ONC Health IT Certification Program Updates (07/14/2017)

ONC Health IT Certification Program Updates (07/14/2017)

Test Method Updates

Recently Updated Test Procedures (TPs)

2015 Edition Test Procedures (TPs)
Criterion Number	Criterion Title	Details
§ 170.315(b)(1)	Transitions of Care	Fixed some minor typos. Including link between SUT and TLV step (page 8 step 7). Corrected link to 170.205(a)(3) HL7 Implementation Guide for CDA Release 2: IHE Health Story Consolidation, DSTU Release 1.1. Removed the use of an explicit cipher suite (TLS_RSA_WITH_RC4_128_MD5, TLS_DHE_DSS_WITH_3DES_EDE_CBC_SHA to account for updates in the Standards. Added the references to RFC 2246, NIST Special Publication 800-52 Rev 1 and RFC 7465. Corrected the expected behavior for SMTP Test 26(a) and 26(b)-CCDA documents with style sheet issues.
§ 170.315(b)(2)	Clinical information reconciliation and incorporation	Addition of statement – reconciliation process must be completed in a simultaneous view.
§ 170.315(h)(2)	Direct Project, Edge Protocol, and XDR/XDM	(Removed the use of an explicit cipher suite (TLS_RSA_WITH_RC4_128_MD5, TLS_DHE_DSS_WITH_3DES_EDE_CBC_SHA to account for updates in the Standards which include: RFC 2246, NIST Special Publication 800-52 Rev 1 and RFC 7465. Removed explicit authentication mechanism as this is intrinsic to the test. Removed test (XDR Test 17) to align with the removal of test (SMTP Test 17).
CCDS Reference Document	Common Clinical Data Set Reference Document	Updated The Office of Management and Budget Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, as revised, October 30, 1997 link
2014 Edition Test Procedures (TPs)
§ 170.315(b)(8)	Optional - transitions of care	Removal of all of the domain from the tool address to avoid the need to update the Test Procedure when the tool is moved.

Recently Updated Certification Companion Guides (CCGs)

2015 Edition Certification Companion Guides (CCGs)
Criterion Number	Criterion Title	Details
§ 170.315(a)(14)	Implantable device list	Added clarification for recording and parsing, and for representing devices in the C-CDA. Also added reference links for FDA best practices and for finding samples for the three UDI issuing agencies.
§ 170.315(a)(15)	Social, psychological, and behavioral data	Added clarifications about the applicability of questionnaires and instruments for testing and certification. Also added flexibility for the testing and certification of health IT to the physical activity domain.
§ 170.315(b)(1)	Transitions of Care	Clarification added – (b)(1) exchange using TLS/SASL or a secure network is permitted. Clarification of the cipher suite requirements due to updated standards.
§ 170.315(g)(2)	Automated measure calculation	Added clarification for patient education materials, MU3 Objective 5 automated measure calculation eligibility.
§ 170.315(g)(7)	Application access – patient selection	Added clarification on API Registration requirements and removed guidance on API registration mechanism (dynamic registration). Added clarification on the definition of a “trusted connection”.
§ 170.315(g)(8)	Application access – data category request	Added clarification on API Registration requirements and removed guidance on API registration mechanism (dynamic registration). Added clarification on the definition of a “trusted connection”. Clarification added to subparagraph (i)(A) on the method used to identify a patient.
§ 170.315(g)(9)	Application access – all data request	Added clarification regarding the number of CCD documents that may be returned for a specific date range. Added clarification on API Registration requirements and removed guidance on API registration mechanism (dynamic registration). Added clarification on the definition of a “trusted connection”. Clarification added to subparagraph (i)(B) on the method used to identify a patient.
§ 170.315(h)(2)	Direct Project, Edge Protocol, and XDR/XDM	Added definition of a secure network. Clarification of the cipher suite requirements due to updated standards.
CCDS Guide	Common Clinical Data Set Guide	Added clarifications related to birth sex and compliance with C-CDA 2.1 errata updates
Privacy & Security	Located under the Additional Resources section	Initial Publication

Alternative Testing Approach for Electronic Clinical Quality Measures

On June 22, 2017, ONC published a blog announcing that the National Coordinator formally approved the National Committee for Quality Assurance’s (NCQA) electronic clinical quality measure (eCQM) testing method as an alternative to the existing test method (i.e., testing with Cypress) used in the ONC Health IT Certification Program. Updated CCGs and NCQA’s test procedures for 2015 Edition certification criteria § 170.315(c)(2) - CQMs – import and calculate, § 170.315(c)(3) - CQMs – report and § 170.315(c)(4) - CQMs – filter, will soon be available on the 2015 Edition Test Method page.

ONC has an open policy for developers, health IT companies, or private entities to submit test procedures, test tools, and test data to be considered for approved use as part of the ONC Health IT Certification Program. Anyone who is interested in submitting new test tools, test procedures and/or test data should review the Federal Register notice which includes details about what should be submitted. Interested parties should contact the ONC Health IT Certification Program at onc.certification@hhs.gov.

Edge Testing Tool: Style Update

The Edge Testing Tool will undergo a user interface update this month so that it matches the style of www.healthit.gov/techlab and www.healthit.gov/SITE. No functionality or capabilities will change, only the style sheets used for color and fonts.

For additional information on the 2015 Edition requirements, please visit https://www.healthit.gov/policy-researchers-implementers/2015-edition-final-rule

Questions may be directed to the ONC Health IT Certification Program via email at: ONC.Certification@hhs.gov