Latest revision as of 18:07, 29 July 2012

This is an electronic, annotated copy of a document available at: http://edocket.access.gpo.gov/2010/pdf/E9-31216.pdf and at http://edocket.access.gpo.gov/2010/E9-31216.htm

Title Page

Part III
Department of Health and Human Services
45 CFR Part 170
Health Information Technology: Initial Set
of Standards, Implementation
Specifications, and Certification Criteria
for Electronic Health Record Technology;
Interim Final Rule

Header

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

45 CFR Part 170

RIN 0991–AB58

Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology

AGENCY: Office of the National
Coordinator for Health Information
Technology, Department of Health and
Human Services.
Action: Interim final rule.

Summary

The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comments to adopt an initial set of standards, implementation specifications, and certification criteria, as required by section 3004(b)(1) of the Public Health Service Act.

This interim final rule represents the first step in an incremental approach to adopting standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health information technology and to support its meaningful use.

The certification criteria adopted in this initial set establish the capabilities and related standards that certified electronic health Record (EHR) technology will need to include in order to, at a minimum, support the achievement of the proposed meaningful use Stage 1 (beginning in 2011) by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR Incentive Programs.

DATES:

Effective Date: This interim final rule is effective February 12, 2010. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of February 12, 2010.

Comment Date: To be assured consideration, written or electronic comments must be received at one of the addresses provided below, no later than 5 p.m. on March 15, 2010.

ADDRESSES:

Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments, identified by RIN 0991–AB58, by any of the following methods (please do not submit duplicate comments).

• Federal eRulemaking Portal:

 Follow the instructions for submitting comments.
 Attachments should be in Microsoft Word, WordPerfect, or Excel;
 however, we prefer Microsoft Word. http://www.regulations.gov.

• Regular, Express, or Overnight Mail:

 Department of Health and Human Services, 
 Office of the National Coordinator for Health Information Technology, 
 Attention: HITECH Initial Set Interim Final Rule,
 Hubert H. Humphrey Building,
 Suite 729D,
 200 Independence Ave., SW.,
 Washington, DC 20201. 

Please submit one original and two copies.

• Hand Delivery or Courier:

 Office of the National Coordinator for Health Information Technology,
 Attention: HITECH Initial Set Interim Final Rule,
 Hubert H. Humphrey Building,
 Suite 729D,
 200 Independence Ave., SW.,
 Washington, DC 20201.

Please submit one original and two copies. 
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the mail drop slots located in the main lobby of the building.)

Inspection of Public Comments:

All comments received before the close of the comment period will be available for public inspection, including any personally identifiable or confidential business information that is included in a comment.

Please do not include anything in your comment submission that you do not wish to share with the general public.

Such information includes, but is not limited to: A person’s social security number; date of birth; driver’s license number; state identification number or foreign country equivalent; passport number; financial account number; credit or debit card number; any personal health information; or any business information that could be considered to be proprietary.

We will post all comments received before the close ofthe comment period at http://www.regulations.gov.

Docket:

For access to the docket to read background documents or comments received, go to http:// www.regulations.gov

or

U.S. Department of Health and Human Services,
Office of the National Coordinator for Health Information Technology,
Hubert H. Humphrey Building, Suite 729D,
200 Independence Ave., SW.,
Washington, DC 20201
(call ahead to the contact listed below to arrange for inspection).

FOR FURTHER INFORMATION CONTACT:

Steven Posnack,
Policy Analyst,
202–690–7151.

SUPPLEMENTARY INFORMATION:

Acronyms

AHIC

American Health Information Community

ANSI

American National Standards Institute

ASP

Application Service Provider

CAH

Critical Access Hospital

CCD

Continuity of Care Document

CCHIT

Certification Commission for Health Information Technology

CCR

Continuity of Care Record

CDA

Clinical Document Architecture

CDC

Centers for Disease Control and Prevention

CFR

Code of Federal Regulations

CGD

Certification Guidance Document

CMS

Centers for Medicare & Medicaid Services

CPOE

Computerized Provider Order Entry

EHR

Electronic Health Record

FIPS

Federal Information Processing Standards

GIPSE

Geocoded Interoperable Population Summary Exchange

HHS

Department of Health and Human Services

HIPAA

Health Insurance Portability and Accountability Act of 1996

HIT

Health Information Technology

HITECH

Health Information Technology for Economic and Clinical Health

HITSP

Healthcare Information Technology Standards Panel

HL7

Health Level Seven

ICD

International Classification of Diseases

ICD–9–CM

ICD, 9th Revision, Clinical Modifications

ICD–10–PCS

ICD, 10th Revision, Procedure Coding System

ICD–10–CM

ICD, 10th Revision, Related Health Problems

IHS

Indian Health Service

LOINC

Logical Observation Identifiers Names and Codes

MA

Medicare Advantage

NCPDP

National Council for Prescription Drug Programs

NCVHS

National Committee on Vital and Health Statistics

NLM

National Library of Medicine

NQF

National Quality Forum

OASIS

Organization for the Advancement of Structured Information Standards

OCR

Office for Civil Rights

OIG

Office of Inspector General

OMB

Office of Management and Budget

ONC

Office of the National Coordinator for Health Information Technology

PHSA

Public Health Service Act

PQRI

Physician Quality Reporting Initiative

REST

Representational state transfer

RFA

Regulatory Flexibility Act

SDOs

Standards Development Organizations

SNOMED CT

Systematized Nomenclature of Medicine Clinical Terms

SOAP

Simple Object Access Protocol

UCUM

Unified Code for Units of Measure

UMLS

Unified Medical Language System

UNII

Unique Ingredient Identifier

XML

eXtensible Markup Language

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

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