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Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology
[July 28, 2010]

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


Jul 28, 2010 (Health and Human Services Department Documents and Publications/ContentWorks via COMTEX) -- SUMMARY: The Department of Health and Human Services (HHS) is issuing this final rule to complete the adoption of an initial set of standards, implementation specifications, and certification criteria, and to more closely align such standards, implementation specifications, and certification criteria with final meaningful use Stage 1 objectives and measures. Adopted certification criteria establish the required capabilities and specify the related standards and implementation specifications that certified electronic health record (EHR) technology will need to include to, at a minimum, support the achievement of meaningful use Stage 1 by eligible professionals, eligible hospitals, and/or critical access hospitals (hereafter, references to "eligible hospitals" in this final rule shall mean "eligible hospitals and/or critical access hospitals") under the Medicare and Medicaid EHR Incentive Programs. Complete EHRs and EHR Modules will be tested and certified according to adopted certification criteria to ensure that they have properly implemented adopted standards and implementation specifications and otherwise comply with the adopted certification criteria.



DATES: Effective Date: This final rule is effective August 27, 2010. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of August 27, 2010.

FOR FURTHER INFORMATION CONTACT: Steven Posnack, Director, Federal Policy Division, Office of Policy and Planning, Office of the National Coordinator for Health Information Technology, 202-690-7151.


SUPPLEMENTARY INFORMATION: Acronyms ANSI American National Standards Institute 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 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 International Classification of Diseases, 9th Revision, Clinical Modification ICD-10-PCS International Classification of Diseases, 10th Revision, Procedure Coding System ICD-10-CM International Classification of Diseases, 10th Revision, Clinical Modification IHS Indian Health Service LOINC Logical Observation Identifiers Names and Codes NCPDP National Council for Prescription Drug Programs NLM National Library of Medicine OCR Office for Civil Rights 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 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 XML eXtensible Markup Language Table of Contents I. Background A. Legislative History B. Regulatory History 1. Initial Set of Standards, Implementation Specifications, and Certification Criteria for EHR Technology Interim Final Rule 2. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements II. Overview of the Final Rule III. Section-by-Section Discussion of the Final Rule and Response to Comments A. Introduction B. General Comments C. Definitions-- SEC 170.102 1. Definition of Disclosure 2. Definition of Standard 3. Definition of Implementation Specification 4. Definition of Certification Criteria 5. Definition of Qualified EHR 6. Definition of Complete EHR 7. Definition of EHR Module 8. Definition of Certified EHR Technology 9. Definition of Human Readable Format 10. Definition of User D. Final Rule Amendments to Adopted Standards, Implementation Specifications, and Certification Criteria SUBSEC 170.202, 170.205, 170.207, 170.210, 170.302, 170.304, 170.306 1. Flexibility and Innovation 2. Transport Standards 3. Certification Criteria and Associated Standards and Implementation Specifications a. General Certification for Complete EHRs or EHR Modules-- SEC 170.302 b. Specific Certification for Complete EHRs or EHR Modules Designed for an Ambulatory Setting-- SEC 170.304 c. Specific Certification for Complete EHRs or EHR Modules Designed for an Inpatient Setting-- SEC 170.306 d. Adoption and Realignment of Certification Criteria to Support the Final Requirements for Meaningful Use Stage 1.

E. Additional Comments F. Comments Beyond the Scope of This Final Rule IV. Collection of Information Requirements V. Regulatory Impact Analysis A. Introduction B. Why is this rule needed? C. Executive Order 12866--Regulatory Planning and Review Analysis 1. Comment and Response 2. Executive Order 12866 Final Analysis a. Costs b. Benefits D. Regulatory Flexibility Act Analysis 1. Comment and Response 2. Final RFA Analysis E. Executive Order 13132--Federalism Regulation Text I. Background A. Legislative History The Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5), was enacted on February 17, 2009. The HITECH Act amended the Public Health Service Act (PHSA) and established "Title XXX--Health Information Technology and Quality" to improve health care quality, safety, and efficiency through the promotion of health information technology (HIT) and the electronic exchange of health information. Section 3004(b)(1) of the PHSA requires the Secretary of Health and Human Services (the Secretary) to adopt an initial set of standards, implementation specifications, and certification criteria by December 31, 2009 to enhance the interoperability, functionality, utility, and security of health information technology. Section 3004(b)(1) of the PHSA also permits the Secretary to adopt the initial set of standards, implementation specifications, and certification criteria on an interim, final basis.

B. Regulatory History 1. Initial Set of Standards, Implementation Specifications, and Certification Criteria for EHR Technology Interim Final Rule On December 30, 2009, the Federal Register made available for public inspection, an interim final rule (the Interim Final Rule) with a request for comments, which adopted an initial set of standards, implementation specifications, and certification criteria. As noted in this rulemaking (75 FR 2014), we described how Congress fundamentally tied the adopted standards, implementation specifications, and certification criteria to the incentives available under the Medicare and Medicaid EHR Incentive Programs by requiring the meaningful use of Certified EHR Technology. Congress outlined several goals for meaningful use, one of which included the "use of certified EHR technology in a meaningful manner." This means that to qualify for incentives, an eligible professional or eligible hospital must both adopt Certified EHR Technology and demonstrate meaningful use of this technology.

The initial set of standards, implementation specifications, and certification criteria adopted in the Interim Final Rule established the capabilities that Certified EHR Technology would need to include to, at a minimum, support eligible professionals' and eligible hospitals' efforts to achieve what had been proposed for meaningful use Stage 1 under the Medicare and Medicaid EHR Incentive Programs proposed rule.

2. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements --This is a summary of a Federal Register article originally published on the page number listed below-- Final rule.

CFR Part: "45 CFR Part 170" RIN Number: "RIN 0991-AB58" Citation: "75 FR 44590" Federal Register Page Number: "44590" "Rules and Regulations"

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