ehr onc final certification - Department of Health Care Services
ehr onc final certification - Department of Health Care Services ehr onc final certification - Department of Health Care Services
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 – §170.102 1. Definition of Disclosure 2. Definition of Standard 3. Definition of Implementation Specification 4. Definition of Certification Criteria Page 4 of 228
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 §§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 - §170.302 b. Specific Certification for Complete EHRs or EHR Modules Designed for an Ambulatory Setting - §170.304 c. Specific Certification for Complete EHRs or EHR Modules Designed for an Inpatient Setting - §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 Page 5 of 228
- Page 1 and 2: DEPARTMENT OF HEALTH AND HUMAN SERV
- Page 3: HHS Department of Health and Human
- Page 7 and 8: technology. Section 3004(b)(1) of t
- Page 9 and 10: esolve identified technical challen
- Page 11 and 12: Some commenters appear to have misi
- Page 13 and 14: efficiencies and desired quality im
- Page 15 and 16: codes must be used “inside” an
- Page 17 and 18: not necessarily have applied to our
- Page 19 and 20: 3. Definition of Implementation Spe
- Page 21 and 22: program established by the National
- Page 23 and 24: criteria adopted by the Secretary a
- Page 25 and 26: Comment. In the context of the defi
- Page 27 and 28: y the certification criteria for a
- Page 29 and 30: commenters asked whether we meant t
- Page 31 and 32: adopted by the Secretary. The secon
- Page 33 and 34: Response. We would like to make cle
- Page 35 and 36: Response. In the Interim Final Rule
- Page 37 and 38: could be a health care professional
- Page 39 and 40: standard for certain purposes. In s
- Page 41 and 42: e voluntary and would not be requir
- Page 43 and 44: already existing regulatory require
- Page 45 and 46: setting). We also include, where ap
- Page 47 and 48: clarification on why the number of
- Page 49 and 50: more clearly specify this capabilit
- Page 51 and 52: Response. While we do not require t
- Page 53 and 54: that check, the functionality show
RFA Regulatory Flexibility Act<br />
SNOMED-CT Systematized Nomenclature <strong>of</strong> Medicine Clinical Terms<br />
SOAP Simple Object Access Protocol<br />
UCUM Unified Code for Units <strong>of</strong> Measure<br />
UMLS Unified Medical Language System<br />
XML eXtensible Markup Language<br />
Table <strong>of</strong> Contents<br />
I. Background<br />
A. Legislative History<br />
B. Regulatory History<br />
1. Initial Set <strong>of</strong> Standards, Implementation Specifications, and Certification Criteria<br />
for EHR Technology Interim Final Rule<br />
2. Interdependencies with Other HITECH Provisions and Relationship to Other<br />
Regulatory Requirements<br />
II. Overview <strong>of</strong> the Final Rule<br />
III. Section-by-Section Discussion <strong>of</strong> the Final Rule and Response to Comments<br />
A. Introduction<br />
B. General Comments<br />
C. Definitions – §170.102<br />
1. Definition <strong>of</strong> Disclosure<br />
2. Definition <strong>of</strong> Standard<br />
3. Definition <strong>of</strong> Implementation Specification<br />
4. Definition <strong>of</strong> Certification Criteria<br />
Page 4 <strong>of</strong> 228