Table of Contents
I. Background
E9-31216 I
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
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
E9-31216 I B 1
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
E9-31216 I B 3
4. Other HHS Regulatory Actions
Other HHS Regulatory Actions
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
E9-31216 I B 4 b
C. Standards, Implementation Specifications, and Certification Criteria Processes Before and After 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
E9-31216 I C 2
D. Future Updates to Standards, Implementation Specifications, and Certification Criteria
E9-31216 I D
II. Overview of the Interim Final Rule
E9-31216 II
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
1. Definition of Standard
E9-31216 III B 1
2. Definition of Implementation Specification
E9-31216 III B 2
3. Definition of Certification Criteria
E9-31216 III B 3
4. Definition of Qualified Electronic Health Record (EHR)
E9-31216 III B 4
5. Definition of EHR Module
E9-31216 III B 5
6. Definition of Complete EHR
E9-31216 III B 6
7. Definition of Certified EHR Technology
E9-31216 III B 7
8. Definition of Disclosure
E9-31216 III B 8
C. Initial Set of Standards, Implementation Specifications, and Certification Criteria
E9-31216 III C
1. Adopted Certification Criteria
E9-31216 III C 1
2. Adopted Standards
E9-31216 III C 2
a. Transport Standards
E9-31216 III C 2 a
b. Content Exchange and Vocabulary Standards
E9-31216 III C 2 b
i. Patient Summary Record
E9-31216 III C 2 b i
ii. Drug Formulary Check
E9-31216 III C 2 b ii
iii. Electronic Prescribing
E9-31216 III C 2 b iii
iv. Administrative Transactions
E9-31216 III C 2 b iv
v. Quality Reporting
E9-31216 III C 2 b v
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
E9-31216 III C 2 b vii
viii. Submission to Immunization Registries
E9-31216 III C 2 b viii
ix. Table 2A
E9-31216 III C 2 b ix
c. Privacy and Security Standards
E9-31216 III C 2 c
3. Adopted Implementation Specifications
E9-31216 III C 3
4. Additional Considerations, Clarifications, and Requests for Public Comments
E9-31216 III C 4
a. Relationship to Other Federal Laws
E9-31216 III C 4 a
b. Human Readable Format
E9-31216 III C 4 b
c. Certification Criterion and Standard Regarding Accounting of Disclosures
E9-31216 III C 4 c
E9-31216 III C 4 d
IV. Collection of Information Requirements
E9-31216 IV
V. Regulatory Impact Analysis
E9-31216 V
A. Introduction
E9-31216 V A
B. Why Is This Rule Needed?
E9-31216 V B
C. Costs and Benefits
E9-31216 V C
1. Costs
E9-31216 V C 1
2. Benefits
E9-31216 V C 2
D. Regulatory Flexibility Act Analysis
E9-31216 V D
E. Executive Order 13132—Federalism
E9-31216 V E
F. Unfunded Mandates Reform Act of 1995 Regulation Text
E9-31216 V F
