1. Certification Commission for Healthcare Information Technology CCHIT Update Alisa Ray, Executive Director, CCHIT Jan 16, 2007 IHE Connectathon Chicago, IL

2. © 2006 | Slide 2 | 1/16/2007 Topics Brief Introduction to CCHIT Update: Certification Development Update: Certification Program Summary Q & A

3. Certification Commission for Healthcare Information Technology Brief Introduction to CCHIT

4. © 2006 | Slide 4 | 1/16/2007 Mission and Milestones Mission: accelerate the adoption of robust, interoperable health IT Reduce the risks of investing in HIT Facilitate interoperability of HIT products Enhance availability of adoption incentives and regulatory relief Ensure that the privacy of personal health information is protected Mission: accelerate the adoption of robust, interoperable health IT Reduce the risks of investing in HIT Facilitate interoperability of HIT products Enhance availability of adoption incentives and regulatory relief Ensure that the privacy of personal health information is protected Milestones: Sept 2004: AHIMA, HIMSS, and the Alliance partner to launch CCHIT June 2005: AAFP, AAP, ACP and others add $325k funding support Sept 2005: CCHIT awarded 3-year, $7.5M HHS development contract May 2006: CCHIT Ambulatory EHR Criteria approved by AHIC and HHS July 2006: First CCHIT Certified sm Ambulatory EHRs released Oct 2006: HHS deems CCHIT a Recognized Certification Body Dec 2006: CCHIT becomes independent nonprofit organization Milestones: Sept 2004: AHIMA, HIMSS, and the Alliance partner to launch CCHIT June 2005: AAFP, AAP, ACP and others add $325k funding support Sept 2005: CCHIT awarded 3-year, $7.5M HHS development contract May 2006: CCHIT Ambulatory EHR Criteria approved by AHIC and HHS July 2006: First CCHIT Certified sm Ambulatory EHRs released Oct 2006: HHS deems CCHIT a Recognized Certification Body Dec 2006: CCHIT becomes independent nonprofit organization

5. © 2006 | Slide 5 | 1/16/2007 CCHIT Role within HHS Health IT Strategy Standards Harmonization Contractor CCHIT: Compliance Certification Contractor Privacy/Security Solutions Contractor Office of the National Coordinator Project Officers American Health Information Community Chaired by HHS Secretary Mike Leavitt NHIN Prototype Contractors Harmonized Standards Network Architecture Privacy Policies Governance and Consensus Process Engaging Public and Private Sector Stakeholders Certification Criteria + Inspection Process for EHRs and Networks Strategic Direction + Breakthrough Use Cases Accelerated adoption of robust, interoperable, privacy-enhancing Health IT

6. Certification Commission for Healthcare Information Technology Update: Certification Development

7. © 2006 | Slide 7 | 1/16/2007 Scope of Work Under HHS Contract Phase I (Oct 05 – Sep 06) –Develop, pilot test, and assess certification of EHR products for ambulatory care settings Phase II (Oct 06 – Sep 07) –Develop, pilot test, and assess certification of EHR products for inpatient care settings Phase III (Oct 07 – Sep 08) –Develop, pilot test, and assess certification of infrastructure or network components through which EHRs interoperate Scope Expansion (effective Oct 06) –Address specialized EHR needs Concurrent effort (April 06 – Sep 08) –Transition to become an independent, self-sustaining organization

8. © 2006 | Slide 8 | 1/16/2007 Development Timeline Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3 2006 2005 2007 2008 Develop, publish proposed criteria Pilot test and publish report Develop, publish proposed inspection process Develop, publish proposed criteria Ambulatory EHR Domain (Update for 2006-07) Inpatient EHR Domain (New for 2006-07) Network Domain (Starts in 2007-08) Pilot test & publish report Final comments, begin certification Update criteria, roadmap; publish Pilot test as needed; publish report Update inspection process; publish Final comments, apply updated criteria Preliminary data-gathering Develop, publish proposed ins. proc. We are here: Preparing for Ambulatory Pilot Test Replanning Inpatient schedule Developing specialty expansion roadmap Initiating data-gathering on networks

9. © 2006 | Slide 9 | 1/16/2007 Update: Inpatient EHR Certification Development Inpatient systems much more complex than ambulatory Modular approach First modules to be certified: CPOE and eMAR Core HIS/CIS probably next Interoperability requirement: functional integration to pharmacy and Core HIS/CIS must be demonstrated –Pharmacy and Core HIS/CIS can be same vendors application, other vendors application, or simulation –Demonstration can be at vendors facility or at customer site -- vendors choice Schedule delayed ~3 months – probable launch July/Aug

10. © 2006 | Slide 10 | 1/16/2007 Update: Specialized EHR Certification Development Core Criteria Specialty A Additional Criteria Setting M Additional Criteria Population X Additional Criteria Concept: –Core Criteria with Additional Criteria serving particular specialties, settings, or populations –All EHRs certify to core criteria; vendors choose which additional sets to certify against –Full transparency on CCHIT website Status –Environmental scan input complete –Commission will publish draft specialty roadmap –Public comment Feb 2007 –Begin development for 2-3 specialties during 2007

11. Certification Commission for Healthcare Information Technology Update: Certification Program

12. © 2006 | Slide 12 | 1/16/2007 Certification Program All requirements published well in advance: –Functionality Criteria –Interoperability Criteria –Security Criteria –Test Scripts –Interoperability Practice Test Files Vendors apply, complete documentation requirements, and receive an inspection date Multiple fail-safe mechanisms Appeals process is available

13. © 2006 | Slide 13 | 1/16/2007 Certification Flowchart Flowchart from CCHIT Certification Handbook (available at www.cchit.org)

14. © 2006 | Slide 14 | 1/16/2007 Functionality Inspection: Jury-Observed Demonstration Vendor personnel follow Test Script to demonstrate system at the vendor facility Juror A (Practicing physician) Juror B Juror C Web conferencing (gotomeeting.com) and concurrent audio conferencing CCHIT Proctor

15. © 2006 | Slide 15 | 1/16/2007 Security Inspection: Demonstration + Self-Attestation Vendor personnel follow Test Script to demonstrate system at the vendor facility Juror D (IT/Security Expert) Web conferencing (gotomeeting.com) and concurrent audio conferencing CCHIT Proctor Juror D (IT/Security Expert) also reviews self-attestation material offline, calls or emails vendor as needed for additional documentation

16. © 2006 | Slide 16 | 1/16/2007 Interoperability Inspection: Demonstration + Self-Attestation Vendor imports Test Files during live demonstration Jurors confirm that result data appears correctly in the record CCHIT Proctor Vendor self-attests to ePrescribing standards compliance (certification by RxHub or SureScripts fulfills requirement) CCHIT staff reviews documentation and verifies valid certification by RxHub or SureScripts Vendor receives official Lab Result Test Files as test begins

17. © 2006 | Slide 17 | 1/16/2007 Current Status of Certification Program Certification Year Certification Quarter Application Window Announcement 2006 Ambulatory EHRs 1stMay 3-12, 2006 22 Certifications Announced 2ndAug 1-14, 2006 11 Certifications Announced 3rd Nov 1-14, 2006 29 Applications Jan 2007 4thFeb 1-14, 2007Apr 2007 2007 Ambulatory EHRs 1stMay 1-14, 2007July 2007

18. © 2006 | Slide 18 | 1/16/2007 Evidence of Certification Impact on HIT Adoption Official recognition/deeming of CCHIT by HHS/AHIC Stark and Anti-Kickback safe harbors require certification of donated EHRs Physician community: certification endorsed by AAFP, AAP, ACP, MGMA, AEP, and Physicians Foundations Evidence that communications efforts reaching physicians in their practices and influencing buying decisions High interest from specialties in expanding EHR certification to their areas

19. Certification Commission for Healthcare Information Technology Summing Up

20. © 2006 | Slide 20 | 1/16/2007 Summary An independent, nonprofit initiative to accelerate the adoption of robust, interoperable HIT Building a reputation for transparency, credibility, integrity Successful launch of Ambulatory EHR certification Officially recognized by HHS; certification required for EHR donations under Stark/AKA safe harbor Next challenges: –Deliver on our commitment to launch inpatient EHR certification in 2007 –Expand certification to specialties / special settings –Establish relationships with emerging networks, learn their challenges, and determine how CCHIT can deliver value

21. Thank You! Q & A For more information: www.cchit.org