1. 2015 Edition Certification NPRM Group 1 - Report Out Implementation, Certification, and Testing (ICT) Workgroup April 27, 2015 Liz Johnson, co-chair Cris Ross, co-chair 1

2. 2015 Q12015 Q22015 Q32015 Q4 JanFebMarAprMayJunJulAugSepOctNovDec FACA Milestones Kick-off Final FACA HIT Strategic Plan Comments FACA Milestone FACA Interoperability Roadmap Comments FACA NPRM Comments FACA workgroups charged with responding to Interoperability Roadmap FACAs charged with responding to NPRMs S&I Task Force Recommendations Estimated timing Data Provenance Task Force Recommendations HITPC membership changes HITSC Milestone 2

3. Current Membership NameOrganization Cris Ross, co-chairMayo Liz Johnson, co-chairTenet Healthcare Corporation Sarah CorleyNext Gen David KatesThe Advisory Board Company Udayan MandaviaiPatientCare Kyle MeadorsDrummond Group Inc. Rick MooreNational Committee for Quality Assurance Andrey OstrovskyCare at Hand Danny RosenthalInova Health System John TravisCerner Corp. Steve WaldrenAmerican Academy of Family Physicians Zabrina GonzagaLantana Kevin Brady, Federal Ex officioNational Institute of Standards and Technology Brett Andriesen, staff leadOffice of the National Coordinator for Health IT 3

4. MeetingsTask April 9, 2015 3:30pm ET Finalize comments on Interoperability Roadmap V.1 Overview of Certification NPRM and prepare to comment April 22, 2015 – HITSC meeting Interoperability Roadmap V.1 comments to the HITSC  April 27, 2015, 2:00pm ET Group 1 to comment on Certification NPRM May 8, 2015 – 12:00 ET Group 2 to comment on Certification NPRM May 14, 2015 – 2:00pm ET Group 3 to comment on Certification NPRM May 19, 2015 – 9:00am ET Finalize comments on Certification NPRM May 20, 2015 – HITSC Meeting Present Certification NPRM Comments to the HITSC Implementation Certification & Testing Workplan 4

5. 5 2015 Edition Certification NPRM

6. Implementation, Certification & Testing NPRM Group 1 Assignments 6 Group 1 – David Kates (lead), Rick Moore, Kevin Brady Costs and Benefits, p.14 Applicability, p.28 Gap Certification Eligibility Table, p.234 Common Clinical Data Set Definition, p.245 Consolidated CDA Creation Performance, p.202 Open Data Certified Health IT Product List (CHPL), p.288 “Removal” of Meaningful Use Measurement Certification Requirements, p.253 The ONC Health IT Certification Program and Health IT Module, p.12

7. Costs and Benefits 7 Intro to rule: Our estimates indicate that this proposed rule is an economically significant rule as its overall costs for health IT developers may be greater than $100 million in at least one year. We have, therefore, projected the costs and benefits of the proposed rule. The estimated costs expected to be incurred by health IT developers to develop and prepare health IT to be tested and certified in accordance with the 2015 Edition health IT certification criteria (and the standards and implementation specifications they include) are represented in monetary terms in Table 1 below Comments Summary:  Enumerate quantitative benefits with hard evidence in quality outcomes that criteria aim to improve. o e.g., level of care coordination could be expected to improve as a result of improved interoperability and reduce avoidable hospital admissions w/ cost reduction of XX.X% by XX date (2020).

8. Applicability 8 Intro to rule: Section 170.300 establishes the applicability of subpart C – Certification Criteria for Health Information Technology. We propose to revise paragraph (d) of § 170.300 to add in a reference to § 170.315 and revise the parenthetical in the paragraph to say “i.e., apply to any health care setting” instead of “i.e., apply to both ambulatory and inpatient settings.” These proposed revisions would clarify which specific capabilities within a certification criterion included in § 170.315 have general applicability (i.e., apply to any health care setting) or apply only to an inpatient setting or an ambulatory setting Comments Summary:  ONC should clearly communicate to vendors that there is an ethical and legal obligation to clearly signal to potential buyers precise attributes of MU that the purchased system facilitates achievement.  ONC should proceed cautiously down this path w/ foresight for greater potential for providers to misunderstand the true capabilities of the health IT they purchase for each module.  It will most likely be impossible for some providers to understand which modules would be needed to achieve MU and subsequent incentive payment programs.

9. Gap Certification Eligibility Table 9 Intro to Rule: Our gap certification policy focuses on the differences between certification criteria that are adopted through rulemaking at different points in time. This allows health IT to be certified to only the differences between certification criteria editions rather than requiring health IT to be fully retested and recertified to certification criteria (or capabilities) that remain unchanged from one edition to the next and for which previously acquired test results are sufficient. Under our gap certification policy, “unchanged” criteria are eligible for gap certification, and each ONC-ACB has discretion over whether it will provide the option of gap certification. Comments Summary:  Simply a naming convention crosswalk, with no gaps identified at this time.  When gap certification criteria are proposed, ONC should note the significant burden a change in standards has in the vendor and industry.  ONC should address specifics of transitional requirements for the change in standards to ensure forward and backward compatibility and be aware of increased testing and cost burdens placed on vendors.  Potential for unintended consequences where production systems break as a result of implementing new criteria.

10. Common Clinical Data Set Definition Intro to Rule: We propose to revise the “Common MU Data Set” definition in § 170.102. We propose to change the name to “Common Clinical Data Set,” which aligns with our approach throughout this proposed rule to make the ONC Health IT Certification Program more open and accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond those included in the EHR Incentive Programs. To effectively rename 221 This is required by the HITECH Act under the term “Qualified EHR” and references a foundational set of certified capabilities all EPs, eligible hospitals, and CAHs need to adopt. the Common MU Data Set as the “Common Clinical Data Set,” the Common MU Data Set definition must be removed from the CFR and the “Common Clinical Data Set” definition must be added. Comments Summary:  Appears to be simply a name change.  ONC should be clear how it plans to handle 2014 certified technologies with 2015 technologies to ensure compatibility between certified health IT –it could be as simple as stating that vendors must ensure backward and forward compatibility with any/all certified technologies.

11. Consolidated CDA Creation Performance 11 Intro to Rule: We propose that the C-CDA creation performance certification criterion would focus on and require the following technical outcomes to be met 1.Reference C-CDA Match 2.Document Template Conformance 3.Vocabulary Conformance Comments Summary:  It’s plausible that testing for correct C-CDA syntax created in a system once signifies system is capable of ongoing performance and requiring testing of that for each functional capability test requiring a CCDA is repetitive and unnecessary.  Syntax checking is only one aspect of interoperability issues.  Semantic check would require production and testing of each C-CDA.  While it appears to lessen burden by only testing the syntax once, may have unintended consequences for semantic interoperability if ONC does not require that the vendor produce each interoperability check to include the correctly formatted message with each test. Having a vendor simply repeat the “performance” of creating a C-CDA is not an undue burden.

12. Consolidated CDA Creation Performance (Cont’d) 12 Intro to Rule: We propose that the C-CDA creation performance certification criterion would focus on and require the following technical outcomes to be met 1.Reference C-CDA Match 2.Document Template Conformance 3.Vocabulary Conformance Comments Summary:  ONC should minimize the “vagueness” of the interoperability requirement by specifying the “exact” requirements for each interoperable exchange. This would require ONC to detail the expected option used for each message. Creation and Validation of a C-CDA without this specificity would be meaningless for interoperability.  ONC must ensure optionality in C-CDA is removed by specifying any optional fields.  ONC should have in-place ongoing, post-certification “interoperability” testing for vendors to prove they are maintaining conformance (occasional send of C-CDA to a test system)  Because deployed systems are usually not exact systems as were certified (e.g. at minimum new certificates), ONC should consider a quick “on-boarding” test to ensure deployed system is compliant by sending a test C-CDA (to same test system).

13. Open Data Certified Health IT Product List (CHPL) 13 Intro to Rule: We propose to revise the “Common MU Data Set” definition in § 170.102. We propose to change the name to “Common Clinical Data Set,” which aligns with our approach throughout this proposed rule to make the ONC Health IT Certification Program more open and accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond those included in the EHR Incentive Programs Comments:  No comments

14. “Removal” of Meaningful Use Measurement Certification Requirements 14 Intro to Rule: We propose to not require ONC-ACBs to certify Health IT Modules to the 2015 Edition “meaningful use measurement” certification criteria (§ 170.315(g)(1) “automated numerator recording” and § 170.315(g)(2) “automated measure calculation”). This is a change from prior certification policy, such as with the certification of technology to the 2014 Edition and the requirements of § 170.550(f)(1). We believe this will make the ONC Health IT Certification more accessible to the certification of health IT for other purposes beyond the EHR Incentive Programs. Comments:  Unclear how proposed change impacts testing requirement for reporting CQMs.  It may be implicit that ONC is not intending to change the CQM reporting and testing requirements with this rule, but just the non-clinical MU measurements.  Suggest that ONC make this proposed change more clear.

15. The ONC Health IT Certification Program and Health IT Module 15 Intro to Rule: We propose not to require ONC-Authorized Certification Bodies (ACBs) to certify all Health IT Modules to the 2015 Edition “meaningful use measurement” certification criteria (§ 170.315(g)(1) “automated numerator recording” and § 170.315(g)(2) “automated measure calculation”). We note that CMS has proposed to include the 2015 Edition “meaningful use measurement” certification criteria in the CEHRT definition as a unique program requirement for the EHR Incentive Programs. Comments:  Proposal to remove the automated numerator and denominator calculations does not apply to CQM reporting, as those reporting requirements are covered by different standards.  Regarding “field surveillance” of a deployed system, ONC should clearly articulate what such a surveillance would entail.  Positive that it recognizes the deployed versions of a lab-tested system vary in performance from site to site, though variations are often a result of site-specific configuration issues.  Alterations to the “standard” implementation should only require documentation if alterations affect the achievement of MU or other programs.  If ONC does not limit with specificity what is meant by the audit and/or the requirement to document and report changes to the “standard” deployment of the “lab-tested” system, there will most certainly by undue burden on the vendor, the site, and that may threaten the forward progress of the MU program.

16. Implementation, Certification & Testing NPRM Assignments Group 2 – John Travis (lead), Steve Waldren, Udayan Mandavia, Kyle Meadors Group 3 – Sarah Corley (lead), Danny Rosenthal, Zabrina Gonzaga, Andrey Ostrovsky Homework due May 4thHomework due May 11th Report out to workgroup May 8, 2015 – 12:00 ETReport out to workgroup May 14, 2015 – 2:00pm ET Base EHR Definitions, p.240 Retesting and Certification, p.197 Safety-enhanced design, p.190 Web Content Accessibility Guidelines, p.164 Design and Performance, p.261 Request for Comment on Summative Testing, p.196 Encounter Diagnoses, p.105 Medication Dosing, p.118 Implantable Device List, p.73 Pharmacogenomics Data – Request for Comment, p.236 There are certification approaches that could enhance the end-user’s (provider’s) adoption and continued use of health IT implementations that guide prescribing through CDS using pharmacogenomic data Data Portability, p.124 Automated Numerator Recording/Calculation, p.190