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Certification Commission for Healthcare Information Technology
CCHIT Update
Alisa Ray, Executive Director, CCHIT
Jan 16, 2007
IHE Connectathon
Chicago, IL
© 2006 | Slide 2 | 1/16/2007
Topics
•Brief Introduction to CCHIT
•Update: Certification Development
•Update: Certification Program
•Summary
•Q & A
Certification Commission for Healthcare Information Technology
Brief Introductionto CCHIT
© 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 Certifiedsm 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 Certifiedsm Ambulatory EHRs released
• Oct 2006: HHS deems CCHIT a Recognized Certification Body
• Dec 2006: CCHIT becomes independent nonprofit organization
© 2006 | Slide 5 | 1/16/2007
CCHIT Role withinHHS Health IT Strategy
StandardsHarmonization
ContractorCCHIT:
ComplianceCertificationContractor
Privacy/SecuritySolutionsContractor
Office of the National CoordinatorProject Officers
American Health Information CommunityChaired by HHS Secretary Mike Leavitt
NHINPrototype
Contractors
HarmonizedStandards
NetworkArchitecture
PrivacyPolicies
Governance and Consensus Process EngagingPublic and Private Sector Stakeholders
CertificationCriteria +
Inspection Processfor EHRs
and Networks
Strategic Direction +Breakthrough Use Cases
Accelerated adoption of robust,
interoperable, privacy-enhancing
Health IT
Accelerated adoption of robust,
interoperable, privacy-enhancing
Health IT
Certification Commission for Healthcare Information Technology
Update: Certification Development
© 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 ofEHR products for inpatient care settings
• Phase III (Oct 07 – Sep 08)– Develop, pilot test, and assess certification of
infrastructure or network componentsthrough 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
© 2006 | Slide 8 | 1/16/2007
Development Timeline
Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3
20062005 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
Final comments, begin certification
Update criteria, roadmap; publish
Pilot test as needed; publish report
Update inspection process; publish
Final comments, apply updated criteria
Preliminarydata-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
We are here: Preparing for Ambulatory Pilot Test
Replanning Inpatient schedule Developing specialty expansion
roadmap Initiating data-gathering on networks
© 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 vendor’s application, other vendor’s application, or simulation
– Demonstration can be at vendor’s facility or at customer site -- vendor’s choice
• Schedule delayed ~3 months – probable launch July/Aug
© 2006 | Slide 10 | 1/16/2007
Update: Specialized EHR Certification Development
Core Criteria
Specialty A Additional
Criteria
Setting M Additional
Criteria
Population XAdditional
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
Certification Commission for Healthcare Information Technology
Update:CertificationProgram
© 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
© 2006 | Slide 13 | 1/16/2007
Certification Flowchart
= CCHIT Process
= Applicant Process
= CCHIT Decision
= Applicant Decision
On inspection date:CCHIT Proctor supervises
the Jury-Observed Demonstration
Same-day retest of noncompliant steps on
first pass
Juror votes collated - items declared
‘noncompliant’ bya majority of the jury
are identified
On inspection date: CCHIT Proctor and Security Inspector observe
demonstration
Items declared ‘noncompliant’ are identified
Passed all items?
YES
Issue Certification Document
Add to list of Certified Vendors on CCHIT Website and issue press release on next batch announcement
date
Completed in allotted time?
YES
Schedule additional test date
(fee charged) NO
NO
Applicant may request retest with new jury/
inspector (no fee charged)
If product is found noncompliant after retest with new jury/inspector, Vendor may appeal for Commission review (no
fee charged)
Commission review – concur with jury/inspector?
YES
NO
LEGEND
FUNCTIONALITYINSPECTION
SECURITYINSPECTION
Issue report on noncompliant inspection to Applicant
ENDCertification denied –Applicant may reapply
ENDCertification granted – Vendor must comply with
Maintenance requirements
CCHIT Proctor and Security Inspector review self attestation materials
Items declared ‘noncompliant’ are identified
Provide clarifications or additional information
SELF ATTESTATION INSPECTION
Same-day retest of noncompliant steps on
first pass
Information reviewed and results compiled
Verify production use
Flowchart from CCHIT Certification Handbook (available at www.cchit.org)
© 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
© 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
© 2006 | Slide 16 | 1/16/2007
Interoperability Inspection:Demonstration + Self-Attestation
Vendor importsTest 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
© 2006 | Slide 17 | 1/16/2007
Current Status ofCertification Program
Certification Year
Certification Quarter
Application Window
Announcement
2006Ambulatory
EHRs
1st May 3-12, 200622 Certifications
Announced
2nd Aug 1-14, 200611 Certifications
Announced
3rdNov 1-14, 200629 Applications
Jan 2007
4th Feb 1-14, 2007 Apr 2007
2007 Ambulatory
EHRs1st May 1-14, 2007 July 2007
© 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
Certification Commission for Healthcare Information Technology
Summing Up
© 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
Thank You!Q & A
For more information:www.cchit.org