E9-31216 TOC: Difference between revisions
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= Table of Contents = | = Table of Contents = | ||
== I. Background == | == I. Background == | ||
[[E9-31216 I]] | |||
=== A. ONC Background === | === 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 === | ||
[[E9-31216 I B]] | |||
==== 1. Medicare and Medicaid EHR Incentive Programs Proposed Rule ==== | ==== 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 ==== | ==== 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 ==== | ==== 3. Previous Recognition of Certification Bodies and New Authority Under the HITECH Act ==== | ||
[[E9-31216 I B 3]] | |||
==== 4. Other HHS Regulatory Actions ==== | ==== 4. Other HHS Regulatory Actions ==== | ||
[[E9-31216 I B 4]] | |||
===== 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 ===== | ||
[[E9-31216 I B 4 a]] | |||
===== b. Electronic Prescribing Standards ===== | ===== b. Electronic Prescribing Standards ===== | ||
[[E9-31216 I B 4 b]] | |||
=== 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 === | ||
[[E9-31216 I C]] | |||
==== 1. ONC’s Processes Prior to 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 ==== | ==== 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 === | === D. Future Updates to Standards, Implementation Specifications, and Certification Criteria === | ||
[[E9-31216 I D]] | |||
== II. Overview of the Interim Final Rule == | == II. Overview of the Interim Final Rule == | ||
[[E9-31216 II]] | |||
== III. Section-By-Section Description of the Interim Final Rule == | == III. Section-By-Section Description of the Interim Final Rule == | ||
[[E9-31216 III]] | |||
=== A. Applicability === | === A. Applicability === | ||
[[E9-31216 III A]] | |||
=== B. Definitions === | === B. Definitions === | ||
[[E9-31216 III B]] | |||
==== 1. Definition of Standard ==== | ==== 1. Definition of Standard ==== | ||
[[E9-31216 III B 1]] | |||
==== 2. Definition of Implementation Specification ==== | ==== 2. Definition of Implementation Specification ==== | ||
[[E9-31216 III B 2]] | |||
==== 3. Definition of Certification Criteria ==== | ==== 3. Definition of Certification Criteria ==== | ||
[[E9-31216 III B 3]] | |||
==== 4. Definition of Qualified Electronic Health Record (EHR) ==== | ==== 4. Definition of Qualified Electronic Health Record (EHR) ==== | ||
[[E9-31216 III B 4]] | |||
==== 5. Definition of EHR Module ==== | ==== 5. Definition of EHR Module ==== | ||
[[E9-31216 III B 5]] | |||
==== 6. Definition of Complete EHR ==== | ==== 6. Definition of Complete EHR ==== | ||
[[E9-31216 III B 6]] | |||
==== 7. Definition of Certified EHR Technology ==== | ==== 7. Definition of Certified EHR Technology ==== | ||
[[E9-31216 III B 7]] | |||
==== 8. Definition of Disclosure ==== | ==== 8. Definition of Disclosure ==== | ||
[[E9-31216 III B 8]] | |||
=== C. Initial Set of Standards, Implementation Specifications, and Certification Criteria === | === C. Initial Set of Standards, Implementation Specifications, and Certification Criteria === | ||
[[E9-31216 III C]] | |||
==== 1. Adopted Certification Criteria ==== | ==== 1. Adopted Certification Criteria ==== | ||
[[E9-31216 III C 1]] | |||
==== 2. Adopted Standards ==== | ==== 2. Adopted Standards ==== | ||
[[E9-31216 III C 2]] | |||
===== a. Transport Standards ===== | ===== a. Transport Standards ===== | ||
[[E9-31216 III C 2 a]] | |||
===== b. Content Exchange and Vocabulary Standards ===== | ===== b. Content Exchange and Vocabulary Standards ===== | ||
[[E9-31216 III C 2 b]] | |||
====== i. Patient Summary Record ====== | ====== i. Patient Summary Record ====== | ||
[[E9-31216 III C 2 b i]] | |||
====== ii. Drug Formulary Check ====== | ====== ii. Drug Formulary Check ====== | ||
[[E9-31216 III C 2 b ii]] | |||
====== iii. Electronic Prescribing ====== | ====== iii. Electronic Prescribing ====== | ||
[[E9-31216 III C 2 b iii]] | |||
====== iv. Administrative Transactions ====== | ====== iv. Administrative Transactions ====== | ||
[[E9-31216 III C 2 b iv]] | |||
====== v. Quality Reporting ====== | ====== v. Quality Reporting ====== | ||
[[E9-31216 III C 2 b v]] | |||
====== vi. Submission of Lab Results to Public Health Agencies ====== | ====== 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 ====== | ====== vii. Submission to Public Health Agencies for Surveillance or Reporting ====== | ||
[[E9-31216 III C 2 b vii]] | |||
====== viii. Submission to Immunization Registries ====== | ====== viii. Submission to Immunization Registries ====== | ||
[[E9-31216 III C 2 b viii]] | |||
====== ix. Table 2A ====== | ====== ix. Table 2A ====== | ||
[[E9-31216 III C 2 b ix]] | |||
===== c. Privacy and Security Standards ===== | ===== c. Privacy and Security Standards ===== | ||
[[E9-31216 III C 2 c]] | |||
==== 3. Adopted Implementation Specifications ==== | ==== 3. Adopted Implementation Specifications ==== | ||
[[E9-31216 III C 3]] | |||
==== 4. Additional Considerations, Clarifications, and Requests for Public Comments ==== | ==== 4. Additional Considerations, Clarifications, and Requests for Public Comments ==== | ||
[[E9-31216 III C 4]] | |||
===== a. Relationship to Other Federal Laws ===== | ===== a. Relationship to Other Federal Laws ===== | ||
[[E9-31216 III C 4 a]] | |||
===== b. Human Readable Format ===== | ===== b. Human Readable Format ===== | ||
[[E9-31216 III C 4 b]] | |||
===== c. Certification Criterion and Standard Regarding Accounting of Disclosures ===== | ===== c. Certification Criterion and Standard Regarding Accounting of Disclosures ===== | ||
[[E9-31216 III C 4 c]] | |||
===== d. Additional Requests for Public Comment ===== | ===== d. Additional Requests for Public Comment ===== | ||
[[E9-31216 III C 4 d]] | |||
== IV. Collection of Information Requirements == | == IV. Collection of Information Requirements == | ||
[[E9-31216 IV]] | |||
== V. Regulatory Impact Analysis == | == V. Regulatory Impact Analysis == | ||
[[E9-31216 V]] | |||
=== A. Introduction === | === A. Introduction === | ||
[[E9-31216 V A]] | |||
=== B. Why Is This Rule Needed? === | === B. Why Is This Rule Needed? === | ||
[[E9-31216 V B]] | |||
=== C. Costs and Benefits === | === C. Costs and Benefits === | ||
[[E9-31216 V C]] | |||
==== 1. Costs ==== | ==== 1. Costs ==== | ||
[[E9-31216 V C 1]] | |||
==== 2. Benefits ==== | ==== 2. Benefits ==== | ||
[[E9-31216 V C 2]] | |||
=== D. Regulatory Flexibility Act Analysis === | === D. Regulatory Flexibility Act Analysis === | ||
[[E9-31216 V D]] | |||
=== E. Executive Order 13132—Federalism === | === E. Executive Order 13132—Federalism === | ||
[[E9-31216 V E]] | |||
=== F. Unfunded Mandates Reform Act of 1995 Regulation Text === | === F. Unfunded Mandates Reform Act of 1995 Regulation Text === | ||
[[E9-31216 V F]] |