§170.315(e)(1) View, download, and transmit to 3rd party

Required by December 31, 2025 

The ONC-ACB verifies the health IT developer of a Health IT Module certified to the 170.315(e)(1) View, download, and transmit to 3^rd party attests conformance to updated 170.315(e)(1) criteria requirements. 

Web Content Accessibility

1. The tester verifies the level of WCAG 2.0, Level A Conformance as specified in § 170.204(a)(1) or Level AA Conformance § 170.204(a)(2), or

     Web Content Accessibility (Approved SVAP Version)

• WCAG 2.1,Level A Conformance, or
• Level AA Conformance 

2. Using the submitted testing results for WCAG Conformance (see http://www.w3.org/TR/2008/REC-WCAG20-20081211/#conformance-reqs) submitted in step 2, the tester evaluates the documentation of referenced practice, testing tools, tool results, and accompanying documentation to ensure the health IT developer has achieved conformance with WCAG 2.0 in accordance with § 170.204(a)(1) or § 170.204(a)(2) as applicable, or

     Web Content Accessibility (Approved SVAP Version)

• WCAG 2.1, Level A Conformance, or
• Level AA Conformance

3. The tester verifies there is WCAG compliance for each internet-based health IT technology associated with the VDT capabilities and that this information is submitted with the documentation provided in step 1.

Expires on January 1, 2026

View

1. The tester verifies that the user is able to download the ONC supplied data instructions for the health IT settings being certified.
2. The tester uses the VDT instruction document downloaded in step 1 of the System Under Test to perform visual inspection to verify that a patient’s view of the patient health data in step 2 of the System Under Test is accurate and without omission, and at a minimum includes the following data as applicable:
   • The data classes in accordance with § 170.213 USCDI as specified in section (e)(1)(i)(A)(1) and
     1. Assessment and Plan of Treatment as specified in section (e)(1)(i)(A)(3)(i);
     2. Goals as specified in section (e)(1)(i)(A)(3)(ii);
     3. Health Concerns as specified in section (e)(1)(i)(A)(3)(iii);
   • Ambulatory setting only: the provider’s name and office contact information as specified in section (e)(1)(i)(A)(4);
   • Inpatient setting only: the admission and discharge dates and locations; discharge instructions; and reason(s) for hospitalization as specified in section (e)(1)(i)(A)(5);
   • Laboratory test report(s) as specified in section (e)(1)(i)(A)(6) when available; and
   • Diagnostic Imaging report(s) as specified in section (e)(1)(i)(A)(7), when available.
3. Based upon the health IT setting(s) being certified, the tester repeats steps 1-2 for each of the ambulatory and/or inpatient setting(s). All of the VDT summary record instruction documents for a given health IT setting must be viewed.

Authorized Viewer

4. The tester verifies that a patient’s authorized representative can view the patient health data, and using the VDT instruction document and the view from step 4 of the System Under Test, performs the same verification as in step 1.
5. Negative Test: Using visual inspection, the tester verifies that a user, who is neither the patient identified in the record nor the patient’s authorized representative, does not have access to view the patient’s health information.

Required by December 31, 2025

View

1. The tester verifies that the user is able to download the ONC supplied data instructions for the health IT settings being certified.
2. The tester uses the VDT instruction document downloaded in step 1 of the System Under Test to perform visual inspection to verify that a patient’s view of the patient health data in step 2 of the System Under Test is accurate and without omission, and at a minimum includes the following data as applicable:

• The data classes in accordance with § 170.213 USCDI as specified in section (e)(1)(i)(A)(1) and
  • Assessment and Plan of Treatment as specified in section (e)(1)(i)(A)(3)(i);
  • Goals as specified in section (e)(1)(i)(A)(3)(ii);
  • Health Concerns as specified in section (e)(1)(i)(A)(3)(iii);
  • Ambulatory setting only: the provider’s name and office contact information as specified in section (e)(1)(i)(A)(4);
  • Inpatient setting only: the admission and discharge dates and locations; discharge instructions; and reason(s) for hospitalization as specified in section (e)(1)(i)(A)(5);
  • Laboratory test report(s) as specified in section (e)(1)(i)(A)(6) when available; and
  • Diagnostic Imaging report(s) as specified in section (e)(1)(i)(A)(7), when available.

3. Based upon the health IT setting(s) being certified, the tester repeats steps 1-2 for each of the ambulatory and/or inpatient setting(s). All of the VDT summary record instruction documents for a given health IT setting must be viewed.

Authorized Viewer

4. The tester verifies that a patient’s authorized representative can view the patient health data, and using the VDT instruction document and the view from step 4 of the System Under Test, performs the same verification as in step 1.
5. Negative Test: Using visual inspection, the tester verifies that a user, who is neither the patient identified in the record nor the patient’s authorized representative, does not have access to view the patient’s health information.

Expires on January 1, 2026

Data Class Requirements

1. Using visual inspection, the tester verifies that the data presented in section (e)(1)(i)(A) step 2 of the System Under Test includes all of the USCDI data classes as specified in the in the standard at § 170.213, as applicable; and human-readable version with English terminology is in English (i.e., non-coded) representation, if associated with a vocabulary/code set, and in accordance with the implementation guides at § 170.205(a)(4) and § 170.205(a)(5).
2. Using visual inspection, the tester verifies that the data presented in section (e)(1)(i)(A)(3)(i) step 2 of the System Under Test includes:
   • The Assessment and Plan Section (V2), or both the Assessment and Plan of Treatment Sections (V2) are specified in accordance with the standard specified in § 170.205(a)(4) as narrative text.
3. Using visual inspection, the tester verifies that the data presented in section (e)(1)(i)(A)(3)(ii) step 2 of the System Under Test includes:
   • The Goals specified in accordance with the standard specified in § 170.205(a)(4) as narrative text.
4. Using visual inspection, the tester verifies that the data presented in section (e)(1)(i)(A)(3)(iii) step 2 of the System Under Test includes:
   • The Health Concerns specified in accordance with the standard specified in § 170.205(a)(4) as narrative text.

Note: The system must consistently and independently represent the data as discrete data that are clearly distinguishable.

Required by December 31, 2025 

Data Class Requirements

1. Using visual inspection, the tester verifies that the data presented in section (e)(1)(i)(A) step 2 of the System Under Test includes all of the USCDI data classes as specified in the in the standard at § 170.213, as applicable; and human-readable version with English terminology is in English (i.e., non-coded) representation, if associated with a vocabulary/code set, and in accordance with the implementation guides at §170.205(a)(4) and § 170.205(a)(6):
2. Using visual inspection, the tester verifies that the data presented in section (e)(1)(i)(A)(3)(i) step 2 of the System Under Test includes:
   • The Assessment and Plan Section (V2), or both the Assessment and Plan of Treatment Sections (V2) are specified in accordance with the standard specified in § 170.205(a)(4) as narrative text.
3. Using visual inspection, the tester verifies that the data presented in section (e)(1)(i)(A)(3)(ii) step 2 of the System Under Test includes:
   • The Goals specified in accordance with the standard specified in § 170.205(a)(4) as narrative text.
4. Using visual inspection, the tester verifies that the data presented in section (e)(1)(i)(A)(3)(iii) step 2 of the System Under Test includes:
   • The Health Concerns specified in accordance with the standard specified in § 170.205(a)(4) as narrative text.

Note: The system must consistently and independently represent the data as discrete data that are clearly distinguishable.

Ambulatory Setting Only

Using visual inspection, the tester verifies that the data presented in section (e)(1)(i)(A) step 2 of the System Under Test, in the case of an ambulatory setting, includes:

• The provider’s name; and
• Office contact information.

Inpatient Setting Only

Using visual inspection, the tester verifies that the data presented in section (e)(1)(i)(A) step 2 of the System Under Test, in the case of an inpatient setting, includes:

• Admissions and discharge dates and locations;
• Discharge instructions; and
• Reason(s) for hospitalization.

Laboratory Test Report

Using the ONC-supplied VDT information and visual inspection, the tester verifies that the correct laboratory test report(s) are displayed in human readable format, and that the laboratory test report is complete and accurate. Additionally, the tester verifies that the laboratory test report includes:

• The Clinical Laboratory Improvement Amendments (CLIA) reporting data requirements specified at 42 CFR 493.1291(c)(1) through (7);
• The CLIA referenced values 42 CFR 493.1291(d); and
• The CLIA corrected report requirements specified at 42 CFR 493.1291(k)(2).

Diagnostic Imaging Report

Using the ONC-supplied VDT information and visual inspection, the tester verifies that the correct diagnostic imaging report(s) are displayed in human readable format and that the diagnostic imaging report(s) are complete and accurate.

Download in Human Readable Format

1. For each data set downloaded in step 1 of the System Under Test, the tester verifies that the data set can be downloaded using visual inspection, and uses the corresponding ONC-supplied VDT summary record information downloaded in (e)(1)(i)(A) step 1 of the System Under Test to verify that the downloaded ambulatory and/or inpatient summary, in human readable format, is accurate and without omission.  Using visual inspection, the tester verifies the summary document includes at a minimum, the following data, as applicable:
   • The USCDI data classes expressed in the standard in § 170.213 as specified in section (e)(1)(i)(A)(1);
   • The following data classes: Assessment and Plan of Treatment, Goals and Health Concerns as specified in (e)(1)(i)(A)(3)(i-iii);
   • For the inpatient setting, the downloaded inpatient summary document in step 1 includes at a minimum, the following data as applicable: the admission and discharge dates and locations; discharge instructions; and reason(s) for hospitalization as specified in section (e)(1)(i)(A)(5);
   • For the ambulatory setting, the downloaded ambulatory summary document in step 1 includes at a minimum, the following data as applicable: the provider’s name and office contact information as specified in section (e)(1)(i)(A)(4);
   • The laboratory report(s) are complete and accurate as specified in section (e)(1)(i)(A)(6). The laboratory test report must include the Clinical Laboratory Improvement Amendments (CLIA) reporting data requirements specified at 42 CFR 493.1291(c)(1) through (7), the CLIA referenced values 42 CFR 493.1291(d), and the CLIA corrected report requirements specified at 42 CFR 493.1291(k)(2); and
   • The diagnostic report is complete and accurate as specified in section (e)(1)(i)(A)(7).

Authorized Downloader

2. The tester verifies that a patient’s authorized representative can download the patient health data in human readable version, and using the VDT instruction document and the download from step 2 of the System Under Test to perform the same verification as in steps 1-5.
3. Negative Test: Using visual inspection, the tester verifies that a user, who is neither the patient identified in the record nor the patient’s authorized representative, does not have access to download the patient’s health information.

Expires on January 1, 2026

Download as a Continuity of Care Document (CCD)

1. For each data set downloaded in step 1 of the System Under Test, the tester verifies that a CCD document has been downloaded using visual inspection.
2. For each CCD submitted in step 2 of the System Under Test, the tester uses the ETT: Message Validators – USCDI v1 R2.1 to upload the CCD submitted by the System Under Test as a sender, by selecting “170.315_e1_VDT_ Amb” or “170.315_e1_VDT_Inp” criteria and the corresponding ONC-supplied VDT summary record file name, and the tester executes the upload. The tester uses the Validation Report produced by the ETT: Message Validators – USCDI v1 R2.1 in step 2 to verify the validation report indicates passing without error to confirm that the VDT summary record is conformant to the standard adopted in § 170.205(a)(4) and 170.205(a)(5), using the CCD document format, including the presentation of the downloaded data is a valid coded document containing:
   • All of the required USCDI data classes expressed in the standard in § 170.213 as specified in section (e)(1)(i)(A)(1);
   • The following data classes: Assessment and Plan of Treatment, Goals and Health Concerns as specified in section (e)(1)(i)(A)(3)(i-iii);
   • Ambulatory setting only: the provider’s name and office contact information as specified in section (e)(1)(i)(A)(4);
   • Inpatient setting only: admission and discharge dates and locations, discharge instructions, and reason(s) for hospitalization) as specified in section (e)(1)(i)(A)(5);
   • Laboratory report(s) as specified in section (e)(1)(i)(A)(6), when available; and
   • Diagnostic imaging report(s) as specified in section (e)(1)(i)(A)(7), when available.
3. Additionally, as required by the ONC-supplied VDT instruction document, the tester uses the ETT: Message Validators –USCDI v1 R2.1 Message Content Report, created in step 2, to verify the additional checks have equivalent text and the content of all section level narrative text.

Required by December 31, 2025

Download as a Continuity of Care Document (CCD)

1. For each data set downloaded in step 1 of the System Under Test, the tester verifies that a CCD document has been downloaded using visual inspection.
2. For each CCD submitted in step 2 of the System Under Test, the tester uses the ETT: Message Validators –USCDI v3 R2.1 to upload the CCD submitted by the System Under Test as a sender, by selecting “170.315_e1_VDT_ Amb” or “170.315_e1_VDT_Inp” criteria and the corresponding ONC-supplied VDT summary record file name, and the tester executes the upload. The tester uses the Validation Report produced by the ETT: Message Validators – USCDI v3 R2.1 in step 2 to verify the validation report indicates passing without error to confirm that the VDT summary record is conformant to the standard adopted in § 170.205(a)(4) and § 170.205(a)(6), using the CCD document format, including the presentation of the downloaded data is a valid coded document containing:

• All of the required USCDI data classes expressed in the standard in § 170.213 as specified in section (e)(1)(i)(A)(1);
• The following data classes: Assessment and Plan of Treatment, Goals and Health Concerns as specified in section (e)(1)(i)(A)(3)(i-iii);
• Ambulatory setting only: the provider’s name and office contact information as specified in section (e)(1)(i)(A)(4);
• Inpatient setting only: admission and discharge dates and locations, discharge instructions, and reason(s) for hospitalization) as specified in section (e)(1)(i)(A)(5);
• Laboratory report(s) as specified in section (e)(1)(i)(A)(6), when available; and
• Diagnostic imaging report(s) as specified in section (e)(1)(i)(A)(7), when available.

3. Additionally, as required by the ONC-supplied VDT instruction document, the tester uses the ETT: Message Validators –USCDI v3 R2.1 Message Content Report, created in step 2, to verify the additional checks have equivalent text and the content of all section level narrative text.

Download CCD - Human Readable Version

1. The tester uses the Message Content Report produced by the ETT: Message Validators in step 2 to verify that the submitted CCD document created by the Health IT module includes the following human readable data:
   • The USCDI data classes expressed in the standard in § 170.213 as specified in section (e)(1)(i)(A)(1);
   • The following data classes: Assessment and Plan of Treatment, Goals and Health Concerns as specified in (e)(1)(i)(A)(3)(i-iii);
   • Ambulatory setting only: the provider’s name and office contact information as specified in section (e)(1)(i)(A)(4);
   • Inpatient setting only: admission and discharge dates and locations; discharge instructions; and reason(s) for hospitalization as specified in section (e)(1)(i)(A)(5);
   • The tester verifies that laboratory test report(s) are present as specified in section (e)(1)(i)(A)(6) when available; and
   • The tester verifies that diagnostic imaging report(s) are present as specified in section (e)(1)(i)(A)(7) when available.

Setup

1. For each transition of care/referral summary record document downloaded in step 1 of the System Under Test, the tester creates a human readable version to be used for verification.

Download Transition of Care/Referral Summary

2. Using visual inspection, the tester verifies that each of the VDT transition of care/referral summary records from System Under Test step 1 is downloaded using the internet-based technology health IT function(s). Additionally, the tester verifies that each of the VDT transition of care/referral summary records downloaded from System Under Test step 2 is accurate and complete according to the human readable version in step 1. This includes verification at a minimum the following content as applicable:
   • The USCDI data classes expressed in the standard in § 170.213 as specified in  the standard at § 170.213; and
   • The following data classes: Assessment and Plan of Treatment, Goals and Health Concerns as specified in (e)(1)(i)(A)(3)(i-iii).

Expires on January 1, 2026

Unencrypted Email Method

1. Using visual inspection, the tester verifies that each ambulatory or inpatient summary document transmitted in steps 1-2 of the System Under Test using an email transmission is received successfully by the third-party, developer-identified email address.
2. For each CCD document transmitted in step 2 of the System Under Test, the tester uses ETT: Message Validators –USCDI v1 R2.1to upload the CCD transmitted as a sender, by selecting “170.315_e1_VDT_ Amb” or “170.315_e1_VDT_ Inp” criteria and the corresponding ONC supplied VDT summary record file name, and the tester executes the upload. The tester uses the Validation Report and Content Report produced by the ETT: Message Validator – USCDI v1 R2.1 to verify the validation report indicates passing without error to confirm that the VDT summary record is conformant to the standard adopted in § 170.205(a)(4) and § 170.205(a)(5) using the CCD document format. The format shall include the presentation of the transmitted data is a valid coded document containing:

• All of the required USCDI data classes expressed in the standard in § 170.213 as specified in section (e)(1)(i)(A)(1). Additionally, the transmitted health information contains the data in human readable version with English terminology (i.e. non-coded representation of vocabulary/code sets) as specified in section (e)(1)(i)(A);
• The following data classes: Assessment and Plan of Treatment, Goals and Health Concerns as specified in section (e)(1)(i)(A)(3)(i-iii);
• Ambulatory setting only: the provider’s name and office contact information as specified in section (e)(1)(i)(A)(4);
• Inpatient setting only: admission and discharge dates and locations, discharge instructions and reason(s) for hospitalization) as specified in section (e)(1)(i)(A)(5), when available;
• Laboratory report(s) as specified in section (e)(1)(i)(A)(6), when available. Additionally, if included, the correct laboratory test report is displayed in human readable format, and that the laboratory test report is complete and accurate. The laboratory test report must include the CLIA reporting data requirements specified at 42 CFR 493.1291(c)(1) through (7), the CLIA referenced values 42 CFR 493.1291(d), and the CLIA corrected report requirements specified at 42 CFR 493.1291(k)(2);
• Diagnostic imaging report(s) as specified in section (e)(1)(i)(A)(7) when available. Additionally, if included, the correct diagnostic imaging report is displayed in human readable format, and that the diagnostic imaging report is complete and accurate; and
• As required by the corresponding ONC supplied VDT instruction document, verification of the additional checks for equivalent text the content of all section level narrative text.

Authorized Email Transmission

3. The tester verifies that the Health IT Module can send an unencrypted email with an attachment.
4. The tester verifies that a patient’s authorized representative can transmit the patient health data as a CCD using an unencrypted email method by using the VDT instruction document and the transmission from steps 3-4 of the System Under Test, and performs the same verification as in steps 1-7.
5. Negative Test: Using visual inspection, the tester verifies that a user who is not the patient identified in the record and is not the patient’s authorized representative does not have access to transmit the patient’s health information.

Required by December 31, 2025

Unencrypted Email Method

1. Using visual inspection, the tester verifies that each ambulatory or inpatient summary document transmitted in steps 1-2 of the System Under Test using an email transmission is received successfully by the third-party, developer-identified email address.
2. For each CCD document transmitted in step 2 of the System Under Test, the tester uses ETT: Message Validators – USCDI v3 R2.1 to upload the CCD transmitted as a sender, by selecting “170.315_e1_VDT_ Amb” or “170.315_e1_VDT_ Inp” criteria and the corresponding ONC supplied VDT summary record file name, and the tester executes the upload. The tester uses the Validation Report and Content Report produced by the ETT: Message Validator – USCDI v3 R2.1 to verify the validation report indicates passing without error to confirm that the VDT summary record is conformant to the standard adopted in § 170.205(a)(4) and § 170.205(a)(6) using the CCD document format. The format shall include the presentation of the transmitted data is a valid coded document containing:

• All of the required USCDI data classes expressed in the standard in § 170.213 as specified in section (e)(1)(i)(A)(1). Additionally, the transmitted health information contains the data in human readable version with English terminology (i.e. non-coded representation of vocabulary/code sets) as specified in section (e)(1)(i)(A);
• The following data classes: Assessment and Plan of Treatment, Goals and Health Concerns as specified in section (e)(1)(i)(A)(3)(i-iii);
• Ambulatory setting only: the provider’s name and office contact information as specified in section (e)(1)(i)(A)(4);
• Inpatient setting only: admission and discharge dates and locations, discharge instructions and reason(s) for hospitalization) as specified in section (e)(1)(i)(A)(5), when available;
• Laboratory report(s) as specified in section (e)(1)(i)(A)(6), when available. Additionally, if included, the correct laboratory test report is displayed in human readable format, and that the laboratory test report is complete and accurate. The laboratory test report must include the CLIA reporting data requirements specified at 42 CFR 493.1291(c)(1) through (7), the CLIA referenced values 42 CFR 493.1291(d), and the CLIA corrected report requirements specified at 42 CFR 493.1291(k)(2);
• Diagnostic imaging report(s) as specified in section (e)(1)(i)(A)(7) when available. Additionally, if included, the correct diagnostic imaging report is displayed in human readable format, and that the diagnostic imaging report is complete and accurate; and
• As required by the corresponding ONC supplied VDT instruction document, verification of the additional checks for equivalent text the content of all section level narrative text.

Authorized Email Transmission

3. The tester verifies that the Health IT Module can send an unencrypted email with an attachment.
4. The tester verifies that a patient’s authorized representative can transmit the patient health data as a CCD using an unencrypted email method by using the VDT instruction document and the transmission from steps 3-4 of the System Under Test, and performs the same verification as in steps 1-7.
5. Negative Test: Using visual inspection, the tester verifies that a user who is not the patient identified in the record and is not the patient’s authorized representative does not have access to transmit the patient’s health information.

Expires on January 1, 2026

Encrypted Method

1. Using visual inspection, the tester verifies that for each ambulatory or inpatient summary transmitted in step 2 of the System Under Test using an encrypted transmission, that the message is received and successfully decrypted.
2. For each CCD document transmitted in step 2 of the System Under Test, the tester uses the ETT: Message Validators - USCDI v1 R2.1 to upload the CCD transmitted as a sender, by selecting “170.315_e1_VDT_ Amb” or “170.315_e1_VDT_Inp” criteria and the corresponding ONC supplied VDT summary record file name, and the tester executes the upload. The tester uses the Validation and Content Reports produced by the ETT: Message Validators - USDCI v1 R2.1 to verify the validation report indicates passing without error to confirm that the VDT summary record is conformant to the standard adopted in § 170.205(a)(4) and § 170.205(a)(5) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R1 Companion Guide, Release 2 using the CCD document format and that the presentation of the transmitted data is a valid coded document as specified in(e)(1)(i)(A) containing:
   • All of the required USCDI data classes expressed in the standard in § 170.213 as specified in section (e)(1)(i)(A)(1).  Additionally, the transmitted health information contains the data in human readable version with English terminology (i.e. non-coded representation of vocabulary/code sets) as specified in section (e)(1)(i)(A);
   • The following data classes: Assessment and Plan of treatment, Goals and Health Concerns as specified in (e)(1)(i)(A)(3)(i-iii);
   • Ambulatory setting only: the provider’s Name and office contact information as specified in section (e)(1)(i)(A)(4);
   • Inpatient setting only: admission and discharge dates and locations, discharge instructions, and reason(s) for hospitalization) as specified in section (e)(1)(i)(A)(5);
   • Laboratory report(s) as specified in section (e)(1)(i)(A)(4)6, when available. Additionally, if included, the correct laboratory test report is displayed in human readable format, and that the laboratory test report is complete and accurate. The laboratory test report must include the CLIA reporting data requirements specified at 42 CFR 493.1291(c)(1) through (7), the CLIA referenced values 42 CFR 493.1291(d), and the CLIA corrected report requirements specified at 42 CFR 493.1291(k)(2);
   • Diagnostic imaging report(s) as specified in section (e)(1)(i)(A)(7) when available. Additionally, if included, the correct diagnostic imaging report is displayed in human readable format, and that the diagnostic imaging report is complete and accurate; and
   • As required by the corresponding ONC supplied VDT instruction document, verification the additional checks for equivalent text for the content of all section level narrative text.

Authorized Encrypted Transmission

3. The tester verifies that the Health IT Module can send an encrypted email with an attachment.
4. The tester verifies that a patient’s authorized representative can transmit the patient health data as a CCD using an encrypted method by using the VDT instruction document and the view from steps 3-4 of the System Under Test, and performs the same verification as in steps 1-7.
5. Negative Test: Using visual inspection, the tester verifies that a user who is not the patient identified in the record and is not the patient’s authorized representative does not have access to transmit the patient’s health information.

Required by December 31, 2025

Encrypted Method

1. Using visual inspection, the tester verifies that for each ambulatory or inpatient summary transmitted in step 2 of the System Under Test using an encrypted transmission, that the message is received and successfully decrypted.
2. For each CCD document transmitted in step 2 of the System Under Test, the tester uses the ETT: Message Validators - USCDI v3 R2.1 to upload the CCD transmitted as a sender, by selecting “170.315_e1_VDT_ Amb” or “170.315_e1_VDT_Inp” criteria and the corresponding ONC supplied VDT summary record file name, and the tester executes the upload. The tester uses the Validation and Content Reports produced by the ETT: Message Validators - USCDI v3 R2.1 to verify the validation report indicates passing without error to confirm that the VDT summary record is conformant to the standard adopted in § 170.205(a)(4) and § 170.205(a)(6) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 using the CCD document format and that the presentation of the transmitted data is a valid coded document as specified in(e)(1)(i)(A) containing:

• All of the required USCDI data classes expressed in the standard in § 170.213 as specified in section (e)(1)(i)(A)(1).  Additionally, the transmitted health information contains the data in human readable version with English terminology (i.e. non-coded representation of vocabulary/code sets) as specified in section (e)(1)(i)(A);
• The following data classes: Assessment and Plan of treatment, Goals and Health Concerns as specified in (e)(1)(i)(A)(3)(i-iii);
• Ambulatory setting only: the provider’s Name and office contact information as specified in section (e)(1)(i)(A)(4);
• Inpatient setting only: admission and discharge dates and locations, discharge instructions, and reason(s) for hospitalization) as specified in section (e)(1)(i)(A)(5);
• Laboratory report(s) as specified in section (e)(1)(i)(A)(46, when available. Additionally, if included, the correct laboratory test report is displayed in human readable format, and that the laboratory test report is complete and accurate. The laboratory test report must include the CLIA reporting data requirements specified at 42 CFR 493.1291(c)(1) through (7), the CLIA referenced values 42 CFR 493.1291(d), and the CLIA corrected report requirements specified at 42 CFR 493.1291(k)(2);
• Diagnostic imaging report(s) as specified in section (e)(1)(i)(A)(7) when available. Additionally, if included, the correct diagnostic imaging report is displayed in human readable format, and that the diagnostic imaging report is complete and accurate; and
• As required by the corresponding ONC supplied VDT instruction document, verification the additional checks for equivalent text for the content of all section level narrative text.

Authorized Encrypted Transmission

3. The tester verifies that the Health IT Module can send an encrypted email with an attachment.
4. The tester verifies that a patient’s authorized representative can transmit the patient health data as a CCD using an encrypted method by using the VDT instruction document and the view from steps 3-4 of the System Under Test, and performs the same verification as in steps 1-7.
5. Negative Test: Using visual inspection, the tester verifies that a user who is not the patient identified in the record and is not the patient’s authorized representative does not have access to transmit the patient’s health information.

Inpatient Setting Only

Unencrypted Email Method - ToC

1. Using visual inspection, the tester verifies that each ToC/referral summary document, transmitted in steps 1-2 of the System Under Test using an email transmission, is received successfully by the third-party, developer-identified email address.
2. Using visual inspection, the tester verifies that each of the VDT ToC/referral summary records transmitted in step 2 of the System Under Test is accurate and complete according to the human readable version as specified in section (e)(1)(i)(B)(3).

Encrypted Method - ToC

3. Using visual inspection, the tester verifies that each ToC/referral summary document transmitted in step 2 of the  System Under Test using an encrypted transmission is received, and the message is successfully decrypted. Additionally, the tester verifies that each of the VDT ToC/referral summary records transmitted in step 2 of the System Under Test is accurate and complete according to the human readable version as specified in section (e)(1)(i)(B)(3).

1. The tester verifies that the user in the role of patient and the patient’s authorized representative can view and download the health information as specified in sections (e)(1)(i)(A) and (e)(1)(i)(B) for a selected date and that the viewed and downloaded health information data associated with that date is accurate and without omission.
2. The tester verifies that the user in the role of patient and the patient’s authorized representative can transmit the health information to a third party as specified in section (e)(1)(i)(C) for a selected date and that the transmitted health information data associated with that date is accurate and without omission.

1. The tester verifies that the user in the role of patient and the patient’s authorized representative can view and download the health information as specified in section (e)(1)(i)(A) and (e)(1)(i)(B) for a selected date range and that the viewed and downloaded health information data associated with that date range is accurate and without omission.
2. The tester verifies that the user in the role of patient and the patient’s authorized representative can transmit the health information to a third party as specified in section (e)(1)(i)(C) for a selected date range and that the transmitted health information data associated with that date range is accurate and without omission.

1. Using visual inspection, the tester verifies that the Health IT Module creates an activity log entry for each of the following actions related to electronic health information:
   • View of patient information;
   • Download patient information; and
   • Transmit patient information.
2. The tester verifies that the Health IT Module has certified to the certification criterion specified in § 170.315(d)(2) using documentation or the tester verifies via visual inspection that for all required actions, an activity log entry related to each action taken has been generated correctly and without omission, containing:
   • The actions that occurred;
   • The date/time, specified in accordance to the standard specified in § 170.210(g);
   • The user who took the action; and
   • The addressee to whom the transmission was sent (if applicable).

Required by December 31, 2025

Using visual inspection, the tester verified user is able to use an internet-based method to request a restriction to be applied for any data expressed in the standards in § 170.213.