View, download, and transmit to 3rd party

Web Content Accessibility

1. The health IT developer provides documentation indicating the level of Web Content Accessibility supported by the Health IT Module:

• Web Content Accessibility Guideline (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)

• Web Content Accessibility Guideline (WCAG) 2.2, Level A Conformance, or
• Level AA Conformance.

2. The health IT developer submits test documentation that demonstrates its internet-based technology’s compliance with either: 

• § 170.204(a)(1) WCAG 2.0, Level A Conformance, 
• § 170.204(a)(2) WCAG 2.0, Level AA Conformance, or

     Web Content Accessibility (Approved SVAP Version)

• Web Content Accessibility Guideline (WCAG) 2.2, Level A Conformance, or
• Level AA Conformance  

3. The health IT developer documentation provided in step 1 includes WCAG compliance for each internet-based health IT technology associated with the view, download, or transmit (VDT) capabilities.

Web Content Accessibility

1. The tester verifies using the submitted test documentation 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 2.2, Level A Conformance, or
• Level AA Conformance 

2. Using the submitted testing results for WCAG Conformance (see Conformance Requirements) 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 2.2, 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.

View

1. Using the SITE: C-CDA Validator USCDI v3, the user downloads the ONC-supplied data instructions through the sender download selections of “170.315_e1_VDT_Amb” or “170.315_e1_VDT_Inp” and one of the VDT instruction documents and executes the download.
2. Using the internet-based technology health IT function(s), the user, with the role of patient, views the ONC-supplied information downloaded in step 1. At a minimum, the view includes the following data as applicable:
   • The data classes in accordance with § 170.213 United States Core Data for Interoperability Standard (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 user 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. Using one of the ONC-supplied test data instructions from step 1 and the internet-based technology health IT function(s), the user, with the role of authorized patient representative, views at a minimum the data referenced in step 2. Note, the data must be visible in the health IT product and not require a download.
5. Negative Test: A user who is neither the patient identified in the patient record nor the patient’s authorized representative attempts to access and view patient data and is prevented from doing so.

All Steps (Approved SVAP Version)

• Complete steps above using SITE: C-CDA Validator – USCDI v4 and;
• Reference United States Core Data for Interoperability (USCDI), Version 4, October 2023 Errata.

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.

Data Class Requirements

1. The data presented in section (e)(1)(i)(A) step 2 of the System Under Test includes the USCDI data classes as specified in the standard at § 170.213 as applicable, and 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. Additionally, the data presented in section (e)(1)(i)(A) step 2 of the System Under Test includes as specified the following data as specified in section (e)(1)(i)(A)(3)(i):

• The Assessment and Plan of Treatment in accordance with either the Assessment and Plan Section (V2), or both the Assessment and Plan of Treatment Sections (V2), specified in accordance with the standard specified in § 170.205(a)(4). At a minimum, the Assessment and plan of treatment data includes the narrative text.

3. Additionally, the data presented in section (e)(1)(i)(A) step 2 of the System Under Test includes as specified the following data as specified in section (e)(1)(i)(A)(3)(ii):

• The Goals specified in accordance with the standard specified at § 170.205(a)(4) and § 170.205(a)(4)(i). At a minimum, the Goals data includes narrative text.

4. Additionally, the data presented in section (e)(1)(i)(A) step 2 of the System Under Test includes as specified the following data as specified in section (e)(1)(i)(A)(3)(iii):

• The Health Concerns specified in accordance with the standard specified at § 170.205(a)(4). At a minimum, the Health Concerns data includes narrative text.

(Approved SVAP Version)

Reference United States Core Data for Interoperability (USCDI), Version 4, October 2023 Errata.

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

The data presented in section (e)(1)(i)(A) step 2 of the System Under Test will also include:

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

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

The data presented in section (e)(1)(i)(A) step 2 of the System Under Test will also include:

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

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

The data presented includes the laboratory test report(s) when available, including the following information:

• The test report must indicate the following information as specified in 42 CFR 493.1291(c)(1) through (7):
  1. For positive patient identification, either the patient's name and identification number or a unique patient identifier and identification number.
  2. The name and address of the laboratory location where the test was performed.
  3. The test report date.
  4. The test performed.
  5. The specimen source, when appropriate.
  6. The test result and, if applicable, the units of measurement or interpretation, or both.
  7. Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability.
• Pertinent “reference intervals” or “normal” values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results as specified in 42 CFR 493.1291(d); and
• The information for corrected reports as specified in 42 CFR 493.1291(k)(2).

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

The data presented includes the diagnostic image report(s) when available.

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 viewed in section (e)(1)(i)(A) step 2, the user, with the role of patient, uses the internet-based technology health IT function(s) to download an ambulatory or inpatient summary document formatted as a human readable document, which at the minimum contains the health information data identified in sections (e)(1)(i)(A)(1,3-7), as applicable.

Authorized Downloader

2. For the data set viewed in section (e)(1)(i)(A) step 4, the user, with the role of patient authorized representative, uses the internet-based technology health IT function(s), to download an ambulatory or inpatient summary document formatted as a human readable document, which at a minimum contains the health information data identified in section (e)(1)(i)(A)(1,3-7), as applicable.
3. Negative Test: A user who is neither the patient identified in the patient record nor a patient’s authorized representative attempts to access and download patient data and is prevented from doing so.

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.

Download as a Continuity of Care Document (CCD)

1. For each data set viewed in section (e)(1)(i)(A) step 2, the user, with the role of patient, uses the internet-based technology health IT function(s) to download an ambulatory or inpatient summary document in section (e)(1)(i)(B) that is formatted as a CCD document according to the standard specified in § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes with Errata, DSTU Release 2.1 and § 170.205(a)(6) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1.
2. The user submits the downloaded CCD document from step 1 for verification.

(Approved SVAP Version)

• Complete steps above using SITE: C-CDA Validator – USCDI v4 and;
• Reference United States Core Data for Interoperability (USCDI), Version 4, October 2023 Errata, and;
• Use HL7® CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes Edition 3.0 - US Realm, May 2024 for § 170.205(a)(4), (a)(5) or (a)(6).

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 SITE: C-CDA Validator – USCDI v3 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 SITE: C-CDA Validator 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 SITE: C-CDA Validator 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. For each of the downloaded CCD documents in section (e)(1)(i)(B)(1)(ii), the VDT summary record downloaded must include, at a minimum, the following human readable data with applicable standards:
   • The USCDI data classes expressed in the standard in § 170.213;
   • The following data classes: Assessment and Plan of Treatment, Goals and Health Concerns.
   • Ambulatory setting only: the provider’s name and office contact information;
   • Inpatient setting only: admission and discharge dates and locations; discharge instructions; and reason(s) for hospitalization;
   • Laboratory test report(s) when available; and
   • Diagnostic imaging report(s) when available.

(Approved SVAP Version)

Reference United States Core Data for Interoperability (USCDI), Version 4, October 2023 Errata.

Download CCD - Human Readable Version

1. The tester uses the Message Content Report produced by SITE: 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.

Inpatient Setting Only - Download Transition of Care/Referral Summary

1. For the inpatient setting only, using SITE: C-CDA Validators, the user downloads the ONC-supplied transition of care/referral summary records instructions provided by the PDF files for “170.315_e1_VDT_Inp” or “170.315_b1_ToC_Inp” to enter the required patient data on the Health IT Module.
2. Using the internet-based technology health IT function(s), the user, with the role of patient, downloads each of the VDT transitions of care/referral summary records created in step 1 formatted as a Discharge Summary document as defined in 170.315(b)(1) Continuity of Care Document and Referral Note.

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 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).

Unencrypted Email Method

1. For each data set viewed in section (e)(1)(i)(A), the user, with the role of patient, uses the Health IT Module’s internet-based technology to transmit, via email, an ambulatory summary or inpatient summary as created in section (e)(1)(i)(B)(2) as a CCD document according to the standards specified in § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes with Errata, DSTU Release 2.1 and § 170.205(a)(6) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 to a valid, third-party email address identified by the user.
2. The user accesses the third-party email account and verifies that the transmission was received, and the correct ambulatory and/or inpatient summary is attached.

Authorized Email Transmission

3. For the test data set viewed in section (e)(1)(i)(A) step 4, a user role of patient authorized representative uses the Health IT Module’s internet-based technology, to transmit, via email, an ambulatory summary or inpatient summary as created in section (e)(1)(i)(B)(2) as a CCD document according to the standards specified in § 170.205(a)(4) HL7 Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes with Errata, DSTU Release 2.1 and § 170.205(a)(6) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 to a valid, third-party email address identified by the user.
4. The user accesses the third-party email account and verifies that the transmission was received, and the correct ambulatory and/or inpatient summary is attached.
5. Negative Test: A user who is neither the patient identified in the test record nor the patient’s authorized representative attempts to access and transmit patient data and is prevented from doing so.

(Approved SVAP Version)

• Complete steps above using SITE: C-CDA Validator – USCDI v4 and;
• Reference United States Core Data for Interoperability (USCDI), Version 4, October 2023 Errata, and;
• Use HL7® CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes Edition 3.0 - US Realm, May 2024 for § 170.205(a)(4), (a)(5) or (a)(6).

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 SITE: C-CDA Validator – USCDI v3 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 SITE: C-CDA Validator 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.

Encrypted Method

1. For the data set viewed in (e)(1)(i)(A), a user, with the role of patient, uses the Health IT Module’s internet-based technology to transmit an ambulatory summary or inpatient summary as created in section (e)(1)(i)(B)(2) as a CCD document according to the standards specified in § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes with Errata, DSTU Release 2.1 and § 170.205(a)(6) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 to any third party using the developer-identified encrypted method of transmission.
2. The user accesses the account to which the encrypted message has been sent and verifies that the transmission was received with the correct ambulatory and/or inpatient summary.

Authorized Encrypted Transmission

3. For the data set viewed in section (e)(1)(i)(A) step 4, a user, with the role of patient authorized representative, uses the Health IT Module’s internet-based technology to transmit an ambulatory summary or inpatient summary as created in section (e)(1)(i)(B)(2) as a CCD document according to the standards specified in § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes with Errata, DSTU Release 2.1 and § 170.205(a)(6) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 to any third party using the developer-identified encrypted method of transmission.
4. The user accesses the account to which the encrypted message has been sent and verifies that the transmission was received, and the correct ambulatory and/or inpatient summary is attached.
5. Negative Test: A user who is neither the patient identified in the test record nor a patient’s authorized representative attempts to access and transmit patient data and is prevented from doing so.

(Approved SVAP Version)

• Complete steps above using HL7® CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes Edition 3.0 - US Realm, May 2024 for § 170.205(a)(4), (a)(5) or (a)(6).

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 SITE: C-CDA Validator - USCDI v3 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 SITE: C-CDA Validator 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)(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.

Inpatient Setting Only

Unencrypted Email Method - Transitions of Care (ToC)

1. For the inpatient setting only, a user, with the role of patient, uses the Health IT Module’s internet-based technology to transmit, via email, to a valid, third-party email address identified by the user, each of the ToC/referral summary as downloaded in section (e)(1)(i)(B)(3) formatted as a:
   • Continuity of Care;
   • Referral Note; and
   • Discharge Summary document.
2. The user accesses the third-party email account and verifies that the transmission was received and the correct ambulatory and/or inpatient summary is attached.

Encrypted Method - ToC

3. For the inpatient setting only, a user role of patient uses the Health IT module’s internet-based technology to transmit via the developer-identified encrypted method of transmission a ToC/referral summary as downloaded in section (e)(1)(i)(B)(3) formatted as a:
   • Continuity of Care;
   • Referral Note; and
   • Discharge Summary document.

Inpatient Setting Only

Unencrypted Email Method - Transitions of Care (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 user in the role of patient and the patient’s authorized representative requests to view and download the data in sections (e)(1)(i)(A) and (e)(1)(i)(B) for a specific date.
2. The user in the role of patient and patient’s authorized representative requests to transmit the data in sections (e)(1)(i)(C) for a specific date.

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 user in the role of patient and the patient’s authorized representative requests to view and download, the data in sections (e)(1)(i)(A) and (e)(1)(i)(B) for a date range.
2. The user in the role of patient and the patient’s authorized representative requests to transmit the data in sections (e)(1)(i)(C) for a date range.

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. When the user utilizes the view, download, or transmit to a third party capabilities as specified in sections (e)(1)(i)(A) through (e)(1)(i)(C), the Health IT Module records a new activity log entry for the following actions related to electronic health information:
   • View of patient information;
   • Download patient information; and
   • Transmit patient information.
2. For each action, the activity log entry includes:
   • Type of action;
   • Date and time of event in accordance with the standard specified in § 170.210(g);
   • User identification; and
   • To whom the transmission was sent (if applicable).

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).

Using the internet-based technology health IT function(s), the user, with the role of patient or authorized representative, requests a restriction to be applied to data expressed in the standards in § 170.213.

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.