Proposed Establishment of Certification Programs for Health Information Technology Notice of Proposed Rulemaking HIT Policy Committee Presentation
Jan 14, 2016
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
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5 Certified HIT Products List
NVLAP-Accredited Testing
Laboratories
NVLAP
ONC-AA
Approve
s
Accredits
Accredit
s