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§ 170.315(g)(9)
Application access — all data request
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Certification Companion Guide
Test Procedure
Certification Companion Guide
v1.4
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Issued Date:
03-11-2024
08-29-2025
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 ONC final rules. It extracts key portions of ONC final rules’ preambles and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the
Certification Regulations
page for links to all ONC final rules or consult other regulatory references as noted. The CCG is for public use and should not be sold or redistributed.
Archived Version:
§ 170.315(g)(9) Application access — all data request CCG
Quick Overview
Required Updates
Design and Performance
Additional Criterion Information
Base EHR Definition
Included
Real World Testing
Yes
Insights Condition
No
SVAP Versions
Yes
CLARIFICATIONS
REGULATORY
STANDARDS
DEPENDENCIES
RESOURCES
CHANGELOG
IN THIS SECTION
Certification Clarifications
Technical Explanations and Clarifications
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Clarifications:
Security:
For the purposes of certification there is no conformance requirement related to the registration of third-party applications that use the application programming interfaces (APIs). If a Health IT module requires registration as a pre-condition for accessing the APIs, then, the process must be clearly specified in the API documentation as required by the criterion. ONC strongly believes that registration should not be used to block information sharing via APIs.
This criterion does not currently include any security requirements beyond the privacy and security approach detailed above, but ONC encourages organizations to follow security best practices and implement security controls, such as penetration testing, encryption, audits, and monitoring as appropriate. ONC expects health IT developers to include information on how to securely use their APIs in the public documentation required by the certification criteria and follow industry best practices. [see also
80 FR 62676
and
85 FR 25642
ONC strongly encourages developers to build security into their APIs following industry best practices. [see also
80 FR 62677
A “trusted connection” means the link is encrypted/integrity protected according to § 170.210(a)(2) or (c)(2). As such, ONC does not believe it is necessary to specifically name HTTPS and/or SSL/TLS as this standard already covers encryption and integrity protection for data in motion. [see also
80 FR 62676
APIs could be used when consent or authorization by an individual is required. In circumstances where there is a requirement to document a patient’s request or particular preferences, APIs can enable compliance with documentation requirements. The Health Insurance Portability and Accountability Act of 1996 Privacy Rule (45 CFR Part 160 and Part 164, Subparts A and E) permits the use of electronic documents to qualify as writings for the purpose of proving signature, e.g., electronic signatures. [see also
80 FR 62677
The audit record should be able to distinguish the specific user who accessed the data using a third-party application through the certified API to meet the requirements of § 170.315(d)(2) or (d)(10).
A health IT developer must demonstrate the API functionality of the Health IT Module properly performs consistent with this certification criterion’s requirements. As part of the demonstration process, a health IT developer is permitted, but is not limited, to using existing tools for creating its own app or “client” to interact with the API or using a third-party application for demonstration.
By requiring that documentation and terms of use be open and transparent to the public by requiring a hyperlink to such documentation to be published with the product on the ONC Certified Health IT Product List, ONC hopes to encourage an open ecosystem of diverse and innovative applications that can successfully and easily interact with different Health IT Modules’ APIs. [see also
80 FR 62679
and
85 FR 25642
Consistent with Executive Order (EO) 14168 and OPM guidance, Health IT Modules certifying and/or currently certified to certification criteria that cross-reference the USCDI standard at 45 CFR 170.213 are only required to demonstrate the capability to categorize data on individuals for the sex data element in accordance with the following SNOMED CT® codes:
248152002 |Female (finding)| and
248153007 |Male (finding)|
Further, these Health IT Modules are no longer required to support the following USCDI data elements for purposes of certification:
Sexual orientation in USCDI version 4;
Gender identity in USCDI version 4;
Sex parameter for clinical use in USCDI version 5;
Name to use in USCDI version 5;
Pronouns in USCDI version 5.
Through the
C-CDA Patch Process
, the HL7® Structured Documents Work Group (SDWG) approves C-CDA “patches”, which are corrections for issues with the C-CDA implementation guide (C-CDA IG) and companion guides. C-CDA “patches” include corrections for issues such as ambiguous requirements and requirements incompatible with real world deployment. Similar to C-CDA “patches” are C-CDA “additional guidance”. C-CDA “additional guidance” approved by the SDWG indicates guidance included in a newer version of the C-CDA IG or companion guide as being relevant to a previous version of the C-CDA IG or companion guide. A C-CDA “patch” may require a code change to correct errors or ambiguities in the guide, while “additional guidance” is purely clarifying and does not require any code changes. Though C-CDA “patches” and “additional guidance” are not required for certification purposes (unless indicated in the Certification Companion Guide), health IT developers may optionally implement C-CDA “additional guidance” in their Health IT Module and still be conformant with § 170.315(g)(9) criterion requirements.
More information regarding the C-CDA Patch Process and C-CDA “patches” and “additional guidance” approved by the SDWG is available on the HL7® Confluence pages of
C-CDA 'Patch' Process
and
Approved Patches and Additional Guidance
Technical outcome – The API must be able to respond to requests for patient data (using an ID or other token) for
all
of the data categories specified in the United States Core Data for Interoperability Standard (USCDI) at one time in a summary record formatted according to the C-CDA Release 2.1 Continuity of Care Document (CCD) template.
Clarifications:
Please refer to the USCDI for the data standards that are required.
The technology specifications should be designed and implemented in such a way as to return meaningful responses to queries, particularly with regard to exceptions and exception handling, and should make it easy for applications to discover what data exists for the patient. [see also
80 FR 62678
The term “token” that is used here is not to be interpreted as the token in the OAuth2 workflow, but simply as something that would uniquely identify a patient.
In order to mitigate potential interoperability errors and inconsistent implementation of the HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes, Release 2.1, ONC assesses, approves, and incorporates corrections as part of required testing and certification to this criterion. [see also
Health IT Certification Program Overview
] Certified health IT adoption and compliance with the following corrections are necessary because they implement updates to vocabularies, update rules for cardinality and conformance statements, and promote proper exchange of C-CDA documents. There will be  a 90-day delay from the time the CCG has been updated with the ONC-approved corrections to when compliance with the corrections will be required to pass testing (i.e., C-CDA 2.1 Validator). There will be an 18-month delay before a finding of a correction’s absence in certified health IT during surveillance would constitute a non-conformity under the Certification Program.
STANDARDS REFERENCED
ADOPTION OF THIS STANDARD EXPIRES ON JANUARY 1, 2026
§ 170.213(a)
United States Core Data for Interoperability (USCDI), July 2020 Errata, Version 1 (v1)
THIS STANDARD IS REQUIRED BY DECEMBER 31, 2025
§ 170.213(b)
United States Core Data for Interoperability, Version 3 (October 2022 Errata)
§ 170.205(a)(4)
HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes, Release 2.1
ADOPTION OF THIS STANDARD EXPIRES ON JANUARY 1, 2026
§ 170.205(a)(5)
HL7® CDA® R2 IG: C-CDA Templates for Clinical Notes R1 Companion Guide, Release 2, October 2019
THIS STANDARD IS REQUIRED BY DECEMBER 31, 2025
§ 170.205(a)(6)
Health Level 7 (HL7®) CDA R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 - US Realm
Technical outcome – The API must be able to respond to requests for patient data associated with a specific date as well as with a specific date range.
Clarifications:
Health IT returning an entire patient record that does not reflect the specific date or date range requested is not permissible when a specific date or date range is requested. [see also
80 FR 62678
The health IT developer can determine the method and the amount of data by which the health IT uniquely identifies a patient. [see also
80 FR 62678
The API must be able to send, at minimum all required data for a specified date range(s). ONC acknowledges that there will be organizational policies and/or safety best practices that will dictate additional data to be sent and when data is considered complete and/or ready for being sent. This should be appropriately described in the API documentation.
The approach used to provide the CCD document(s) is set by the API. An approach based on providing one or more CCD documents matching to the patient’s selected date or date range is a valid approach.
Technical outcome – The API must include accompanying documentation which contains, at a minimum:
API syntax, function names, required and optional parameters and their data types, return variables and their types/structures, exceptions and exception handling methods and their returns;
Software components and configurations that would be necessary for an application to implement in order to be able to successfully interact with the API and process its response(s); and
The terms of use for the API, including, at a minimum, any associated developer policies and required developer agreements.
Clarifications:
No additional clarifications.
Technical outcome – The documentation used to meet the provisions in (g)(9)(ii)(A)(
)-(
) must be available through a publicly accessible hyperlink.
Clarifications:
The hyperlink provided for all of the documentation referenced by provision (g)(9)(ii)(A) must reflect the most current version of the health IT developer’s documentation.
All the documentation referenced by provision (g)(9)(ii)(A) must be accessible to the public via a hyperlink
without
additional access requirements, including, without limitation, any form of registration, account creation, “click-through” agreements, or requirement to provide contact details or other information prior to accessing the documentation.
Regulation Text
§ 170.315 (g)(9) Application access – all data request—
The following technical outcome and conditions must be met through the demonstration of an application programming interface.
(i) Functional requirements.
Respond to requests for patient data (based on an ID or other token) for all of the data classes expressed in the standards in § 170.213 at one time and return such data (according to the specified standards, where applicable) in a summary record formatted in accordance with § 170.205(a)(4) and (5) following the CCD document template, and as specified in paragraphs (g)(9)(i)(A)(
)(
) through (
iv
) of this section for the time period up to and including December 31, 2025, or
Respond to requests for patient data (based on an ID or other token) for all of the data classes expressed in the standards in § 170.213 at one time and return such data (according to the specified standards, where applicable) in a summary record formatted in accordance with § 170.205(a)(4) and (6) following the CCD document template, and as specified in paragraphs (g)(9)(i)(A)(3)(i) through (iv) of this section.
The following data classes:
Assessment and plan of treatment.
In accordance with the “Assessment and Plan Section (V2)” of the standards specified in § 170.205(a)(4); or in accordance with the “Assessment Section (V2)” and “Plan of Treatment Section (V2)” of the standards specified in § 170.205(a)(4).
Goals.
In accordance with the “Goals Section” of the standard specified in § 170.205(a)(4).
Health concerns
. In accordance with the “Health Concerns Section” of the standard specified in § 170.205(a)(4).
Unique device identifier(s) for a patient's implantable device(s).
In accordance with the “Product Instance” in the “Procedure Activity Procedure Section” of the standard specified in § 170.205(a)(4).
Respond to requests for patient data associated with a specific date as well as requests for patient data within a specified date range.
(ii) Documentation.
The API must include accompanying documentation that contains, at a minimum:
API syntax, function names, required and optional parameters and their data types, return variables and their types/structures, exceptions and exception handling methods and their returns.
The software components and configurations that would be necessary for an application to implement in order to be able to successfully interact with the API and process its response(s).
The documentation used to meet paragraph (g)(9)(ii)(A) of this section must be available via a publicly accessible hyperlink.
Standards & References
The following standards are referenced within the certification criteria for:
§ 170.315(g)(9) Application access — all data request
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§ 170.213(a)
United States Core Data for Interoperability (USCDI), July 2020 Errata, Version 1 (v1)
Standard expires on:
January 1, 2026
Referenced in the Following:
Paragraph (g)(9)(i)(A)
SVAP-approved Versions:
United States Core Data for Interoperability (USCDI), Version 3.1
§ 170.213(b)
United States Core Data for Interoperability, Version 3 (October 2022 Errata)
Standard required by:
December 31, 2025
Referenced in the Following:
Paragraph (g)(9)(i)(A)
SVAP-approved Versions:
United States Core Data for Interoperability (USCDI), Version 5
§ 170.205(a)(4)
HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes, Release 2.1
Referenced in the Following:
Paragraph (g)(9)(i)(A)
SVAP-approved Versions:
HL7 CDA® R2 Implementation Guide: Consolidated -CDA Templates for Clinical Notes Edition 4.0 - US Realm
§ 170.205(a)(5)
HL7® CDA® R2 IG: C-CDA Templates for Clinical Notes R1 Companion Guide, Release 2, October 2019
Standard expires on:
January 1, 2026
Referenced in the Following:
Paragraph (g)(9)(i)(A)
SVAP-approved Versions:
HL7 CDA® R2 Implementation Guide: Consolidated -CDA Templates for Clinical Notes Edition 4.0 - US Realm
§ 170.205(a)(6)
Health Level 7 (HL7®) CDA R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 - US Realm
Standard required by:
December 31, 2025
Referenced in the Following:
Paragraph (g)(9)(i)(A)
SVAP-approved Versions:
HL7 CDA® R2 Implementation Guide: Consolidated -CDA Templates for Clinical Notes Edition 4.0 - US Realm
Paragraph (g)(9)(i)(A)
Functional requirements
§ 170.213(a)
United States Core Data for Interoperability (USCDI), July 2020 Errata, Version 1 (v1)
(Adoption of this standard expires on January 1, 2026)
§ 170.213(b)
United States Core Data for Interoperability, Version 3 (October 2022 Errata)
(This standard is required by December 31, 2025)
§ 170.205(a)(4)
HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes, Release 2.1
§ 170.205(a)(5)
HL7® CDA® R2 IG: C-CDA Templates for Clinical Notes R1 Companion Guide, Release 2, October 2019
(Adoption of this standard expires on January 1, 2026)
§ 170.205(a)(6)
Health Level 7 (HL7®) CDA R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 - US Realm
(This standard is required by December 31, 2025)
Certification Dependencies
IN THIS SECTION
§ 170.405
Real World Testing
Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
Note: Enforcement discretion has been issued for CY 2025–2026. Refer to the
Enforcement Discretion Notices
for full details.
Privacy and Security
This certification criterion was adopted at § 170.315(g)(9). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to this criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific criterion unless it is the only criterion for which certification is requested.
As a general rule, a product presented for certification only needs to be tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging”, which are explicitly stated.
For more information on the approaches to meet these Privacy and Security requirements, please download the Privacy and Security CCG below:
Privacy and Security CCG
if choosing
Approach 1
Authentication, access control, and authorization (§ 170.315(d)(1))
Trusted connection (§ 170.315(d)(9))
Either
Auditable events and tamper-resistance (§ 170.315(d)(2))
or
Auditing actions on health information (§ 170.315(d)(10))
Note: If a developer elects to demonstrate §170.315(d)(2), they only need to demonstrate § 170.315(d)(2)(i)(A) – (B) and § 170.315(d)(2)(ii) – (v) for the privacy and security requirements for this criterion.
Encrypt authentication credentials (§ 170.315(d)(12))
Multi-factor authentication (MFA) (§ 170.315(d)(13))
if choosing
Approach 2
For each applicable privacy and security certification criterion not certified for Approach 1, the health IT developer may certify using system documentation that is sufficiently detailed to enable integration such that the Health IT Module has implemented service interfaces for each applicable privacy and security certification criterion that enable the Health IT Module to access external services necessary to meet the requirements of the privacy and security certification criterion. Please see the
21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program
Final Rule at
85 FR 25710
for additional clarification.
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.
Consolidated CDA creation performance (§ 170.315(g)(6))
: Consolidated Clinical Document Architecture (C-CDA) creation performance (§ 170.315(g)(6)) does not need to be explicitly tested with this criterion unless it is the only criterion within the scope of the requested certification that includes C-CDA creation capabilities. Note that the application of § 170.315(g)(6) depends on the C-CDA templates explicitly required by the C-CDA-referenced criterion or criteria included within the scope of the certificate sought. Please refer to the C-CDA creation performance CCG for more details.
Resources
The following resources can offer assistance or additional information:
§ 170.315(g)(9) Application access — all data request
PDF DOCUMENT
Real World Testing Resource Guide
2025-10-01
PDF DOCUMENT
Real World Testing Fact Sheet
PDF DOCUMENT
API Conditions and Maintenance Certification Requirements Fact Sheet
2024-11-01
Certification Companion Guide Changelog
The following changelog applies to:
§ 170.315(g)(9)Application access — all data request
Changelog functionality is not available.
Revision History
Version #
Description of Change
Version Date
1.0
Initial publication
03-11-2024
1.1
Standards Referenced updated to reflect 2024 Approved SVAP Standards.
08-19-2024
1.2
For entire criterion, added clarification regarding compliance with EO 14168 and OPM guidance
03-27-2025
1.3
Added clarification for entire criterion providing information regarding C-CDA patch process. Added update to Certification Dependencies section to reflect recent Real World Testing enforcement discretion notice.
07-23-2025
1.4
Standards Referenced updated to reflect 2025 Approved SVAP Standards
08-29-2025
Test Procedure
v1.2
View Changelog
Issued Date:
03-11-2024
03-21-2025
This Test Procedure illustrates the test steps required to certify a Health IT Module to this criterion. Please consult the most recent ONC Final Rule on the
Certification Regulations
page for a detailed description of the certification criterion with which these testing steps are associated. 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.
Archived Version:
§ 170.315(g)(9) Application access — all data request TP
Quick Overview
Required Updates
Design and Performance
Additional Criterion Information
Base EHR Definition
Included
Real World Testing
Yes
Insights Condition
No
SVAP Versions
Yes
TESTING STEPS
TOOLS AND DATA
TESTING COMPONENTS
CHANGELOG
IN THIS SECTION
View Regulation Text
Testing Steps
Note: The test step order does not necessarily prescribe the order in which the tests should take place.
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Testing Steps
System Under Test
A health IT developer of a Health IT Module currently certified to the § 170.315(g)(9) Application access — all data access will attest directly to the ONC-ACB to conformance with the updated § 170.315(g)(9) requirements outlined in the
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1)
Final Rule.
ONC-ACB Verification
The ONC-ACB verifies the health IT developer of a Health IT Module certified to § 170.315(g)(9) Application access — all data access attests conformance to the updated § 170.315(g)(9) criterion requirements.
The following technical outcome and conditions must be met through the demonstration of an application programming interface (API).
Testing Steps
System Under Test
Setup
Using the ASTP Standards Implementation & Testing Environment (SITE): C-CDA Validator – USCDI v1, the health IT developer downloads the ONC-supplied data instructions through the sender download selections of the “APIAccess_Amb” or “APIAccess_Inp” criteria and one of the API instruction documents, and then executes the download.
Demonstrate API
Using the ONC-supplied API instruction document returned in step 1, and the Health IT Module’s identified API functions (including the ID or token generated as part of the “Application Access – patient selection” certification criterion at § 170.315(g)(7)), the user demonstrates that the API responds to and returns all data classes expressed in the standard in § 170.213 USCDI and the data classes in § 170.215(g)(9)(i)(A)(3) in a summary record formatted in accordance with the standard adopted at § 170.205(a)(4) HL7
Implementation Guide for CDA
Release 2: Consolidated CDA Templates for Clinical Notes with Errata, DSTU Release 2.1 and § 170.205(a)(5) HL7
CDA
R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2 following the CCD document template for the unique patient identified by the ID or token.
For each CCD document created in step 2, the user submits the CCD document to the tester for verification.
Based on the health IT setting(s) to be certified, the user repeats steps 1-3, for each of the ambulatory and/or inpatient care plan instruction documents found in SITE: C-CDA Validator - USCDI v1. Demonstration of the API is required for all of the API instruction documents for a given health IT setting.
All Steps
Approved SVAP Version)
Complete steps above using SITE C-CDA Validator – USCDI v4 and;
Reference United States Core Data for Interoperability (USCDI), Version 4, October 2023 Errata, and;
Use HL7® CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes Edition 3.0 - US Realm, May 2024 for § 170.205(a)(4), (a)(5) or (a)(6).
Using SITE: C-CDA Validator - USCDI v3, the health IT developer downloads the ONC-supplied data instructions through the sender download selections of the “APIAccess_Amb” or “APIAccess_Inp” criteria and one of the API instruction documents, and then executes the download.
Demonstrate API
Using the ONC-supplied API instruction document returned in step 1, and the Health IT Module’s identified API functions (including the ID or token generated as part of the “Application Access – patient selection” certification criterion at § 170.315(g)(7)), the user demonstrates that the API responds to and returns all data classes expressed in the standard in § 170.213 USCDI and the data classes in § 170.215(g)(9)(i)(A)(3) in a summary record formatted in accordance with the standard adopted at § 170.205(a)(4) HL7® Implementation Guide for CDA
Release 2: Consolidated CDA Templates for Clinical Notes with Errata, DSTU Release 2.1 and § 170.205(a)(6) HL7
CDA
R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 following the CCD document template for the unique patient identified by the ID or token.
For each CCD document created in step 2, the user submits the CCD document to the tester for verification.
Based on the health IT setting(s) to be certified, the user repeats steps 1-3, for each of the ambulatory and/or inpatient care plan instruction documents found in SITE: C-CDA Validator - USCDI v3. Demonstration of the API is required for all of the API instruction documents for a given health IT setting.
All Steps
Approved SVAP Version)
Complete steps above using SITE C-CDA Validator – USCDI v4 and;
Reference United States Core Data for Interoperability (USCDI), Version 4, October 2023 Errata, and;
Use HL7® CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes Edition 3.0 - US Realm, May 2024 for § 170.205(a)(4), (a)(5) or (a)(6).
Test Lab Verification
Demonstrate API
For each API instruction set downloaded in step 1, of the System Under Test, the tester verifies the identified API routine(s) can respond to a request for “all patient data” and return all data in the USCDI in a single document using the CCD template.
Using SITE: C-CDA Validator – USCDI v1, the tester uploads the submitted CCD document returned from the identified API routine(s) through the sender upload selection of the “APIAccess_Amb” or “APIAccess_Inp” criteria and file name of the API instruction document, and the tester executes the upload of the submitted file to the SITE: C-CDA Validator.
The tester uses the validation report produced by the SITE: C-CDA Validator in step 2, to verify it indicates passing without error to confirm the CCD document returned by the API is in a summary record formatted in accordance with the standard adopted at § 170.205(a)(4), § 170.205(a)(5), and the data classes defined in § 170.215(g)(9)(i)(A)(3) using the CCD document template.
As required by the ONC-supplied API instructions with the corresponding file names as uploaded in step 2, the tester uses the ONC-supplied API instruction document and the SITE: C-CDA Validator Message Content Report to verify the additional checks for equivalent text for the content of all section level narrative text.
Demonstrate API
For each API instruction set downloaded in step 1, of the System Under Test, the tester verifies the identified API routine(s) can respond to a request for “all patient data” and return all data in the USCDI in a single document using the Continuity of Care Document (CCD) template.
Using SITE: C-CDA Validator – USCDI v3, the tester uploads the submitted CCD document returned from the identified API routine(s) through the sender upload selection of the “APIAccess_Amb” or “APIAccess_Inp” criteria and file name of the API instruction document, and the tester executes the upload of the submitted file to the SITE: C-CDA Validator.
The tester uses the validation report produced by the SITE: C-CDA Validator in step 2, to verify it indicates passing without error to confirm the CCD document returned by the API is in a summary record formatted in accordance with the standard adopted at § 170.205(a)(4), § 170.205(a)(6), and the data classes defined in § 170.215(g)(9)(i)(A)(3) using the CCD document template.
As required by the ONC-supplied API instructions with the corresponding file names as uploaded in step 2, the tester uses the ONC-supplied API instruction document and the SITE: C-CDA Validator Message Content Report to verify the additional checks for equivalent text for the content of all section level narrative text.
Testing Steps
System Under Test
The following data classes are to be present and expressed within the resultant CCD document
The Assessment and Plan of Treatment in accordance with either the Assessment and Plan Section (V2), or both the Assessment and Plan of Treatment Sections (V2), specified in accordance with the standard specified in § 170.205(a)(4). At a minimum, the Assessment and Plan of Treatment data includes the narrative text.
The Goals specified in accordance with the standard specified at § 170.205(a)(4). At a minimum, the Goals data includes narrative text.
The Health Concerns specified in accordance with the standard specified at § 170.205(a)(4). At a minimum, the Health concerns data includes narrative text.
Test Lab Verification
Using visual inspection, the tester verifies the data presented in section (g)(9)(A)(1) includes:
The Assessment and Plan or both the Assessment and Plan of Treatment are specified in accordance with the standard specified in § 170.205(a)(4) as narrative text.
The Goals are specified in accordance with the standard specified in § 170.205(a)(4) as narrative text.
The Health Concerns are specified in accordance with the standard specified in § 170.205(a)(4) as narrative text
Note: The system must consistently and independently represent the data as discrete data that are clearly distinguishable.
Testing Steps
System Under Test
The Health IT Module’s identified API returns data to the developer-identified requesting application for a specific date that the requesting application identifies.
The Health IT Module’s identified API returns data to the developer-identified requesting application for a specific date range that the requesting application identifies.
Test Lab Verification
The tester verifies the API routine(s) can respond to a request for patient data for a specific date, and that the patient data returned is accurate and without omission based upon the health IT developer’s documentation for data return based upon a date request.
The tester verifies the API routine(s) can respond to a request for patient data for a date range, and the patient data returned is accurate and without omission based upon the health IT developer’s documentation for data return based upon a date range request.
Testing Steps
System Under Test
The health IT developer supplies documentation describing the API, with the intended audience of developers, and includes at a minimum:
API syntax;
function names;
required and optional parameters and their data types;
return variables and their types/structures; and
exceptions and exception handling methods and their returns.
Test Lab Verification
The tester verifies the identified documentation for the Health IT Module’s API definition is accurate and without omission, and that it matches the version of the software release.
Testing Steps
System Under Test
The health IT developer supplies accompanying documentation describing the Health IT Module’s API implementation requirements, with the intended audience of developers, which must include:
The software components and configurations that would be necessary for an application to implement to be able to successfully interact with the API and process its response(s).
Test Lab Verification
The tester verifies the identified documentation for interfacing with the Health IT Module’s API (including both the software components and the configuration) is accurate and without omission and that it matches the version of the software release.
Testing Steps
System Under Test
The documentation used to meet paragraph (g)(9)(ii)(A) of this section must be available via a publicly accessible hyperlink.
Test Lab Verification
The tester verifies the supplied documentation is publicly accessible by hyperlink.
TEST TOOL DOCUMENTATION
Testing Tools
§ 170.315(g)(9) Application access — all data request
Standards Implementation & Testing Environment (SITE)
C-CDA Validators
SITE is a centralized collection of testing tools and resources designed to assist health IT developers and health IT users fully evaluating specific technical standards and maximizing the potential of their health IT implementations. SITE is organized in a collection of sandboxes that provide test tools, sample data, collaboration resources, and useful links.
Test Data
Test data for implementation and validation.
(g)(9)(i)
Inpatient setting: - 170.315_g9_api_access_inp_sample*.docx (All Samples)
Ambulatory setting - 170.315_g9_api_access _amb_sample*.docx (All Samples)
Testing Components
§ 170.315(g)(9) Application access — all data request
Documentation is an approved method to demonstrate conformance. This may include documents from the health IT developer or third-party that demonstrate/attest to the compliance with the criterion.
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
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.
SVAP
Indicates that the Standards Version Advancement Process (SVAP) is applicable to the criterion.
Test Data
The test data for this criterion is provided within the testing tools tab. Click the link below to be directed to the testing tools tab.
Review Test Data
Test Method Changelog
The following changelog applies to:
§ 170.315(g)(9)Application access — all data request
Changelog functionality is not available.
Revision History
Version #
Description of Change
Version Date
1.0
Initial publication
03-11-2024
1.1
Updated test tool link
12-02-2024
1.2
Updated test steps with 2024 SVAP approved standards and new SITE UI language
03-21-2025
The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
Additional Criteria:
§ 170.315(g)(4)
Quality management system
Description:
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.
§ 170.315(g)(5)
Accessibility-centered design
Description:
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.
§ 170.315(g)(6)
Consolidated CDA creation performance
Description:
Consolidated Clinical Document Architecture (C-CDA) creation performance (§ 170.315(g)(6)) does not need to be explicitly tested with this criterion unless it is the only criterion within the scope of the requested certification that includes C-CDA creation capabilities. Note that the application of § 170.315(g)(6) depends on the C-CDA templates explicitly required by the C-CDA-referenced criterion or criteria included within the scope of the certificate sought. Please refer to the C-CDA Creation Performance CCG for more details.
Required Updates
The following outlines deadlines for required updates for this criterion as they relate to changes published in recent ONC final rules. Developers must update their products to the requirements outlined and provide them to their customers by the stated deadlines. These represent one-time deadlines as set by recent regulatory updates and do not encompass ongoing deadlines related to the Conditions and Maintenance of Certification. Please review those requirements for additional compliance activities related to one’s certification under Certification Dependencies.
Deadlines:
December 31, 2025
Actions to be taken:
Developers must update their certification to the newer versions of USCDI and C-CDA Companion Guide as outlined in paragraphs (g)(9)(i)(A)(1-2).
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Standards Version Advancement Process (SVAP)
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.
Learn More About SVAP
SVAP Approved Version:
JUNE 2025
United States Core Data for Interoperability (USCDI), Version 3.1
Related to standard reference: § 170.213(a)
MARCH 2025 ERRATA
United States Core Data for Interoperability (USCDI), Version 5
Related to standard reference: § 170.213(b)
HL7 CDA® R2 Implementation Guide: Consolidated -CDA Templates for Clinical Notes Edition 4.0 - US Realm
Related to standard reference: § 170.205(a)(4)
HL7 CDA® R2 Implementation Guide: Consolidated -CDA Templates for Clinical Notes Edition 4.0 - US Realm
Related to standard reference: § 170.205(a)(5)
HL7 CDA® R2 Implementation Guide: Consolidated -CDA Templates for Clinical Notes Edition 4.0 - US Realm
Related to standard reference: § 170.205(a)(6)
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