Proposed Establishment of Certification Programs for Health Information TechnologyNotice of Proposed Rulemaking

HIT Standards 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

10

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/Procedures

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

12

Technical Requirements

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

Testing:Tools/Data/Procedures