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§ 170.315(b)(9)
Care plan
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Certification Companion Guide
Test Procedure
Certification Companion Guide
v1.3
View Changelog
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(b)(9) Care plan CCG
Quick Overview
Required Updates
Design and Performance
Additional Criterion Information
Base EHR Definition
Not 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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Technical outcome – A user can record, change, access, create, and receive care plan information according to the Care Plan document template in the HL7® Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1, including the Health Status Evaluations and Outcomes Section and Interventions Section (V2).
Clarifications:
In combination with the C-CDA R2.1 standard, developers certifying to the Care Plan criterion must follow the guidance and templates provided in HL7
CDA
R2 IG: C-CDA Templates for Clinical Notes R2 Companion Guide, Release 2 for implementation of the C-CDA Release 2.1 standard for a period up to and including December 31, 2025 or use the templates provided in HL7
CDA
R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1 - US Realm.
The Care Plan document template supports broader information about the patient, including education, physical therapy/range of motion, and social interventions not commonly found in other parts of the C-CDA standard, and is also distinct from the 'Plan of Treatment Section' in Version 2.1 of the C-CDA. (The Plan of Care Section in C-CDA 1.1 was renamed Plan of Treatment Section in C-CDA 2.1). [see also
80 FR 62648
The Care Plan document template is distinct from the “Plan of Care Section” in previous versions of the C-CDA. [see also
80 FR 62648
Consistent with ONC policy, health IT must enable a user to record, change, access, create, and receive information for those sections of the C-CDA Care Plan template that are required, including the “Goals” and “Health Concerns” Sections. [see also
80 FR 62648
] ONC would expect that these sections could contain patient-expressed information, including patient-expressed goals and health concerns. Because of this, the information contained within the “Goals” and “Health Concerns” Sections of the Care Plan document could differ from the information contained within those same sections in a transition of care/referral summary document.
Health IT must enable a user to record, change, access, create, and receive information for the “Health Status Evaluations and Outcomes Section” and “Interventions Section (V2)”. Although these sections are deemed optional in the C-CDA standard, they are required for certification. [see also
80 FR 62649
Although a system will need to be able to receive a care plan in accordance with C-CDA Release 2.1, the system is not required to enable a user to reconcile the care plan data. [see also
80 FR 62649
In order to mitigate potential interoperability errors and inconsistent implementation of the HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, Draft Standard for Trial Use, Release 2.1, ONC assesses, approves, and incorporates corrections as part of required testing and certification to this criterion [see the
ONC 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 is 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., ETT: Message Validators). Similarly, 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.
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(b)(7) 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
STANDARDS REFERENCED
§ 170.205(a)(4)
HL7 CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2
ADOPTION OF THIS STANDARD EXPIRES ON JANUARY 1, 2026
§ 170.205(a)(5)
HL7® CDA® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2-US Realm, October 2019
THIS STANDARD IS REQUIRED BY DECEMBER 31, 2025
§ 170.205(a)(6)
HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1—US Realm
Regulation Text
§ 170.315 (b)(9) Care plan—
Enable a user to record, change, access, create, and receive care plan information in accordance with:
(i) The Care Plan document template, including the Health Status Evaluations and Outcomes Section and Interventions Section (V2), in the standard specified in § 170.205(a)(4); and
(ii) The standard in § 170.205(a)(5) for the time period up to and including December 31, 2025; or § 170.205(a)(6).
Standards & References
The following standards are referenced within the certification criteria for:
§ 170.315(b)(9) Care plan
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§ 170.205(a)(4)
HL7 CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2
Referenced in the Following:
§170.315(b)(9)
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 R2.1 Companion Guide, Release 2-US Realm, October 2019
Standard expires on:
January 1, 2026
Referenced in the Following:
§170.315(b)(9)
SVAP-approved Versions:
HL7 CDA® R2 Implementation Guide: Consolidated -CDA Templates for Clinical Notes Edition 4.0 - US Realm
§ 170.205(a)(6)
HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1—US Realm
Standard required by:
December 31, 2025
Referenced in the Following:
§170.315(b)(9)
SVAP-approved Versions:
HL7 CDA® R2 Implementation Guide: Consolidated -CDA Templates for Clinical Notes Edition 4.0 - US Realm
§170.315(b)(9)
Applies to Entire Criterion
§ 170.205(a)(4)
HL7 CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2
§ 170.205(a)(5)
HL7® CDA® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2-US Realm, October 2019
(Adoption of this standard expires on January 1, 2026)
§ 170.205(a)(6)
HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU 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(b)(9). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(b) 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 paragraph (a) 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))
Auditable events and tamper-resistance (§ 170.315(d)(2))
Audit reports (§ 170.315(d)(3))
Automatic access time-out (§ 170.315(d)(5))
Emergency access (§ 170.315(d)(6))
End-user device encryption (§ 170.315(d)(7))
Integrity (§ 170.315(d)(8))
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, when different QMS are used, each QMS needs to be separately 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, when different QMS are used, each QMS needs to be separately identified for every capability to which it was applied.
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(b)(9) Care plan
PDF DOCUMENT
Real World Testing Resource Guide
2025-10-01
PDF DOCUMENT
Real World Testing Fact Sheet
Certification Companion Guide Changelog
The following changelog applies to:
§ 170.315(b)(9)Care plan
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
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
1.3
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(b)(9) Care plan TP
Quick Overview
Required Updates
Design and Performance
Additional Criterion Information
Base EHR Definition
Not 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 Module currently certified to the § 170.315(b)(9) Care plan will attest directly to the ONC-ACB to conformance with the updated § 170.315(b)(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 Module certified to § 170.315(b)(9) Care plan attests conformance to updated § 170.315(b)(9) criterion requirements.
Testing Steps
System Under Test
Record
Using the ASTP Standards Implementation & Testing Environment (SITE): C-CDA Validator – USCDI v1, the health IT developer chooses "Sender" then selects the “170.315_b9_CP_Amb” or “170.315_b9_CP_Inp” criteria and one of the care plan instruction documents and executes the download.
Using the ONC-supplied care plan instruction document returned in step 1, the user enters the care plan information into the Health IT Module.
The user records care plan information that includes the following:
Patient Name;
Goals;
Health Concerns;
Health Status Evaluations and Outcomes; and
Interventions.
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 the SITE: C-CDA Validator – USCDI v1. The recording of a care plan is required for all of the care plan instruction documents for a given health IT setting.
(Approved SVAP Version)
Complete steps above using SITE C-CDA Validator for USCDI v4; and
Reference United States Core Data for Interoperability (USCDI), Version 4, October 2023 Errata
Record
Using the SITE: C-CDA Validator USCDI v3, the health IT developer chooses “Sender” then selects the “170.315_b9_CP_Amb” or “170.315_b9_CP_Inp” criteria and one of the care plan instruction documents and executes the download.
Using the ONC-supplied care plan instruction document returned in step 1, the user enters the care plan information into the Health IT Module.
The user records care plan information that includes the following:
Patient Name;
Goals;
Health Concerns;
Health Status Evaluations and Outcomes; and
Interventions.
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. The recording of a care plan is required for all of the care plan instruction documents for a given health IT setting.
(Approved SVAP Version)
Complete steps above using SITE C-CDA Validator for USCDI v4; and
Reference United States Core Data for Interoperability (USCDI), Version 4, October 2023 Errata
Test Lab Verification
Record
The tester verifies the health IT developer can download the care plan instruction document for the health IT setting to be certified.
The tester verifies the user can enter all of the care plan information outlined in the ONC-supplied care plan instruction documents returned in step 1.
The tester verifies the outlined care plan information has been recorded correctly and without omission through visual inspection of the System Under Test using the ONC-supplied care plan instruction document associated with the recorded care plan.
For each of the health IT setting(s) to be certified, the tester repeats steps 1-3.
Record
The tester verifies the health IT developer can download the care plan instruction document for the health IT setting to be certified.
The tester verifies the user can enter all of the care plan information outlined in the ONC-supplied care plan instruction documents returned in step 1.
The tester verifies the outlined care plan information has been recorded correctly and without omission through visual inspection of the System Under Test using the ONC-supplied care plan instruction document associated with the recorded care plan. For each of the health IT setting(s) to be certified, the tester repeats steps 1-3.
Testing Steps
System Under Test
Change and Access
Using the Health IT Module, the user accesses and changes the care plan information for a specific patient that includes the following:
Patient Name;
Goals;
Health Concerns;
Health Status Evaluations and Outcomes; and
Interventions.
Test Lab Verification
Change and Access
The tester verifies care plan information can be accessed and changed using visual inspection of the System Under Test.
Testing Steps
System Under Test
Create
For each care plan recorded by the Health IT Module, the user creates a care plan document formatted in accordance with the Care Plan document template in the standard adopted at § 170.205(a)(4) HL7
Implementation Guide for CDA
Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1 C-CDA 2.1 with Errata, August 2015, June 2019 (with Errata), and § 170.205(a)(5) HL7
CDA
R2 IG: C-CDA Templates for Clinical Notes R1 Companion Guide, Release 2, and includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2), which at a minimum includes:
Patient Name;
Goals;
Health Concerns;
Health Status Evaluations and Outcomes; and
Interventions.
For each care plan document created in step 1, the user submits the care plan document to the tester for verification.
All Steps
Approved SVAP Version)
Complete steps above using SITE C-CDA Validator for 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).
Create
For each care plan recorded by the Health IT Module, the user creates a care plan document formatted in accordance with the Care Plan document template in the standard adopted at § 170.205(a)(4) HL7
Implementation Guide for CDA
Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1 C-CDA 2.1 with Errata, August 2015, June 2019 (with Errata), and § 170.205(a)(6) HL7
CDA
R2 IG: C-CDA Templates for Clinical Notes R1 Companion Guide, Release 4.1, and includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2), which at a minimum includes:
Patient Name;
Goals;
Health Concerns;
Health Status Evaluations and Outcomes; and
Interventions.
For each care plan document created in step 1, the user submits the care plan document to the tester for verification.
All Steps
Approved SVAP Version)
Complete steps above using SITE C-CDA Validator for 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
Create
Using SITE: C-CDA Validator – USCDI v1, the tester uploads the submitted care plan (xml file) created by the Health IT Module in step 1 of the System Under Test, through the sender upload selection of the “170.315_b9_CP_Amb” or “170.315_b9_CP_Inp” criteria and file name of the care plan recorded by the System Under Test, and executes the upload of the submitted file to the SITE: C-CDA Validator.
The tester uses the Validation Report produced by SITE: C-CDA Validator in step 1, to verify the validation report indicates passing without error to confirm that the care plan is a C-CDA R2.1 document conformant to the standard specified at § 170.205(a)(4) and § 170.205(a)(5) and includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2). Additionally, as required by the ONC-supplied care plan instructions with the corresponding file names as uploaded in step 1, the tester uses the ONC-supplied care plan 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.
Create
Using SITE: C-CDA Validator – USCDI v3, the tester uploads the submitted care plan (xml file) created by the Health IT Module in step 1 of the System Under Test, through the sender upload selection of the “170.315_b9_CP_Amb” or “170.315_b9_CP_Inp” criteria and file name of the care plan recorded by the System Under Test, and executes the upload of the submitted file to SITE: C-CDA Validator.
The tester uses the Validation Report produced by SITE: C-CDA Validator in step 1, to verify the validation report indicates passing without error to confirm that the care plan is a C-CDA R2.1 document conformant to the standard specified at § 170.205(a)(4) and § 170.205(a)(6) and includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2). Additionally, as required by the ONC-supplied care plan instructions with the corresponding file names as uploaded in step 1, the tester uses the ONC-supplied care plan 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
Receive
Using SITE: C-CDA Validator – USCDI v1, the health IT developer downloads the ONC-supplied care plan xml documents through the receiver download selections of the “170.315_CP_Amb” or “170.315_CP_Inp” criteria and care plan xml file and executes the download of the care plan xml file.
Using the Health IT Module, the user receives the care plan (xml files) downloaded from SITE: C-CDA Validator – USCDI v1, in step 1, which is formatted in accordance with the care plan document template in the standard adopted at § 170.205(a)(4) and § 170.205(a)(5) and includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2), which at a minimum includes:
Patient Name;
Goals;
Health Concerns;
Health Status Evaluations and Outcomes; and
Interventions.
Based upon the health IT setting(s) to be certified, the user repeats steps 1-2, for each ambulatory and/or inpatient care plan (xml) document in SITE: C-CDA Validator – USCDI v1. All of the care plan (xml) documents for a given health IT setting must be received.
Negative Test
Using SITE: C-CDA Validator – USCDI v1, the health IT developer downloads the ONC-supplied care plan negative test xml documents through the receiver download selections of the “NegativeTesting CarePlan” criteria and one of the invalid C-CDA documents and executes the download of the invalid C-CDA xml file.
Using the Health IT Module, the user receives the applicable C-CDA document types containing errors in the corresponding “document-templates,” “section-templates,” and “entry-templates” including invalid vocabulary standards and codes not specified in the standards adopted in at § 170.205(a)(4) and § 170.205(a)(5), and reports the errors.
The user repeats steps 4-5 for each of the negative test samples in SITE: C-CDA Validator - USCDI v1 “NegativeTesting_CarePlan.” All of the negative test care plan (xml) documents must be received.
All Steps
Approved SVAP Version)
Complete steps above using SITE C-CDA Validator for 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).
Receive
Using SITE: C-CDA Validator – USCDI v3, the health IT developer downloads the ONC-supplied care plan xml documents through the receiver download selections of the “170.315_CP_Amb” or “170.315_CP_Inp” criteria and care plan xml file and executes the download of the care plan xml file.
Using the Health IT Module, the user receives the care plan (xml files) downloaded from SITE: C-CDA Validator – USCDI v3, in step 1, which is formatted in accordance with the care plan document template in the standard adopted at § 170.205(a)(4) and § 170.205(a)(6) and includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2), which at a minimum includes:
Patient Name;
Goals;
Health Concerns;
Health Status Evaluations and Outcomes; and
Interventions.
Based upon the health IT setting(s) to be certified, the user repeats steps 1-2, for each ambulatory and/or inpatient care plan (xml) document in the SITE: C-CDA Validator – USCDI v3. All of the care plan (xml) documents for a given health IT setting must be received.
Negative Test
Using SITE: C-CDA Validator – USCDI v3, the health IT developer downloads the ONC-supplied care plan negative test xml documents through the receiver download selections of the “NegativeTesting CarePlan” criteria and one of the invalid C-CDA documents and executes the download of the invalid C-CDA xml file.
Using the Health IT Module, the user receives the applicable C-CDA document types containing errors in the corresponding “document-templates,” “section-templates,” and “entry-templates” including invalid vocabulary standards and codes not specified in the standards adopted in at § 170.205(a)(4) and § 170.205(a)(6), and reports the errors.
The user repeats steps 4-5 for each of the negative test samples in SITE: C-CDA Validator – USCDI v3, “NegativeTesting_CarePlan.” All of the negative test care plan (xml) documents must be received.
All Steps
Approved SVAP Version)
Complete steps above using SITE C-CDA Validator for 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
Receive
The tester creates a version in human readable format of the care plan document downloaded in step 1, of the System Under Test to be used for verification.
For each care plan document received, the tester verifies that the Health IT Module can receive a care plan document formatted in accordance with the standard specified at § 170.205(a)(4) and170.205(a)(5), and includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2) using visual inspection.
Using the Health IT Module, the tester verifies the care plan document received in step 2 is accurate and without omission through the visual inspection.
Negative Test
The tester verifies the health IT developer can download all of the ONC-supplied care plan negative test xml documents.
For each invalid C-CDA document received, the tester uses visual inspection to verify the Health IT Module can successfully identify errors in the C-CDA documents not specified in accordance with the standards adopted in § 170.205(a)(4) and 170.205(a)(5) including:
“document-templates”;
“section-templates”;
Invalid vocabulary standards; and
Invalid codes.
For each of the care plan negative test xml documents downloaded in step 4, the tester repeats step 5.
Receive
The tester creates a version in human readable format of the care plan document downloaded in step 1, of the System Under Test to be used for verification.
For each care plan document received, the tester verifies that the Health IT Module can receive a care plan document formatted in accordance with the standard specified at § 170.205(a)(4) and 170.205(a)(6), and includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2) using visual inspection.
Using the Health IT Module, the tester verifies the care plan document received in step 2 is accurate and without omission through the visual inspection.
Negative Test
The tester verifies the health IT developer can download all of the ONC-supplied care plan negative test xml documents.
For each invalid C-CDA document received, the tester uses visual inspection to verify the Health IT Module can successfully identify errors in the C-CDA documents not specified in accordance with the standards adopted in § 170.205(a)(4) and 170.205(a)(6) including:
“document-templates”;
“section-templates”;
Invalid vocabulary standards; and
Invalid codes.
For each of the care plan negative test xml documents downloaded in step 4, the tester repeats step 5.
TEST TOOL DOCUMENTATION
Testing Tools
§ 170.315(b)(9) Care plan
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.
(b)(9)
Inpatient setting: - 170.315_b9_cp_inp_sample*.docx (All Samples)
Ambulatory setting - 170.315_b9_cp_amb_sample*.docx (All Samples)
All settings: 170.315_b9_cp_sample*.xml (All Samples)
Negative testing: NT*r21*.xml (All Samples)
Testing Components
§ 170.315(b)(9) Care plan
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
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(b)(9)Care plan
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, when different QMS are used, each QMS needs to be separately 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, when different QMS are used, each QMS needs to be separately identified for every capability to which it was applied.
§ 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 certified to this criterion must update their version of C-CDA Companion Guide used as outlined in paragraph (b)(9)(ii).
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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:
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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