Establishment of HIT Certification Programs & Meaningful Use Regulations

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

2. 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

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.”

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

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

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

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

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).

9. 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

10. 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

11. 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

12. 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