E9-31216 TOC: Difference between revisions

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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 ===
[[E9-31216 I C]]
==== 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 ==
[[E9-31216 III]]
=== 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 ====
[[E9-31216 III B 3]]
==== 4. Definition of Qualified Electronic Health Record (EHR) ====
==== 4. Definition of Qualified Electronic Health 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 =====
[[E9-31216 III C 2 b]]
====== i. Patient Summary Record ======
====== i. Patient Summary 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]]

Revision as of 20:19, 27 January 2010

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