Report on Certification NPRM by HC120808065258

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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”
                                                             Combination of
     Meaningful Use
 Objectives & Measures
       Regulations
                                         Certified
                                       Complete EHR    =      Certified EHR
                                                                Modules
                                          HIT Certification Programs
                                                 Regulations

                                               ONC-ATCB / ONC-ACB

             Correlated        Certification
                                                       Complete        EHR
                               Criteria
                                  HIT Standards &
                                       Standards      Certification Criteria
                                                         EHRs        Modules
                                               Regulations

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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.”
                                                   3
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


                                                          4
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




                                                  5
    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
 Beginning of Proposed
                                         Stage 1                                         Stage 2
 Meaningful Use Stage
                            Q2/   Q3/   Q4/   Q1/   Q2/   Q3/   Q4/   Q1/   Q2/   Q3/   Q4/   Q1/
        Quarter
                            10    10    10    11    11    11    11    12    12    12    12    13+
Certification   Temporary
 Program        Permanent

    • Two Comment periods:
         – 30 days for temporary certification program proposals
         – 60 days for permanent certification program proposals
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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
                                                                   7
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).



                                                                           8
Temporary Certification Program

                        National
 NIST
                       Coordinator




                             Authorizes
   Develops




 Test                ONC-Authorized
Methods       Testing & Certification Bodies

                              Tests and Certifies
                              Complete EHRs/EHR Modules

                        Vendors/
                     Self-Developers

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Permanent Certification Program
                  [Testing]                  [Certification]
                                                    National
                 NIST
                                                   Coordinator
  NVLAP
                                      Approves




                                                                  Authorizes
     Accredits




                                           ONC-AA
                                      Accredits

    NVLAP-Accredited                             ONC-Authorized
   Testing Laboratories                         Certification Bodies

         Tests                                        Certifies
     Complete EHRs/                                Complete EHRs/
      EHR Modules                                   EHR Modules
                                 Vendors/
                              Self-Developers
                                                                               10
 Temporary Certification Program
                                                             Publishes

   NIST
                                   National                      5       Certified HIT
                                  Coordinator                            Products List
           Testing:
           Tools/Data/Scripts




                                   Authorizes
             Technical
           Requirements                                   Reports Certified
                                                      4   Product Info
                 ONC-Authorized
          Testing & Certification Bodies


Complete EHR/        2   Test                   3   Certification
EHR Module               Report                     Application and Agreement
Submitted
            1
                        Vendors/
                     Self-Developers

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 Permanent Certification Program
                                                                     Publishes
                                        National                                 Certified HIT
      NIST          Testing:           Coordinator                       5       Products List
                    Tools/Data/
 NVLAP




                                       Approves
                    Scripts




                                                        Authorizes
                  Technical
                Requirements
    Accredits




                                      ONC-AA
                                                                         Reports Certified
                                                                     4   Product Info
                                       Accredits

   NVLAP-Accredited                ONC-Authorized
  Testing Laboratories            Certification Bodies

Complete EHR/                Test                     Certification
EHR Module               2                        3   Application and Agreement
Submitted
              1              Report

                            Vendors/
                         Self-Developers
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