ONC Health IT Certification Program Updates (10/27/2017)
Annual Value Set Update
The C-CDA Validator module of the Edge Testing Tool (ETT) validates clinical document conformance to vocabularies explicitly specified by the 2014 and 2015 Edition certification criteria. The versions of clinical vocabularies are dynamic and are updated regularly. As such, ONC will be updating the vocabularies used in the C-CDA Validator in the ETT on the evening of October 30, 2017 as follows:
No change to the vocabularies for the 2014 Edition.
2015 Edition C-CDA validator:
- All new versions of vocabulary validations incorporated into the 2015 Edition Validator will be additive--previous versions of the vocabularies specified by rule will always be maintained.
- As codes expire or get retired in a newer version of the vocabularies, WARNINGS will be flagged rather than errors because the minimum interoperable level will be tied to the version specified in the 2015 Edition final rule.
If you have any questions about the updates to ETT or the C-CDA Validator, please send an email to: SITTeam@hhs.gov or ONC.Certification@hhs.gov.
Certification Ban Guidance
On October 19th, ONC issued Program Guidance #17-03 summarizing the certification ban process finalized in the Enhanced Oversight and Accountability final rule (81 FR 72442-44; and at 45 CFR 170.581). This guidance document provides clarification on the circumstances that could trigger a certification ban, and specifies responsibilities of ONC-Authorized Certification Bodies (ONC-ACBs) as part of the certification ban process.
Information on all ONC Health IT Certification Program Guidance can be accessed on the Resources section of our website.
Test Method Updates
On September 21st, 30 of the 55 2015 Edition certification criteria that were adopted to, in part, support the Centers for Medicare & Medicaid Services (CMS) Quality Payment Programs, were updated to be “self-declaration only. ” The health IT developers are now required to self-declare that their products conform to the requirements outlined in these criteria without testing them with an ONC-Authorized Testing Laboratory (ATL). Additional information on how these actions support the testing efficiency goals of ONC can be found in the “Certification Program Updates to Support Efficiency & Reduce Burden” blog post.
Recently Updated Test Procedures (TPs)
2015 Edition Test Procedures | ||
Criterion Number | Criterion Title | Details |
§ 170.315(b)(1) | Transitions of Care | Clarification of the types of XDM package attachments that must be verified in Section (i)(C) – XDM Processing (Received via Edge Protocol) Wording clarification in (i)(B) – Receive Using Edge Protocol for SMTP Step 3 (establish and not initiate). Our regulation is only concerned that a TLS connection can be established. It can be a 1-way TLS, or a 2-way. |
Recently Updated Test Data
2015 Edition Test Data | ||
Criterion Number | Criterion Title | Details |
§ 170.315(g)(2) | Automated measure calculation (EP/EC Test Data) | Updated test data in Required Test 3. |
Recently Updated Certification Companion Guides (CCGs)
2015 Edition Certification Companion Guides (CCGs) | ||
Criterion Number | Criterion Title | Details |
§ 170.315(d)(2) | Auditable events and tamper-resistance | Clarification added for the entire criterion related to testing of “portal” products. |
Test Procedures (TPs) Updated to Developer Self-declaration
2015 Edition Test Procedures | ||
Criterion Number | Criterion Title | Details |
§ 170.315(a)(1) | Computerized provider order entry (CPOE) – medications | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(2) | CPOE – laboratory | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(3) | CPOE – diagnostic imaging | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(4) | Drug-drug, drug-allergy interaction checks for CPOE | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(5) | Demographics | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(6) | Problem List | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(7) | Medication List | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(8) | Medication Allergy List | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(9) | Clinical Decision Support | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(10) | Drug-formulary and preferred drug list checks | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(11) | Smoking Status | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(12) | Family Health History | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(13) | Patient-specific education resources | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(14) | Implantable Device List | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(a)(15) | Social, psychological, and behavioral data | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(d)(1) | Authentication, access control, authorization | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(d)(2) | Auditable events and tamper-resistance | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(d)(3) | Audit Report(s) | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(d)(4) | Amendments | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(d)(5) | Automatic access time-out | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(d)(6) | Emergency Access | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(d)(7) | End-user device encryption | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(d)(8) | Integrity | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(d)(9) | Trusted Connection | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(d)(10) | Auditing actions on health information | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(d)(11) | Accounting of disclosures | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(e)(2) | Secure Messaging | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(e)(3) | Patient health information capture | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(f)(5) | Transmission to public health agencies – electronic case reporting | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
§ 170.315(g)(7) | Application access – patient selection | As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only |
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
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