The Certification Commission for Healthcare Information Technology (CCHIT®) is pleased to welcome you to its Health Information Exchange (HIE) Certification Program. 

This is the first year of the HIE certification program developed to award CCHIT Certified® 09 HIE status to those organizations meeting the Commission’s rigorous requirements. Here are the most important highlights:

HIE Certification Scope

The HIE Certification program focuses on operational HIEs.  The criteria guiding certification testing cover security and interoperability.   To achieve certification an HIE must meet all security requirements and must demonstrate the ability to receive and send at least one of the following transactions:

• HL7 Lab 2.5.1, Lab Result Transaction Testing (HITSP C36 and C35)
• HL7 CDAr2, Lab Report Document Transaction Testing (HITSP C37 and C35)
• CCD, Patient Summary Document Transaction Testing (HITSP C32)

An HIE can choose to be certified in more than one transaction.  The HIE’s certification will indicate the specific transaction testing that the HIE has passed.

HIE Certification Testing Process

HIE Certification requires that the testing process be conducted in an operational environment.  This contrasts with the other Certification Commission testing programs that primarily inspect health information technology (HIT) software products in mostly developmental environments. To address the considerations of testing in an operational environment, the Commission is developing new testing approaches and extending existing testing methods.  For transaction testing HIE Certification will use the Laika automated testing tool with enhancements for additional transactions and transport protocols.  Laika (www.projectlaika.org) is an open-source tool that is free and publicly available.   The Laika tool is being enhanced to address each of the transactions, and new versions will be available for you to use during your preparation in advance of certification testing.

For documentation inspection, the Commission has added testing methods that demonstrate the compliance with the criteria in a live environment, e.g., an HIE must submit evidence that virus protections have been updated in the live environment. 

HIE Certification Program Timeline

To meet these new and more complex testing requirements, the HIE certification program modules will be released over six months.  The expected HIE certification release schedule and the areas covered are shown in the table below.

HIE Certification Release Timetable

Release	Criteria Covered
October 2008 Security	Time synchronization Audit logging including providing audit information in a form that user can interpret Unique identifiers for participating organizations Internal and external scanning to identify system vulnerabilities Anti-virus protection Routine system audits
January 2009 Lab Result Transaction Testing	HL7 Lab 2.5.1 (HITSP C36 and C35) Secure peer to peer communications Audit logging including security relevant events Authentication of remote nodes Means to provide certificates to authorized systems (HITSP C19)
April 2009 Lab Report Document Transaction Testing and Patient Summary Document  Transaction Testing	HL7 CDAr2 (HITSP C37 and C35) CCD (HITSP C32) Patient identifier cross reference consumer and manager (HITSP TP22) Document consumer, source, repository, registry, and patient identity source (HITSP TP13) Patient demographics supplier (HITSP TP23) PIX/PDQ (HITSP IS 01, 02, and 03) Summary patient record (HITSP TP 13 Manage Sharing of Documents) Protection of the integrity and confidentiality of PHI Evidence of the origin of the information from the sending system Evidence of the receipt of information by the receiving system Audit logging including security relevant events Authentication of remote nodes Means to provide certificates to authorized systems (HITSP C19)

Duration of Certification

HIE full certification will be attained at the point of successful completion of the Security test and one transaction test.  The duration of the certification term will be for 2 years from the completion of the first transaction test.  Upon successful completion of additional transaction tests the certification period will be adjusted to extend to 2 years from the most recently completed transaction test during a testing cycle (i.e. 09 testing).

Certification Fee Reduction Grants

Recognizing that some HIEs are in an early stage of funding and business development, and wishing to lower the barriers to certification for these entities, the Commission has arranged for a limited amount of Federal funding to support Fee Reduction Grants for eligible HIEs.  We invite prospective applicants to review the parameters for these Grants and, if qualified, to request such assistance at the time of application.  Note that the funding pool is limited and Fee Reduction Grants can only be offered on a first-come, first-served basis until funds are depleted. Details are found in HIE Certification Handbook.

Materials for HIE certification

CCHIT has published the following CCHIT Certified® 09 HIE documents for your review and preparation.

CCHIT Certified 09 HIE

12/23/2008	Laika ORU Test Guide
12/23/2008	FINAL HIE Lab Transaction test script
10/1/2008	Final HIE criteria
10/1/2008	Final HIE test script
10/1/2008	CCHIT Certified 09 HIE Handbook
10/1/2008	Self-attestation Guidance
10/1/2008	Self-attestation Form
10/1/2008	Certification Agreement
10/1/2008	Application for CCHIT Certified 09 HIE

Preview: 5 Steps to Certification

1. Review the Certification Handbook and Certification Agreemen.
   The Handbook provides a program overview, defines product eligibility,describes the inspection process, outlines juror requirements and a complaint process, and provides CCHIT Certified marketing guidelines. The Certification Agreement details the relationship between CCHIT and your organization for the purposes of certification.
2. Review the Test Scripts.
   The Test Scripts outline the specific procedural steps that you must meet to demonstrate conformance with the CCHIT certification criteria. The Test Scripts represent real life medical scenarios against which an EHR product can be tested. Applicants must prepare for their inspection by reviewing and practicing their demonstration of the Test Scripts. It has been proven time and again that applicants who had prepared and practiced the Test Scripts completed the inspection process more quickly and required less repeat testing to demonstrate that their product met the criteria.
3. Review the Application Form and How to Apply.
   All applications are first completed electronically. Then, CCHIT must receive two (2) signed agreements and payment within five (5) business days of applying for the product application to be accepted for testing within the available testing period.
4. Prepare and Submit Self-Attestation Materials.
   Testing is scheduled only after that review establishes that the product is eligible and ready for inspection. CCHIT has developed Self-Attestation Guidance to help you in this regard. Use the Self-Attestation Submission Form to submit materials.
5. Schedule a Test Date.
   You will be invited to schedule an available inspection date after you have completed the previous steps. After that date is confirmed, CCHIT staff will work with you to coordinate the inspection.

Questions about CCHIT's inspection process? Feel free to contact the Certification Commission.

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