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

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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

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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

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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

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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

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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

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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

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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

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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)

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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

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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

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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

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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

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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

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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