ONC Health IT Certification Program Updates (04/13/2018)

Test Method Updates

Recently Updated Certification Companion Guides (CCGs)

2015 Edition Certification Companion Guides (CCGs)
Criterion Number	Criterion Title	Details
§ 170.315(a)(10)	Drug-formulary and preferred drug list checks	Updated 'CEHRT Definition' value from "No" to "Yes" to match regulation text.
§ 170.315(c)(4)	Clinical quality measures (CQMs) — filter	Added clarification for paragraph (c)(4)(ii) regarding expectations for filtering unstructured data.

Recently Updated Test Procedures (TPs)

2015 Edition Certification Test Procedures (TPs)
Criterion Number	Criterion Title	Details
§ 170.315(b)(1)	Transitions of care	Version 2.2 Added an “or” on step 4 under the SUT of paragraph (b)(1)(i)(B) – Receive Using Edge Protocol for IHE XDR profile for Limited Metadata Document Sources. For paragraph (b)(1)(i)(B) – Receive Using Edge Protocol for SMTP, updated step number from 10 to 6 within step 6 under the TLV; updated step number from 13 to 9 within step 9 under the TLV; updated step number from 14 to 10 within step 10 under the TLV. Updated “C-CA documents” to “C-CDA documents” on step 7 under the TLV of paragraph (b)(1)(i)(B) – Receive Using Edge Protocol for POP3. Added an “or” on step 1 under the TLV of paragraph (b)(1)(ii)(A). Clarified reference step number is from the SUT on the step under the TLV of paragraph (b)(1)(ii)(B). For paragraph (b)(1)(ii)(C), added language to specify that sections for each supported document type needs to be set on step 4 under the SUT; updated step number from 5 to 4 within step 5 under the TLV; updated step number from 7 to 6 within step number 7 under the SUT; clarified referenced step numbers are from the SUT for steps 2, 3, 5, and 7 under the TLV; updated step number from 5 to 4 within step 5 under the TLV; updated step number from 7 to 6 within step 7 under the TLV. For paragraph (b)(1)(iii), added an “or” on step 1 under the SUT; updated step number from 1-4 to 1-3 within step number 4 under the SUT. Clarified referenced step numbers are from the TLV under the TLV for paragraphs (b)(1)(iii)(A), (b)(1)(iii)(B), (b)(1)(iii)(E), and (b)(1)(iii)(F). Updated step number from 2-3 to 3 under the TLV of paragraph (b)(1)(iii)(F). Updated the subparagraph number from (iii)(G)(1)(i) (Optional) to (iii)(G)(1)(ii) (Optional) to match the regulation text. Version 2.3 Addition of Conditional status to paragraph (b)(1)(i)(C)XDM processing test step as it is only relevant for Health IT Modules using SMTP protocols.
§ 170.315(b)(4)	Common Clinical Data Set summary record - create	Removed “(i)” from the sentence Each of the C-CDA R2 R2.1 documents created in (b)(4)(i) includes…” for paragraphs (b)(4)(ii) – (b)(4)(vii). Clarified reference step numbers are from the TLV on the steps under the TLV of paragraphs (b)(4)(i) – (b)(4)(vii).
§ 170.315(b)(5)	Common Clinical Data Set summary record - receive	Clarification of the “rejection” of an invalid C-CDA document in step 4 under the TLV of paragraph (b)(5)(i).
§ 170.315(c)(1)	Clinical quality measures (CQMs) — record and export	Version 1.5 Clarification that record batch entry is not required for developers only seeking certification for (c)(1) and not other CQM criteria. "Record Sampling" was changed to "Record Entry" for clarity. Version 1.6 In paragraph (c)(1)(ii), updated the Alternative section to align with the correct steps a tester would take if using the Cypress Certification API.
§ 170.315(c)(2)	Clinical quality measures (CQMs) — import and calculate	Added numbers to the Execute Any Time section for paragraph (c)(2)(i) and continued the numbering for the next sections (Setup and Import). Updated the numbering to restart at 1 for the SUT section of Calculate under paragraph (c)(2)(ii). Added a continued number to the section of Alternative: Cypress Certification API under the TLV of paragraph (c)(2)(ii). In paragraph (c)(2)(ii), updated the Alternative section to align with the correct steps a tester would take if using the Cypress Certification API.
§ 170.315(c)(4)	Clinical quality measures (CQMs) — filter	Corrected reference to CDC Race & Ethnicity standard.
§ 170.315(e)(1)	View, download, and transmit to 3rd party	Updated paragraphs (e)(1)(i)(B)(3) and (e)(1)(i)(C)(2) to clarify that for the Health IT Modules supporting the inpatient setting they must be able to download and transmit a transition of care/referral summary record however it does not require additional certification to criteria 170.315(b)(1).

C-CDA R2.1 Validator Update for HL7 ERRATA

On April 30 2018, the C-CDA R2.1 Validator on the Edge Testing Tool will be updated to incorporate ERRATA adopted by HL7 in September 2017. This update will mitigate potential interoperability errors and inconsistent implementation of the HL7 C-CDA Implementation Guide Release 2.1. ONC will respectively update the appropriate Certification Companion Guide(s) (CCG) to incorporate the corrections and provide any necessary interpretative explanations. The CCG notations will include a 90-day delayed effective date for the use of the updates in testing and certification, in accordance with FAQ #51: https://www.healthit.gov/faq/51-question-3-17-051-1

2015 Edition Readiness by Hospital/Clinician Market Share

Health IT developers have made significant progress toward certifying 2015 Edition certified products. ONC posted visualizations mashing-up progress by health IT developers to certify to the 2015 Edition Base EHR definition criteria with those developers’ share of the hospital and clinician health IT market. ONC expects to update the graphics with the latest progress of health IT developer’s attainment of 2015 Edition certification weekly. Learn more by reading the latest ONC Buzz Blog post, Visualized: Mashing up 2015 Edition Certification Progress Attestation Requirements.

For additional information on the 2015 Edition requirements, please visit the ONC Standards and Certification Regulation webpage. Questions may be directed to the ONC Health IT Certification Program via email at: ONC.Certification@hhs.gov