§170.315(j)(20)
Issued Date:
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product certification. The CCG is not a substitute for the requirements outlined in regulation and related ASTP/ONC final rules. It extracts key portions of ASTP/ONC final rules’ preambles and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the Certification Program Regulations page for links to all final rules or consult other regulatory references as noted. The CCG is for public use and should not be sold or redistributed.
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Technical Explanations and Clarifications
Clarifications:
Technical outcome – The Health IT Module supports registration capabilities applicable to “CDS Clients” according to the HL7 FHIR® CDS Hooks IG.
Clarifications:
Technical outcome – The Health IT Module supports authentication and authorization, with client authentication using JSON web tokens (JWT) and data access authorization of a “CDS Service” using access tokens.
Clarifications:
Technical outcome – The Health IT Module supports the execution of decision support workflow triggers.
Clarifications:
Technical outcome –The Health IT Module supports sending a decision support request to a “CDS Service,” including support for (A) access to FHIR® Resources via a RESTful API, and (B) the receipt of a decision support response.
Clarifications:
§ 170.315(j)(20) Workflow triggers for decision support interventions—clients.
Support the requirements applicable to a “CDS Client” according to at least one of the implementation specifications in § 170.215(f) including the following:
Support registration capabilities applicable to “CDS Clients”.
Support authentication and authorization, including the following:
Support the execution of decision support workflow triggers.
Send a decision support request to a “CDS Service,” including support for the following:
The following standards are referenced within the certification criteria for:
Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
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The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
The following resources can offer assistance or additional information:
The following changelog applies to:
§170.315(j)(20) Workflow triggers for decision support interventions — clients
Changelog functionality is not available.
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 | Initial publication | 09-30-2025 |
Issued Date:
This Test Procedure illustrates the test steps required to certify a Health IT Module to this criterion. Please consult the most recent ASTP/ONC Final Rule on the Certification Regulations page for a detailed description of the certification criterion with which these testing steps are associated. ASTP/ONC also encourages developers to consult the Certification Companion Guide in tandem with the test procedure as it provides clarifications that may be useful for product development and testing.
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Note: The tests step order does not necessarily prescribe the order in which the tests should take place.
The health IT developer demonstrates the Health IT Module supports the following capabilities as a “CDS Client” in accordance with an implementation specification at § 170.215(f):
The tester verifies the Health IT Module supports the following capabilities as a “CDS Client” in accordance with an implementation specification at § 170.215(f):
Documentation may be used as a method to demonstrate conformance but is not required for this criterion. Health IT developers may optionally provide documentation to supplement other testing methods.
Visual inspection is an approved method to demonstrate conformance. Most commonly, this will be accomplished via a live demonstration of functionality that meets the criterion.
Testing tools indicate that a test tool(s) exists and must be used to test a portion or all of a Health IT Module's conformance to the criterion.
The Standards Version Advancement Process (SVAP) is not applicable to this criterion.
The test data for this criterion is not provided by ASTP. Developers will be expected to provide their own data in order to validate testing.
The following changelog applies to:
§170.315(j)(20) Workflow triggers for decision support interventions — clients
Changelog functionality is not available.
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 | Initial publication | 10-01-2025 |
The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
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The Standards Version Advancement Process (SVAP) permits health IT developers to voluntarily update health IT products certified under the ONC Health IT Certification Program (Certification Program) to newer versions of adopted standards as part of the "Real World Testing" Condition and Maintenance of Certification requirement (§ 170.405) of the 21st Century Cures Act.
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