ONC Health IT Certification Program Updates (04/28/2017)

IN THIS ISSUE

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	Reformatted the transport test steps for readability. The System Under Test (SUT) aligns closer to the to the Test Lab Verification (TLV) columns. Several numbering and narrative formatting changes. Test numbering included on both the SUT and TLV sides. Addition of alternative SUT Connection – Systems may not be connected using TLS and SASL or a “secure network”. Additional updates were made to indicate which tests were required only for the TLS and SASL alternative throughout the test procedure (See updated test case decoupling below). As part of this update the ordering of the test steps were altered to make them consistent throughout the test procedure. Updates to test procedure were made to reflect decoupling of the TSL and SASL from the send/receive test cases corresponding to the changes made in the Edge Testing Tool (ETT). This includes the following changes: SMTP Test (1-8, 14) included TLS, SASL and SMTP Send. The new test cases are SMTP Test 8 StartTLS, SMTP Test 14 SASL and SMTP Test 18 SMTP Send. SMTP Test (9, 16, 20) included TLS, SASL and SMTP Receive. The new test cases are SMTP Test 9 StartTLS, SMTP Test 16 SASL and SMTP Test 20 SMTP Receive. IMAP Test (19, 20,24) included TLS, SASL and IMAP Receive. The new test cases are IMAP Test 19 StartTLS, IMAP Test 20 SASL and IMAP Test 20 IMAP Receive (new test step). POP Test (19, 20,24) included TLS, SASL and IMAP Receive. The new test cases are POP Test 19 StartTLS, POP Test 20 SASL and IMAP Test 20 POP Receive (new test step). Removed the following test cases to reduce the burden of Edge testing: XDR MT Test 19, XDR MT Test 48, XDR MT Test 50a and 50b, SMTP MT Test 17, SMTP MT Test 18, SMTP Test 47 and Test 47a, SMTP Test 10, SMTP Test 11, SMTP Test 13 Removed negative connection test steps SMTP Test 22, documentation of negative authentication due to an invalid DIGEST-MD5 value, Updated the link to the ETT
§ 170.315(g)(1)	Automated Numerator Recording	Modified language on which systems need to test for each calculation method. Modified language to clarify that health IT developers are not required to test steps 2a, 2b, and 2c and 4a, 4b, and 4c.

Recently Updated Test Data

2015 Edition Test Data
Criterion Number	Criterion Title	Details
§ 170.315(g)(1)	Automated numerator recording (Eligible Provider/Eligible Clinician (EP/EC) Test Data)	Removed the requirement to calculate data for a Taxpayer Identification Number (TIN)/ National Provider Identifier (NPI) combination at a group TIN level. Removed Scenario 2 from Required Tests 2a, 2b, 2c, and 3.
§ 170.315(g)(2)	Automated measure calculation (EP/EC Test Data)	Modified Column I Row 50 in Required Test 2b to indicate No.

Recently Updated Certification Companion Guides (CCGs)

2015 Edition Certification Companion Guides (CCGs)
Criterion Number	Criterion Title	Details
§ 170.315(a)(4R	Drug-drug, drug-allergy interaction checks for CPOE	Revised upon further analysis of the privacy and security (P&S) Framework framework and the applicability of the “amendments” certification criterion (§ 170.315(d)(4)) to health IT capabilities that would not necessarily have any patient data for which a request for an amendment would be relevant.
§ 170.315(a)(9)	Clinical decision support	Revised as a result of further analysis of the applicability of the 2015 Edition “amendments” certification criterion (§ 170.315(d)(4)) to health IT capabilities that would not necessarily have any patient data for which a request for an amendment would be relevant.
§ 170.315(a)(10)	Drug-formulary and preferred drug list checks	Revised as a result of further analysis of the applicability of the 2015 Edition “amendments” certification criterion (§ 170.315(d)(4)) to health IT capabilities that would not necessarily have any patient data for which a request for an amendment would be relevant.
§ 170.315(a)(13)	Patient-specific education resources	Revised as a result of further analysis of the applicability of the 2015 Edition “amendments” certification criterion (§ 170.315(d)(4)) to health IT capabilities that would not necessarily have any patient data for which a request for an amendment would be relevant.
§ 170.315(c)(4)	Clinical quality measures – filter	Revised to clarify the requirements for filtering by SNOMED CT® codes for problem list data.
§ 170.315(g)(1)	Automated Numerator Recording	Added clarification on Health IT Module’s capability requirements on recording TIN/NPI combinations. Added clarification on confirmation of receipt of a Consolidated Clinical Document Architecture (C-CDA) by a receiving provider prior to incrementing the numerator. Added links to measure-specific guidance.

§ 170.315(f)(7) Transmission to public health agencies – health care surveys

In support of the Centers for Disease Control National Center for Health Care Statistics mission and in response to industry feedback, ONC will permit testing and certification for § 170.315(f)(7) to conformance of HL7 CDA® R2 Implementation Guide (IG): National Health Care Surveys (NHCS), R1 DSTU Release 1.2 - US Realmas part of the 2015 Edition certification. The Release 1.2 test tool is currently being developed and expected to be completed summer 2017. We encourage developers to work with their ONC-Approved Testing Laboratories (ONC-ATL) for pilot testing and to provide feedback of the Release 1.2 beta test tool which is currently available at http://cda-validation.nist.gov/cda-validation/muNHCS12.html.

Products already certified to IG Release 1.0 prior to the availability and switch over to the Release 1.2 test tool will not be required to retest or recertify to release 1.2. Updates to the Certification Companion Guide (CCG) with additional details are forthcoming.

New ONC Regulation FAQ (#51)

ONC has released a new FAQ providing clarification for instances in which a voluntary consensus standards organization (or steward) issues a correction to a standard or implementation specification after it has been adopted by ONC in the final rule. FAQ #51 can be found on the ONC Regulations FAQs page.

Edge Test Tool Update

On April 25, 2017, the Edge Test Tool (ETT) release 1.2.4.1 was deployed with the following changes:

The Direct Certificate Discovery Tool has been updated to use the ETT User Interface framework
The links for the tools have been updated and can be accessed at:

Please note that the old links will no longer be accessible.

The C-CDA validator updates for the release include defect fixes to the Reference C-CDA content validation for

Care Plan documents submitted for § 170.315 (b)(9)
Clinical Information Reconciliation and Incorporation (CIRI) documents submitted for § 170.315 (b)(2); and
Data Segmentation for Privacy (DS4P) documents submitted for § 170.315 (b)(7).

Certified Health IT Product List (CHPL) Updates

The CHPL now reports all “identifiable surveillance.” Under the ONC Health IT Certification Program: Enhanced Oversight and Accountability final rule (81 FR 72404) all identifiable surveillance results, results where no non-conformities are determined, must be publically available on the CHPL on a quarterly basis to provide stakeholders with a more readily available means for accessing surveillance results. Results where non-conformities are determined will still be updated weekly as required.

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