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

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

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