Difference between revisions of "E9-31216 TOC"
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= Table of Contents = | = Table of Contents = | ||
== I. Background == | == I. Background == | ||
| + | [[E9-31216 I]] | ||
=== A. ONC Background === | === A. ONC Background === | ||
| + | [[E9-31216 I A]] | ||
=== B. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements and Related Activities === | === B. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements and Related Activities === | ||
| + | {{:E9-31216 I B}} | ||
==== 1. Medicare and Medicaid EHR Incentive Programs Proposed Rule ==== | ==== 1. Medicare and Medicaid EHR Incentive Programs Proposed Rule ==== | ||
| + | [[E9-31216 I B 1]] | ||
==== 2. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule Accounting of Disclosures Regulation ==== | ==== 2. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule Accounting of Disclosures Regulation ==== | ||
| + | [[E9-31216 I B 2]] | ||
==== 3. Previous Recognition of Certification Bodies and New Authority Under the HITECH Act ==== | ==== 3. Previous Recognition of Certification Bodies and New Authority Under the HITECH Act ==== | ||
| + | [[E9-31216 I B 3]] | ||
==== 4. Other HHS Regulatory Actions ==== | ==== 4. Other HHS Regulatory Actions ==== | ||
| + | {{E9-31216 I B 4}} | ||
===== a. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Transactions and Code Sets Standards ===== | ===== a. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Transactions and Code Sets Standards ===== | ||
| + | [[E9-31216 I B 4 a]] | ||
===== b. Electronic Prescribing Standards ===== | ===== b. Electronic Prescribing Standards ===== | ||
| + | [[E9-31216 I B 4 b]] | ||
| + | |||
=== C. Standards, Implementation Specifications, and Certification Criteria Processes Before and After the HITECH Act === | === C. Standards, Implementation Specifications, and Certification Criteria Processes Before and After the HITECH Act === | ||
| + | |||
==== 1. ONC’s Processes Prior to the HITECH Act ==== | ==== 1. ONC’s Processes Prior to the HITECH Act ==== | ||
| + | [[E9-31216 I C 1]] | ||
==== 2. HITECH Act Requirements for the Adoption of Standards, Implementation Specifications, and Certification Criteria ==== | ==== 2. HITECH Act Requirements for the Adoption of Standards, Implementation Specifications, and Certification Criteria ==== | ||
| + | [[E9-31216 I C 2]] | ||
| + | |||
=== D. Future Updates to Standards, Implementation Specifications, and Certification Criteria === | === D. Future Updates to Standards, Implementation Specifications, and Certification Criteria === | ||
| + | [[E9-31216 I D]] | ||
== II. Overview of the Interim Final Rule == | == II. Overview of the Interim Final Rule == | ||
| + | [[E9-31216 II]] | ||
| + | |||
== III. Section-By-Section Description of the Interim Final Rule == | == III. Section-By-Section Description of the Interim Final Rule == | ||
| + | |||
=== A. Applicability === | === A. Applicability === | ||
| + | {{:E9-31216 III A}} | ||
| + | |||
=== B. Definitions === | === B. Definitions === | ||
| + | {{:E9-31216 III B}} | ||
==== 1. Definition of Standard ==== | ==== 1. Definition of Standard ==== | ||
| + | [[E9-31216 III B 1]] | ||
| + | |||
==== 2. Definition of Implementation Specification ==== | ==== 2. Definition of Implementation Specification ==== | ||
| + | [[E9-31216 III B 2]] | ||
==== 3. Definition of Certification Criteria ==== | ==== 3. Definition of Certification Criteria ==== | ||
| − | ==== 4. Definition of Qualified Electronic Health Record (EHR) ==== | + | [[E9-31216 III B 3]] |
| + | ==== 4. Definition of Qualified Electronic Health [[Record~|Record]] (EHR) ==== | ||
| + | [[E9-31216 III B 4]] | ||
==== 5. Definition of EHR Module ==== | ==== 5. Definition of EHR Module ==== | ||
| + | [[E9-31216 III B 5]] | ||
==== 6. Definition of Complete EHR ==== | ==== 6. Definition of Complete EHR ==== | ||
| + | [[E9-31216 III B 6]] | ||
==== 7. Definition of Certified EHR Technology ==== | ==== 7. Definition of Certified EHR Technology ==== | ||
| + | [[E9-31216 III B 7]] | ||
==== 8. Definition of Disclosure ==== | ==== 8. Definition of Disclosure ==== | ||
| + | [[E9-31216 III B 8]] | ||
| + | |||
=== C. Initial Set of Standards, Implementation Specifications, and Certification Criteria === | === C. Initial Set of Standards, Implementation Specifications, and Certification Criteria === | ||
| + | [[E9-31216 III C]] | ||
==== 1. Adopted Certification Criteria ==== | ==== 1. Adopted Certification Criteria ==== | ||
| + | [[E9-31216 III C 1]] | ||
==== 2. Adopted Standards ==== | ==== 2. Adopted Standards ==== | ||
| + | [[E9-31216 III C 2]] | ||
===== a. Transport Standards ===== | ===== a. Transport Standards ===== | ||
| + | [[E9-31216 III C 2 a]] | ||
===== b. Content Exchange and Vocabulary Standards ===== | ===== b. Content Exchange and Vocabulary Standards ===== | ||
| − | ====== i. Patient Summary Record ====== | + | [[E9-31216 III C 2 b]] |
| + | ====== i. Patient Summary [[Record~|Record]] ====== | ||
| + | [[E9-31216 III C 2 b i]] | ||
====== ii. Drug Formulary Check ====== | ====== ii. Drug Formulary Check ====== | ||
| + | [[E9-31216 III C 2 b ii]] | ||
====== iii. Electronic Prescribing ====== | ====== iii. Electronic Prescribing ====== | ||
| + | [[E9-31216 III C 2 b iii]] | ||
====== iv. Administrative Transactions ====== | ====== iv. Administrative Transactions ====== | ||
| + | [[E9-31216 III C 2 b iv]] | ||
====== v. Quality Reporting ====== | ====== v. Quality Reporting ====== | ||
| + | [[E9-31216 III C 2 b v]] | ||
====== vi. Submission of Lab Results to Public Health Agencies ====== | ====== vi. Submission of Lab Results to Public Health Agencies ====== | ||
| + | [[E9-31216 III C 2 b vi]] | ||
====== vii. Submission to Public Health Agencies for Surveillance or Reporting ====== | ====== vii. Submission to Public Health Agencies for Surveillance or Reporting ====== | ||
| + | [[E9-31216 III C 2 b vii]] | ||
====== viii. Submission to Immunization Registries ====== | ====== viii. Submission to Immunization Registries ====== | ||
| + | [[E9-31216 III C 2 b viii]] | ||
====== ix. Table 2A ====== | ====== ix. Table 2A ====== | ||
| + | [[E9-31216 III C 2 b ix]] | ||
===== c. Privacy and Security Standards ===== | ===== c. Privacy and Security Standards ===== | ||
| + | [[E9-31216 III C 2 c]] | ||
==== 3. Adopted Implementation Specifications ==== | ==== 3. Adopted Implementation Specifications ==== | ||
| + | [[E9-31216 III C 3]] | ||
==== 4. Additional Considerations, Clarifications, and Requests for Public Comments ==== | ==== 4. Additional Considerations, Clarifications, and Requests for Public Comments ==== | ||
| + | [[E9-31216 III C 4]] | ||
===== a. Relationship to Other Federal Laws ===== | ===== a. Relationship to Other Federal Laws ===== | ||
| + | [[E9-31216 III C 4 a]] | ||
===== b. Human Readable Format ===== | ===== b. Human Readable Format ===== | ||
| + | [[E9-31216 III C 4 b]] | ||
===== c. Certification Criterion and Standard Regarding Accounting of Disclosures ===== | ===== c. Certification Criterion and Standard Regarding Accounting of Disclosures ===== | ||
| + | [[E9-31216 III C 4 c]] | ||
===== d. Additional Requests for Public Comment ===== | ===== d. Additional Requests for Public Comment ===== | ||
| + | [[E9-31216 III C 4 d]] | ||
| + | |||
== IV. Collection of Information Requirements == | == IV. Collection of Information Requirements == | ||
| + | [[E9-31216 IV]] | ||
== V. Regulatory Impact Analysis == | == V. Regulatory Impact Analysis == | ||
| + | [[E9-31216 V]] | ||
=== A. Introduction === | === A. Introduction === | ||
| + | [[E9-31216 V A]] | ||
=== B. Why Is This Rule Needed? === | === B. Why Is This Rule Needed? === | ||
| + | [[E9-31216 V B]] | ||
=== C. Costs and Benefits === | === C. Costs and Benefits === | ||
| + | [[E9-31216 V C]] | ||
==== 1. Costs ==== | ==== 1. Costs ==== | ||
| + | [[E9-31216 V C 1]] | ||
==== 2. Benefits ==== | ==== 2. Benefits ==== | ||
| + | [[E9-31216 V C 2]] | ||
=== D. Regulatory Flexibility Act Analysis === | === D. Regulatory Flexibility Act Analysis === | ||
| + | [[E9-31216 V D]] | ||
=== E. Executive Order 13132—Federalism === | === E. Executive Order 13132—Federalism === | ||
| + | [[E9-31216 V E]] | ||
=== F. Unfunded Mandates Reform Act of 1995 Regulation Text === | === F. Unfunded Mandates Reform Act of 1995 Regulation Text === | ||
| + | [[E9-31216 V F]] | ||
Latest revision as of 09:59, 1 April 2012
Contents
- 1 Table of Contents
- 1.1 I. Background
- 1.1.1 A. ONC Background
- 1.1.2 B. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements and Related Activities
- 1.1.2.1 1. Medicare and Medicaid EHR Incentive Programs Proposed Rule
- 1.1.2.2 2. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule Accounting of Disclosures Regulation
- 1.1.2.3 3. Previous Recognition of Certification Bodies and New Authority Under the HITECH Act
- 1.1.2.4 4. Other HHS Regulatory Actions
- 1.1.3 C. Standards, Implementation Specifications, and Certification Criteria Processes Before and After the HITECH Act
- 1.1.4 D. Future Updates to Standards, Implementation Specifications, and Certification Criteria
- 1.2 II. Overview of the Interim Final Rule
- 1.3 III. Section-By-Section Description of the Interim Final Rule
- 1.3.1 A. Applicability
- 1.3.2 B. Definitions
- 1.3.2.1 1. Definition of Standard
- 1.3.2.2 2. Definition of Implementation Specification
- 1.3.2.3 3. Definition of Certification Criteria
- 1.3.2.4 4. Definition of Qualified Electronic Health Record (EHR)
- 1.3.2.5 5. Definition of EHR Module
- 1.3.2.6 6. Definition of Complete EHR
- 1.3.2.7 7. Definition of Certified EHR Technology
- 1.3.2.8 8. Definition of Disclosure
- 1.3.3 C. Initial Set of Standards, Implementation Specifications, and Certification Criteria
- 1.3.3.1 1. Adopted Certification Criteria
- 1.3.3.2 2. Adopted Standards
- 1.3.3.2.1 a. Transport Standards
- 1.3.3.2.2 b. Content Exchange and Vocabulary Standards
- 1.3.3.2.2.1 i. Patient Summary Record
- 1.3.3.2.2.2 ii. Drug Formulary Check
- 1.3.3.2.2.3 iii. Electronic Prescribing
- 1.3.3.2.2.4 iv. Administrative Transactions
- 1.3.3.2.2.5 v. Quality Reporting
- 1.3.3.2.2.6 vi. Submission of Lab Results to Public Health Agencies
- 1.3.3.2.2.7 vii. Submission to Public Health Agencies for Surveillance or Reporting
- 1.3.3.2.2.8 viii. Submission to Immunization Registries
- 1.3.3.2.2.9 ix. Table 2A
- 1.3.3.2.3 c. Privacy and Security Standards
- 1.3.3.3 3. Adopted Implementation Specifications
- 1.3.3.4 4. Additional Considerations, Clarifications, and Requests for Public Comments
- 1.4 IV. Collection of Information Requirements
- 1.5 V. Regulatory Impact Analysis
- 1.1 I. Background
Table of Contents
I. Background
A. ONC Background
B. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements and Related Activities
B. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements and Related Activities
The HITECH Act creates multiple interdependencies between this interim final rule and other regulatory requirements, processes, and programs.
1. Medicare and Medicaid EHR Incentive Programs Proposed Rule
2. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule Accounting of Disclosures Regulation
3. Previous Recognition of Certification Bodies and New Authority Under the HITECH Act
4. Other HHS Regulatory Actions
Other HHS Regulatory Actions
a. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Transactions and Code Sets Standards
b. Electronic Prescribing Standards
C. Standards, Implementation Specifications, and Certification Criteria Processes Before and After the HITECH Act
1. ONC’s Processes Prior to the HITECH Act
2. HITECH Act Requirements for the Adoption of Standards, Implementation Specifications, and Certification Criteria
D. Future Updates to Standards, Implementation Specifications, and Certification Criteria
II. Overview of the Interim Final Rule
III. Section-By-Section Description of the Interim Final Rule
A. Applicability
A. Applicability--Sec. 170.101
This part establishes the applicable standards, implementation specifications, and certification criteria that must be used to test and certify HIT.
B. Definitions
B. Definitions--Sec. 170.102
