1. Proposed Establishment of Certification Programs for Health Information Technology Notice of Proposed Rulemaking HIT Standards Committee Presentation

2. 2 How Does All This Work? “Meaningful User of Certified EHR Technology” Certified Complete EHR Combination of Certified EHR Modules = ObjectivesMeasures & ONC-ATCB / ONC-ACB Certification Criteria Standards EHR Modules Complete EHRs Correlated Meaningful Use Regulations Meaningful Use Regulations HIT Certification Programs Regulations HIT Standards & Certification Criteria Regulations

3. 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

4. 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

5. 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

6. 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 6 Beginning of Proposed Meaningful Use Stage Stage 1Stage 2 Quarter Q2/ 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 Temporary Permanent

7. 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

8. 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

9. Temporary Certification Program 9 Authorizes ONC-Authorized Testing & Certification Bodies Vendors/ Self-Developers National Coordinator Tests and CertifiesComplete EHRs/EHR Modules NIST Test Methods Develops

10. Permanent Certification Program 10 Authorizes NIST National Coordinator ONC-Authorized Certification Bodies Vendors/ Self-Developers NVLAP-Accredited Testing Laboratories NVLAP ONC-AA Approves Accredits [Testing] [Certification] Tests Complete EHRs/ EHR Modules Certifies Complete EHRs/ EHR Modules

11. Temporary Certification Program 11 Testing: Tools/Data/ Procedures Test Report Complete EHR/ EHR Module Submitted Certification Application and Agreement Reports Certified Product Info Publishes Authorizes NIST ONC-Authorized Testing & Certification Bodies Vendors/ Self-Developers Technical Requirements 1 23 4 5 Certified HIT Products List National Coordinator

12. Permanent Certification Program 12 Technical Requirements Test Report Complete EHR/ EHR Module Submitted Certification Application and Agreement Reports Certified Product Info Publishes Authorizes NIST National Coordinator ONC-Authorized Certification Bodies Vendors/ Self-Developers 1 2 3 4 5 Certified HIT Products List NVLAP-Accredited Testing Laboratories NVLAP ONC-AA Approves Accredits Testing: Tools/Data/ Procedures