§170.315(j)(21) Subscriptions — client
170.315(j)(21) Subscriptions—client. Support subscriptions as a client according to at least one of the implementation specifications in § 170.215(h), including the following:
- Support the requirements in section “Topic-Based Subscriptions—FHIR R4.”
- Support the “R4/B Topic-Based Subscription” profile.
- Support the accompanying client capabilities for the minimum requirements included in the “R4 Topic-Based Subscription Server Capability Statement,” including support for “create,” “update,” and “delete” interactions for Subscription Resources.
- Receive subscription notifications according to section “Topic-Based Subscriptions—FHIR R4,” including support for consuming notifications via the “REST-Hook” channel as specified in the “Channels” section.
Entire Criterion
§ 170.215(h)(1) HL7® FHIR® Subscriptions R5 Backport Implementation Guide Version 1.1.0—Standard for Trial Use
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- Quality management system (§ 170.315(g)(4)): 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.
- Accessibility-centered design (§ 170.315(g)(5)): 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.
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 |
Initial Publication |
10-01-2025
|
- Regulation Text
-
Regulation Text
170.315(j)(21) Subscriptions—client. Support subscriptions as a client according to at least one of the implementation specifications in § 170.215(h), including the following:
- Support the requirements in section “Topic-Based Subscriptions—FHIR R4.”
- Support the “R4/B Topic-Based Subscription” profile.
- Support the accompanying client capabilities for the minimum requirements included in the “R4 Topic-Based Subscription Server Capability Statement,” including support for “create,” “update,” and “delete” interactions for Subscription Resources.
- Receive subscription notifications according to section “Topic-Based Subscriptions—FHIR R4,” including support for consuming notifications via the “REST-Hook” channel as specified in the “Channels” section.
- Standard(s) Referenced
-
Entire Criterion
§ 170.215(h)(1) HL7® FHIR® Subscriptions R5 Backport Implementation Guide Version 1.1.0—Standard for Trial Use
- Certification Dependencies
-
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- Quality management system (§ 170.315(g)(4)): 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.
- Accessibility-centered design (§ 170.315(g)(5)): 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.
- Testing
-
Testing Tool
Inferno Framework (A link will be provided once the testing tool is available.)
Test Tool Documentation (A link will be provided once the testing tool is available.)
- Revision History
-
Version # Description of Change Version Date 1.0 Initial Publication
10-01-2025
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.
Note: The tests step order does not necessarily prescribe the order in which the tests should take place.
Testing components
Paragraph (j)(21)
The health IT developer demonstrates the Health IT Module supports the following capabilities as a client in accordance with an implementation specification at § 170.215(h):
- SUN-1: Identification of a server’s supported subscription topics using the server’s “R4 Topic-Based Subscription Server Capability Statement.”
- SUN-2: Creation, updating, and deletion of a subscription with a server. This subscription must use the “REST-hook” channel and be formatted according to the “R4/B Topic-Based Subscription” resource profile.
- SUN-3: Query the status of a subscription with a server using the “$status” operation.
- SUN-4: Read (i.e., retrieve) a subscription from a server using the “id” of a “Subscription” resource.
- SUN-5: The Health IT Module’s “REST-hook” endpoint supports server subscription negotiation and processing including support for “handshake,” “heartbeat,” and “event-notification” transactions.
The tester verifies the Health IT Module supports the following capabilities as a client in accordance with an implementation specification at § 170.215(h):
- SUN-1: Identification of a server’s supported subscription topics using the server’s “R4 Topic-Based Subscription Server Capability Statement.”
- SUN-2: Creation, updating, and deletion of a subscription with a server. This subscription must use the “REST-hook” channel and be formatted according to the “R4/B Topic-Based Subscription” resource profile.
- SUN-3: Query the status of a subscription with a server using the “$status” operation.
- SUN-4: Read (i.e., retrieve) a subscription from a server using the “id” of a “Subscription” resource.
- SUN-5: The Health IT Module’s “REST-hook” endpoint supports server subscription negotiation and processing including support for “handshake,” “heartbeat,” and “event-notification” transactions.
| System Under Test |
Test Lab Verification
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|---|---|
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The health IT developer demonstrates the Health IT Module supports the following capabilities as a client in accordance with an implementation specification at § 170.215(h):
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The tester verifies the Health IT Module supports the following capabilities as a client in accordance with an implementation specification at § 170.215(h):
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170.315(j)(21) Subscriptions—client. Support subscriptions as a client according to at least one of the implementation specifications in § 170.215(h), including the following:
- Support the requirements in section “Topic-Based Subscriptions—FHIR R4.”
- Support the “R4/B Topic-Based Subscription” profile.
- Support the accompanying client capabilities for the minimum requirements included in the “R4 Topic-Based Subscription Server Capability Statement,” including support for “create,” “update,” and “delete” interactions for Subscription Resources.
- Receive subscription notifications according to section “Topic-Based Subscriptions—FHIR R4,” including support for consuming notifications via the “REST-Hook” channel as specified in the “Channels” section.
Entire Criterion
§ 170.215(h)(1) HL7® FHIR® Subscriptions R5 Backport Implementation Guide Version 1.1.0—Standard for Trial Use
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- Quality management system (§ 170.315(g)(4)): 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.
- Accessibility-centered design (§ 170.315(g)(5)): 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.
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 |
Initial Publication |
10-01-2025
|
- Regulation Text
-
Regulation Text
170.315(j)(21) Subscriptions—client. Support subscriptions as a client according to at least one of the implementation specifications in § 170.215(h), including the following:
- Support the requirements in section “Topic-Based Subscriptions—FHIR R4.”
- Support the “R4/B Topic-Based Subscription” profile.
- Support the accompanying client capabilities for the minimum requirements included in the “R4 Topic-Based Subscription Server Capability Statement,” including support for “create,” “update,” and “delete” interactions for Subscription Resources.
- Receive subscription notifications according to section “Topic-Based Subscriptions—FHIR R4,” including support for consuming notifications via the “REST-Hook” channel as specified in the “Channels” section.
- Standard(s) Referenced
-
Entire Criterion
§ 170.215(h)(1) HL7® FHIR® Subscriptions R5 Backport Implementation Guide Version 1.1.0—Standard for Trial Use
- Certification Dependencies
-
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- Quality management system (§ 170.315(g)(4)): 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.
- Accessibility-centered design (§ 170.315(g)(5)): 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.
- Revision History
-
Version # Description of Change Version Date 1.0 Initial publication
09-30-2025 - Testing
-
Testing Tool
Inferno Framework (A link will be provided once the testing tool is available.)
Test Tool Documentation (A link will be provided once the testing tool is available.)
Certification Companion Guide: Subscriptions — client
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.
The below table outlines whether this criterion has additional Maintenance of Certification dependencies, update requirements and/or eligibility for standards updates via SVAP. Review the Certification Dependencies and Required Update Deadline drop-downs above if this table indicates “yes” for any field.
| Base EHR Definition | Real World Testing | Insights Condition | SVAP | Requires Updates |
|---|---|---|---|---|
| Not Included | Yes | No | No | No |
Applies to entire criterion
Clarifications:
- No additional clarifications.
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Clarifications:
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Paragraph (j)(21)(i) Topic-based subscriptions
Technical outcome – The Health IT Module supports the requirements in section “Topic-Based Subscriptions—FHIR R4” of the HL7® FHIR® Subscriptions R5 Backport Implementation Guide.
Clarifications:
- No additional clarifications.
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Technical outcome – The Health IT Module supports the requirements in section “Topic-Based Subscriptions—FHIR R4” of the HL7® FHIR® Subscriptions R5 Backport Implementation Guide. Clarifications:
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Technical outcome – The Health IT Module supports the “Topic-Based Subscriptions—FHIR R4” profile.
Clarifications:
- No additional clarifications.
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Technical outcome – The Health IT Module supports the “Topic-Based Subscriptions—FHIR R4” profile. Clarifications:
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Paragraph (j)(21)(iii) Client capabilities
Technical outcome – The Health IT Module supports the accompanying client capabilities for the minimum requirements included in the “R4 Topic-Based Subscription Server Capability Statement” of the HL7® FHIR® Subscriptions R5 Backport Implementation Guide, including support for “create,” “update,” and “delete” interactions for Subscription Resources.
Clarifications:
- No additional clarifications.
|
Technical outcome – The Health IT Module supports the accompanying client capabilities for the minimum requirements included in the “R4 Topic-Based Subscription Server Capability Statement” of the HL7® FHIR® Subscriptions R5 Backport Implementation Guide, including support for “create,” “update,” and “delete” interactions for Subscription Resources. Clarifications:
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Paragraph (j)(21)(iv) Subscription notifications
Technical outcome – The Health IT Module can receive subscription notifications according to section “Topic-Based Subscriptions—FHIR R4” of the HL7® FHIR® Subscriptions R5 Backport Implementation Guide, including support for consuming notifications via the “REST-Hook” channel as specified in the “Channels” section.
Clarifications:
- No additional clarifications.
|
Technical outcome – The Health IT Module can receive subscription notifications according to section “Topic-Based Subscriptions—FHIR R4” of the HL7® FHIR® Subscriptions R5 Backport Implementation Guide, including support for consuming notifications via the “REST-Hook” channel as specified in the “Channels” section. Clarifications:
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