E9-31216 TOC

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

E9-31216 I B

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

E9-31216 I B 4

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

E9-31216 I C

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

E9-31216 III

A. Applicability

E9-31216 III A

B. Definitions

E9-31216 III B

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

d. Additional Requests for Public Comment

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