6
SECTION 162.412
162.412 Implementation specifications: Health plans.
45:2.0.1.2.19.3.1.7
SECTION 162.414
162.414 Implementation specifications: Health care clearinghouses.
45:2.0.1.2.19.4
SUBPART E
Subpart E [Reserved]
45:2.0.1.2.19.5
SUBPART F
Subpart F - Standard Unique Employer Identifier
45:2.0.1.2.19.5.1.1
SECTION 162.600
162.600 Compliance dates of the implementation of the standard unique employer identifier.
45:2.0.1.2.19.5.1.2
SECTION 162.605
162.605 Standard unique employer identifier.
45:2.0.1.2.19.5.1.3
SECTION 162.610
162.610 Implementation specifications for covered entities.
45:2.0.1.2.19.6
SUBPART G
Subparts G-H [Reserved]
45:2.0.1.2.19.7
SUBPART I
Subpart I - General Provisions for Transactions
45:2.0.1.2.19.7.1.1
SECTION 162.900
162.900 [Reserved]
45:2.0.1.2.19.7.1.2
SECTION 162.910
162.910 Maintenance of standards and adoption of modifications and new standards.
45:2.0.1.2.19.7.1.3
SECTION 162.915
162.915 Trading partner agreements.
45:2.0.1.2.19.7.1.4
SECTION 162.920
162.920 Availability of implementation specifications and operating rules.
45:2.0.1.2.19.7.1.5
SECTION 162.923
162.923 Requirements for covered entities.
45:2.0.1.2.19.7.1.6
SECTION 162.925
162.925 Additional requirements for health plans.
45:2.0.1.2.19.7.1.7
SECTION 162.930
162.930 Additional rules for health care clearinghouses.
45:2.0.1.2.19.7.1.8
SECTION 162.940
162.940 Exceptions from standards to permit testing of proposed modifications.
45:2.0.1.2.19.8
SUBPART J
Subpart J - Code Sets
45:2.0.1.2.19.8.1.1
SECTION 162.1000
162.1000 General requirements.
45:2.0.1.2.19.8.1.2
SECTION 162.1002
162.1002 Medical data code sets.
45:2.0.1.2.19.8.1.3
SECTION 162.1011
162.1011 Valid code sets.
45:2.0.1.2.19.9
SUBPART K
Subpart K - Health Care Claims or Equivalent Encounter Information
45:2.0.1.2.19.9.1.1
SECTION 162.1101
162.1101 Health care claims or equivalent encounter information transaction.
45:2.0.1.2.19.9.1.2
SECTION 162.1102
162.1102 Standards for health care claims or equivalent encounter information transaction.
45:2.0.1.2.19.10
SUBPART L
Subpart L - Eligibility for a Health Plan
45:2.0.1.2.19.10.1.1
SECTION 162.1201
162.1201 Eligibility for a health plan transaction.
45:2.0.1.2.19.10.1.2
SECTION 162.1202
162.1202 Standards for eligibility for a health plan transaction.
45:2.0.1.2.19.10.1.3
SECTION 162.1203
162.1203 Operating rules for eligibility for a health plan transaction.
45:2.0.1.2.19.11
SUBPART M
Subpart M - Referral Certification and Authorization
45:2.0.1.2.19.11.1.1
SECTION 162.1301
162.1301 Referral certification and authorization transaction.
45:2.0.1.2.19.11.1.2
SECTION 162.1302
162.1302 Standards for referral certification and authorization transaction.
45:2.0.1.2.19.12
SUBPART N
Subpart N - Health Care Claim Status
45:2.0.1.2.19.12.1.1
SECTION 162.1401
162.1401 Health care claim status transaction.
45:2.0.1.2.19.12.1.2
SECTION 162.1402
162.1402 Standards for health care claim status transaction.
45:2.0.1.2.19.12.1.3
SECTION 162.1403
162.1403 Operating rules for health care claim status transaction.
45:2.0.1.2.19.13
SUBPART O
Subpart O - Enrollment and Disenrollment in a Health Plan
45:2.0.1.2.19.13.1.1
SECTION 162.1501
162.1501 Enrollment and disenrollment in a health plan transaction.
45:2.0.1.2.19.13.1.2
SECTION 162.1502
162.1502 Standards for enrollment and disenrollment in a health plan transaction.
45:2.0.1.2.19.14
SUBPART P
Subpart P - Health Care Electronic Funds Transfers (EFT) and Remittance Advice
45:2.0.1.2.19.14.1.1
SECTION 162.1601
162.1601 Health care electronic funds transfers (EFT) and remittance advice transaction.
45:2.0.1.2.19.14.1.2
SECTION 162.1602
162.1602 Standards for health care electronic funds transfers (EFT) and remittance advice transaction.
45:2.0.1.2.19.14.1.3
SECTION 162.1603
162.1603 Operating rules for health care electronic funds transfers (EFT) and remittance advice transaction.
45:2.0.1.2.19.15
SUBPART Q
Subpart Q - Health Plan Premium Payments
45:2.0.1.2.19.15.1.1
SECTION 162.1701
162.1701 Health plan premium payments transaction.
45:2.0.1.2.19.15.1.2
SECTION 162.1702
162.1702 Standards for health plan premium payments transaction.
45:2.0.1.2.19.16
SUBPART R
Subpart R - Coordination of Benefits
45:2.0.1.2.19.16.1.1
SECTION 162.1801
162.1801 Coordination of benefits transaction.
45:2.0.1.2.19.16.1.2
SECTION 162.1802
162.1802 Standards for coordination of benefits information transaction.
45:2.0.1.2.19.17
SUBPART S
Subpart S - Medicaid Pharmacy Subrogation
45:2.0.1.2.19.17.1.1
SECTION 162.1901
162.1901 Medicaid pharmacy subrogation transaction.
45:2.0.1.2.19.17.1.2
SECTION 162.1902
162.1902 Standard for Medicaid pharmacy subrogation transaction.
45:2.0.1.2.20
PART 163
PART 163 [RESERVED]
45:2.0.1.2.21
PART 164
PART 164 - SECURITY AND PRIVACY
45:2.0.1.2.21.1
SUBPART A
Subpart A - General Provisions
45:2.0.1.2.21.1.1.1
SECTION 164.102
164.102 Statutory basis.
45:2.0.1.2.21.1.1.2
SECTION 164.103
164.103 Definitions.
45:2.0.1.2.21.1.1.3
SECTION 164.104
164.104 Applicability.
45:2.0.1.2.21.1.1.4
SECTION 164.105
164.105 Organizational requirements.
45:2.0.1.2.21.1.1.5
SECTION 164.106
164.106 Relationship to other parts.
45:2.0.1.2.21.2
SUBPART B
Subpart B [Reserved]
45:2.0.1.2.21.3
SUBPART C
Subpart C - Security Standards for the Protection of Electronic Protected Health Information
45:2.0.1.2.21.3.1.1
SECTION 164.302
164.302 Applicability.
45:2.0.1.2.21.3.1.2
SECTION 164.304
164.304 Definitions.
45:2.0.1.2.21.3.1.3
SECTION 164.306
164.306 Security standards: General rules.
45:2.0.1.2.21.3.1.4
SECTION 164.308
164.308 Administrative safeguards.
45:2.0.1.2.21.3.1.5
SECTION 164.310
164.310 Physical safeguards.
45:2.0.1.2.21.3.1.6
SECTION 164.312
164.312 Technical safeguards.
45:2.0.1.2.21.3.1.7
SECTION 164.314
164.314 Organizational requirements.
45:2.0.1.2.21.3.1.8
SECTION 164.316
164.316 Policies and procedures and documentation requirements.
45:2.0.1.2.21.3.1.9
SECTION 164.318
164.318 Compliance dates for the initial implementation of the security standards.
45:2.0.1.2.21.3.1.10.1
APPENDIX Appendix A
Appendix A to Subpart C of Part 164 - Security Standards: Matrix
45:2.0.1.2.21.4
SUBPART D
Subpart D - Notification in the Case of Breach of Unsecured Protected Health Information
45:2.0.1.2.21.4.1.1
SECTION 164.400
164.400 Applicability.
45:2.0.1.2.21.4.1.2
SECTION 164.402
164.402 Definitions.
45:2.0.1.2.21.4.1.3
SECTION 164.404
164.404 Notification to individuals.
45:2.0.1.2.21.4.1.4
SECTION 164.406
164.406 Notification to the media.
45:2.0.1.2.21.4.1.5
SECTION 164.408
164.408 Notification to the Secretary.
45:2.0.1.2.21.4.1.6
SECTION 164.410
164.410 Notification by a business associate.
45:2.0.1.2.21.4.1.7
SECTION 164.412
164.412 Law enforcement delay.
45:2.0.1.2.21.4.1.8
SECTION 164.414
164.414 Administrative requirements and burden of proof.
45:2.0.1.2.21.5
SUBPART E
Subpart E - Privacy of Individually Identifiable Health Information
45:2.0.1.2.21.5.1.1
SECTION 164.500
164.500 Applicability.
45:2.0.1.2.21.5.1.2
SECTION 164.501
164.501 Definitions.
45:2.0.1.2.21.5.1.3
SECTION 164.502
164.502 Uses and disclosures of protected health information: General rules.
45:2.0.1.2.21.5.1.4
SECTION 164.504
164.504 Uses and disclosures: Organizational requirements.
45:2.0.1.2.21.5.1.5
SECTION 164.506
164.506 Uses and disclosures to carry out treatment, payment, or health care operations.
45:2.0.1.2.21.5.1.6
SECTION 164.508
164.508 Uses and disclosures for which an authorization is required.
45:2.0.1.2.21.5.1.7
SECTION 164.510
164.510 Uses and disclosures requiring an opportunity for the individual to agree or to object.
45:2.0.1.2.21.5.1.8
SECTION 164.512
164.512 Uses and disclosures for which an authorization or opportunity to agree or object is not required.
45:2.0.1.2.21.5.1.9
SECTION 164.514
164.514 Other requirements relating to uses and disclosures of protected health information.
45:2.0.1.2.21.5.1.10
SECTION 164.520
164.520 Notice of privacy practices for protected health information.
45:2.0.1.2.21.5.1.11
SECTION 164.522
164.522 Rights to request privacy protection for protected health information.
45:2.0.1.2.21.5.1.12
SECTION 164.524
164.524 Access of individuals to protected health information.
45:2.0.1.2.21.5.1.13
SECTION 164.526
164.526 Amendment of protected health information.
45:2.0.1.2.21.5.1.14
SECTION 164.528
164.528 Accounting of disclosures of protected health information.
45:2.0.1.2.21.5.1.15
SECTION 164.530
164.530 Administrative requirements.
45:2.0.1.2.21.5.1.16
SECTION 164.532
164.532 Transition provisions.
45:2.0.1.2.21.5.1.17
SECTION 164.534
164.534 Compliance dates for initial implementation of the privacy standards.
45:2.0.1.2.22
PART 165-169
PARTS 165-169 [RESERVED]