§170.315(b)(1) Transitions of care

Required by December 31, 2025

A health IT developer of a Health IT Module currently certified to the § 170.315(b)(1) Transitions of Care will attest directly to the ONC-ACB to conformance with the updated § 170.315(b)(1) requirements outlined in the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule. 

System Under Test Connection – Using TLS and SASL

1. Using the ETT “XDR Cases” with “System as Sender” and the Cures checkbox checked, the user establishes a Mutual TLS session for the Health IT Module to authenticate to the ETT (XDR Test 6).
2. The user authenticates the Health IT Module to the ETT using an incorrect Mutual TLS session (XDR Test 7).

System Under Test Connection – Secure Network If Not Using TLS

3. The user demonstrates the ability to provide a secure connection to the System Under Test by providing evidence and demonstration that the system uses a “secure network” as described at § 170.202(d) ONC Implementation Guide for Direct Edge Protocols, v1.1.

Send Payload

4. The user configures the ETT’s endpoints within the Health IT Module by providing the Health IT Module’s Direct “From” address to generate endpoints. The Health IT Module sends the payloads created at section (b)(1)(iii) of the SUT as applicable through the user selection of the criteria “170.315_b1_ToC_Amb” or “170.315_b1_ToC_Inp” based upon the health IT setting and the file name as a Continuity of Care Document (CCD), Referral Note, or (inpatient setting only) a Discharge Summary using the following types of messages:
   • Limited Metadata (XDR Test 1); and
   • Full Metadata (XDR Test 2).
     Note: The user is required to send at least one payload using Limited Metadata and at least one payload using Full Metadata.

Message Tracking

5. The user sends health information to the ETT and receives both a positive (success) Delivery Status Notification (XDR MT Test 20a) and a negative (failure) Delivery Status Notification (XDR MT Test 20b).

Delivery Notification

6. The user sends an XDR message to Endpoint 14 using the Edge Testing Tool with a valid Direct Address Block and Delivery Notifications header (XDR MT Test 49).

System Under Test Connection – TLS and SASL

1. Using the ETT “SMTP Tests,” “System as Sender,” and the Cures checkbox checked, the user initiates a TLS session for the Health IT Module with the ETT (SMTP Test 8).
2. The user authenticates the Health IT Module with the ETT using PLAIN SASL as an SMTP server from the username supplied by the ETT email account being authenticated to the ETT SMTP email address (SMTP Test 14).
3. The Health IT Module provides documentation of the Health IT Module’s ability to reject the connection for a TLS session initiated with a HISP due to an invalid certificate.

System Under Test Connection – Secure Network If Not Using TLS

4. The user demonstrates the ability to provide a secure connection to the System Under Test by providing evidence and demonstration that the system uses a “secure network” as described at § 170.202(d) ONC Implementation Guide for Direct Edge Protocols, v1.1.

Send Payload

5. The user sends a document to the ETT (SMTP Test 18). The payloads created at section (b)(1)(iii) shall be sent as applicable by the user selection of the criteria “170.315_b1_ToC_Amb” or “170.315_b1_ToC_Inp” based upon the health IT setting and the file name as a CCD, Referral Note, or (inpatient setting only) a Discharge Summary.

Delivery Notification

6. The user sends an SMTP mail message to the ETT with a valid Disposition-Notifications-Options Header per section 1.3 of the § 170.202(e)(1) ONC Implementation Guide for Delivery Notification in Direct v1.0 (SMTP MT Test 46).

System Under Test Connection – Using TLS and SASL

1. Using the ETT “XDR Tests” for “System as Receiver” and the Cures checkbox checked, the user establishes authentication from the ETT to the Health IT Module using Mutual TLS correctly (XDR Test 8).
2. Using the ETT, the user establishes authentication from the ETT to the Health IT Module using bad certificates (incorrect Mutual TLS configuration (XDR Test 9)).

System Under Test Connection – Secure Network If Not Using TLS

3. The user demonstrates the ability to provide a secure connection to the System Under Test by providing evidence and demonstration that the system uses a “secure network” as described at § 170.202(d) ONC Implementation Guide for Direct Edge Protocols, v1.1.

Receive Payload

4. For each required payload specified in (b)(1)(ii), the user selects the appropriate criteria “170.315_b1_ToC_Amb,” “170.315_b1_ToC_Inp,” or “NegativeTesting_USCDI” and then selects the file name to be received by the Health IT Module as a properly formatted XDR message with limited metadata from the ETT (XDR Test 3).
5. The Health IT Module receives a properly formatted XDR message with full metadata from the ETT (XDR Test 5).
   Note: The user is required to receive a single payload using both limited and full metadata.

Incorrect XDR Message Receive

6. The Health IT Module returns errors when a malformed message is received from the ETT with an invalid SOAP header (XDR Test 4a).
7. The Health IT Module returns errors when the following malformed messages are received from the ETT, the case with invalid SOAP body details (XDR Test 4b) including:
   • Missing metadata elements;
   • Missing associations between ebRIM constructs;
   • Missing Direct Address block.

System Under Test Connection – Using TLS and SASL

1. Using the ETT “SMTP Tests” for “System as Receiver” and the Cures checkbox checked, the user initiates a valid TLS session for the Health IT Module with the ETT sent from the email address the username supplied by the Health IT Module email account being authenticated to the Health IT Module SMTP email address (SMTP Test 9).
2. The user authenticates the ETT with the Health IT Module using PLAIN SASL as an SMTP server from the username supplied by the Health IT Module email account being authenticated to the Health IT Module SMTP email address (SMTP Test 16).
3. The Health IT Module provides documentation of the ability to establish a STARTTLS connection and reject the connection upon receiving an invalid certificate from a HISP.

System Under Test Connection – Secure Network If Not Using TLS

4. The user demonstrates the ability to provide a secure connection to the System Under Test by providing evidence and demonstration that the system uses a "secure network" as described at § 170.202(d) ONC Implementation Guide for Direct Edge Protocols, v1.1.

Receive Payload

5. For each of the applicable ambulatory and/or inpatient setting transition of care/referral summary payloads (Continuity of Care Document (CCD), Referral Note, and Discharge Summary) and the Negative Consolidated-Clinical Document Architecture (C-CDA) tests, the user selects the payload type and receives a document from the ETT using valid SMTP commands from the username supplied by the Health IT Module email account being authenticated and establishes a connection with the ETT (SMTP Test 20).

Receive Multiple Attachments

6. The user receives multiple attachments (with appropriate MIME type) by running each of the following ETT Test Cases:
   • Text and C-CDA (SMTP Test 25(a));
   • PDF and C-CDA (SMTP Test 25(b));
   • Text and XDM Package (SMTP Test 25(c));
   • C-CDA and Text (SMTP Test 25(d));
   • C-CDA and PDF (SMTP Test 25(e));
   • XDM and Text (SMTP Test 25(f)).

Style Sheet/Header (Negative Testing)

7. The user receives a bad attachment by running each of the following ETT Test Cases:
   • A bad C-CDA with a broken reference to the style sheet (SMTP Test 26(a));
   • A good C-CDA with a bad style sheet (SMTP Test 26(b)).
8. The user receives an XDM package with a bad XHTML (SMTP Test 27).

MIME Type

9. The user receives an XDM package with a MIME type of ‘application/octet-stream’ (SMTP layer) (SMTP Test 28).
10. The user receives an XDM package containing a C-CDA with a MIME type of ‘application/xml’ (XDM layer) (SMTP Test 29).

System Under Test Connection – Using TLS and SASL

1. Using the ETT “IMAP Tests” for “System as Receiver” and the Cures checkbox checked, the user initiates an IMAP session with STARTTLS and PLAIN SSL authentication with the ETT (IMAP Test 19).
2. The Health IT Module provides documentation of the ability to connect using a valid cipher suite in accordance with RFC 3501 and the subsequently updated standards: RFC 2246, NIST Special Publication 800-52 Revision 1, RFC 7465, and is in accordance with § 170.202(d) ONC Implementation Guide for Direct Edge Protocols, v1.1 and the security standards specified in the § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2. (IMAP Test 20),

or

• (Approved SVAP Version)
  • Direct Project: ONC Applicability Statement for Secure Health Transport, v1.3. 

      3. The Health IT Module provides documentation of the ability to establish a STARTTLS connection and reject the connection upon receiving an invalid certificate from a HISP.

System Under Test Connection – Secure Network If Not Using TLS

4. The user demonstrates the ability to provide a secure connection to the System Under Test by providing evidence and demonstration that the system uses a “secure network” as described at § 170.202(d) ONC Implementation Guide for Direct Edge Protocols, v1.1.

IMAP Receive

5. The user demonstrates the Health IT Module can retrieve the email attachment from the specified ETT email server (IMAP Test 24).
6. The user demonstrates the Health IT Module can use either the uppercase, lowercase, or mixed case mailbox names and access data (IMAP Test 21).
7. The Health IT Module is able to receive status and size updates from the IMAP4 server (IMAP Test 25).
8. The user demonstrates the Health IT Module’s capability to accept XDM packages sent using appropriate MIME types (IMAP Test 27).
9. The user demonstrates the Health IT Module’s capability to receive multiple attachments from the ETT (IMAP Test 28).
10. The user demonstrates the Health IT Module’s capability to receive the following bad attachments from the ETT:
    • C-CDA document including a broken reference to a style sheet (IMAP Test 29a); and
    • C-CDA document including a good reference to an invalid style sheet (IMAP Test 29b).
11. The user demonstrates the Health IT Module’s capability to receive an XDM package with a bad XHTML from the ETT (IMAP Test 30).
12. The user demonstrates the Health IT Module’s capability to receive different attachments (IMAP Test 31).

System Under Test Connection – TLS and SASL

1. Using the ETT “POP3 Tests” for “System as Receiver” and the Cures checkbox checked, the user initiates POP3 sessions with the ETT (POP Test 19).
2. The Health IT Module provides documentation of the ability to connect using a valid cipher suite in accordance with RFC 3501 and the subsequently updated standards: RFC 2246, NIST Special Publication 800-52 Revision 1, RFC 7465, and is in accordance with § 170.202(d) ONC Implementation Guide for Direct Edge Protocols, v1.1 and the security standards specified in the § 170.202(a)(2) Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2. (POP Test 20),

or

• (Approved SVAP Version)
  • Direct Project: ONC Applicability Statement for Secure Health Transport, v1.3. 

     3. The Health IT Module provides documentation of the ability to establish a STARTTLS connection and reject the connection upon receiving an invalid certificate from a HISP.

System Under Test Connection – Secure Network If Not Using TLS

4. The user demonstrates the ability to provide a secure connection to the System Under Test by providing evidence and demonstration that the system uses a “secure network” as described at § 170.202(d) ONC Implementation Guide for Direct Edge Protocols v1.1.

POP3 Receive

5. The user demonstrates the Health IT Module’s ability to retrieve an email attachment from the specified ETT email server (POP Test 24).
6. The user demonstrates the Health IT Module’s ability to accept XDM packages sent using appropriate MIME types (POP Test 27).
7. The user demonstrates the Health IT Module’s capability to receive multiple attachments from the ETT (POP Test 28).
8. The user demonstrates the Health IT Module’s capability to receive the following bad attachments from the ETT:
   • C-CDA document including a broken reference to a style sheet (POP Test 29a); and
   • C-CDA document including a good reference to an invalid style sheet (POP Test 29b).
9. The user demonstrates the Health IT Module’s capability to receive an XDM package with a bad XHTML from the ETT (POP Test 30).
10. The user demonstrates the Health IT Module’s capability to receive different attachments (POP Test 31).

Receive XDM Payload

1. Using the ETT “SMTP Tests” for “System as Receiver” and the Cures checkbox checked, the user selects each of the XDM payload attachment types (limited and full metadata) within the ETT and receives an XDM document from the ETT using valid SMTP commands from the username supplied by the Health IT Module email account being authenticated (SMTP Test 20).

Validate XDM Package

2. The user downloads the XDM payload from the System Under Test, navigates to the ETT Message Validator, XDM Validator, and uploads the XDM payload to the XDM Validator to perform validation of the XDM package.

Expires on January 1, 2026

Receive Payload

1. Based upon the health IT setting(s) to be certified, the Health IT Module receives transition of care/referral summary payloads via the Edge Protocol as specified in section (b)(1)(i)(B) for each ambulatory and/or inpatient transition of care (xml) document. All of the transitions of care documents for a given health IT setting must be received (both C-CDA Release 1.1 and C-CDA Release 2.1 formats).

Parse and Process

2. The Health IT Module parses each of the following ambulatory and/or inpatient setting applicable C-CDA document types formatted as a CCD in accordance with the standards specified in § 170.205(a)(3) HL7^® Implementation Guide for CDA^® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 or a C-CDA according to § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2 Consolidation CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1 C-CDA 2.1 with Errata, August 2015, June 2019 (with Errata) and § 170.205(a)(5) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2, October 2019 with one of following document-templates:
   • Continuity of Care;
   • Referral Note; and
   • Inpatient setting only: Discharge Summary.
3. The Health IT Module processes the valid document-templates and the data elements required in the corresponding section-templates and entry-templates from the standards adopted in § 170.205(a)(3), and § 170.205(a)(4) and § 170.205(a)(5).
4. Each of these documents includes, at a minimum, as applicable, the following:
   • All of the data elements as specified in the standard at § 170.213 with the data classes expressed in accordance with the implementation guides at § 170.205(a)(4) and § 170.205(a)(5);
   • Encounter diagnoses;
   • Cognitive status;
   • Functional status;
   • Ambulatory setting only, the following data elements: reason for referral, and referring or transitioning provider's name and office contact information; and
   • Inpatient setting only: the discharge instructions.
5. The Health IT Module further processes the document for valid document-templates with empty sections and null combinations in accordance with document-templates from the standards adopted in § 170.205(a)(3), or § 170.205(a)(4) and § 170.205(a)(5), and interprets them correctly.

Negative Testing

6. The Health IT Module receives a series of invalid C-CDA document types via the Edge Protocol (b)(1)(i)(B) for C-CDA R2 Release 1.1 and C-CDA R2 Release 2.1 documents, and correctly parses the invalid documents which contain errors in the “document-templates,” “section-templates,” and “entry-templates,” including invalid vocabulary standards and codes not specified in the standards adopted in § 170.205(a)(3) or § 170.205(a)(4) and § 170.205(a)(5) and reports the errors.

Error Reporting

7. A user is notified or can review the recorded errors encountered during the parsing and processing of C-CDA documents.

Required by December 31, 2025

Receive Payload

1. Based upon the health IT setting(s) to be certified, the Health IT Module receives transition of care/referral summary payloads via the Edge Protocol as specified in section (b)(1)(i)(B) for each ambulatory and/or inpatient transition of care (xml) document. All of the transitions of care documents for a given health IT setting must be received (both C-CDA Release 1.1 and C-CDA Release 2.1 with Cures Update formats).

Parse and Process

2. The Health IT Module parses each of the following ambulatory and/or inpatient setting applicable C-CDA document types formatted as a CCD in accordance with the standards specified in § 170.205(a)(3) HL7^® Implementation Guide for CDA^® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 or a C-CDA according to § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2 Consolidation CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1 C-CDA 2.1 with Errata, August 2015, June 2019 (with Errata) and § 170.205(a)(6) HL7^® CDA^® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1 - US Realm with one of following document-templates:
   • Continuity of Care;
   • Referral Note; and
   • Inpatient setting only: Discharge Summary.
3. The Health IT Module processes the valid document-templates and the data elements required in the corresponding section-templates and entry-templates from the standards adopted in § 170.205(a)(3), and § 170.205(a)(4) and § 170.205(a)(6).
4. Each of these documents includes, at a minimum, as applicable, the following:
   • All of the data elements as specified in the standard at § 170.213 with the data classes expressed in accordance with the implementation guides at § 170.205(a)(4) and § 170.205(a)(6);
   • Encounter diagnoses;
   • Cognitive status;
   • Functional status;
   • Ambulatory setting only, the following data elements: reason for referral, and referring or transitioning provider's name and office contact information; and
   • Inpatient setting only: the discharge instructions.
5. The Health IT Module further processes the document for valid document-templates with empty sections and null combinations in accordance with document-templates from the standards adopted in § 170.205(a)(3), or § 170.205(a)(4) and § 170.205(a)(6), and interprets them correctly.

Negative Testing

6. The Health IT Module receives a series of invalid C-CDA document types via the Edge Protocol (b)(1)(i)(B) for C-CDA R2 Release 1.1 and C-CDA R2 Release 2.1 documents, and correctly parses the invalid documents which contain errors in the “document-templates,” “section-templates,” and “entry-templates,” including invalid vocabulary standards and codes not specified in the standards adopted in § 170.205(a)(3) or § 170.205(a)(4) and § 170.205(a)(6) and reports the errors.

Error Reporting

7. A user is notified or can review the recorded errors encountered during the parsing and processing of C-CDA documents.

Expires on January 1, 2026

The user is able to view the processed C-CDA documents in section (b)(1)(ii)(A), in human readable format, including the data which is formatted in accordance to the standards specified in § 170.205(a)(3) or § 170.205(a)(4) and § 170.205(a)(5), and includes, at a minimum, the following content in English (i.e., non-coded) representation if they associate with a vocabulary/code set, as applicable, for the following:

• All of the data elements as specified in the standard at § 170.213 with the data classes expressed in accordance with the implementation guides at § 170.205(a)(4) and § 170.205 (a)(5);
• The “Assessment and plan of treatment, in accordance with the “Assessment and Plan Section (V2)” of the standard specified in § 170.205(a)(4); or in accordance with the “Assessment Section (V2)” and “Plan of Treatment Section (V2)” of the standard specified in § 170.205(a)(4). At a minimum the Assessment and Plan of Treatment data includes the narrative text;
• Encounter diagnoses;
• Cognitive status;
• Functional status;
• 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 discharge instructions.
• The Goals, in accordance with the “Goals Section” of the standard specified in § 170.205(a)(4). At a minimum the Goals data includes narrative text; and
• 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.

Required by December 31, 2025

The user is able to view the processed C-CDA documents in section (b)(1)(ii)(A), in human readable format, including the data which is formatted in accordance to the standards specified in § 170.205(a)(3) or § 170.205(a)(4) and § 170.205(a)(6), and includes, at a minimum, the following content in English (i.e., non-coded) representation if they associate with a vocabulary/code set, as applicable, for the following:

• All of the data elements as specified in the standard at § 170.213 with the data classes expressed in accordance with the implementation guides at § 170.205(a)(4) and § 170.205 (a)(6);
• The “Assessment and plan of treatment, in accordance with the “Assessment and Plan Section (V2)” of the standard specified in § 170.205(a)(4); or in accordance with the “Assessment Section (V2)” and “Plan of Treatment Section (V2)” of the standard specified in § 170.205(a)(4). At a minimum the Assessment and Plan of Treatment data includes the narrative text;
• Encounter diagnoses;
• Cognitive status;
• Functional status;
• 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 discharge instructions.
• The Goals, in accordance with the “Goals Section” of the standard specified in § 170.205(a)(4). At a minimum the Goals data includes narrative text; and
• 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.

Expires on January 1, 2026

Display Section Views

1. Using the transition of care/referral summaries received and processed in section (b)(1)(ii)(A), the user displays each individual section (and the accompanying document header information) of the received transition of care/referral summaries displayed in section (b)(1)(ii)(B) formatted according to the standards specified in § 170.205(a)(3) or § 170.205(a)(4) and § 170.205(a)(5).
2. Using the transition of care/referral summaries received and processed in section (b)(1)(ii)(A), the user displays additional sections (and the accompanying document header information) of the received transition of care/referral summaries displayed in section (b)(1)(ii)(B), formatted according to the standards specified in § 170.205(a)(3), and § 170.205(a)(4) and § 170.205(a)(5).
3. Using the transition of care/referral summaries received and processed in section (b)(1)(ii)(A), the user can display data from a particular section.

Section Order

4. The user uses the Health IT Module to set the preference for the display order of specific sections for each of the supported document types.
5. The user uses the Health IT Module to demonstrate that the sections displayed for the transition of care/referral summaries received and processed in section (b)(1)(ii)(A) are ordered correctly based upon the section order preference set in step 4.

Quantity of Sections

6. The user uses the Health IT Module to set the initial quantity of sections to be displayed.
7. The user uses the Health IT Module to demonstrate that the initial number of transition of care/referral summary sections displayed corresponds to the quantity of sections set in step 6.

Required by December 31, 2025

Display Section Views

1. Using the transition of care/referral summaries received and processed in section (b)(1)(ii)(A), the user displays each individual section (and the accompanying document header information) of the received transition of care/referral summaries displayed in section (b)(1)(ii)(B) formatted according to the standards specified in § 170.205(a)(3) or § 170.205(a)(4) and § 170.205(a)(6).
2. Using the transition of care/referral summaries received and processed in section (b)(1)(ii)(A), the user displays additional sections (and the accompanying document header information) of the received transition of care/referral summaries displayed in section (b)(1)(ii)(B), formatted according to the standards specified in § 170.205(a)(3), and § 170.205(a)(4) and § 170.205(a)(6).
3. Using the transition of care/referral summaries received and processed in section (b)(1)(ii)(A), the user can display data from a particular section.

Section Order

4. The user uses the Health IT Module to set the preference for the display order of specific sections for each of the supported document types.
5. The user uses the Health IT Module to demonstrate that the sections displayed for the transition of care/referral summaries received and processed in section (b)(1)(ii)(A) are ordered correctly based upon the section order preference set in step 4.

Quantity of Sections

6. The user uses the Health IT Module to set the initial quantity of sections to be displayed.
7. The user uses the Health IT Module to demonstrate that the initial number of transition of care/referral summary sections displayed corresponds to the quantity of sections set in step 6.

Expires on January 1, 2026

Data Entry

1. Based upon the health IT setting, the health IT developer uses the ETT: Message Validators - USCDI v1 R2.1, to download the appropriate ONC-supplied transition of care instruction documents by selecting the "170.315_b1_ToC_Amb" or "170.315_b1_ToC_Inp" criteria, selecting the file name, and executes the download. The user enters the transition of care information downloaded in order to create a patient record with the necessary information.

Create

2. Using the Health IT Module, the user sends a transition of care document using one of the transport mechanisms specified in section (b)(1)(i)(A) as a C-CDA document, which contains a transition of care/referral summaries, formatted according to the standard adopted in § 170.205(a)(4) and § 170.205(a)(5) in the following formats as applicable:
   • Continuity of Care;
   • Referral Note; and
   • Inpatient setting only: Discharge Summary.
3. At a minimum, the C-CDA document created in step 2, includes the data elements as expressed in § 170.213 the standard and the following content in accordance with the specified standards at § 170.205(a)(4) and § 170.205(a)(5) as applicable:
   • Assessment and plan of treatment as specified in section (b)(1)(iii)(A)(3)(i);
   • Encounter diagnoses;
   • Goals as specified in section (b)(1)(iii)(A)(3)(ii);
   • Cognitive status;
   • Health concerns as specified in section (b)(1)(iii)(A)(iii);
   • Functional status as specified in section (b)(1)(iii)(D);
   • Ambulatory setting only, the following data elements: as specified in section (b)(1)(iii)(E):
     • The reason for referral; and
     • Referring or transitioning provider’s name and office contact information;
   • Inpatient setting only: the discharge instructions as specified in section (b)(1)(iii)(F); and
   • Patient match data as specified in section (b)(1)(iii)(G).
4. Based upon the supported health IT setting(s), the user repeats steps 1-3, for each of the ambulatory and/or inpatient transition of care instruction documents found in the ETT: Message Validators. A transition of care document must be sent for every transition of care instruction document for a given health IT setting.

Required by December 31, 2025

Data Entry

1. Based upon the health IT setting, the health IT developer uses the ETT: Message Validators - USCDI v3 R2.1, to download the appropriate ONC-supplied transition of care instruction documents by selecting the "170.315_b1_ToC_Amb" or "170.315_b1_ToC_Inp" criteria, selecting the file name, and executes the download. The user enters the transition of care information downloaded in order to create a patient record with the necessary information.

Create

2. Using the Health IT Module, the user sends a transition of care document using one of the transport mechanisms specified in section (b)(1)(i)(A) as a C-CDA document, which contains a transition of care/referral summaries, formatted according to the standard adopted in § 170.205(a)(4) and § 170.205(a)(6) in the following formats as applicable:
   • Continuity of Care;
   • Referral Note; and
   • Inpatient setting only: Discharge Summary.
3. At a minimum, the C-CDA document created in step 2, includes the data elements as expressed in § 170.213 the standard and the following content in accordance with the specified standards at § 170.205(a)(4) and § 170.205(a)(6) as applicable:
   • Assessment and plan of treatment as specified in section (b)(1)(iii)(A)(3)(i);
   • Encounter diagnoses;
   • Goals as specified in section (b)(1)(iii)(A)(3)(ii);
   • Cognitive status;
   • Health concerns as specified in section (b)(1)(iii)(A)(iii);
   • Functional status as specified in section (b)(1)(iii)(D);
   • Ambulatory setting only, the following data elements: as specified in section (b)(1)(iii)(E):
     • The reason for referral; and
     • Referring or transitioning provider’s name and office contact information;
   • Inpatient setting only: the discharge instructions as specified in section (b)(1)(iii)(F); and
   • Patient match data as specified in section (b)(1)(iii)(G).
4. Based upon the supported health IT setting(s), the user repeats steps 1-3, for each of the ambulatory and/or inpatient transition of care instruction documents found in the ETT: Message Validators. A transition of care document must be sent for every transition of care instruction document for a given health IT setting.

Expires on January 1, 2026

The Data Set Requirements

1. At a minimum, the transition of care/referral summaries contain the data elements specified in the standard in § 170.213 and are expressed in accordance with the implementation specifications at § 170.205(a)(4) and § 170.205(a)(5).

Assessment and Plan of Treatment

2. The content of the transition of care/referral summaries created in section (b)(1)(iii) contains 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) and § 170.205(a)(5). At a minimum the Assessment and Plan of Treatment data includes the narrative text.

Note that the system does not have to represent the assessment and plan of treatment using the C-CDA’s syntax. The system must consistently and independently represent the assessment and plan of treatment as discrete data that are clearly distinguishable.

Goals

3. The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the Goals specified in accordance with the standard specified at § 170.205(a)(4) and § 170.205(a)(5). At a minimum the Goals data includes narrative text.

Note that the system does not have to represent the Goals using the C-CDA’s syntax. The system must consistently and independently represent the Goals as discrete data that are clearly distinguishable.

Health Concerns

4. The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the Health concerns specified in accordance with the standard specified at § 170.205(a)(4) and § 170.205(a)(5). At a minimum the Health concerns data includes narrative text.

Note that the system does not have to represent the Health Concerns using the C-CDA’s syntax. The system must consistently and independently represent the Health Concerns as discrete data that are clearly distinguishable.

Required by December 31, 2025

The Data Set Requirements

1. At a minimum, the transition of care/referral summaries contain the data elements specified in the standard in § 170.213 and are expressed in accordance with the implementation specifications at § 170.205(a)(4) and § 170.205(a)(6).

Assessment and Plan of Treatment

2. The content of the transition of care/referral summaries created in section (b)(1)(iii) contains 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) and § 170.205(a)(6). At a minimum the Assessment and Plan of Treatment data includes the narrative text.

Note that the system does not have to represent the assessment and plan of treatment using the C-CDA’s syntax. The system must consistently and independently represent the assessment and plan of treatment as discrete data that are clearly distinguishable.

Goals

3. The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the Goals specified in accordance with the standard specified at § 170.205(a)(4) and § 170.205(a)(6). At a minimum the Goals data includes narrative text.

Note that the system does not have to represent the Goals using the C-CDA’s syntax. The system must consistently and independently represent the Goals as discrete data that are clearly distinguishable.

Health Concerns

4. The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the Health concerns specified in accordance with the standard specified at § 170.205(a)(4) and § 170.205(a)(6). At a minimum the Health concerns data includes narrative text.

Note that the system does not have to represent the Health Concerns using the C-CDA’s syntax. The system must consistently and independently represent the Health Concerns as discrete data that are clearly distinguishable.

Expires on January 1, 2026

Encounter Diagnoses

The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the Encounter diagnoses using at least one standard, either:

• 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.
• or at a minimum the version of the standard specified at § 170.207(a)(4) SNOMED CT^®.

Required by December 31, 2025

Encounter Diagnoses

The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the Encounter diagnoses using at least one standard, either:

• 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.
• or at a minimum the version of the standard specified at § 170.207(a)(1) SNOMED CT^®.

Cognitive Status

The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the Cognitive status when present. Cognitive Status is included in the Mental Status section and represented in both machine readable and human readable format.

Functional Status

The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the Functional Status when present. Functional Status is included in the Functional Status section. 

Ambulatory Setting Only

The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the reason for referral, referring or transitioning provider’s name, and office contact information.

Inpatient Setting Only

The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the discharge instructions.

Expires on January 1, 2026

Patient Matching Data

The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the following patient matching data:

• Full name including first name, last name, previous name, middle name (including middle initial), and suffix;
• Date of birth including the year, month, and day when known and null when unknown;
• Current address;
• Phone number(s) which are constrained in accordance with the standard specified at § 170.207(q)(1) ITU-T E.123 and ITU-T E.164, and if multiple phone numbers are present within the Health IT Module they are reflected in the transition of care/referral summaries; and
• Birth sex which is constrained in accordance with the standard specified at § 170.207(n)(1) Birth sex coded in accordance with HL7^® Version 3, Value Sets for AdministrativeGender and NullFlavor attributed as follows:
  1. Male. M
  2. Female. F
  3. Unknown. nullFlavor UNK

Required by December 31, 2025

Patient Matching Data

The content of the transition of care/referral summaries created in section (b)(1)(iii) contains the following patient matching data:

• Full name including first name, last name, previous name, middle name (including middle initial), and suffix;
• Date of birth including the year, month, and day when known and null when unknown;
• Current address;
• Phone number(s) which are constrained in accordance with the standard specified at § 170.207(q)(1) ITU-T E.123 and ITU-T E.164, and if multiple phone numbers are present within the Health IT Module they are reflected in the transition of care/referral summaries; and
• Represent sex in accordance with the standard adopted in § 170.207(n)(2) Sex must be coded in accordance with, at a minimum, the version of SNOMED CT ® U.S. Edition codes specified in § 170.207(a)(1).

Birth with Time

If the time of birth (hours, minutes, and seconds) is included the correct time zone offset is used.