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§170.315(f)(5) Transmission to public health agencies — electronic case reporting

Updated on 09-21-2017
Version # Description of Change Version Date
1.0

Final Test Procedure
08-11-2017
1.1

As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only.
09-21-2017
1.2

Changed language from self-declaration to attestation.
08-25-2021
Regulation Text
Regulation Text

§ 170.315 (f)(5) Transmission to public health agencies – electronic case reporting—

  1. Consume and maintain a table of trigger codes to determine which encounters may be reportable.
  2. Match a patient visit or encounter to the trigger code based on the parameters of the trigger code table.
  3. Case report creation. Create a case report for electronic transmission:
    1. Based on a matched trigger from paragraph (f)(5)(ii).
    2. That includes, at a minimum:
      1. The Common Clinical Data Set.
      2. Encounter diagnoses. Formatted according to at least one of the following standards:
        1. The standard specified in §170.207(i).
        2. At a minimum, the version of the standard specified in §170.207(a)(4).
      3. The provider's name, office contact information, and reason for visit.
      4. An identifier representing the row and version of the trigger table that triggered the case report.
Standard(s) Referenced

Paragraph (f)(5)(iii)

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

§ 170.207(i) Encounter diagnoses: The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions ICD-10-CM as maintained and distributed by HHS, for the following conditions:

  1. Diseases.
  2. Injuries.
  3. Impairments.
  4. Other health problems and their manifestations.
  5. Causes of injury, disease, impairment, or other health problems.

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

Resource Documents
Resource Document
Revision History
Version # Description of Change Version Date
1.0

Final Test Procedure
08-11-2017
1.1

As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only.
09-21-2017
1.2

Changed language from self-declaration to attestation.
08-25-2021
Regulation Text
Regulation Text

§ 170.315 (f)(5) Transmission to public health agencies – electronic case reporting—

  1. Consume and maintain a table of trigger codes to determine which encounters may be reportable.
  2. Match a patient visit or encounter to the trigger code based on the parameters of the trigger code table.
  3. Case report creation. Create a case report for electronic transmission:
    1. Based on a matched trigger from paragraph (f)(5)(ii).
    2. That includes, at a minimum:
      1. The Common Clinical Data Set.
      2. Encounter diagnoses. Formatted according to at least one of the following standards:
        1. The standard specified in §170.207(i).
        2. At a minimum, the version of the standard specified in §170.207(a)(4).
      3. The provider's name, office contact information, and reason for visit.
      4. An identifier representing the row and version of the trigger table that triggered the case report.
Standard(s) Referenced

Paragraph (f)(5)(iii)

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

§ 170.207(i) Encounter diagnoses: The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions ICD-10-CM as maintained and distributed by HHS, for the following conditions:

  1. Diseases.
  2. Injuries.
  3. Impairments.
  4. Other health problems and their manifestations.
  5. Causes of injury, disease, impairment, or other health problems.

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

Testing components

Attestation: As of September 21, 2017, the testing approach for this criterion is satisfied by attestation.

The archived version of the Test Procedure is attached below for reference.

System Under Test

ONC-ACB Verification

The health IT developer will attest directly to the ONC-ACB to conformance with the §170.315 (f)(5) Transmission to public health agencies — electronic case reporting requirements. 

The ONC-ACB verifies the health IT developer attests conformance to the §170.315 (f)(5) Transmission to public health agencies — electronic case reporting requirements.
Archived Version:
§170.315(f)(5) Test Procedure
Reference Documents
Trigger Code Table Examples 08-11-2016
Updated on 06-15-2020
Version # Description of Change Version Date
1.0

Initial Publication
10-27-2015
1.1

Modified to provide methods and clarifications for demonstrating conformance with the certification criterion.
08-11-2017
1.2

Updated the Security requirements per 21st Century Cures Act.
06-15-2020
Regulation Text
Regulation Text

§ 170.315 (f)(5) Transmission to public health agencies – electronic case reporting—

  1. Consume and maintain a table of trigger codes to determine which encounters may be reportable.
  2. Match a patient visit or encounter to the trigger code based on the parameters of the trigger code table.
  3. Case report creation. Create a case report for electronic transmission:
    1. Based on a matched trigger from paragraph (f)(5)(ii).
    2. That includes, at a minimum:
      1. The Common Clinical Data Set.
      2. Encounter diagnoses. Formatted according to at least one of the following standards:
        1. The standard specified in §170.207(i).
        2. At a minimum, the version of the standard specified in §170.207(a)(4).
      3. The provider's name, office contact information, and reason for visit.
      4. An identifier representing the row and version of the trigger table that triggered the case report.
Standard(s) Referenced

Paragraph (f)(5)(iii)

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

§ 170.207(i) Encounter diagnoses: The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions ICD-10-CM as maintained and distributed by HHS, for the following conditions:

  1. Diseases.
  2. Injuries.
  3. Impairments.
  4. Other health problems and their manifestations.
  5. Causes of injury, disease, impairment, or other health problems.

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

Resource Documents
Resource Document
Revision History
Version # Description of Change Version Date
1.0

Initial Publication
10-27-2015
1.1

Modified to provide methods and clarifications for demonstrating conformance with the certification criterion.
08-11-2017
1.2

Updated the Security requirements per 21st Century Cures Act.
06-15-2020
Regulation Text
Regulation Text

§ 170.315 (f)(5) Transmission to public health agencies – electronic case reporting—

  1. Consume and maintain a table of trigger codes to determine which encounters may be reportable.
  2. Match a patient visit or encounter to the trigger code based on the parameters of the trigger code table.
  3. Case report creation. Create a case report for electronic transmission:
    1. Based on a matched trigger from paragraph (f)(5)(ii).
    2. That includes, at a minimum:
      1. The Common Clinical Data Set.
      2. Encounter diagnoses. Formatted according to at least one of the following standards:
        1. The standard specified in §170.207(i).
        2. At a minimum, the version of the standard specified in §170.207(a)(4).
      3. The provider's name, office contact information, and reason for visit.
      4. An identifier representing the row and version of the trigger table that triggered the case report.
Standard(s) Referenced

Paragraph (f)(5)(iii)

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

§ 170.207(i) Encounter diagnoses: The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions ICD-10-CM as maintained and distributed by HHS, for the following conditions:

  1. Diseases.
  2. Injuries.
  3. Impairments.
  4. Other health problems and their manifestations.
  5. Causes of injury, disease, impairment, or other health problems.

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

Certification Companion Guide: Transmission to public health agencies — electronic case reporting

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

Link to Final Rule Preamble

 

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

Privacy and Security: This certification criterion was adopted at § 170.315(f)(5). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(f) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.

  • The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (f) criterion unless it is the only criterion for which certification is requested.
  • As a general rule, a product presented for certification only needs to be presented once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
  • § 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.
Table for Privacy and Security

Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.

  • When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
  • When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used for which a certificate would be requested.
Table for Design and Performance
Certification Requirements

Privacy and Security: This certification criterion was adopted at § 170.315(f)(5). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(f) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.

  • The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (f) criterion unless it is the only criterion for which certification is requested.
  • As a general rule, a product presented for certification only needs to be presented once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
  • § 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.

Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.

  • When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
  • When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used for which a certificate would be requested.
Table for Privacy and Security
Table for Design and Performance
Technical Explanations and Clarifications

 

Applies to entire criterion

Clarifications:

  • For the public health certification criteria in § 170.315(f), health IT will only need to be certified to those criteria that are required to meet the measures the provider intends to report on to meet Objective 8: Public Health and Clinical Data Registry Reporting.
  • A specific content exchange standard for electronic case reporting (eCR) is not required to meet this criterion. [see also 80 FR 62667]
  • This criterion may be met through one of the following two ways:
    • Documentation that sufficiently describes how the Health IT Module meets the functional requirements of the criterion.
    • Documentation of participation in an initial eCR implementation as part of the Digital Bridge initiative and the ability to meet paragraph (i) of this criterion.
  • The optional use of an ONC-approved test tool for case reporting using standards such as Consolidated Clinical Document Architecture (C-CDA), the Structured Data Capture (IHE SDC) Implementation Guide, or the Fast Health Interoperability Resources (FHIR®) Structured Data Capture Implementation Guide may be available in the future. While not required to meet this criterion, testing through an ONC-approved test tool for case reporting would meet the requirements of this criterion.

 

Applies to entire criterion

Clarifications:

  • For the public health certification criteria in § 170.315(f), health IT will only need to be certified to those criteria that are required to meet the measures the provider intends to report on to meet Objective 8: Public Health and Clinical Data Registry Reporting.
  • A specific content exchange standard for electronic case reporting (eCR) is not required to meet this criterion. [see also 80 FR 62667]
  • This criterion may be met through one of the following two ways:
    • Documentation that sufficiently describes how the Health IT Module meets the functional requirements of the criterion.
    • Documentation of participation in an initial eCR implementation as part of the Digital Bridge initiative and the ability to meet paragraph (i) of this criterion.
  • The optional use of an ONC-approved test tool for case reporting using standards such as Consolidated Clinical Document Architecture (C-CDA), the Structured Data Capture (IHE SDC) Implementation Guide, or the Fast Health Interoperability Resources (FHIR®) Structured Data Capture Implementation Guide may be available in the future. While not required to meet this criterion, testing through an ONC-approved test tool for case reporting would meet the requirements of this criterion.

Paragraph (f)(5)(i)

Technical outcome – A Health IT Module is able to consume and maintain a table of trigger codes to determine which encounters should initiate an initial case report being sent to a public health agency.

Clarifications:

  • An example table of trigger codes is in "Trigger Code Table Examples" under the Reference Documents section on the Test Procedures tab.

Paragraph (f)(5)(i)

Technical outcome – A Health IT Module is able to consume and maintain a table of trigger codes to determine which encounters should initiate an initial case report being sent to a public health agency.

Clarifications:

  • An example table of trigger codes is in "Trigger Code Table Examples" under the Reference Documents section on the Test Procedures tab.

Paragraph (f)(5)(ii)

Technical outcome – A Health IT Module can match information recorded in a patient visit or encounter to a trigger code in the trigger code table.

Clarifications:

  • No additional clarifications.

Paragraph (f)(5)(ii)

Technical outcome – A Health IT Module can match information recorded in a patient visit or encounter to a trigger code in the trigger code table.

Clarifications:

  • No additional clarifications.

Paragraph (f)(5)(iii)

Technical outcome – When a trigger is matched in accordance with provision (f)(5)(ii), the Health IT Module electronically creates an initial case report with only the following subset of Common Clinical Data Set (CCDS) data elements:

  • Patient Name
  • Sex 
  • Date of Birth
  • Race and Ethnicity
  • Preferred language 
  • Problems
  • Medications
  • Laboratory Tests 
  • Laboratory Values(s)/Result(s)
  • Vital Signs 
  • Procedures 
  • Care Team Member(s)
  • Immunizations 
  • Assessment and Plan of Treatment 

Clarifications

  • ONC provides the following object identifiers (OID) to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards [80 FR 62612-13]:
    • SNOMED CT® OID: 2.16.840.1.113883.6.96
    • LOINC® OID: 2.16.840.1.113883.6.1
    • RxNorm OID: 2.16.840.1.113883.6.88
    • HL7® Standard Code Set CVX-Vaccines Administered OID: 2.16.840.1.113883.12.292
    • National Drug Code Directory OID: 2.16.840.1.113883.6.69
    • International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) OID: 2.16.840.1.113883.6.4
    • CDC Race and Ethnicity Code Set Version 1.0 (March 2000) OID: 2.16.840.1.113883.6.238
    • Tags for Identifying Languages—Request for Comment (RFC) 5646 (preferred language) OID: 2.16.840.1.113883.6.316
    • Healthcare Provider Taxonomy OID: 2.16.840.1.113883.6.101
  • A Health IT Module can present for testing and certification to more recent versions of the following vocabulary standards than the versions adopted in the 2015 Edition final rule [80 FR 62612]:
    • SNOMED CT®
    • LOINC®
    • RxNorm
    • CVX
    • NDC
    • CDC Race Ethnicity Code Set
  • All data elements included in the CCDS are required to be available by the Health IT Module; however, the test procedure includes only a subset of elements that are required to be included in the case report by public health to support case reporting at this time.
  • The requirement for an identifier representing the row and version of the trigger table that triggered the case report in (f)(5)(iii)(B) can be met by providing an identifier that will uniquely identify the original file from which the “matched trigger” described above originated (the version of the trigger table) as well as uniquely identify the individual trigger (row) itself.

Paragraph (f)(5)(iii)

Technical outcome – When a trigger is matched in accordance with provision (f)(5)(ii), the Health IT Module electronically creates an initial case report with only the following subset of Common Clinical Data Set (CCDS) data elements:

  • Patient Name
  • Sex 
  • Date of Birth
  • Race and Ethnicity
  • Preferred language 
  • Problems
  • Medications
  • Laboratory Tests 
  • Laboratory Values(s)/Result(s)
  • Vital Signs 
  • Procedures 
  • Care Team Member(s)
  • Immunizations 
  • Assessment and Plan of Treatment 

Clarifications

  • ONC provides the following object identifiers (OID) to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards [80 FR 62612-13]:
    • SNOMED CT® OID: 2.16.840.1.113883.6.96
    • LOINC® OID: 2.16.840.1.113883.6.1
    • RxNorm OID: 2.16.840.1.113883.6.88
    • HL7® Standard Code Set CVX-Vaccines Administered OID: 2.16.840.1.113883.12.292
    • National Drug Code Directory OID: 2.16.840.1.113883.6.69
    • International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) OID: 2.16.840.1.113883.6.4
    • CDC Race and Ethnicity Code Set Version 1.0 (March 2000) OID: 2.16.840.1.113883.6.238
    • Tags for Identifying Languages—Request for Comment (RFC) 5646 (preferred language) OID: 2.16.840.1.113883.6.316
    • Healthcare Provider Taxonomy OID: 2.16.840.1.113883.6.101
  • A Health IT Module can present for testing and certification to more recent versions of the following vocabulary standards than the versions adopted in the 2015 Edition final rule [80 FR 62612]:
    • SNOMED CT®
    • LOINC®
    • RxNorm
    • CVX
    • NDC
    • CDC Race Ethnicity Code Set
  • All data elements included in the CCDS are required to be available by the Health IT Module; however, the test procedure includes only a subset of elements that are required to be included in the case report by public health to support case reporting at this time.
  • The requirement for an identifier representing the row and version of the trigger table that triggered the case report in (f)(5)(iii)(B) can be met by providing an identifier that will uniquely identify the original file from which the “matched trigger” described above originated (the version of the trigger table) as well as uniquely identify the individual trigger (row) itself.
Updated on 10-05-2021
Version # Description of Change Version Date
1.0

Initial Publication
06-15-2020
1.1

Updated compliance date per the Interim Final Rule (IFR), Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency
11-02-2020
1.2

Removed the reliance on C-CDA R2.1 and C-CDA Companion Guide that was included in the ONC Cures Act Final Rule in error, and updated Clarification to include eCR Now guidance
04-02-2021
1.3

Updated “Technical Outcome” text in CCG sections to align with regulation text. Clarified that the optional certification pathway using the eCR Now FHIR® application may require a different set of data elements than specified in § 170.315(f)(5)(iii)(B)(1) or (2). Removed the subset list of USCDI data elements from the paragraph (f)(5)(iii) clarification. Added a clarification regarding health IT developer attestation for data element support.
07-12-2021
1.4

Removed paragraph describing the optional use of ONC-approved testing tools for this criterion, given that there are currently no ONC-approved testing tools that specifically support this criterion. 
10-05-2021
Regulation Text
Regulation Text

§ 170.315 (f)(5) Transmission to public health agencies – electronic case reporting—

  1. Consume and maintain a table of trigger codes to determine which encounters may be reportable.
  2. Match a patient visit or encounter to the trigger code based on the parameters of the trigger code table.
  3. Case report creation. Create a case report for electronic transmission:
    1. Based on a matched trigger from paragraph (f)(5)(ii).
    2. That includes, at a minimum:
      1. The data classes expressed in the standards in § 170.213, or
      2. The Common Clinical Data Set until December 31, 2022.
      3. Encounter diagnoses. Formatted according to at least one of the following standards:
        1. The standard specified in § 170.207(i).
        2. At a minimum, the version of the standard specified in § 170.207(a)(4).
      4. The provider's name, office contact information, and reason for visit.
      5. An identifier representing the row and version of the trigger table that triggered the case report.
Standard(s) Referenced

Paragraph (f)(5)(iii)

§ 170.213 United States Core Data for Interoperability (USCDI), Version 1

§ 170.207(a)(4)International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®), U.S. Edition, September 2019 Release

§ 170.207(i) Encounter diagnoses: The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions ICD-10-CM as maintained and distributed by HHS, for the following conditions:

  1. Diseases.
  2. Injuries.
  3. Impairments.
  4. Other health problems and their manifestations.
  5. Causes of injury, disease, impairment, or other health problems.

 

Standards Version Advancement Process Approved

§ 170.213 United States Core Data for Interoperability (USCDI), Version 2

Resource Documents
Resource Document
Revision History
Version # Description of Change Version Date
1.0

Initial Publication
06-15-2020
1.1

Updated compliance date per the Interim Final Rule (IFR), Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency
11-02-2020
1.2

Removed the reliance on C-CDA R2.1 and C-CDA Companion Guide that was included in the ONC Cures Act Final Rule in error, and updated Clarification to include eCR Now guidance
04-02-2021
1.3

Updated “Technical Outcome” text in CCG sections to align with regulation text. Clarified that the optional certification pathway using the eCR Now FHIR® application may require a different set of data elements than specified in § 170.315(f)(5)(iii)(B)(1) or (2). Removed the subset list of USCDI data elements from the paragraph (f)(5)(iii) clarification. Added a clarification regarding health IT developer attestation for data element support.
07-12-2021
1.4

Removed paragraph describing the optional use of ONC-approved testing tools for this criterion, given that there are currently no ONC-approved testing tools that specifically support this criterion. 
10-05-2021
Regulation Text
Regulation Text

§ 170.315 (f)(5) Transmission to public health agencies – electronic case reporting—

  1. Consume and maintain a table of trigger codes to determine which encounters may be reportable.
  2. Match a patient visit or encounter to the trigger code based on the parameters of the trigger code table.
  3. Case report creation. Create a case report for electronic transmission:
    1. Based on a matched trigger from paragraph (f)(5)(ii).
    2. That includes, at a minimum:
      1. The data classes expressed in the standards in § 170.213, or
      2. The Common Clinical Data Set until December 31, 2022.
      3. Encounter diagnoses. Formatted according to at least one of the following standards:
        1. The standard specified in § 170.207(i).
        2. At a minimum, the version of the standard specified in § 170.207(a)(4).
      4. The provider's name, office contact information, and reason for visit.
      5. An identifier representing the row and version of the trigger table that triggered the case report.
Standard(s) Referenced

Paragraph (f)(5)(iii)

§ 170.213 United States Core Data for Interoperability (USCDI), Version 1

§ 170.207(a)(4)International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®), U.S. Edition, September 2019 Release

§ 170.207(i) Encounter diagnoses: The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions ICD-10-CM as maintained and distributed by HHS, for the following conditions:

  1. Diseases.
  2. Injuries.
  3. Impairments.
  4. Other health problems and their manifestations.
  5. Causes of injury, disease, impairment, or other health problems.

 

Standards Version Advancement Process Approved

§ 170.213 United States Core Data for Interoperability (USCDI), Version 2

Certification Companion Guide: Transmission to public health agencies — electronic case reporting (Cures)

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

Link to ONC Cures Act Final Rule Preamble
Link to Interim Final Rule

 

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

Privacy and Security: This certification criterion was adopted at § 170.315(f)(5). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(f) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.

  • The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (f) criterion unless it is the only criterion for which certification is requested.
  • As a general rule, a product presented for certification only needs to be presented once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging”, which are explicitly stated.
Table for Privacy and Security

Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified for the product to be certified.

  • When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, when different QMS are used, each QMS needs to be separately identified for every capability to which it was applied.
  • When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
Table for Design and Performance
Certification Requirements

Privacy and Security: This certification criterion was adopted at § 170.315(f)(5). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(f) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.

  • The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (f) criterion unless it is the only criterion for which certification is requested.
  • As a general rule, a product presented for certification only needs to be presented once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging”, which are explicitly stated.

Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified for the product to be certified.

  • When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, when different QMS are used, each QMS needs to be separately identified for every capability to which it was applied.
  • When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
Table for Privacy and Security
Table for Design and Performance
Technical Explanations and Clarifications

 

Applies to entire criterion

Clarifications:

  • For the public health certification criteria in § 170.315(f), health IT will only need to be certified to those criteria that are required to meet the measures the provider intends to report on to meet Objective 8: Public Health and Clinical Data Registry Reporting.
  • A specific content exchange standard for electronic case reporting (eCR) is not required to meet this criterion. [see also 80 FR 62667]
  • This criterion may be met through one of the following two ways:
    • Documentation that sufficiently describes how the Health IT Module meets the functional requirements of the criterion.
    • Documentation eCR implementation using the eCR Now Fast Health Interoperability Resources (FHIR®) application and the ability to meet paragraph (i) of this criterion. Note that this optional certification pathway using the eCR Now FHIR® application may require a different set of data elements than specified in § 170.315(f)(5)(iii)(B)(1) or (2).

 

Applies to entire criterion

Clarifications:

  • For the public health certification criteria in § 170.315(f), health IT will only need to be certified to those criteria that are required to meet the measures the provider intends to report on to meet Objective 8: Public Health and Clinical Data Registry Reporting.
  • A specific content exchange standard for electronic case reporting (eCR) is not required to meet this criterion. [see also 80 FR 62667]
  • This criterion may be met through one of the following two ways:
    • Documentation that sufficiently describes how the Health IT Module meets the functional requirements of the criterion.
    • Documentation eCR implementation using the eCR Now Fast Health Interoperability Resources (FHIR®) application and the ability to meet paragraph (i) of this criterion. Note that this optional certification pathway using the eCR Now FHIR® application may require a different set of data elements than specified in § 170.315(f)(5)(iii)(B)(1) or (2).

Paragraph (f)(5)(i)

Technical outcome – A Health IT Module is able to consume and maintain a table of trigger codes to determine which encounters may be reportable.

Clarifications:

  • An example table of trigger codes is in "Trigger Code Table Examples" under the Reference Documents section on the Test Procedures tab.

Paragraph (f)(5)(i)

Technical outcome – A Health IT Module is able to consume and maintain a table of trigger codes to determine which encounters may be reportable.

Clarifications:

  • An example table of trigger codes is in "Trigger Code Table Examples" under the Reference Documents section on the Test Procedures tab.

Paragraph (f)(5)(ii)

Technical outcome – A Health IT Module can match a patient visit or encounter to the trigger code based on the parameters of the trigger code table.

Clarifications:

  • No additional clarifications.

Paragraph (f)(5)(ii)

Technical outcome – A Health IT Module can match a patient visit or encounter to the trigger code based on the parameters of the trigger code table.

Clarifications:

  • No additional clarifications.

Paragraph (f)(5)(iii)

Technical outcome – A Health IT Module can create a case report for electronic transmission.

Clarifications

  • For attestation, a health IT developer must attest to their product’s ability to support the referenced standard(s) in § 170.315(f)(5)(iii)(B)(1) or (2). However, individual public health authorities may require a subset of this data for reporting.
  • ONC provides the following object identifier (OID) to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards [see also 80 FR 62612-13]:
    • SNOMED CT® OID: 2.16.840.1.113883.6.96
    • LOINC® OID: 2.16.840.1.113883.6.1
    • RxNorm OID: 2.16.840.1.113883.6.88
    • HL7® Standard Code Set CVX-Vaccines Administered OID: 2.16.840.1.113883.12.292
    • National Drug Code (NDC) Directory OID: 2.16.840.1.113883.6.69
    • International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) OID: 2.16.840.1.113883.6.4
    • CDC Race and Ethnicity Code Set Version 1.0 (March 2000) OID: 2.16.840.1.113883.6.238
    • Tags for Identifying Languages—Request for Comment (RFC) 5646 (preferred language) OID: 2.16.840.1.113883.6.316
    • Healthcare Provider Taxonomy OID: 2.16.840.1.113883.6.101
  • A Health IT Module can present for testing and certification to more recent versions of the following vocabulary standards than the versions adopted in the 2015 Edition Health Information Technology Certification Criteria, 2015 Edition Base Electronic Health Record Definition, and ONC Health IT Certification Program Modifications Final Rule [see also 80 FR 62612]:
    • SNOMED CT®
    • LOINC®
    • RxNorm
    • CVX
    • NDC
    • CDC Race Ethnicity Code Set
  • The requirement for an identifier representing the row and version of the trigger table that triggered the case report in (f)(5)(iii)(B) can be met by providing an identifier that will uniquely identify the original file from which the “matched trigger” described above originated (the version of the trigger table) as well as uniquely identify the individual trigger (row) itself.

Paragraph (f)(5)(iii)

Technical outcome – A Health IT Module can create a case report for electronic transmission.

Clarifications

  • For attestation, a health IT developer must attest to their product’s ability to support the referenced standard(s) in § 170.315(f)(5)(iii)(B)(1) or (2). However, individual public health authorities may require a subset of this data for reporting.
  • ONC provides the following object identifier (OID) to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards [see also 80 FR 62612-13]:
    • SNOMED CT® OID: 2.16.840.1.113883.6.96
    • LOINC® OID: 2.16.840.1.113883.6.1
    • RxNorm OID: 2.16.840.1.113883.6.88
    • HL7® Standard Code Set CVX-Vaccines Administered OID: 2.16.840.1.113883.12.292
    • National Drug Code (NDC) Directory OID: 2.16.840.1.113883.6.69
    • International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) OID: 2.16.840.1.113883.6.4
    • CDC Race and Ethnicity Code Set Version 1.0 (March 2000) OID: 2.16.840.1.113883.6.238
    • Tags for Identifying Languages—Request for Comment (RFC) 5646 (preferred language) OID: 2.16.840.1.113883.6.316
    • Healthcare Provider Taxonomy OID: 2.16.840.1.113883.6.101
  • A Health IT Module can present for testing and certification to more recent versions of the following vocabulary standards than the versions adopted in the 2015 Edition Health Information Technology Certification Criteria, 2015 Edition Base Electronic Health Record Definition, and ONC Health IT Certification Program Modifications Final Rule [see also 80 FR 62612]:
    • SNOMED CT®
    • LOINC®
    • RxNorm
    • CVX
    • NDC
    • CDC Race Ethnicity Code Set
  • The requirement for an identifier representing the row and version of the trigger table that triggered the case report in (f)(5)(iii)(B) can be met by providing an identifier that will uniquely identify the original file from which the “matched trigger” described above originated (the version of the trigger table) as well as uniquely identify the individual trigger (row) itself.
Updated on 08-29-2022
Version # Description of Change Version Date
1.0

Final Test Procedure
08-11-2017
1.1

As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only.
09-21-2017
1.2

Changed language from self-declaration to attestation.
08-25-2021
1.3

Updated to include approved Standards Version Advancement Process (SVAP) standards for 2022.
08-29-2022
Regulation Text
Regulation Text

§ 170.315 (f)(5) Transmission to public health agencies – electronic case reporting—

  1. Consume and maintain a table of trigger codes to determine which encounters may be reportable.
  2. Match a patient visit or encounter to the trigger code based on the parameters of the trigger code table.
  3. Case report creation. Create a case report for electronic transmission:
    1. Based on a matched trigger from paragraph (f)(5)(ii).
    2. That includes, at a minimum:
      1. The data classes expressed in the standards in § 170.213, or
      2. The Common Clinical Data Set until December 31, 2022.
      3. Encounter diagnoses. Formatted according to at least one of the following standards:
        1. The standard specified in § 170.207(i).
        2. At a minimum, the version of the standard specified in § 170.207(a)(4).
      4. The provider's name, office contact information, and reason for visit.
      5. An identifier representing the row and version of the trigger table that triggered the case report.
Standard(s) Referenced

Paragraph (f)(5)(iii)

§ 170.213 United States Core Data for Interoperability (USCDI), Version 1

§ 170.207(a)(4)International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®), U.S. Edition, September 2019 Release

§ 170.207(i) Encounter diagnoses: The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions ICD-10-CM as maintained and distributed by HHS, for the following conditions:

  1. Diseases.
  2. Injuries.
  3. Impairments.
  4. Other health problems and their manifestations.
  5. Causes of injury, disease, impairment, or other health problems.

 

Standards Version Advancement Process Approved

§ 170.213 United States Core Data for Interoperability (USCDI), Version 2

Resource Documents
Resource Document
Revision History
Version # Description of Change Version Date
1.0

Final Test Procedure
08-11-2017
1.1

As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only.
09-21-2017
1.2

Changed language from self-declaration to attestation.
08-25-2021
1.3

Updated to include approved Standards Version Advancement Process (SVAP) standards for 2022.
08-29-2022
Regulation Text
Regulation Text

§ 170.315 (f)(5) Transmission to public health agencies – electronic case reporting—

  1. Consume and maintain a table of trigger codes to determine which encounters may be reportable.
  2. Match a patient visit or encounter to the trigger code based on the parameters of the trigger code table.
  3. Case report creation. Create a case report for electronic transmission:
    1. Based on a matched trigger from paragraph (f)(5)(ii).
    2. That includes, at a minimum:
      1. The data classes expressed in the standards in § 170.213, or
      2. The Common Clinical Data Set until December 31, 2022.
      3. Encounter diagnoses. Formatted according to at least one of the following standards:
        1. The standard specified in § 170.207(i).
        2. At a minimum, the version of the standard specified in § 170.207(a)(4).
      4. The provider's name, office contact information, and reason for visit.
      5. An identifier representing the row and version of the trigger table that triggered the case report.
Standard(s) Referenced

Paragraph (f)(5)(iii)

§ 170.213 United States Core Data for Interoperability (USCDI), Version 1

§ 170.207(a)(4)International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®), U.S. Edition, September 2019 Release

§ 170.207(i) Encounter diagnoses: The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions ICD-10-CM as maintained and distributed by HHS, for the following conditions:

  1. Diseases.
  2. Injuries.
  3. Impairments.
  4. Other health problems and their manifestations.
  5. Causes of injury, disease, impairment, or other health problems.

 

Standards Version Advancement Process Approved

§ 170.213 United States Core Data for Interoperability (USCDI), Version 2

Testing components

Attestation: As of September 21, 2017, the testing approach for this criterion is satisfied by attestation.

The archived version of the Test Procedure is attached below for reference.

System Under Test

ONC-ACB Verification

The health IT developer will attest directly to the ONC-ACB to conformance with the § 170.315 (f)(5) Transmission to public health agencies — electronic case reporting requirements. 

The ONC-ACB verifies the health IT developer attests conformance to the § 170.315 (f)(5) Transmission to public health agencies — electronic case reporting requirements.
Archived Version:
§170.315(f)(5) Test Procedure
Reference Documents
Trigger Code Table Examples 08-11-2016