E9-31216
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
Contents
- 1 Title Page
- 2 Header
- 3 Summary
- 4 DATES:
- 5 ADDRESSES:
- 6 Inspection of Public Comments:
- 7 Docket:
- 8 FOR FURTHER INFORMATION CONTACT:
- 9 SUPPLEMENTARY INFORMATION:
- 10 Table of Contents
- 10.1 I. Background
- 10.1.1 A. ONC Background
- 10.1.2 B. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements and Related Activities
- 10.1.2.1 1. Medicare and Medicaid EHR Incentive Programs Proposed Rule
- 10.1.2.2 2. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule Accounting of Disclosures Regulation
- 10.1.2.3 3. Previous Recognition of Certification Bodies and New Authority Under the HITECH Act
- 10.1.2.4 4. Other HHS Regulatory Actions
- 10.1.3 C. Standards, Implementation Specifications, and Certification Criteria Processes Before and After the HITECH Act
- 10.1.4 D. Future Updates to Standards, Implementation Specifications, and Certification Criteria
- 10.2 II. Overview of the Interim Final Rule
- 10.3 III. Section-By-Section Description of the Interim Final Rule
- 10.3.1 A. Applicability
- 10.3.2 B. Definitions
- 10.3.2.1 1. Definition of Standard
- 10.3.2.2 2. Definition of Implementation Specification
- 10.3.2.3 3. Definition of Certification Criteria
- 10.3.2.4 4. Definition of Qualified Electronic Health Record (EHR)
- 10.3.2.5 5. Definition of EHR Module
- 10.3.2.6 6. Definition of Complete EHR
- 10.3.2.7 7. Definition of Certified EHR Technology
- 10.3.2.8 8. Definition of Disclosure
- 10.3.3 C. Initial Set of Standards, Implementation Specifications, and Certification Criteria
- 10.3.3.1 1. Adopted Certification Criteria
- 10.3.3.2 2. Adopted Standards
- 10.3.3.2.1 a. Transport Standards
- 10.3.3.2.2 b. Content Exchange and Vocabulary Standards
- 10.3.3.2.2.1 i. Patient Summary Record
- 10.3.3.2.2.2 ii. Drug Formulary Check
- 10.3.3.2.2.3 iii. Electronic Prescribing
- 10.3.3.2.2.4 iv. Administrative Transactions
- 10.3.3.2.2.5 v. Quality Reporting
- 10.3.3.2.2.6 vi. Submission of Lab Results to Public Health Agencies
- 10.3.3.2.2.7 vii. Submission to Public Health Agencies for Surveillance or Reporting
- 10.3.3.2.2.8 viii. Submission to Immunization Registries
- 10.3.3.2.2.9 ix. Table 2A
- 10.3.3.2.3 c. Privacy and Security Standards
- 10.3.3.3 3. Adopted Implementation Specifications
- 10.3.3.4 4. Additional Considerations, Clarifications, and Requests for Public Comments
- 10.4 IV. Collection of Information Requirements
- 10.5 V. Regulatory Impact Analysis
- 10.1 I. Background
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
A. ONC Background
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
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
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
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
