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2015 Edition Proposed Rule
Modifications to the
ONC Health IT Certification Program and
2015 Edition Health IT Certification Criteria
Health IT Goals
1
USER/MARKET RELIABILITY
INTEROPERABILITY
SUPPORTING THE CARE CONTINUUM
ACCESS
Supporting Health IT Goals Through
the 2015 Edition
2
INTEROPERABILITY
• New and Updated vocabulary and
content standards for the
structured recording and
exchange of health information
(including the Common Clinical
Data Set)
• Transitions of Care
Both versions of the
Consolidated CDA (Release 1.1
and Release 2.0) + Edge Protocol
 Rigorously testing C-CDA
creation, templates, vocabulary
codes; and XDM processing
3
Base EHR Capabilities Certification Criteria
Includes patient demographic
and clinical health
information, such as medical
history and problem lists
Demographics, Problem List, Medication List, Medication Allergy List,
Smoking, and Implantable Device List
Capacity to provide clinical
decision support
Clinical Decision Support
Capacity to support physician
order entry
Computerized Provider Order Entry
Capacity to capture and query
information relevant to health
care quality
Clinical Quality Measures (CQMs)- record and export
Capacity to exchange
electronic health information
with, and integrate such
information from other
sources
Transitions of Care, Data Portability, Application Access to Common
Clinical Data Set, and [“Direct” or “Direct, Edge Protocol, and
XDR/XDM”]
2015 Base EHR Definition
Focuses on the functionalities that all users of certified Health
IT should minimally possess consistent with the HITECH Act requirements.
INTEROPERABILITY
• The Common Clinical Data Set includes key health
data that should be exchanged using specified
vocabulary standards and code sets as applicable
4
Patient name Lab values/results
Sex Vital signs
Date of birth Procedures
Race Care team members
Ethnicity Immunizations
Preferred language Unique device identifiers for
implantable devices
Problems Assessment and plan of treatment
Medications Goals
Medication allergies Health concerns
Lab tests
2015-2017
Send,
receive, find
and use a
common
clinical data
set to
improve
health and
health care
quality.
ONC Interoperability
Roadmap Goal
INTEROPERABILITY ACCESS
• The 2015 Edition also proposes that Common Clinical Data Set be available
for additional use cases, including data portability, VDT and API.
5
View, download, and
transmit
Respond to application
programming interface
(API) requests for data
ACCESS
Data Portability
• Privacy and Security
• Patient Safety
• Surveillance and Certification
Maintenance
• Transparency
6
USER/MARKET RELIABILITY
Supporting the
Broader Care Continuum
• Current: Prior editions were adopted with a specific focus on the
EHR Incentive Programs
• Proposed: A more accessible ONC Health IT Certification Program
supportive of:
 Diverse health IT systems, including but not limited to EHR technology (“Health
IT Module” instead of “EHR Module”)
 Health IT across the care continuum, including long-term and post acute care
settings
• “Available/Optional” certification criteria, including supporting
health disparities:
 Exchange of sensitive health information (data segmentation for privacy)
 Record of social, psychological, and behavioral data
 Laboratory exchange
 Care plan
7
SUPPORTING THE CARE CONTINUUM
A number of programs currently use or propose to use
the ONC Health IT Certification Program. Here are a few:
• Physician Self-Referral Law exception and Anti-kickback
Statute safe harbor for certain EHR donations
• CMS chronic care management services
• Department of Defense Healthcare Management System
Modernization Program
• The Joint Commission for participation as ORYX vendor –
eCQMs for hospitals
8
SUPPORTING THE CARE CONTINUUM
When and How to Comment
• ONC published the 2015 Edition Proposed Rule in the Federal Register
on March 30, 2015
• The comment period is open until May 29, 2015
• You can review the proposed rule and comment here:
http://www.regulations.gov/#!documentDetail;D=HHS_FRDOC_0001-
0572
• To assist in commenting on the rule, ONC provides a:
 Microsoft Word version of the rule
(http://www.healthit.gov/sites/default/files/2015_editionnprm_ofr_disclai
mer_3-20-15.docx); and
 Public Comment Template
(http://www.healthit.gov/sites/default/files/2015editionnprm_public_com
ment_template_4-1-15_final508_.docx)
9

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2015 Edition Proposed Rule Modifications to the ONC Health IT Certification Program and 2015 Edition Health IT Certification Criteria

  • 1. 2015 Edition Proposed Rule Modifications to the ONC Health IT Certification Program and 2015 Edition Health IT Certification Criteria
  • 2. Health IT Goals 1 USER/MARKET RELIABILITY INTEROPERABILITY SUPPORTING THE CARE CONTINUUM ACCESS
  • 3. Supporting Health IT Goals Through the 2015 Edition 2 INTEROPERABILITY • New and Updated vocabulary and content standards for the structured recording and exchange of health information (including the Common Clinical Data Set) • Transitions of Care Both versions of the Consolidated CDA (Release 1.1 and Release 2.0) + Edge Protocol  Rigorously testing C-CDA creation, templates, vocabulary codes; and XDM processing
  • 4. 3 Base EHR Capabilities Certification Criteria Includes patient demographic and clinical health information, such as medical history and problem lists Demographics, Problem List, Medication List, Medication Allergy List, Smoking, and Implantable Device List Capacity to provide clinical decision support Clinical Decision Support Capacity to support physician order entry Computerized Provider Order Entry Capacity to capture and query information relevant to health care quality Clinical Quality Measures (CQMs)- record and export Capacity to exchange electronic health information with, and integrate such information from other sources Transitions of Care, Data Portability, Application Access to Common Clinical Data Set, and [“Direct” or “Direct, Edge Protocol, and XDR/XDM”] 2015 Base EHR Definition Focuses on the functionalities that all users of certified Health IT should minimally possess consistent with the HITECH Act requirements. INTEROPERABILITY
  • 5. • The Common Clinical Data Set includes key health data that should be exchanged using specified vocabulary standards and code sets as applicable 4 Patient name Lab values/results Sex Vital signs Date of birth Procedures Race Care team members Ethnicity Immunizations Preferred language Unique device identifiers for implantable devices Problems Assessment and plan of treatment Medications Goals Medication allergies Health concerns Lab tests 2015-2017 Send, receive, find and use a common clinical data set to improve health and health care quality. ONC Interoperability Roadmap Goal INTEROPERABILITY ACCESS
  • 6. • The 2015 Edition also proposes that Common Clinical Data Set be available for additional use cases, including data portability, VDT and API. 5 View, download, and transmit Respond to application programming interface (API) requests for data ACCESS Data Portability
  • 7. • Privacy and Security • Patient Safety • Surveillance and Certification Maintenance • Transparency 6 USER/MARKET RELIABILITY
  • 8. Supporting the Broader Care Continuum • Current: Prior editions were adopted with a specific focus on the EHR Incentive Programs • Proposed: A more accessible ONC Health IT Certification Program supportive of:  Diverse health IT systems, including but not limited to EHR technology (“Health IT Module” instead of “EHR Module”)  Health IT across the care continuum, including long-term and post acute care settings • “Available/Optional” certification criteria, including supporting health disparities:  Exchange of sensitive health information (data segmentation for privacy)  Record of social, psychological, and behavioral data  Laboratory exchange  Care plan 7 SUPPORTING THE CARE CONTINUUM
  • 9. A number of programs currently use or propose to use the ONC Health IT Certification Program. Here are a few: • Physician Self-Referral Law exception and Anti-kickback Statute safe harbor for certain EHR donations • CMS chronic care management services • Department of Defense Healthcare Management System Modernization Program • The Joint Commission for participation as ORYX vendor – eCQMs for hospitals 8 SUPPORTING THE CARE CONTINUUM
  • 10. When and How to Comment • ONC published the 2015 Edition Proposed Rule in the Federal Register on March 30, 2015 • The comment period is open until May 29, 2015 • You can review the proposed rule and comment here: http://www.regulations.gov/#!documentDetail;D=HHS_FRDOC_0001- 0572 • To assist in commenting on the rule, ONC provides a:  Microsoft Word version of the rule (http://www.healthit.gov/sites/default/files/2015_editionnprm_ofr_disclai mer_3-20-15.docx); and  Public Comment Template (http://www.healthit.gov/sites/default/files/2015editionnprm_public_com ment_template_4-1-15_final508_.docx) 9