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

E9-31216

Contents

Title Page

Header

Summary

DATES:

ADDRESSES:

Inspection of Public Comments:

Docket:

FOR FURTHER INFORMATION CONTACT:

SUPPLEMENTARY INFORMATION:

Acronyms

Table of Contents

I. Background

A. ONC Background

B. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements and Related Activities

1. Medicare and Medicaid EHR Incentive Programs Proposed Rule

2. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule Accounting of Disclosures Regulation

3. Previous Recognition of Certification Bodies and New Authority Under the HITECH Act

4. Other HHS Regulatory Actions

a. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Transactions and Code Sets Standards

b. Electronic Prescribing Standards

C. Standards, Implementation Specifications, and Certification Criteria Processes Before and After the HITECH Act

1. ONC’s Processes Prior to the HITECH Act

2. HITECH Act Requirements for the Adoption of Standards, Implementation Specifications, and Certification Criteria

D. Future Updates to Standards, Implementation Specifications, and Certification Criteria

II. Overview of the Interim Final Rule

III. Section-By-Section Description of the Interim Final Rule

A. Applicability

B. Definitions

1. Definition of Standard

2. Definition of Implementation Specification

3. Definition of Certification Criteria

4. Definition of Qualified Electronic Health Record (EHR)

5. Definition of EHR Module

6. Definition of Complete EHR

7. Definition of Certified EHR Technology

8. Definition of Disclosure

C. Initial Set of Standards, Implementation Specifications, and Certification Criteria

1. Adopted Certification Criteria

2. Adopted Standards

a. Transport Standards

b. Content Exchange and Vocabulary Standards

i. Patient Summary Record

ii. Drug Formulary Check

iii. Electronic Prescribing

iv. Administrative Transactions

v. Quality Reporting

vi. Submission of Lab Results to Public Health Agencies

vii. Submission to Public Health Agencies for Surveillance or Reporting

viii. Submission to Immunization Registries

ix. Table 2A

c. Privacy and Security Standards

3. Adopted Implementation Specifications

4. Additional Considerations, Clarifications, and Requests for Public Comments

a. Relationship to Other Federal Laws

b. Human Readable Format

c. Certification Criterion and Standard Regarding Accounting of Disclosures

d. Additional Requests for Public Comment

IV. Collection of Information Requirements

V. Regulatory Impact Analysis

A. Introduction

B. Why Is This Rule Needed?

C. Costs and Benefits

1. Costs

2. Benefits

D. Regulatory Flexibility Act Analysis

E. Executive Order 13132—Federalism

F. Unfunded Mandates Reform Act of 1995 Regulation Text

Navigation menu

Search