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Proposed Establishment of Certification Programs for Health Information Technology Notice of Proposed Rulemaking. HIT Standards Committee Presentation. How Does All This Work?. “Meaningful User of Certified EHR Technology”. =. Meaningful Use Regulations.

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

HIT Standards Committee Presentation

how does all this work
How Does All This Work?

“Meaningful User of Certified EHR Technology”

=

Meaningful Use

Regulations

HIT Certification Programs Regulations

Certified Complete EHR

Combination of Certified EHR Modules

Objectives

Measures

&

ONC-ATCB / ONC-ACB

Complete EHRs

EHR Modules

Correlated

HIT Standards & Certification Criteria Regulations

Certification Criteria

Standards

the basics
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.”
hit policy committee recommendations
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
programmatic purpose
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
rulemaking approach
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
temporary permanent certification program proposals
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
authorized testing certification methods
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).
temporary certification program
Temporary Certification Program

NIST

National Coordinator

Authorizes

Develops

Tests and Certifies

Complete EHRs/EHR Modules

ONC-Authorized

Testing & Certification Bodies

Test

Methods

Vendors/

Self-Developers

permanent certification program
Permanent Certification Program

[Testing]

[Certification]

NIST

National Coordinator

Approves

NVLAP

Authorizes

Accredits

ONC-AA

Accredits

NVLAP-Accredited Testing Laboratories

ONC-Authorized

Certification Bodies

Tests

Complete EHRs/

EHR Modules

Certifies

Complete EHRs/

EHR Modules

Vendors/

Self-Developers

10

temporary certification program1
Temporary Certification Program

Publishes

NIST

National Coordinator

5

Certified HIT Products List

Testing:

Tools/Data/

Procedures

Authorizes

Technical Requirements

Reports Certified Product Info

4

ONC-Authorized

Testing & Certification Bodies

2

Test

Report

3

Complete EHR/

EHR Module Submitted

Certification

Application and Agreement

1

Vendors/

Self-Developers

11

permanent certification program1
Permanent Certification Program

Publishes

NIST

National Coordinator

Certified HIT Products List

5

Testing:

Tools/Data/

Procedures

NVLAP

Approves

Technical Requirements

Authorizes

Accredits

ONC-AA

Reports Certified Product Info

Accredits

4

NVLAP-Accredited Testing Laboratories

ONC-Authorized

Certification Bodies

Certification

Application and Agreement

Complete EHR/

EHR Module Submitted

Test

Report

3

2

1

Vendors/

Self-Developers

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