Preface | | xi | |
About the Editor | | xv | |
About the Contributors | | xvii | |
| | 1 | (4) |
|
| Background and History of HIPAA |
| | 5 | (4) |
|
| HIPAA Privacy and Security |
| | 9 | (4) |
|
| Relationship Among HIPAA, the Privacy Rule, and the Security Rule |
| | 9 | (1) |
| HIPAA Statutory Requirement for Security |
| | 10 | (2) |
| Security Requirements in the Privacy Rule |
| | 12 | (1) |
| Scope and Applicability of the Security Rule |
| | 13 | (12) |
|
| Scope of Information Protected Under the Security Rule |
| | 13 | (3) |
| Entities Regulated by the Security Rule |
| | 16 | (9) |
| Business Associates and Business Associate Contracts; Governmental Interagency Arrangements |
| | 18 | (2) |
| | 20 | (1) |
| Hybrid Entities and Health Care Components |
| | 21 | (1) |
| Affiliated Covered Entities |
| | 22 | (1) |
| Organized Health Care Arrangements |
| | 23 | (2) |
| | 25 | (70) |
|
|
| | 25 | (2) |
| Administrative Safeguards---Section 164.308 |
| | 27 | (35) |
| Security Management Process (Standard)---Section 164.308(a)(1)(i) |
| | 29 | (1) |
| Risk Analysis (Required)---Section 164.308(a)(1)(ii)(A) |
| | 29 | (5) |
| Risk Management (Required)---Section 164.308(a)(1)(ii)(B) |
| | 34 | (2) |
| Sanction Policy (Required)---Section 164.308(a)(1)(ii)(C) |
| | 36 | (1) |
| Information System Activity Review (Required)---Section 164.308(a)(1)(ii)(D) |
| | 36 | (1) |
| Assigned Security Responsibility (Standard)---Section 164.308(a)(2) |
| | 37 | (1) |
| Workforce Security (Standard)---Section 164.308(a)(3)(i) |
| | 38 | (1) |
| Authorization and/or Supervision (Addressable)---Section 164.308(a)(3)(ii)(A) |
| | 38 | (1) |
| Workforce Clearance Procedure (Addressable)---Section 164.308(a)(3)(ii)(B) |
| | 39 | (1) |
| Termination Procedures (Addressable)---Section 164.308(a)(3)(ii)(C) |
| | 40 | (1) |
| Information Access Management (Standard)---Section 164.308(a)(4)(i) |
| | 41 | (1) |
| Isolating Health Care Clearinghouse Functions (Required)---Section 164.308(a)(4)(ii)(A) |
| | 41 | (1) |
| Access Authorization (Addressable)---Section 164.308(a)(4)(ii)(B) |
| | 42 | (1) |
| Access Establishment and Modification (Addressable)---Section 164.308(a)(4)(ii)(C) |
| | 43 | (1) |
| Security Awareness and Training (Standard)---Section 164.308(a)(5)(i) |
| | 44 | (1) |
| Security Reminders (Addressable)---Section 164.308(a)(5)(ii)(A) |
| | 44 | (1) |
| Protection from Malicious Software (Addressable)---Section 164.308(a)(5)(ii)(B) |
| | 45 | (1) |
| Log-in Monitoring (Addressable)---Section 164.308(a)(5)(ii)(C) |
| | 46 | (1) |
| Password Management (Addressable)---Section 164.308(a)(5)(ii)(D) |
| | 46 | (1) |
| Security Incident Procedures and Responses---Section 164.308(a)(6) |
| | 47 | (1) |
| Security Incident Procedures (Standard)---Section 164.308(a)(6)(i) |
| | 47 | (2) |
| Response and Reporting (Required)---Section 164.308(a)(6)(ii) |
| | 49 | (1) |
| Contingency Plan (Standard)---Section 164.308(a)(7)(i) |
| | 50 | (1) |
| Data Backup Plan (Required)---Section 164.308(a)(7)(ii)(A) |
| | 51 | (1) |
| Disaster Recovery Plan (Required)---Section 164.308(a)(7)(ii)(B) |
| | 52 | (1) |
| Emergency Mode Operation Plan (Required)---Section 164.308(a)(7)(ii)(C) |
| | 52 | (2) |
| Testing and Revision Procedures (Addressable)---Section 164.308(a)(7)(ii)(D) |
| | 54 | (1) |
| Applications and Data Criticality Analysis (Addressable)---Section 164.308(a)(7)(ii)(E) |
| | 55 | (1) |
| Evaluation (Standard)---Section 164.308(a)(8) |
| | 55 | (3) |
| Imposing Security Requirements on Business Associates---Section 164.308(b) |
| | 58 | (1) |
| Business Associate Contracts and Other Arrangements (Standard)---Section 164.308(b)(1) |
| | 58 | (1) |
| Exceptions to the Business Associate Standard---Section 164.308(b)(2) |
| | 59 | (1) |
| Violations of the Standard---Section 164.308(b)(3) |
| | 60 | (1) |
| Implementation Specifications: Written Contract or Other Arrangement (Required)---Section 164.308(b)(4) |
| | 60 | (1) |
| Conclusion Regarding Administrative Safeguards |
| | 61 | (1) |
| Physical Safeguards---Section 164.310 |
| | 62 | (14) |
| Facility Access---Section 164.310(a) |
| | 63 | (1) |
| Facility Access Controls (Standard)---Section 164.310(a)(1) |
| | 63 | (3) |
| Facility Access Controls Implementation Specifications---Section 164.310(a)(2) |
| | 66 | (1) |
| Contingency Operations (Addressable)---Section 164.310(a)(2)(i) |
| | 66 | (1) |
| Facility Security Planning (Addressable)---Section 164.310(a)(2)(ii) |
| | 67 | (1) |
| Access Control and Validation (Addressable)---Section 164.310(a)(2)(iii) |
| | 68 | (1) |
| Maintenance Records (Addressable)---Section 164.310(a)(2)(iv) |
| | 69 | (1) |
| Workstation Use (Standard)---Section 164.310(b) |
| | 70 | (1) |
| Workstation Security (Standard)---Section 164.310(c) |
| | 71 | (1) |
| Device and Media Controls---Section 164.310(d) |
| | 72 | (1) |
| Device and Media Controls (Standard)---Section 164.310(d)(1) |
| | 72 | (1) |
| Device and Media Controls Implementation Specifications---Section 164.310(d)(2) |
| | 73 | (1) |
| Disposal (Required)---Section 164.310(d)(2)(i) |
| | 73 | (1) |
| Media Re-Use (Required)---Section 164.310(d)(2)(ii) |
| | 74 | (1) |
| Accountability (Addressable)---Section 164.310(d)(2)(iii) |
| | 74 | (1) |
| Data backup and storage (Addressable)---Section 164.310(d)(2)(iv) |
| | 75 | (1) |
| Conclusion Regarding Physical Safeguards |
| | 75 | (1) |
| Technical Safeguards---Section 164.312 |
| | 76 | (13) |
| Access Control Safeguards---Section 164.312(a) |
| | 77 | (1) |
| Access Control (Standard)---Section 164.312(a)(1) |
| | 77 | (2) |
| Access Control Implementation Specifications---Section 164.312(a)(2) |
| | 79 | (1) |
| Unique User Identification (Required)---Section 164.312(a)(2)(i) |
| | 79 | (1) |
| Emergency Access Procedure (Required)---Section 164.312(a)(2)(ii) |
| | 79 | (1) |
| Automatic log-off (Addressable)---Section 164.312(a)(2)(iii) |
| | 80 | (1) |
| Encryption and Decryption (Addressable)---Section 164.312(a)(2)(iv) |
| | 80 | (1) |
| Audit Controls (Standard)---Section 164.312(b) |
| | 81 | (1) |
| | 81 | (1) |
| Integrity (Standard)---Section 164.312(c)(1) |
| | 81 | (2) |
| Implementation Specification: Mechanism to Authenticate Electronic Protected Health Information (Addressable)---Section 164.312(c)(2) |
| | 83 | (1) |
| Person or Entity Authentication (Standard)---Section 164.312(d) |
| | 83 | (3) |
| Transmission Security---Section 164.312(e) |
| | 86 | (1) |
| Transmission Security (Standard)---Section 164.312(e)(1) |
| | 86 | (1) |
| Transmission Security Implementation Specifications---Section 164.312(e)(2) |
| | 87 | (1) |
| Integrity Controls (Addressable)---Section 164.312(e)(2)(i) |
| | 87 | (1) |
| Encryption (Addressable)---Section 164.312(e)(2)(ii) |
| | 87 | (1) |
| Conclusion Regarding Technical Safeguards |
| | 88 | (1) |
| Policies, procedures, and documentation---Section 164.316 |
| | 89 | (6) |
| Policies and Procedures (Standard)---Section 164.316(a) |
| | 89 | (2) |
| Documentation---Section 164.316(b) |
| | 91 | (1) |
| Documentation (Standard)---Section 164.316(b)(1) |
| | 91 | (1) |
| Documentation Implementation Specifications---Section 164.316(b)(2) |
| | 92 | (3) |
| | 95 | (6) |
|
|
| The Process of Implementing the Security Rule |
| | 95 | (1) |
| | 96 | (5) |
| | 101 | (26) |
|
| No Cumulative Civil and Criminal Penalties |
| | 102 | (1) |
| | 102 | (2) |
| | 104 | (3) |
| | 107 | (1) |
| Final Rule for the Imposition of Civil Money Penalties |
| | 108 | (19) |
| | 109 | (1) |
| Development of the Final Enforcement Rule |
| | 109 | (2) |
| Comparing the Final Enforcement Rule with Prior Drafts |
| | 111 | (1) |
| Detailed Review of the Final Enforcement Rule |
| | 111 | (1) |
| | 111 | (1) |
| | 111 | (1) |
| Investigations and Compliance Review under the Enforcement Rule |
| | 112 | (1) |
| Investigational Subpoenas |
| | 113 | (1) |
| | 113 | (1) |
| | 114 | (1) |
| Secretarial Action Regarding Complaints and Compliance Reviews |
| | 115 | (1) |
| Notice of Proposed Determination |
| | 116 | (1) |
| Failure to Request a Hearing |
| | 116 | (1) |
| Hearing before Administrative Law Judge |
| | 117 | (1) |
| | 117 | (1) |
| | 117 | (1) |
| | 118 | (2) |
| Appeal of the Administrative Law Judge's Decision |
| | 120 | (2) |
| | 122 | (1) |
| Basis for Civil Money Penalties |
| | 122 | (1) |
| Amount of Civil Money Penalties |
| | 123 | (1) |
| Violation of an Identical Requirement or Prohibition |
| | 124 | (1) |
| Factors Considered in Determining the Amount of Civil Money Penalties |
| | 124 | (1) |
| Collection of the Penalty |
| | 125 | (1) |
| | 126 | (1) |
| | 126 | (1) |
| | 127 | (10) |
|
| Liability and Litigation Overview |
| | 127 | (6) |
| | 133 | (4) |
| | 137 | (2) |
|
Appendix 1 HIPAA Administrative Simplification Provisions | | 139 | (24) |
Appendix 2 HIPAA Security and Privacy Regulations | | 163 | (146) |
Appendix 3 HIPAA Security Resources on the Internet | | 309 | (4) |
Index | | 313 | |