E9-31216 TOC
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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
1.1.2.4.1
a. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Transactions and Code Sets Standards
1.1.2.4.2
b. Electronic Prescribing Standards
1.1.3
C. Standards, Implementation Specifications, and Certification Criteria Processes Before and After the HITECH Act
1.1.3.1
1. ONC’s Processes Prior to the HITECH Act
1.1.3.2
2. HITECH Act Requirements for the Adoption of Standards, Implementation Specifications, and Certification Criteria
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
1.3.3.4.1
a. Relationship to Other Federal Laws
1.3.3.4.2
b. Human Readable Format
1.3.3.4.3
c. Certification Criterion and Standard Regarding Accounting of Disclosures
1.3.3.4.4
d. Additional Requests for Public Comment
1.4
IV. Collection of Information Requirements
1.5
V. Regulatory Impact Analysis
1.5.1
A. Introduction
1.5.2
B. Why Is This Rule Needed?
1.5.3
C. Costs and Benefits
1.5.3.1
1. Costs
1.5.3.2
2. Benefits
1.5.4
D. Regulatory Flexibility Act Analysis
1.5.5
E. Executive Order 13132—Federalism
1.5.6
F. Unfunded Mandates Reform Act of 1995 Regulation Text
Table of Contents
I. Background
A. ONC Background
B. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements and Related Activities
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
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
B. Definitions
1. Definition of Standard
2. Definition of Implementation Specification
3. Definition of Certification Criteria
4. Definition of Qualified Electronic Health Record (EHR)
5. Definition of EHR Module
6. Definition of Complete EHR
7. Definition of Certified EHR Technology
8. Definition of Disclosure
C. Initial Set of Standards, Implementation Specifications, and Certification Criteria
1. Adopted Certification Criteria
2. Adopted Standards
a. Transport Standards
b. Content Exchange and Vocabulary Standards
i. Patient Summary Record
ii. Drug Formulary Check
iii. Electronic Prescribing
iv. Administrative Transactions
v. Quality Reporting
vi. Submission of Lab Results to Public Health Agencies
vii. Submission to Public Health Agencies for Surveillance or Reporting
viii. Submission to Immunization Registries
ix. Table 2A
c. Privacy and Security Standards
3. Adopted Implementation Specifications
4. Additional Considerations, Clarifications, and Requests for Public Comments
a. Relationship to Other Federal Laws
b. Human Readable Format
c. Certification Criterion and Standard Regarding Accounting of Disclosures
d. Additional Requests for Public Comment
IV. Collection of Information Requirements
V. Regulatory Impact Analysis
A. Introduction
B. Why Is This Rule Needed?
C. Costs and Benefits
1. Costs
2. Benefits
D. Regulatory Flexibility Act Analysis
E. Executive Order 13132—Federalism
F. Unfunded Mandates Reform Act of 1995 Regulation Text
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