© 2003 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. Prepared for Cerner Illuminations 16TPL00033 – 07/31/ /2012 ONC- ATCB Certification Experience John Travis, Senior Director and Solution Strategist – Regulatory Compliance, Cerner

© Cerner Corporation All Rights Reserved © 2003 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. Prepared for Cerner Illuminations 16TPL00033 – 07/31/2003 Testimony Outline Cerner’s Certification Effort and My Role In It Challenges, Barriers and Successes Certification From Our Point of View Our Outcomes and Results Experience with ONC, CMS and NIST Communications

© Cerner Corporation All Rights Reserved © 2003 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. Prepared for Cerner Illuminations 16TPL00033 – 07/31/2003 Cerner’s Certification Cerner successfully completed “Complete EHR” certification in October, 2010 for both EP and Hospital incentive programs We used CCHIT as our ONC-ATCB We had past experience with CCHIT dating back to 2005 with their historic ambulatory, ED and Inpatient certifications My role was to manage and coordinate the certification effort including Putting the team together from Cerner Maintaining contact with CCHIT, ONC, CMS and NIST on questions both about process, requirement and interpretation of the certification criteria and test procedures Shepherding our team through the certification process from planning to post inspection

© Cerner Corporation All Rights Reserved © 2003 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. Prepared for Cerner Illuminations 16TPL00033 – 07/31/2003 Challenges, Barriers and Successes Challenges Certification is a team effort as an “and” – must prepare early and often – involve key subject matter experts from across the organization Every round of update of HITPC objective definition, HHS rule making and NIST test procedure development bore close watching Every iteration had some material change that begat potential new development requirement Limited or no notice by NIST of changes to conformance test tools referenced by test procedures was problematic (CCD test tool example) Stability in test procedures prior to certification program launch is critical Impact on vendor dry run efforts Impact on market perception of what a vendor certification really means (suggestion of a pilot testing phase such as CCHIT has done prior to program launch)

© Cerner Corporation All Rights Reserved © 2003 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. Prepared for Cerner Illuminations 16TPL00033 – 07/31/2003 Challenges, Barriers and Successes Barriers Need for guidance on definition, interpretation and intent of quality measures Impact on certification criteria as a literal statement of requirement challenging (2009 PQRI Registry XML example for use with hospital measures) Change control process and coordination for specification development with other CMS programs – PQRI and RHQDAPU Specific EP suggestions found in written testimony Question of how Hospital Clinical Quality Measures specifications are to be managed between RHQDAPU and MU as to interval, timing, versioning, etc and what vendors are expected to maintain vis-à-vis what was certified and what version should be reflected in use by hospitals – the specifications themselves are published every six months The version referenced in the final rule? The version in effect at the start of a hospital’s measurement period? The version in effect at the end of a hospital’s measurement period? Need for more explicit statements of specification for automated calculated measures and for timely guidance on interpretation Most vendors certified before the ED guidance came out that allowed for the “plain language” or “FAQ” based approaches that impact the unique patient concept materially

© Cerner Corporation All Rights Reserved © 2003 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. Prepared for Cerner Illuminations 16TPL00033 – 07/31/2003 Challenges, Barriers and Successes Successes Our ONC-ATCB and their efforts to help us get answers, support our certification activities and to provide a very high level of service The willingness of the staff at ONC, CMS and NIST to engage with us to get questions answered, and to engage in as much give and take as their authority would allow The inheritance concept of the certification program allowing vendors greater flexibility to obtain certification of more than one version of their software

© Cerner Corporation All Rights Reserved © 2003 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. Prepared for Cerner Illuminations 16TPL00033 – 07/31/2003 Certification From Our Point of View What Did Not Work So Well Instability of test procedures within a short span of time impacting vendor preparation and dry runs Lack of advance notification and change control for changes in conformance test tools embedded within test procedures Lack of early clarity or available guidance on how to make use of the specifications or statements of requirement for quality measures and automated calculated measures The test procedure was applied pretty literally to us for something that had a lot of interpretation or vendor judgment to it – the need for clarity for the sake of a clear conformance test cannot be underemphasized – 2009 PQRI Registry XML example again The pacing of meaningful use objective and certification criteria development and nature of incremental change in possible development requirements Impact on vendor development lifecycles and advance planning – see written testimony More information needed earlier in the process

© Cerner Corporation All Rights Reserved © 2003 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. Prepared for Cerner Illuminations 16TPL00033 – 07/31/2003 Certification From Our Point of View What Worked Well Professionalism, patience and dedication of ONC-ATCB staff at CCHIT as well as at ONC, NIST and CMS Inheritance provision for what was stated earlier FAQ guidance when it has been made available has generally been quite good Responsiveness of ONC and CMS staff operating within the constraint of their authority to offer response and guidance on our questions

© Cerner Corporation All Rights Reserved © 2003 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. Prepared for Cerner Illuminations 16TPL00033 – 07/31/2003 Our Outcomes and Results We achieved what we expected to achieve! One observation about the CHPL If we understand it right, certification history of a vendor may be shown as individual listings Modular on way to complete EHR status reflected as own listing when it was only an incremental interim result with no lasting value once complete EHR status attained Naming changes on the face of the label Possible risk of confusion with later modular certification effort vendor really intends to attain Perhaps publish listing history or change control in the details page available for each certified product listing versus as a face up listing Index it by the ONC Certified Product Number – Otherwise they appear to be distinct certified products