HIT Policy Committee Presentation
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Proposed Establishment of Certification Programs for Health Information Technology Notice of Proposed Rulemaking HIT Policy Committee Presentation
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Proposed Establishment of Certification Programs for Health Information Technology Notice of Proposed Rulemaking. HIT Policy Committee Presentation. How Does All This Work?. “Meaningful User of Certified EHR Technology”. =. Meaningful Use Regulations. - PowerPoint PPT Presentation
Transcript of HIT Policy Committee Presentation
Proposed Establishment of Certification Programs for Health Information TechnologyNotice of Proposed Rulemaking
HIT Policy Committee Presentation
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How Does All This Work?
“Meaningful User of Certified EHR Technology”
Certified Complete EHR
Combination of Certified EHR
Modules=Objectives Measures&
ONC-ATCB / ONC-ACB
Certification Criteria
Standards
EHR Modules
Complete EHRs
Correlated
Meaningful UseRegulations
Meaningful UseRegulations
HIT Certification Programs Regulations
HIT Certification Programs Regulations
HIT Standards & Certification Criteria Regulations
HIT Standards & Certification Criteria Regulations
The Basics
• §3001(c)(5) of the PHSA requires the National Coordinator in consultation with the Director of NIST to “keep or recognize a certification program or programs for the voluntary certification of HIT… such program shall include, as appropriate, testing… in accordance with §13201(b) of the HITECH Act”
• §13201(b) “…the Director of NIST shall support the establishment of a conformance testing infrastructure… may include a program to accredit independent, non-Federal laboratories to perform testing.”
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HIT Policy Committee Recommendations
• The HIT Policy Committee recommended that the certification process address the following objectives:– Focus certification on meaningful use– Leverage the certification process to improve
progress on privacy, security, and interoperability– Improve the objectivity and transparency of the
certification process– Expand certification to include a range of software
sources (e.g., open source, self-developed, etc.)– Develop a short-term certification transition plan
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Programmatic Purpose
• Establish the process for National Coordinator to “authorize” organizations to perform HIT testing and certification
• Specify how Complete EHRs and EHR Modules would be tested and certified
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Rulemaking Approach
• One NPRM – Two Final Rules– Two Proposed Programs
• Temporary Certification Program– Operational for Meaningful Use Stage 1– Anticipate publishing final rule synchronously with final rules for
meaningful use and standards and certification criteria• Permanent Certification Program
– Operational for Meaningful Use Stage 2– Anticipated final rule early fall
• Two Comment periods:– 30 days for temporary certification program proposals– 60 days for permanent certification program proposals
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Beginning of Proposed Meaningful Use Stage
Stage 1 Stage 2
QuarterQ2/10
Q3/10
Q4/10
Q1/11
Q2/11
Q3/11
Q4/11
Q1/12
Q2/12
Q3/12
Q4/12
Q1/13+
Certification Program
TemporaryPermanent
Temporary & Permanent Certification Program Proposals
• Both include an open application process– Temporary includes 2 part application
• National Coordinator serves as the accreditation organization
– Permanent includes streamlined application
• Organizations would be authorized to perform the [testing and] certification of Complete EHRs, EHR Modules, or both
• Accreditation requirements proposed for permanent certification program– National Coordinator would approve an accreditation organization
for certification bodies– NVLAP (NIST) would accredit testing laboratories
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Authorized Testing/Certification Methods
• Primary Method: ONC-ATCBs/ONC-ACBs must have the capacity to [test] and certify Complete EHRs and/or EHR Modules at their facility.
• Secondary Methods: also have the capacity to [test] and certify Complete EHRs and/or EHR Modules through some secondary means or at a secondary location.
– at the site (i.e., physical location) where a Complete EHR or EHR Module has been developed (e.g., at a Complete EHR developer’s facility); or
– at the site where the Complete EHR or EHR Module resides (e.g., at a hospital where the HIT has been installed); or
– remotely (i.e., through other means, such as through secure electronic transmissions and automated web-based tools, or at a location other than the ONC-ATCB’s facilities).
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Temporary Certification Program
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Authorize
s
ONC-Authorized Testing & Certification Bodies
Vendors/Self-Developers
National Coordinator
Tests and CertifiesComplete EHRs/EHR Modules
NIST
TestMethods
Develop
s
Permanent Certification Program
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Authorize
sNIST
National Coordinator
ONC-Authorized Certification Bodies
Vendors/Self-Developers
NVLAP-Accredited Testing
Laboratories
NVLAP
ONC-AA
Approves
Accredits
Accredit
s
[Testing] [Certification]
Tests Complete
EHRs/EHR Modules
Certifies Complete
EHRs/EHR Modules
Temporary Certification Program
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Testing:Tools/Data/Scripts
TestReport
Complete EHR/EHR Module Submitted
CertificationApplication and Agreement
Reports Certified Product Info
Publishes
Authorize
s
NIST
ONC-Authorized Testing & Certification Bodies
Vendors/Self-Developers
Technical Requirements
12 3
4
5 Certified HIT Products List
National Coordinator
Permanent Certification Program
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Technical Requirements
Testing:Tools/Data/Scripts
TestReport
Complete EHR/EHR Module Submitted
CertificationApplication and Agreement
Reports Certified Product Info
Publishes
Authorize
s
NISTNational
Coordinator
ONC-Authorized Certification Bodies
Vendors/Self-Developers
1 2 3
4
5 Certified HIT Products List
NVLAP-Accredited Testing
Laboratories
NVLAP
ONC-AA
Approve
s
Accredits
Accredit
s
