E9-31216 - Revision history

NeilArmstrong: Added a glossary link to Action~

2012-07-29T18:07:20Z

Added a glossary link to Action~

← Older revision		Revision as of 18:07, 29 July 2012
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	Technology, Department of Health and		Technology, Department of Health and
	Human Services.		Human Services.
	ACTION: Interim final rule.		[[ACTION~\|Action]]: Interim final rule.

	== Summary ==		== Summary ==

NeilArmstrong: Added a glossary link to record~

2012-04-01T09:56:12Z

Added a glossary link to record~

← Older revision		Revision as of 09:56, 1 April 2012
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	of Standards, Implementation		of Standards, Implementation
	Specifications, and Certification Criteria		Specifications, and Certification Criteria
	for Electronic Health Record Technology;		for Electronic Health [[Record~\|Record]] Technology;
	Interim Final Rule		Interim Final Rule

Line 22:		Line 22:
	RIN 0991–AB58		RIN 0991–AB58

	Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology		Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health [[Record~\|Record]] Technology

	AGENCY: Office of the National		AGENCY: Office of the National
Line 36:		Line 36:
	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.		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.		The certification criteria adopted in this initial set establish the capabilities and related standards that certified electronic health [[record~\|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: ==		== DATES: ==

DavidWhitten at 20:57, 27 January 2010

2010-01-27T20:57:51Z

← Older revision		Revision as of 20:57, 27 January 2010
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	This is an electronic, ~~anotated~~ copy of a document available at:		This is an electronic, annotated copy of a document available at:
	http://edocket.access.gpo.gov/2010/pdf/E9-31216.pdf		http://edocket.access.gpo.gov/2010/pdf/E9-31216.pdf and at
			http://edocket.access.gpo.gov/2010/E9-31216.htm

	== Title Page ==		== Title Page ==

DavidWhitten: /* Table of Contents */

2010-01-27T20:12:54Z

Table of Contents

← Older revision		Revision as of 20:12, 27 January 2010
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	{{:E9-31216 Acronyms}}		{{:E9-31216 Acronyms}}

	~~= Table of Contents =~~		{{:E9-31216 TOC}}
	~~== 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 ===~~

DavidWhitten: /* Acronyms */

2010-01-27T20:10:25Z

Acronyms

@@ Line 105: / Line 105: @@
 == SUPPLEMENTARY INFORMATION: ==
-=== Acronyms ===
+{{:E9-31216 Acronyms}}
 = Table of Contents =

DavidWhitten at 20:09, 27 January 2010

2010-01-27T20:09:00Z

← Older revision		Revision as of 20:09, 27 January 2010
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	:eXtensible Markup Language		:eXtensible Markup Language

	== Table of Contents ==		= Table of Contents =
	=== I. Background ===		== I. Background ==
	==== A. ONC 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 ===
	===== 1. Medicare and Medicaid EHR Incentive Programs Proposed Rule =====		==== 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 =====		==== 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 =====		==== 3. Previous Recognition of Certification Bodies and New Authority Under the HITECH Act ====
	===== 4. Other HHS Regulatory Actions =====		==== 4. Other HHS Regulatory Actions ====
	====== 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 =====
	====== b. Electronic Prescribing Standards ======		===== b. Electronic Prescribing Standards =====
	==== 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 ===
	===== 1. ONC’s Processes Prior to 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 =====		==== 2. HITECH Act Requirements for the Adoption of Standards, Implementation Specifications, and Certification Criteria ====
			=== D. Future Updates to Standards, Implementation Specifications, and Certification Criteria ===
	==== D. Future Updates to Standards, Implementation Specifications, and Certification Criteria ====		== II. Overview of the Interim Final Rule ==
	=== II. Overview of the Interim Final Rule ===		== III. Section-By-Section Description of the Interim Final Rule ==
	=== III. Section-By-Section Description of the Interim Final Rule ===		=== A. Applicability ===
	==== A. Applicability ====		=== B. Definitions ===
	==== B. Definitions ====		==== 1. Definition of Standard ====
	===== 1. Definition of Standard =====		==== 2. Definition of Implementation Specification ====
	===== 2. Definition of Implementation Specification =====		==== 3. Definition of Certification Criteria ====
	===== 3. Definition of Certification Criteria =====		==== 4. Definition of Qualified Electronic Health Record (EHR) ====
	===== 4. Definition of Qualified Electronic Health Record (EHR) =====		==== 5. Definition of EHR Module ====
	===== 5. Definition of EHR Module =====		==== 6. Definition of Complete EHR ====
	===== 6. Definition of Complete EHR =====		==== 7. Definition of Certified EHR Technology ====
	===== 7. Definition of Certified EHR Technology =====		==== 8. Definition of Disclosure ====
	===== 8. Definition of Disclosure =====		=== C. Initial Set of Standards, Implementation Specifications, and Certification Criteria ===
	==== C. Initial Set of Standards, Implementation Specifications, and Certification Criteria ====		==== 1. Adopted Certification Criteria ====
	===== 1. Adopted Certification Criteria =====		==== 2. Adopted Standards ====
	===== 2. Adopted Standards =====		===== a. Transport Standards =====
	====== a. Transport Standards ======		===== b. Content Exchange and Vocabulary Standards =====
	====== b. Content Exchange and Vocabulary Standards ======		====== i. Patient Summary Record ======
	======= i. Patient Summary Record =======		====== ii. Drug Formulary Check ======
	======= ii. Drug Formulary Check =======		====== iii. Electronic Prescribing ======
	======= iii. Electronic Prescribing =======		====== iv. Administrative Transactions ======
	======= iv. Administrative Transactions =======		====== v. Quality Reporting ======
	======= v. Quality Reporting =======		====== vi. Submission of Lab Results to Public Health Agencies ======
	======= vi. Submission of Lab Results to Public Health Agencies =======		====== vii. Submission to Public Health Agencies for Surveillance or Reporting ======
	======= vii. Submission to Public Health Agencies for Surveillance or Reporting =======		====== viii. Submission to Immunization Registries ======
	======= viii. Submission to Immunization Registries =======		====== ix. Table 2A ======
	======= ix. Table 2A =======		===== c. Privacy and Security Standards =====
	====== c. Privacy and Security Standards ======		==== 3. Adopted Implementation Specifications ====
	===== 3. Adopted Implementation Specifications =====		==== 4. Additional Considerations, Clarifications, and Requests for Public Comments ====
	===== 4. Additional Considerations, Clarifications, and Requests for Public Comments =====		===== a. Relationship to Other Federal Laws =====
	====== a. Relationship to Other Federal Laws ======		===== b. Human Readable Format =====
	====== b. Human Readable Format ======		===== c. Certification Criterion and Standard Regarding Accounting of Disclosures =====
	====== c. Certification Criterion and Standard Regarding Accounting of Disclosures ======		===== d. Additional Requests for Public Comment =====
	====== d. Additional Requests for Public Comment ======		== IV. Collection of Information Requirements ==
	=== IV. Collection of Information Requirements ===		== V. Regulatory Impact Analysis ==
	=== V. Regulatory Impact Analysis ===		=== A. Introduction ===
	==== A. Introduction ====		=== B. Why Is This Rule Needed? ===
	==== B. Why Is This Rule Needed? ====		=== C. Costs and Benefits ===
	==== C. Costs and Benefits ====		==== 1. Costs ====
	===== 1. Costs =====		==== 2. Benefits ====
	===== 2. Benefits =====		=== D. Regulatory Flexibility Act Analysis ===
	==== D. Regulatory Flexibility Act Analysis ====		=== E. Executive Order 13132—Federalism ===
	==== E. Executive Order 13132—Federalism ====		=== F. Unfunded Mandates Reform Act of 1995 Regulation Text ===
	==== F. Unfunded Mandates Reform Act of 1995 Regulation Text ====

DavidWhitten at 20:04, 27 January 2010

2010-01-27T20:04:22Z

← Older revision		Revision as of 20:04, 27 January 2010
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	==== 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 ====
	===== 1. ONC’s Processes Prior to the HITECH Act =====		===== 1. ONC’s Processes Prior to the HITECH Act =====
	===== 2. HITECH Act Requirements for the Adoption of Standards, Implementation		===== 2. HITECH Act Requirements for the Adoption of Standards, Implementation Specifications, and Certification Criteria =====
	Specifications, and Certification Criteria =====
	==== D. Future Updates to Standards, Implementation Specifications, and Certification Criteria ====		==== D. Future Updates to Standards, Implementation Specifications, and Certification Criteria ====
	=== II. Overview of the Interim Final Rule ===		=== II. Overview of the Interim Final Rule ===

DavidWhitten at 19:59, 27 January 2010

2010-01-27T19:59:33Z

← Older revision		Revision as of 19:59, 27 January 2010
Line 204:		Line 204:
	;XML		;XML
	:eXtensible Markup Language		: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 ====
			===== 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 ====

DavidWhitten at 19:48, 27 January 2010

2010-01-27T19:48:58Z

Show changes

DavidWhitten at 19:27, 27 January 2010

2010-01-27T19:27:20Z

New page

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

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

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.