§170.315(b)(6) Data export

Certification Companion Guide (CCG)
Test Procedure

Updated on 01-20-2016

Regulation Text

§ 170.315(b)(6) Data export—

General requirements for export summary configuration.
1. Enable a user to set the configuration options specified in paragraphs (b)(6)(iii) and (iv) of this section when creating an export summary as well as a set of export summaries for patients whose information is stored in the technology. A user must be able to execute these capabilities at any time the user chooses and without subsequent developer assistance to operate.
2. Limit the ability of users who can create export summaries in at least one of these two ways:
  1. To a specific set of identified users.
  2. As a system administrative function.
Creation. Enable a user to create export summaries formatted in accordance with the standard specified in § 170.205(a)(4) using the Continuity of Care Document document template that includes, at a minimum:
1. The Common Clinical Data Set.
2. Encounter diagnoses. Formatted according to at least one of the following standards:
  1. The standard specified in § 170.207(i).
  2. At a minimum, the version of the standard specified in § 170.207(a)(4).
3. Cognitive status.
4. Functional status.
5. Ambulatory setting only. The reason for referral; and referring or transitioning provider's name and office contact information.
6. Inpatient setting only. Discharge instructions.
Timeframe configuration.
1. Enable a user to set the date and time period within which data would be used to create the export summaries. This must include the ability to enter in a start and end date and time range.
2. Consistent with the date and time period specified in paragraph (b)(6)(iii)(A) of this section, enable a user to do each of the following:
  1. Create export summaries in real-time;
  2. Create export summaries based on a relative date and time (e.g., the first of every month at 1:00 a.m.); and
  3. Create export summaries based on a specific date and time (e.g., on 10/24/2015 at 1:00 a.m.).
Location configuration. Enable a user to set the storage location to which the export summary or export summaries are intended to be saved.

Standard(s) Referenced

Paragraph (b)(6)(ii)

§ 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, August 2015

§ 170.207(a)(4) International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT^®), U.S. Edition, September 2015 Release

§ 170.207(i) ICD-10-CM

Please refer to the Data Elements and Vocabularies applicable to the Common Clinical Data Set (CCDS) as outlined in the Common Clinical Data Set Reference Document.

Revision History

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

Regulation Text

Regulation Text

§ 170.315(b)(6) Data export—

General requirements for export summary configuration.
1. Enable a user to set the configuration options specified in paragraphs (b)(6)(iii) and (iv) of this section when creating an export summary as well as a set of export summaries for patients whose information is stored in the technology. A user must be able to execute these capabilities at any time the user chooses and without subsequent developer assistance to operate.
2. Limit the ability of users who can create export summaries in at least one of these two ways:
  1. To a specific set of identified users.
  2. As a system administrative function.
Creation. Enable a user to create export summaries formatted in accordance with the standard specified in § 170.205(a)(4) using the Continuity of Care Document document template that includes, at a minimum:
1. The Common Clinical Data Set.
2. Encounter diagnoses. Formatted according to at least one of the following standards:
  1. The standard specified in § 170.207(i).
  2. At a minimum, the version of the standard specified in § 170.207(a)(4).
3. Cognitive status.
4. Functional status.
5. Ambulatory setting only. The reason for referral; and referring or transitioning provider's name and office contact information.
6. Inpatient setting only. Discharge instructions.
Timeframe configuration.
1. Enable a user to set the date and time period within which data would be used to create the export summaries. This must include the ability to enter in a start and end date and time range.
2. Consistent with the date and time period specified in paragraph (b)(6)(iii)(A) of this section, enable a user to do each of the following:
  1. Create export summaries in real-time;
  2. Create export summaries based on a relative date and time (e.g., the first of every month at 1:00 a.m.); and
  3. Create export summaries based on a specific date and time (e.g., on 10/24/2015 at 1:00 a.m.).
Location configuration. Enable a user to set the storage location to which the export summary or export summaries are intended to be saved.

Standard(s) Referenced

Paragraph (b)(6)(ii)

§ 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, August 2015

§ 170.207(a)(4) International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT^®), U.S. Edition, September 2015 Release

§ 170.207(i) ICD-10-CM

Please refer to the Data Elements and Vocabularies applicable to the Common Clinical Data Set (CCDS) as outlined in the Common Clinical Data Set Reference Document.

Testing

Testing Tool

Edge Testing Tool (ETT): Message Validators

Test Tool Documentation

Test Tool Supplemental Guide

Criterion Subparagraph	Test Data
(b)(6)(ii)	Inpatient Settings: 170.315_b6_de_inp_sample.pdf (All Samples) Ambulatory Settings: 170.315_b6_de_amb_sample.pdf (All Samples)

Revision History

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

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)(6)(i)

System Under Test

Configuration

The user demonstrates the ability to configure the following data export configuration options at any time:
- Timeframe configuration as specified in (b)(6)(iii); and
- Location configuration as specified in (b)(6)(iv).
The user demonstrates the ability to limit the set of users who can create export summaries, either:
- by specifying an identified set of users; or
- providing this functionality as an administrative function.
Negative Test: The user demonstrates that a user who has not been granted the ability to create export summaries cannot create export summaries.

Export Any Time

A user can execute the export summary configuration capability described in (b)(6)(i) steps 1, and 2, any time the user chooses and without subsequent developer assistance to operate.

Test Lab Verification

Configuration

The tester verifies an authorized user can modify the following configuration options without assistance from a developer:
- Timeframe configuration; and
- Location Configuration.
Negative test: The tester verifies an unauthorized user cannot modify any of the configuration options associated with the data export including:
- Document creation configuration;
- Timeframe configuration; and
- Location Configuration.
The tester verifies an authorized user can limit the set of users who can create export summaries either:
- by specifying an identified set of users; or
- providing this functionality as an administrative function.
The tester verifies an authorized user can create export summary documents.
Negative test: The tester verifies an unauthorized user cannot create export summaries.

Export Any Time

Via documentation submitted by the health IT developer, the tester verifies a user can configure an export summary as specified in (b)(6)(i) any time the user chooses and without subsequent developer assistance to operate.

Paragraph (b)(6)(i)

System Under Test	Test Lab Verification
Configuration The user demonstrates the ability to configure the following data export configuration options at any time: Timeframe configuration as specified in (b)(6)(iii); and Location configuration as specified in (b)(6)(iv). The user demonstrates the ability to limit the set of users who can create export summaries, either: by specifying an identified set of users; or providing this functionality as an administrative function. Negative Test: The user demonstrates that a user who has not been granted the ability to create export summaries cannot create export summaries. Export Any Time A user can execute the export summary configuration capability described in (b)(6)(i) steps 1, and 2, any time the user chooses and without subsequent developer assistance to operate.	Configuration The tester verifies an authorized user can modify the following configuration options without assistance from a developer: Timeframe configuration; and Location Configuration. Negative test: The tester verifies an unauthorized user cannot modify any of the configuration options associated with the data export including: Document creation configuration; Timeframe configuration; and Location Configuration. The tester verifies an authorized user can limit the set of users who can create export summaries either: by specifying an identified set of users; or providing this functionality as an administrative function. The tester verifies an authorized user can create export summary documents. Negative test: The tester verifies an unauthorized user cannot create export summaries. Export Any Time Via documentation submitted by the health IT developer, the tester verifies a user can configure an export summary as specified in (b)(6)(i) any time the user chooses and without subsequent developer assistance to operate.

System Under Test

Test Lab Verification

Configuration

The user demonstrates the ability to configure the following data export configuration options at any time:
- Timeframe configuration as specified in (b)(6)(iii); and
- Location configuration as specified in (b)(6)(iv).
The user demonstrates the ability to limit the set of users who can create export summaries, either:
- by specifying an identified set of users; or
- providing this functionality as an administrative function.
Negative Test: The user demonstrates that a user who has not been granted the ability to create export summaries cannot create export summaries.

Export Any Time

A user can execute the export summary configuration capability described in (b)(6)(i) steps 1, and 2, any time the user chooses and without subsequent developer assistance to operate.

Configuration

The tester verifies an authorized user can modify the following configuration options without assistance from a developer:
- Timeframe configuration; and
- Location Configuration.
Negative test: The tester verifies an unauthorized user cannot modify any of the configuration options associated with the data export including:
- Document creation configuration;
- Timeframe configuration; and
- Location Configuration.
The tester verifies an authorized user can limit the set of users who can create export summaries either:
- by specifying an identified set of users; or
- providing this functionality as an administrative function.
The tester verifies an authorized user can create export summary documents.
Negative test: The tester verifies an unauthorized user cannot create export summaries.

Export Any Time

Via documentation submitted by the health IT developer, the tester verifies a user can configure an export summary as specified in (b)(6)(i) any time the user chooses and without subsequent developer assistance to operate.

Paragraph (b)(6)(ii)

System Under Test

Create

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_DE_Amb” or “170.315_DE_Inp” criteria and one of the data export instruction documents, and executes the download.
Using the ONC-supplied data export data instruction document returned in step 1, the user creates patient records in the Health IT Module.
Using the Health IT Module and the downloaded instruction document from step 1, an authorized user creates export summary documents formatted as a Continuity of Care (CCD) document template in accordance with the standard specified in § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, including at minimum the following data elements:
- Common Clinical Data Set (CCDS);
- Encounter diagnoses;
- Cognitive status;
- Functional status;
- Ambulatory setting only: reason for referral, and referring or transitioning provider's name and office contact information; and
- Inpatient setting only: the discharge instructions.
The user submits the data export summary created in step 3, to be verified.
Based on the health IT setting(s) to be certified, a user repeats steps 1-4, for each of the ambulatory and/or inpatient data export instruction document found in the ETT: Message Validators. The data export is required for all of the data export instruction documents for a given health IT setting.

All Patient Data Export

Using the Health IT Developer-supplied data, the user creates records for multiple patients which can be used for data export in the Health IT Module.
An authorized user creates a set of export summaries which includes data from all of the patients in the Health IT Module.

Sub-Set of Patients Data Export

Using the Health IT Developer-supplied selection criteria, an authorized user creates a set of export summaries which includes a sub-set of the patients in the Health IT Module.

Test Lab Verification

Create

Using the ETT: Message Validators – C-CDA R2.1 Validator, the tester uploads the submitted data export summary record (xml file) created by the Health IT Module, through the sender upload selection of the “170.315_DE_Amb” or “170.315_DE_Inp” criteria and file name, and executes the uploads of the submitted file to the ETT: Message Validators.

Note: In the case where the data export summary contains multiple xml files, the xml files must be submitted to the ETT: Message Validators one at a time.

For each submitted data export summary document, the tester uses the Validation Report produced by the ETT: Message Validators to verify the Health IT Module passes without error to confirm that the data export summary record is a CCD document conformant to the standard adopted in § 170.205(a)(4) and including, at a minimum, the following applicable data elements defined in the Common Clinical Data Set and (b)(6)(ii)(A)-(F).
As required by the ONC-supplied data export summary record instructions, the tester uses the ONC-supplied data export summary record instructions and ETT: Message Validators Message Content Report to verify the additional checks for equivalent text for the content of all section level narrative text.

All Patient Data Export

Using the health IT developer-supplied data from the SUT in step 6, and the data export summaries with all of the patients created from the SUT in step 7, the tester verifies that the number of data export documents is correct.
The tester creates a human readable version of the data export summaries from step 4, and verifies all of the patients in the Health IT Module are present in the data export summaries.

Sub-Set of Patients Data Export

Using the health IT developer-supplied data from the SUT in step 6, and the selection criteria and the data export summaries with a sub-set of the patients created from the SUT in step 8, the tester verifies the number of data export documents is correct.
The tester creates a human readable version of the data export summaries from step 6, and verifies the correct patients are present in the set of data export summaries.

Paragraph (b)(6)(ii)

System Under Test	Test Lab Verification
Create 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_DE_Amb” or “170.315_DE_Inp” criteria and one of the data export instruction documents, and executes the download. Using the ONC-supplied data export data instruction document returned in step 1, the user creates patient records in the Health IT Module. Using the Health IT Module and the downloaded instruction document from step 1, an authorized user creates export summary documents formatted as a Continuity of Care (CCD) document template in accordance with the standard specified in § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, including at minimum the following data elements: Common Clinical Data Set (CCDS); Encounter diagnoses; Cognitive status; Functional status; Ambulatory setting only: reason for referral, and referring or transitioning provider's name and office contact information; and Inpatient setting only: the discharge instructions. The user submits the data export summary created in step 3, to be verified. Based on the health IT setting(s) to be certified, a user repeats steps 1-4, for each of the ambulatory and/or inpatient data export instruction document found in the ETT: Message Validators. The data export is required for all of the data export instruction documents for a given health IT setting. All Patient Data Export Using the Health IT Developer-supplied data, the user creates records for multiple patients which can be used for data export in the Health IT Module. An authorized user creates a set of export summaries which includes data from all of the patients in the Health IT Module. Sub-Set of Patients Data Export Using the Health IT Developer-supplied selection criteria, an authorized user creates a set of export summaries which includes a sub-set of the patients in the Health IT Module.	Create Using the ETT: Message Validators – C-CDA R2.1 Validator, the tester uploads the submitted data export summary record (xml file) created by the Health IT Module, through the sender upload selection of the “170.315_DE_Amb” or “170.315_DE_Inp” criteria and file name, and executes the uploads of the submitted file to the ETT: Message Validators. Note: In the case where the data export summary contains multiple xml files, the xml files must be submitted to the ETT: Message Validators one at a time. For each submitted data export summary document, the tester uses the Validation Report produced by the ETT: Message Validators to verify the Health IT Module passes without error to confirm that the data export summary record is a CCD document conformant to the standard adopted in § 170.205(a)(4) and including, at a minimum, the following applicable data elements defined in the Common Clinical Data Set and (b)(6)(ii)(A)-(F). As required by the ONC-supplied data export summary record instructions, the tester uses the ONC-supplied data export summary record instructions and ETT: Message Validators Message Content Report to verify the additional checks for equivalent text for the content of all section level narrative text. All Patient Data Export Using the health IT developer-supplied data from the SUT in step 6, and the data export summaries with all of the patients created from the SUT in step 7, the tester verifies that the number of data export documents is correct. The tester creates a human readable version of the data export summaries from step 4, and verifies all of the patients in the Health IT Module are present in the data export summaries. Sub-Set of Patients Data Export Using the health IT developer-supplied data from the SUT in step 6, and the selection criteria and the data export summaries with a sub-set of the patients created from the SUT in step 8, the tester verifies the number of data export documents is correct. The tester creates a human readable version of the data export summaries from step 6, and verifies the correct patients are present in the set of data export summaries.

System Under Test

Test Lab Verification

Create

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_DE_Amb” or “170.315_DE_Inp” criteria and one of the data export instruction documents, and executes the download.
Using the ONC-supplied data export data instruction document returned in step 1, the user creates patient records in the Health IT Module.
Using the Health IT Module and the downloaded instruction document from step 1, an authorized user creates export summary documents formatted as a Continuity of Care (CCD) document template in accordance with the standard specified in § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, including at minimum the following data elements:
- Common Clinical Data Set (CCDS);
- Encounter diagnoses;
- Cognitive status;
- Functional status;
- Ambulatory setting only: reason for referral, and referring or transitioning provider's name and office contact information; and
- Inpatient setting only: the discharge instructions.
The user submits the data export summary created in step 3, to be verified.
Based on the health IT setting(s) to be certified, a user repeats steps 1-4, for each of the ambulatory and/or inpatient data export instruction document found in the ETT: Message Validators. The data export is required for all of the data export instruction documents for a given health IT setting.

All Patient Data Export

Using the Health IT Developer-supplied data, the user creates records for multiple patients which can be used for data export in the Health IT Module.
An authorized user creates a set of export summaries which includes data from all of the patients in the Health IT Module.

Sub-Set of Patients Data Export

Using the Health IT Developer-supplied selection criteria, an authorized user creates a set of export summaries which includes a sub-set of the patients in the Health IT Module.

Create

Using the ETT: Message Validators – C-CDA R2.1 Validator, the tester uploads the submitted data export summary record (xml file) created by the Health IT Module, through the sender upload selection of the “170.315_DE_Amb” or “170.315_DE_Inp” criteria and file name, and executes the uploads of the submitted file to the ETT: Message Validators.

Note: In the case where the data export summary contains multiple xml files, the xml files must be submitted to the ETT: Message Validators one at a time.

For each submitted data export summary document, the tester uses the Validation Report produced by the ETT: Message Validators to verify the Health IT Module passes without error to confirm that the data export summary record is a CCD document conformant to the standard adopted in § 170.205(a)(4) and including, at a minimum, the following applicable data elements defined in the Common Clinical Data Set and (b)(6)(ii)(A)-(F).
As required by the ONC-supplied data export summary record instructions, the tester uses the ONC-supplied data export summary record instructions and ETT: Message Validators Message Content Report to verify the additional checks for equivalent text for the content of all section level narrative text.

All Patient Data Export

Using the health IT developer-supplied data from the SUT in step 6, and the data export summaries with all of the patients created from the SUT in step 7, the tester verifies that the number of data export documents is correct.
The tester creates a human readable version of the data export summaries from step 4, and verifies all of the patients in the Health IT Module are present in the data export summaries.

Sub-Set of Patients Data Export

Using the health IT developer-supplied data from the SUT in step 6, and the selection criteria and the data export summaries with a sub-set of the patients created from the SUT in step 8, the tester verifies the number of data export documents is correct.
The tester creates a human readable version of the data export summaries from step 6, and verifies the correct patients are present in the set of data export summaries.

Paragraphs (b)(6)(ii)(A)–(F)

System Under Test

The Data Export Summary CCD Document created in section (b)(6)(ii) at a minimum contains the following data elements:

CCDS as specified in the 2015 Edition of the CCDS Reference Document, as applicable.
Encounter diagnoses in the standard specified at a minimum the version of the standard specified at § 170.207(a)(4) SNOMED CT^® or the standard specified at § 170.207(i) ICD-10-CM for the following conditions:
1. Diseases.
2. Injuries.
3. Impairments.
4. Other health problems and their manifestations.
5. Causes of injury, disease, impairment, or other health problems.
Cognitive status when present in the Health IT Module;
Functional Status when present in the Health IT Module;
Ambulatory setting only: reason for referral, and referring or transitioning provider's name and office contact information; and
Inpatient setting only: the discharge instructions.

Test Lab Verification

The verification of the minimum required data elements and the associated standards is performed as part of the Create verification in (b)(6)(ii). This includes the following verification:

CCDS data elements are in accordance with the CCDS Reference Document for a document specified in accordance with § 170.205(a)(4).
Encounter diagnoses data element is specified in accordance with the constrained standard specified at § 170.207(i) or at a minimum the version of the standard specified at § 170.207(a)(4).
Cognitive Status data element, when present in the Health IT Module.
Functional Status data element, when present in the Health IT Module.
Ambulatory setting only, the following data elements: reason for referral, and referring or transitioning provider's name and office contact information.
Inpatient setting only, the following data elements: the discharge instructions.

Paragraphs (b)(6)(ii)(A)–(F)

System Under Test	Test Lab Verification
The Data Export Summary CCD Document created in section (b)(6)(ii) at a minimum contains the following data elements: CCDS as specified in the 2015 Edition of the CCDS Reference Document, as applicable. Encounter diagnoses in the standard specified at a minimum the version of the standard specified at § 170.207(a)(4) SNOMED CT^® or the standard specified at § 170.207(i) ICD-10-CM for the following conditions: Diseases. Injuries. Impairments. Other health problems and their manifestations. Causes of injury, disease, impairment, or other health problems. Cognitive status when present in the Health IT Module; Functional Status when present in the Health IT Module; Ambulatory setting only: reason for referral, and referring or transitioning provider's name and office contact information; and Inpatient setting only: the discharge instructions.	The verification of the minimum required data elements and the associated standards is performed as part of the Create verification in (b)(6)(ii). This includes the following verification: CCDS data elements are in accordance with the CCDS Reference Document for a document specified in accordance with § 170.205(a)(4). Encounter diagnoses data element is specified in accordance with the constrained standard specified at § 170.207(i) or at a minimum the version of the standard specified at § 170.207(a)(4). Cognitive Status data element, when present in the Health IT Module. Functional Status data element, when present in the Health IT Module. Ambulatory setting only, the following data elements: reason for referral, and referring or transitioning provider's name and office contact information. Inpatient setting only, the following data elements: the discharge instructions.

System Under Test

Test Lab Verification

The Data Export Summary CCD Document created in section (b)(6)(ii) at a minimum contains the following data elements:

CCDS as specified in the 2015 Edition of the CCDS Reference Document, as applicable.
Encounter diagnoses in the standard specified at a minimum the version of the standard specified at § 170.207(a)(4) SNOMED CT^® or the standard specified at § 170.207(i) ICD-10-CM for the following conditions:
1. Diseases.
2. Injuries.
3. Impairments.
4. Other health problems and their manifestations.
5. Causes of injury, disease, impairment, or other health problems.
Cognitive status when present in the Health IT Module;
Functional Status when present in the Health IT Module;
Ambulatory setting only: reason for referral, and referring or transitioning provider's name and office contact information; and
Inpatient setting only: the discharge instructions.

The verification of the minimum required data elements and the associated standards is performed as part of the Create verification in (b)(6)(ii). This includes the following verification:

CCDS data elements are in accordance with the CCDS Reference Document for a document specified in accordance with § 170.205(a)(4).
Encounter diagnoses data element is specified in accordance with the constrained standard specified at § 170.207(i) or at a minimum the version of the standard specified at § 170.207(a)(4).
Cognitive Status data element, when present in the Health IT Module.
Functional Status data element, when present in the Health IT Module.
Ambulatory setting only, the following data elements: reason for referral, and referring or transitioning provider's name and office contact information.
Inpatient setting only, the following data elements: the discharge instructions.

Paragraph (b)(6)(iii)(A)

System Under Test

An authorized user demonstrates that the time period within which data would be used to create the export summary or set of export summaries can be configured with a start and end date and time range so that the export can occur:

In real-time, and include data from the entered start date and time until now;
Based upon a relative date and time (e.g., the first of every month at 1:00am) from the entered start and end dates and times; and
Based upon a specific date (e.g., on 10/24/2015 at 1:00am) from the entered start and end dates and times.

Test Lab Verification

The tester verifies the timeframe configuration start and end dates and times can be modified for a:

real-time export;
export based upon a relative date; and
export based upon a specific date.

Paragraph (b)(6)(iii)(A)

System Under Test	Test Lab Verification
An authorized user demonstrates that the time period within which data would be used to create the export summary or set of export summaries can be configured with a start and end date and time range so that the export can occur: In real-time, and include data from the entered start date and time until now; Based upon a relative date and time (e.g., the first of every month at 1:00am) from the entered start and end dates and times; and Based upon a specific date (e.g., on 10/24/2015 at 1:00am) from the entered start and end dates and times.	The tester verifies the timeframe configuration start and end dates and times can be modified for a: real-time export; export based upon a relative date; and export based upon a specific date.

System Under Test

Test Lab Verification

In real-time, and include data from the entered start date and time until now;
Based upon a relative date and time (e.g., the first of every month at 1:00am) from the entered start and end dates and times; and
Based upon a specific date (e.g., on 10/24/2015 at 1:00am) from the entered start and end dates and times.

The tester verifies the timeframe configuration start and end dates and times can be modified for a:

real-time export;
export based upon a relative date; and
export based upon a specific date.

Paragraph (b)(6)(iii)(B)

System Under Test

The user exports a summary based upon the export summary document template created in (6)(b)(ii) for each of the types of export summaries or set of export summaries:

A real-time export;
A relative date export; and
A specific date export.

Test Lab Verification

The tester verifies the data in the export summaries cover the correct time periods and the data contained within the export is complete and without omission.

Paragraph (b)(6)(iii)(B)

System Under Test	Test Lab Verification
The user exports a summary based upon the export summary document template created in (6)(b)(ii) for each of the types of export summaries or set of export summaries: A real-time export; A relative date export; and A specific date export.	The tester verifies the data in the export summaries cover the correct time periods and the data contained within the export is complete and without omission.

Paragraph (b)(6)(iv)

System Under Test

An authorized user is able to set the location where the export summaries are to be saved.
An authorized user is able to store export summaries to a configured location.

Test Lab Verification

The tester verifies an authorized user can set the location where the export summaries are to be saved to the local disk or a network disk.
The tester verifies export summaries can be saved to the configured export location.

Paragraph (b)(6)(iv)

System Under Test	Test Lab Verification
An authorized user is able to set the location where the export summaries are to be saved. An authorized user is able to store export summaries to a configured location.	The tester verifies an authorized user can set the location where the export summaries are to be saved to the local disk or a network disk. The tester verifies export summaries can be saved to the configured export location.

Updated on 09-10-2021

Regulation Text

§ 170.315(b)(6) Data export—

General requirements for export summary configuration.
1. Enable a user to set the configuration options specified in paragraphs (b)(6)(iii) and (iv) of this section when creating an export summary as well as a set of export summaries for patients whose information is stored in the technology. A user must be able to execute these capabilities at any time the user chooses and without subsequent developer assistance to operate.
2. Limit the ability of users who can create export summaries in at least one of these two ways:
  1. To a specific set of identified users.
  2. As a system administrative function.
Creation. Enable a user to create export summaries formatted in accordance with the standard specified in § 170.205(a)(4) using the Continuity of Care Document document template that includes, at a minimum:
1. The Common Clinical Data Set.
2. Encounter diagnoses. Formatted according to at least one of the following standards:
  1. The standard specified in § 170.207(i).
  2. At a minimum, the version of the standard specified in § 170.207(a)(4).
3. Cognitive status.
4. Functional status.
5. Ambulatory setting only. The reason for referral; and referring or transitioning provider's name and office contact information.
6. Inpatient setting only. Discharge instructions.
Timeframe configuration.
1. Enable a user to set the date and time period within which data would be used to create the export summaries. This must include the ability to enter in a start and end date and time range.
2. Consistent with the date and time period specified in paragraph (b)(6)(iii)(A) of this section, enable a user to do each of the following:
  1. Create export summaries in real-time;
  2. Create export summaries based on a relative date and time (e.g., the first of every month at 1:00 a.m.); and
  3. Create export summaries based on a specific date and time (e.g., on 10/24/2015 at 1:00 a.m.).
Location configuration. Enable a user to set the storage location to which the export summary or export summaries are intended to be saved.

Standard(s) Referenced

Paragraph (b)(6)(ii)

§ 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, August 2015

§ 170.207(a)(4) International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT^®), U.S. Edition, September 2015 Release

§ 170.207(i) ICD-10-CM

Please refer to the Data Elements and Vocabularies applicable to the Common Clinical Data Set (CCDS) as outlined in the Common Clinical Data Set Reference Document.

Revision History

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

Regulation Text

Regulation Text

§ 170.315(b)(6) Data export—

General requirements for export summary configuration.
1. Enable a user to set the configuration options specified in paragraphs (b)(6)(iii) and (iv) of this section when creating an export summary as well as a set of export summaries for patients whose information is stored in the technology. A user must be able to execute these capabilities at any time the user chooses and without subsequent developer assistance to operate.
2. Limit the ability of users who can create export summaries in at least one of these two ways:
  1. To a specific set of identified users.
  2. As a system administrative function.
Creation. Enable a user to create export summaries formatted in accordance with the standard specified in § 170.205(a)(4) using the Continuity of Care Document document template that includes, at a minimum:
1. The Common Clinical Data Set.
2. Encounter diagnoses. Formatted according to at least one of the following standards:
  1. The standard specified in § 170.207(i).
  2. At a minimum, the version of the standard specified in § 170.207(a)(4).
3. Cognitive status.
4. Functional status.
5. Ambulatory setting only. The reason for referral; and referring or transitioning provider's name and office contact information.
6. Inpatient setting only. Discharge instructions.
Timeframe configuration.
1. Enable a user to set the date and time period within which data would be used to create the export summaries. This must include the ability to enter in a start and end date and time range.
2. Consistent with the date and time period specified in paragraph (b)(6)(iii)(A) of this section, enable a user to do each of the following:
  1. Create export summaries in real-time;
  2. Create export summaries based on a relative date and time (e.g., the first of every month at 1:00 a.m.); and
  3. Create export summaries based on a specific date and time (e.g., on 10/24/2015 at 1:00 a.m.).
Location configuration. Enable a user to set the storage location to which the export summary or export summaries are intended to be saved.

Standard(s) Referenced

Paragraph (b)(6)(ii)

§ 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, August 2015

§ 170.207(a)(4) International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT^®), U.S. Edition, September 2015 Release

§ 170.207(i) ICD-10-CM

Please refer to the Data Elements and Vocabularies applicable to the Common Clinical Data Set (CCDS) as outlined in the Common Clinical Data Set Reference Document.

Revision History

Version #	Description of Change	Version Date
1.0	Initial Publication	10-29-2015
1.1	Updated to reflect refined language included in corrections notice issued on December 11, 2015. Clarifications added around date range requirement, and cognitive status observation. Typographical errors removed.	02-08-2016
1.2	Provides notification of March 2017 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements within paragraph (b)(6)(ii).	09-29-2017
1.3	Provides notification of April 2018 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements within paragraph (b)(6)(ii). 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 within paragraph (b)(6)(ii).	09-21-2018
1.5	Added clarification for time-limited certification to this criterion per the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule.	06-15-2020
1.6	Corrected information in the Privacy & Security section.	08-03-2020
1.7	Corrected ICD-10 Procedure Coding System OID: 2.16.840.1.113883.6.4 to ICD-10-CM OID: 2.16.840.1.113883.6.90	09-10-2021

Testing

Testing Tool

Edge Testing Tool (ETT): Message Validators

Test Tool Documentation

Test Tool Supplemental Guide

Criterion Subparagraph	Test Data
(b)(6)(ii)	Inpatient Settings: 170.315_b6_de_inp_sample.pdf (All Samples) Ambulatory Settings: 170.315_b6_de_amb_sample.pdf (All Samples)

Certification Companion Guide: Data export

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 Final Rule Preamble

Link to Correction Notice Preamble

Base EHR Definition	In Scope for CEHRT Definition	Real World Testing	USCDI	SVAP
Included	Yes	Yes	No	No

Certification Requirements

Privacy and Security: This certification criterion was adopted at § 170.315(b)(6). 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 3rd 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 for the criterion using system documentation which provides a clear description of how the external services necessary to meet the privacy and security criteria would be deployed and used. 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, 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 3rd 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, 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 for the criterion using system documentation which provides a clear description of how the external services necessary to meet the privacy and security criteria would be deployed and used. 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:

§ 170.314(b)(7) “Data portability” is now named § 170.315(b)(6) “Data export”. To provide additional clarity of the criterion concept, ONC has decided to name the adopted certification criterion “Data export”. [see also 80 FR 62645]
This criterion will be removed from 2015 Edition Base EHR definition effective July 2, 2020. [see also 80 FR 25671]
§ 170.315(b)(10) “EHI export” will replace § 170.315(b)(6) “Data export”. ONC-ACBs will be permitted to issue certificates for § 170.315(b)(6) until May 1, 2023 during the transition period to § 170.315(b)(10). ONC has included a provision in § 170.550(m)(2) to only allow ONC-ACBs to issue certificates for this criterion until May 1, 2023. [see also 80 FR 25720]
Developers with health IT certified to the prior certification criterion in § 170.315(b)(6) do not have to update such certified health IT to the Cures update revisions, but are permitted to maintain or seek new Health IT Module certification to this criterion should they desire this functionality. [see also 80 FR 25671]

Applies to entire criterion

Clarifications:

§ 170.314(b)(7) “Data portability” is now named § 170.315(b)(6) “Data export”. To provide additional clarity of the criterion concept, ONC has decided to name the adopted certification criterion “Data export”. [see also 80 FR 62645]
This criterion will be removed from 2015 Edition Base EHR definition effective July 2, 2020. [see also 80 FR 25671]
§ 170.315(b)(10) “EHI export” will replace § 170.315(b)(6) “Data export”. ONC-ACBs will be permitted to issue certificates for § 170.315(b)(6) until May 1, 2023 during the transition period to § 170.315(b)(10). ONC has included a provision in § 170.550(m)(2) to only allow ONC-ACBs to issue certificates for this criterion until May 1, 2023. [see also 80 FR 25720]
Developers with health IT certified to the prior certification criterion in § 170.315(b)(6) do not have to update such certified health IT to the Cures update revisions, but are permitted to maintain or seek new Health IT Module certification to this criterion should they desire this functionality. [see also 80 FR 25671]

Paragraph (b)(6)(i)(A)

Technical outcome – A user can set configuration options for data elements, date and time ranges, and locations as specified in paragraphs (b)(6)(ii) through (iv) of this section when creating an export summary as well as a set of export summaries for patients whose information is stored in the technology.

Clarifications:

ONC expects that health IT must be able to send all required data for a specific date range specified, but acknowledges that there will be organizational policies and/or safety best practices that will dictate when records qualify on readiness. ONC expects that vendors will employ user-centered design and return information in a way that prioritizes patient preferences and usability.

Paragraph (b)(6)(i)(A)

Clarifications:

ONC expects that health IT must be able to send all required data for a specific date range specified, but acknowledges that there will be organizational policies and/or safety best practices that will dictate when records qualify on readiness. ONC expects that vendors will employ user-centered design and return information in a way that prioritizes patient preferences and usability.

Paragraph (b)(6)(i)(B)

Technical outcome – The technology limits users who can create export summaries in at least one of two ways:

To a specific set of identified users.
As a system administrative function.

Clarification:

This provision that “limits” functionality on the type of users that may execute the data export functionality is intended to be used by and at the discretion of the provider organization implementing the technology. In other words, this functionality cannot be used by health IT developers as an implicit way to thwart or moot the overarching user-driven aspect of this certification criterion. [see also 80 FR 62646]

Paragraph (b)(6)(i)(B)

Technical outcome – The technology limits users who can create export summaries in at least one of two ways:

To a specific set of identified users.
As a system administrative function.

Clarification:

This provision that “limits” functionality on the type of users that may execute the data export functionality is intended to be used by and at the discretion of the provider organization implementing the technology. In other words, this functionality cannot be used by health IT developers as an implicit way to thwart or moot the overarching user-driven aspect of this certification criterion. [see also 80 FR 62646]

Paragraph (b)(6)(ii)

Technical outcome – A user can configure the technology to create export summaries using the Continuity of Care Document (CCD) template (from the Consolidated CDA Release 2.1) that includes the data specified in (ii)(A)-(F), as applicable for the setting.

Clarifications:

To demonstrate compliance with this certification criterion, EHR technology must “enable a user to electronically create a set of export summaries for all patients in EHR technology formatted according to” the C-CDA standard (77 FR 54193). [see also Health IT Certification Program Overview] For the 2015 Edition, the user must be able to choose to create export summaries for one patient, a set of patients, or all patients (“for as many patients selected”). If the user chooses to create export summaries for a set of patients or all patients, this functionality cannot be satisfied by a user individually creating an export summary for each patient one-by-one. [see also 77 FR 54193]
This certification criterion’s purpose is to enable a user to export clinical data from health IT for one patient, a set of patients, or a subset of that set of patients. The functionality included in the criterion is intended to support a range of uses determined by a user and it was not ONC's intention to prescribe or imply particular uses for this functionality. ONC also notes that this functionality is not intended to and may not be sufficient to accomplish a full migration from one product to another without additional intervention because of the scope of this criterion. Specifically, the data and document templates specified in this criterion would not likely support a full migration, which could include administrative data such as billing information. The criterion’s functionality could, however, support the migration of clinical data between health IT systems and can play a role in expediting such an activity if so determined by the user. [see also 80 FR 62645]
Consistent with other responses provided in this final rule, this certification criterion requires conformance to the C-CDA R2.1. In consideration of comments received on the proposed rule, ONC has limited the C-CDA document template scope for this criterion to the CCD document template. ONC notes that the vocabularies used by the C-CDA R2.1 are defined through the Standards Developing Organization (SDO) process and does not seek to change that approach via this rulemaking (i.e., we adopt the C-CDA R2.1 as published). ONC notes that this criterion has been adopted with the proposed inclusion of the Common Clinical Data Set and other specified data. [see also 80 FR 62645]
Substitution of test data codes for valid alternative codes is acceptable provided they are valid, appropriate, and meet the 2015 Edition certification criteria requirements.
- Procedures and lab tests are both required to be coded with respective standards. “Lab tests”, if referred to as “future scheduled tests” needs to be coded. The HL7® C-CDA companion guide suggests that future scheduled tests belong in the Plan of Care section and that is what the C-CDA validator is built to follow. Thus, coded entries for future procedures and lab tests need to be in the Plan of Care section.
- In order to facilitate the translation of SNOMED CT^®codes to ICD-10-CM in administrative systems, developers are encouraged to reference the publicly available mapping that the National Library of Medicine provides. [see also 77 FR 54220]
- ONC provides the following OIDs to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards.
  - ICD-10-CM OID: 2.16.840.1.113883.6.90
  - SNOMED CT^® OID: 2.16.840.1.113883.6.96 [see also 80 FR 62612]
Health IT Modules can present for certification to a more recent version of SNOMED CT^®, U.S. Edition than the September 2015 Release per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [see also 80 FR 62620]
CPT codes are acceptable for the Test Procedure and test data. Please refer to the Test Procedure for more details.
The C-CDA Cognitive Status Observation template has been deprecated in Release 2.1 and has been replaced with the Mental Status Observation template. Developers should use the Mental Status Observation template for cognitive status and be aware that the C-CDA validator will issue an error if the deprecated Cognitive Status Observation template is used instead.
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]

Paragraph (b)(6)(ii)

Clarifications:

To demonstrate compliance with this certification criterion, EHR technology must “enable a user to electronically create a set of export summaries for all patients in EHR technology formatted according to” the C-CDA standard (77 FR 54193). [see also Health IT Certification Program Overview] For the 2015 Edition, the user must be able to choose to create export summaries for one patient, a set of patients, or all patients (“for as many patients selected”). If the user chooses to create export summaries for a set of patients or all patients, this functionality cannot be satisfied by a user individually creating an export summary for each patient one-by-one. [see also 77 FR 54193]
This certification criterion’s purpose is to enable a user to export clinical data from health IT for one patient, a set of patients, or a subset of that set of patients. The functionality included in the criterion is intended to support a range of uses determined by a user and it was not ONC's intention to prescribe or imply particular uses for this functionality. ONC also notes that this functionality is not intended to and may not be sufficient to accomplish a full migration from one product to another without additional intervention because of the scope of this criterion. Specifically, the data and document templates specified in this criterion would not likely support a full migration, which could include administrative data such as billing information. The criterion’s functionality could, however, support the migration of clinical data between health IT systems and can play a role in expediting such an activity if so determined by the user. [see also 80 FR 62645]
Consistent with other responses provided in this final rule, this certification criterion requires conformance to the C-CDA R2.1. In consideration of comments received on the proposed rule, ONC has limited the C-CDA document template scope for this criterion to the CCD document template. ONC notes that the vocabularies used by the C-CDA R2.1 are defined through the Standards Developing Organization (SDO) process and does not seek to change that approach via this rulemaking (i.e., we adopt the C-CDA R2.1 as published). ONC notes that this criterion has been adopted with the proposed inclusion of the Common Clinical Data Set and other specified data. [see also 80 FR 62645]
Substitution of test data codes for valid alternative codes is acceptable provided they are valid, appropriate, and meet the 2015 Edition certification criteria requirements.
- Procedures and lab tests are both required to be coded with respective standards. “Lab tests”, if referred to as “future scheduled tests” needs to be coded. The HL7® C-CDA companion guide suggests that future scheduled tests belong in the Plan of Care section and that is what the C-CDA validator is built to follow. Thus, coded entries for future procedures and lab tests need to be in the Plan of Care section.
- In order to facilitate the translation of SNOMED CT^®codes to ICD-10-CM in administrative systems, developers are encouraged to reference the publicly available mapping that the National Library of Medicine provides. [see also 77 FR 54220]
- ONC provides the following OIDs to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards.
  - ICD-10-CM OID: 2.16.840.1.113883.6.90
  - SNOMED CT^® OID: 2.16.840.1.113883.6.96 [see also 80 FR 62612]
Health IT Modules can present for certification to a more recent version of SNOMED CT^®, U.S. Edition than the September 2015 Release per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [see also 80 FR 62620]
CPT codes are acceptable for the Test Procedure and test data. Please refer to the Test Procedure for more details.
The C-CDA Cognitive Status Observation template has been deprecated in Release 2.1 and has been replaced with the Mental Status Observation template. Developers should use the Mental Status Observation template for cognitive status and be aware that the C-CDA validator will issue an error if the deprecated Cognitive Status Observation template is used instead.
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]

Paragraph (b)(6)(iii)(A)

Technical outcome – A user can set/enter the date and time period within which data would be used to create the export summaries.

Clarifications:

A user must be able to express a start and end date range to meet this requirement. [see also 80 FR 62646]
The request to enter back dated test data is to simulate previously entered tests so that certain portions of data sit inside a specific period of time.

Paragraph (b)(6)(iii)(A)

Technical outcome – A user can set/enter the date and time period within which data would be used to create the export summaries.

Clarifications:

A user must be able to express a start and end date range to meet this requirement. [see also 80 FR 62646]
The request to enter back dated test data is to simulate previously entered tests so that certain portions of data sit inside a specific period of time.

Paragraph (b)(6)(iii)(B)

Technical outcome – A user can do each of the following for the date and time specified in provision (iii)(A):

Create export summaries in real-time;
Create export summaries based on a relative date and time (e.g., the first of every month at 1:00am); and
Create export summaries based on a specific date and time (e.g., on 10/24/2015 at 1:00am).

Clarifications:

A user would need to be able to 1) create an export summary or export summaries in real-time (i.e., on demand); 2) configure technology to create such summaries based on a relative date and time (e.g., generate a set of export summaries from the prior month on the first of every month); and 3) configure technology to create such summaries based on a specific date and time (e.g., generate a set of export summaries with a date range between January 1, 2015 and March 31, 2015 on April 1, 2015 at 1:00AM EDT). ONC reiterates that a Health IT Module will need to support the user’s ability to select and configure those dates and times. [see also 80 FR 62646]

Paragraph (b)(6)(iii)(B)

Technical outcome – A user can do each of the following for the date and time specified in provision (iii)(A):

Create export summaries in real-time;
Create export summaries based on a relative date and time (e.g., the first of every month at 1:00am); and
Create export summaries based on a specific date and time (e.g., on 10/24/2015 at 1:00am).

Clarifications:

A user would need to be able to 1) create an export summary or export summaries in real-time (i.e., on demand); 2) configure technology to create such summaries based on a relative date and time (e.g., generate a set of export summaries from the prior month on the first of every month); and 3) configure technology to create such summaries based on a specific date and time (e.g., generate a set of export summaries with a date range between January 1, 2015 and March 31, 2015 on April 1, 2015 at 1:00AM EDT). ONC reiterates that a Health IT Module will need to support the user’s ability to select and configure those dates and times. [see also 80 FR 62646]

Paragraph (b)(6)(iv)

Technical outcome – A user can set the storage location to which the export summary or export summaries are intended to be saved.

Clarifications:

A Health IT Module must, at a minimum, permit a user to select a local or network storage location. ONC has intentionally left the specific transport method (e.g., sending to a Direct email address) or further product integration (e.g., routing the export to a web service or integration engine) to the discretion of the health IT developer and its customers. [see 80 FR 62646]

Paragraph (b)(6)(iv)

Technical outcome – A user can set the storage location to which the export summary or export summaries are intended to be saved.

Clarifications:

A Health IT Module must, at a minimum, permit a user to select a local or network storage location. ONC has intentionally left the specific transport method (e.g., sending to a Direct email address) or further product integration (e.g., routing the export to a web service or integration engine) to the discretion of the health IT developer and its customers. [see 80 FR 62646]