§170.315(b)(9) Care plan

Resource Document

Version #	Description of Change	Version Date
1.0	Final Test Procedure	01-20-2016

Regulation Text

§ 170.315 (b)(9) Care plan—

§ 170.205(a)(4) Health Level 7 (HL7^®) Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1, August 2015

Applies to entire criterion

Testing Tool

Edge Testing Tool (ETT): Message Validators

Test Tool Documentation

§ 170.205(a)(4) Health Level 7 (HL7^®) Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1, August 2015

Criterion Subparagraph	Test Data
(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: NTr21*.xml (All Samples)

Please consult the Final Rule entitled: 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications for a detailed description of the certification criterion with which these testing steps are associated. We also encourage developers to consult the Certification Companion Guide in tandem with the test procedure as they provide clarifications that may be useful for product development and testing.

Note: The order in which the test steps are listed reflects the sequence of the certification criterion and does not necessarily prescribe the order in which the test should take place.

Testing components

Paragraph (b)(9) - Record

System Under Test

Record

Using the ETT: Message Validators – C-CDA R2.1 Validator, the health IT developer downloads the ONC-supplied data instructions through the sender download selections of 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, a 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, a user repeats steps 1-3, for each of the ambulatory and/or inpatient care plan instruction documents found in the ETT: Message Validators. The recording of a care plan is required for all the care plan instruction documents for a given health IT setting.

Test Lab Verification

Record

For each care plans recorded by the SUT, the tester verifies the outlined care plan information has been recorded correctly and without omission through visual inspection of the SUT using the ONC-supplied care plan instruction document associated with the recorded care plan.

Paragraph (b)(9) - Record

System Under Test	Test Lab Verification
Record Using the ETT: Message Validators – C-CDA R2.1 Validator, the health IT developer downloads the ONC-supplied data instructions through the sender download selections of 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, a 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, a user repeats steps 1-3, for each of the ambulatory and/or inpatient care plan instruction documents found in the ETT: Message Validators. The recording of a care plan is required for all the care plan instruction documents for a given health IT setting.	Record For each care plans recorded by the SUT, the tester verifies the outlined care plan information has been recorded correctly and without omission through visual inspection of the SUT using the ONC-supplied care plan instruction document associated with the recorded care plan.

System Under Test

Test Lab Verification

Record

Using the ETT: Message Validators – C-CDA R2.1 Validator, the health IT developer downloads the ONC-supplied data instructions through the sender download selections of 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, a 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, a user repeats steps 1-3, for each of the ambulatory and/or inpatient care plan instruction documents found in the ETT: Message Validators. The recording of a care plan is required for all the care plan instruction documents for a given health IT setting.

Record

For each care plans recorded by the SUT, the tester verifies the outlined care plan information has been recorded correctly and without omission through visual inspection of the SUT using the ONC-supplied care plan instruction document associated with the recorded care plan.

Paragraph (b)(9) - Change and Access

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 SUT.

Paragraph (b)(9) - Change and Access

System Under Test	Test Lab Verification
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.	Change and Access The tester verifies care plan information can be accessed and changed using visual inspection of the SUT.

Paragraph (b)(9) - Create

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, DSTU Release 2.1, 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
- Interventions.
For each care plan document created in step 1, the user submits the care plan document to the tester for verification.

Test Lab Verification

Create

Using the ETT: Message Validators – C-CDA R2.1 Validator, the tester uploads the submitted care plan (xml file) created by the Health IT Module in step 1, of the SUT, 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 SUT, and executes the upload of the submitted file to the ETT: Message Validators.
The tester uses the Validation Report produced by the ETT: Message Validators in step 1 to verify the validation report indicates passing without error to confirm that the care plan is a C-CDA R2 Release 2.1, document conformant to the standard specified at § 170.205(a)(4) and includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2).
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 ETT: Message Validators Message Content Report to verify the additional checks for equivalent text for the content of all section level narrative text.

Paragraph (b)(9) - Create

System Under Test	Test Lab Verification
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, DSTU Release 2.1, 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 Interventions. For each care plan document created in step 1, the user submits the care plan document to the tester for verification.	Create Using the ETT: Message Validators – C-CDA R2.1 Validator, the tester uploads the submitted care plan (xml file) created by the Health IT Module in step 1, of the SUT, 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 SUT, and executes the upload of the submitted file to the ETT: Message Validators. The tester uses the Validation Report produced by the ETT: Message Validators in step 1 to verify the validation report indicates passing without error to confirm that the care plan is a C-CDA R2 Release 2.1, document conformant to the standard specified at § 170.205(a)(4) and includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2). 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 ETT: Message Validators Message Content Report to verify the additional checks for equivalent text for the content of all section level narrative text.

System Under Test

Test Lab Verification

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, DSTU Release 2.1, 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
- Interventions.
For each care plan document created in step 1, the user submits the care plan document to the tester for verification.

Create

Using the ETT: Message Validators – C-CDA R2.1 Validator, the tester uploads the submitted care plan (xml file) created by the Health IT Module in step 1, of the SUT, 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 SUT, and executes the upload of the submitted file to the ETT: Message Validators.
The tester uses the Validation Report produced by the ETT: Message Validators in step 1 to verify the validation report indicates passing without error to confirm that the care plan is a C-CDA R2 Release 2.1, document conformant to the standard specified at § 170.205(a)(4) and includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2).
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 ETT: Message Validators Message Content Report to verify the additional checks for equivalent text for the content of all section level narrative text.

Paragraph (b)(9) - Receive

System Under Test

Receive

Using the ETT: Message Validators - C-CDA R2.1 Validator, 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, a user receives the care plan (xml files) downloaded from the ETT: Message Validators in step 1, which is 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, DSTU Release 2.1, 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.
Based upon the health IT setting(s) to be certified, a user repeats steps 1-2, for each ambulatory and/or inpatient care plan (xml) document in the ETT: Message Validators. All of the care plan (xml) documents for a given health IT setting must be received.

Negative Test

Using the ETT: Message Validators – C-CDA R2.1 Validator, 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) HL7^® Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, and reports the errors.
A user repeats steps 4 and 5, for each of the negative test samples in ETT: Message Validators “NegativeTesting_CarePlan.” All of the negative test care plan (xml) documents must be received.

Test Lab Verification

Receive

The tester creates a human readable version of the care plan document downloaded in step 1, of the SUT 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 includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2) using visual inspection.
Using the Health IT Module, the tester verifies that the care plan document received in step 2, is accurate and without omission through the visual inspection.

Negative Test

For each invalid C-CDA document received, the tester uses visual inspection to verify that 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) including:
- “document-templates;”
- “section-templates;”
- “entry-templates;”
- Invalid vocabulary standards; and
- Invalid codes.

Paragraph (b)(9) - Receive

System Under Test	Test Lab Verification
Receive Using the ETT: Message Validators - C-CDA R2.1 Validator, 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, a user receives the care plan (xml files) downloaded from the ETT: Message Validators in step 1, which is 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, DSTU Release 2.1, 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. Based upon the health IT setting(s) to be certified, a user repeats steps 1-2, for each ambulatory and/or inpatient care plan (xml) document in the ETT: Message Validators. All of the care plan (xml) documents for a given health IT setting must be received. Negative Test Using the ETT: Message Validators – C-CDA R2.1 Validator, 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) HL7^® Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, and reports the errors. A user repeats steps 4 and 5, for each of the negative test samples in ETT: Message Validators “NegativeTesting_CarePlan.” All of the negative test care plan (xml) documents must be received.	Receive The tester creates a human readable version of the care plan document downloaded in step 1, of the SUT 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 includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2) using visual inspection. Using the Health IT Module, the tester verifies that the care plan document received in step 2, is accurate and without omission through the visual inspection. Negative Test For each invalid C-CDA document received, the tester uses visual inspection to verify that 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) including: “document-templates;” “section-templates;” “entry-templates;” Invalid vocabulary standards; and Invalid codes.

System Under Test

Test Lab Verification

Receive

Using the ETT: Message Validators - C-CDA R2.1 Validator, 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, a user receives the care plan (xml files) downloaded from the ETT: Message Validators in step 1, which is 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, DSTU Release 2.1, 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.
Based upon the health IT setting(s) to be certified, a user repeats steps 1-2, for each ambulatory and/or inpatient care plan (xml) document in the ETT: Message Validators. All of the care plan (xml) documents for a given health IT setting must be received.

Negative Test

Using the ETT: Message Validators – C-CDA R2.1 Validator, 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) HL7^® Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, and reports the errors.
A user repeats steps 4 and 5, for each of the negative test samples in ETT: Message Validators “NegativeTesting_CarePlan.” All of the negative test care plan (xml) documents must be received.

Receive

The tester creates a human readable version of the care plan document downloaded in step 1, of the SUT 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 includes the Health Status Evaluations and Outcomes Section and Interventions Section (V2) using visual inspection.
Using the Health IT Module, the tester verifies that the care plan document received in step 2, is accurate and without omission through the visual inspection.

Negative Test

For each invalid C-CDA document received, the tester uses visual inspection to verify that 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) including:
- “document-templates;”
- “section-templates;”
- “entry-templates;”
- Invalid vocabulary standards; and
- Invalid codes.

Updated on 06-15-2020

Revision History

Version #	Description of Change	Version Date
1.0	Initial Publication	10-30-2015
1.1	Added clarifications that Consolidated CDA creation performance is required for this certification criterion per the 2015 Edition final rule Correction Notice. Added clarification about the data expected in the “Goals” and “Health Concerns” Sections. Added clarification that Health IT Modules are not required to enable a user to reconcile received care plan data.	01-05-2016
1.2	Provides notification of March 2017 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion.	09-29-2017
1.3	Provides notification of April 2018 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion. Note: Due to an error in calculation ONC is also updating the dates for compliance with the March 2017 Validator Update of C-CDA 2.1 Corrections that were adopted September 29, 2017.	05-02-2018
1.4	Provides notification of August 2018 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion.	09-21-2018
1.5	Updated the Security requirements per 21st Century Cures Act.	06-15-2020

Regulation Text

§ 170.315 (b)(9) Care plan—

Standard(s) Referenced

Applies to entire criterion

Resource Document

Version #	Description of Change	Version Date
1.0	Initial Publication	10-30-2015
1.1	Added clarifications that Consolidated CDA creation performance is required for this certification criterion per the 2015 Edition final rule Correction Notice. Added clarification about the data expected in the “Goals” and “Health Concerns” Sections. Added clarification that Health IT Modules are not required to enable a user to reconcile received care plan data.	01-05-2016
1.2	Provides notification of March 2017 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion.	09-29-2017
1.3	Provides notification of April 2018 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion. Note: Due to an error in calculation ONC is also updating the dates for compliance with the March 2017 Validator Update of C-CDA 2.1 Corrections that were adopted September 29, 2017.	05-02-2018
1.4	Provides notification of August 2018 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion.	09-21-2018
1.5	Updated the Security requirements per 21st Century Cures Act.	06-15-2020

Regulation Text

§ 170.315 (b)(9) Care plan—

§ 170.205(a)(4) Health Level 7 (HL7^®) Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1, August 2015

Applies to entire criterion

Testing Tool

Edge Testing Tool (ETT): Message Validators

Test Tool Documentation

Link to Final Rule Preamble

Criterion Subparagraph	Test Data
(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: NTr21*.xml (All Samples)

Certification Companion Guide: Care plan

This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.

Link to Correction Notice Preamble

Edition Comparision	Gap Certification Eligible	Base EHR Definition	In Scope for CEHRT Definition
New	No	Not Included	No

Certification Requirements

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 (b) 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 3^rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
§ 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.

Table for Privacy and Security

If choosing Approach 1:
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 which is sufficiently detailed to enable integration such that the Health IT Module has implemented service interfaces the Health IT Module to access external services necessary to meet the requirements of the privacy and security certification criterion. Please see the 21^st 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.

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.
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.

Table for Design and Performance

Certification Requirements

The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (b) 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 3^rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
§ 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.

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.

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.
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.

Table for Privacy and Security

If choosing Approach 1:
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 which is sufficiently detailed to enable integration such that the Health IT Module has implemented service interfaces the Health IT Module to access external services necessary to meet the requirements of the privacy and security certification criterion. Please see the 21^st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule at 85 FR 25710 for additional clarification.

Table for Design and Performance

Technical Explanations and Clarifications

Applies to entire criterion

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:

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 2.0 and 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 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., C-CDA 2.1 Validator). 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.
- March 2017 Validator Update of C-CDA 2.1 Corrections [Effective for testing on December 28, 2017; Surveillance compliance date is March 29, 2019]
- April 2018 Validator Update of C-CDA 2.1 Corrections [Effective for testing on July 31, 2018; Surveillance compliance date is November 2, 2019]
- August 2018 Validator Update of C-CDA 2.1 Corrections [Effective for testing on December 20, 2018; Surveillance compliance date is March 21, 2020]

Applies to entire criterion

Clarifications:

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 2.0 and 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 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., C-CDA 2.1 Validator). 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.
- March 2017 Validator Update of C-CDA 2.1 Corrections [Effective for testing on December 28, 2017; Surveillance compliance date is March 29, 2019]
- April 2018 Validator Update of C-CDA 2.1 Corrections [Effective for testing on July 31, 2018; Surveillance compliance date is November 2, 2019]
- August 2018 Validator Update of C-CDA 2.1 Corrections [Effective for testing on December 20, 2018; Surveillance compliance date is March 21, 2020]

Updated on 11-02-2020

Revision History

Version #	Description of Change	Version Date
1.0	Initial Publication	06-15-2020
1.1	Updated compliance date per the Interim Final Rule (IFR), Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency	11-02-2020

Regulation Text

§ 170.315 (b)(9) Care plan—

Enable a user to record, change, access, create, and receive care plan information in accordance with:

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
The standard in § 170.205(a)(5) on and after December 31, 2022.

Standard(s) Referenced

Applies to entire criterion

§ 170.205(a)(4) Health Level 7 (HL7^®) Implementation Guide for CDA Release 2 Consolidation CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1 C-CDA 2.1, August 2015, June 2019 (with Errata)

§ 170.205(a)(5) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2-US Realm, October 2019

Standards Version Advancement Process (SVAP) Version(s) Approved

§ 170.205(a)(5) HL7^® CDA R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 3-US Realm, May 2022

Resource Document

Version #	Description of Change	Version Date
1.0	Initial Publication	06-15-2020
1.1	Updated compliance date per the Interim Final Rule (IFR), Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency	11-02-2020

Regulation Text

§ 170.315 (b)(9) Care plan—

Enable a user to record, change, access, create, and receive care plan information in accordance with:

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
The standard in § 170.205(a)(5) on and after December 31, 2022.

Applies to entire criterion

§ 170.205(a)(5) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2-US Realm, October 2019

Standards Version Advancement Process (SVAP) Version(s) Approved

§ 170.205(a)(5) HL7^® CDA R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 3-US Realm, May 2022

Testing Tool

Edge Testing Tool (ETT): Message Validators

Test Tool Documentation

Link to ONC Cures Act Final Rule Preamble

Criterion Subparagraph	Test Data
(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: NTr21*.xml (All Samples)

Certification Companion Guide: Care plan

This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 21^st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the ONC Cures Act Final Rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.

Edition Comparision	Gap Certification Eligible	Base EHR Definition	In Scope for CEHRT Definition	SVAP
New	No	Not Included	No	Yes

Certification Requirements

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 3^rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.

Table for Privacy and Security

If choosing Approach 1:
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 ONC Cures Act 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.

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.
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 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.

Table for Design and Performance

Certification Requirements

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 3^rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.

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.

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.
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 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.

Table for Privacy and Security

If choosing Approach 1:
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 ONC Cures Act Final Rule at 85 FR 25710 for additional clarification.

Table for Design and Performance

Technical Explanations and Clarifications

Applies to entire criterion

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.
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 – Cures Update C-CDA R2.1 Validator). 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.

Applies to entire criterion

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.
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 – Cures Update C-CDA R2.1 Validator). 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.

Updated on 08-29-2022

Revision History

Version #	Description of Change	Version Date
1.0	Final Test Procedure.	06-01-2020
1.1	Compliance date updated per the IFR, Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency.	11-02-2020
1.2	Updated to include approved Standards Version Advancement Process (SVAP) standards for 2022.	08-29-2022

Regulation Text

§ 170.315 (b)(9) Care plan—

Enable a user to record, change, access, create, and receive care plan information in accordance with:

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
The standard in § 170.205(a)(5) on and after December 31, 2022.

Standard(s) Referenced

Applies to entire criterion

§ 170.205(a)(5) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2-US Realm, October 2019

Standards Version Advancement Process (SVAP) Version(s) Approved

§ 170.205(a)(5) HL7^® CDA R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 3-US Realm, May 2022

Resource Document

Version #	Description of Change	Version Date
1.0	Final Test Procedure.	06-01-2020
1.1	Compliance date updated per the IFR, Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency.	11-02-2020
1.2	Updated to include approved Standards Version Advancement Process (SVAP) standards for 2022.	08-29-2022

Regulation Text

§ 170.315 (b)(9) Care plan—

Enable a user to record, change, access, create, and receive care plan information in accordance with:

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
The standard in § 170.205(a)(5) on and after December 31, 2022.

Applies to entire criterion

§ 170.205(a)(5) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2-US Realm, October 2019

Standards Version Advancement Process (SVAP) Version(s) Approved

§ 170.205(a)(5) HL7^® CDA R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 3-US Realm, May 2022

Testing Tool

Edge Testing Tool (ETT): Message Validators

Test Tool Documentation