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§170.315(f)(3) Transmission to public health agencies — reportable laboratory tests and value/results

Updated on 03-11-2024
Regulation Text
Regulation Text

§ 170.315 (f)(3) Transmission to public health agencies – reportable laboratory tests and value/results—

Create reportable laboratory tests and values/results for electronic transmission in accordance with:

  1. The standard (and applicable implementation specifications) specified in § 170.205(g).
  2. At a minimum, the versions of the standards specified in § 170.207(a)(1) and (c)(1).
Standard(s) Referenced

Paragraph (f)(3)(i)

§ 170.205(g) Electronic transmission of lab results to public health agencies. Health Level 7 (HL7®) 2.5.1. Implementation specifications. HL7® Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) with Errata and Clarifications and ELR 2.5.1 Clarification Document for EHR Technology Certification

Paragraph (f)(3)(ii)

§ 170.207(a)(3) International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) International Release July 2012 and US Extension to SNOMED CT® March 2012 Release (Adoption of this standard expires on January 1, 2026)

§ 170.207(a)(1) SNOMED CT®, U.S. Edition, March 2022 Release (This standard is required by December 31, 2025)

§ 170.207(c)(2) Logical Observation Identifiers Names and Codes (LOINC®) Database version 2.40, Released July 2012, a universal code system for identifying laboratory and clinical observations produced by the Regenstrief Institute, Inc. (Adoption of this standard expires on January 1, 2026)

§ 170.207(c)(1) Logical Observation Identifiers Names and Codes (LOINC®) Database Version 2.76, February 16, 2022, a universal code system for identifying laboratory and clinical observations produced by the Regenstrief Institute, Inc. (This standard is required by December 31, 2025)

Required Update Deadlines

The following outlines deadlines for required updates for this criterion as they relate to changes published in recent ONC final rules. Developers must update their products to the requirements outlined and provide them to their customers by the stated deadlines. These represent one-time deadlines as set by recent regulatory updates and do not encompass ongoing deadlines related to the Conditions and Maintenance of Certification. Please review those requirements for additional compliance activities related to one’s certification under Certification Dependencies.

Deadline: December 31, 2025

Action to be taken: Developers certified to this criterion must update their code sets to reflect at a minimum the code sets outlined in subparagraph 170.315(f)(3)(ii). 

Certification Dependencies

Conditions and Maintenance of Certification

Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.

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.

  • Quality management system (§ 170.315(g)(4)): 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.
  • Accessibility-centered design (§ 170.315(g)(5)): 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.
Privacy & Security Requirements

This certification criterion was adopted at § 170.315(f)(3). 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 tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification.
  • However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
  • § 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.

For more information on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG.

Version # Description of Change Version Date
1.0

Initial publication
03-11-2024
Regulation Text
Regulation Text

§ 170.315 (f)(3) Transmission to public health agencies – reportable laboratory tests and value/results—

Create reportable laboratory tests and values/results for electronic transmission in accordance with:

  1. The standard (and applicable implementation specifications) specified in § 170.205(g).
  2. At a minimum, the versions of the standards specified in § 170.207(a)(1) and (c)(1).
Standard(s) Referenced

Paragraph (f)(3)(i)

§ 170.205(g) Electronic transmission of lab results to public health agencies. Health Level 7 (HL7®) 2.5.1. Implementation specifications. HL7® Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) with Errata and Clarifications and ELR 2.5.1 Clarification Document for EHR Technology Certification

Paragraph (f)(3)(ii)

§ 170.207(a)(3) International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) International Release July 2012 and US Extension to SNOMED CT® March 2012 Release (Adoption of this standard expires on January 1, 2026)

§ 170.207(a)(1) SNOMED CT®, U.S. Edition, March 2022 Release (This standard is required by December 31, 2025)

§ 170.207(c)(2) Logical Observation Identifiers Names and Codes (LOINC®) Database version 2.40, Released July 2012, a universal code system for identifying laboratory and clinical observations produced by the Regenstrief Institute, Inc. (Adoption of this standard expires on January 1, 2026)

§ 170.207(c)(1) Logical Observation Identifiers Names and Codes (LOINC®) Database Version 2.76, February 16, 2022, a universal code system for identifying laboratory and clinical observations produced by the Regenstrief Institute, Inc. (This standard is required by December 31, 2025)

Required Update Deadlines

The following outlines deadlines for required updates for this criterion as they relate to changes published in recent ONC final rules. Developers must update their products to the requirements outlined and provide them to their customers by the stated deadlines. These represent one-time deadlines as set by recent regulatory updates and do not encompass ongoing deadlines related to the Conditions and Maintenance of Certification. Please review those requirements for additional compliance activities related to one’s certification under Certification Dependencies.

Deadline: December 31, 2025

Action to be taken: Developers certified to this criterion must update their code sets to reflect at a minimum the code sets outlined in subparagraph 170.315(f)(3)(ii). 

Certification Dependencies

Conditions and Maintenance of Certification

Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.

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.

  • Quality management system (§ 170.315(g)(4)): 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.
  • Accessibility-centered design (§ 170.315(g)(5)): 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.
Privacy & Security Requirements

This certification criterion was adopted at § 170.315(f)(3). 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 tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification.
  • However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
  • § 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.

For more information on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG.

Testing
Testing Tool

NIST HL7® v2 Electronic Laboratory Reporting (ELR) Validation Tool

Test Tool Documentation

NIST Normative Test Process Document

Criterion Subparagraph Test Data
(f)(3)

Refer to NIST HL7® v2 Electronic Laboratory Reporting (ELR) Validation Tool
Revision History
Version # Description of Change Version Date
1.0

Initial publication
03-11-2024

This Test Procedure illustrates the test steps required to certify a Health IT Module to this criterion. Please consult the most recent ONC Final Rule on the Certification Regulations page for a detailed description of the certification criterion with which these testing steps are associated. ONC also encourages developers to consult the Certification Companion Guide in tandem with the test procedure as it provides clarifications that may be useful for product development and testing.

Note: The test step order does not necessarily prescribe the order in which the tests should take place.

Testing components

No Documentation Icon Visual Inspection Icon Test Tool Icon ONC Supplied Test Data Icon No SVAP Icon

Paragraph (f)(3) – (Conditional – For Modules with existing certification to (f)(3))

System Under Test
Required by December 31, 2025

The health IT developer of a Health IT Module currently certified to the § 170.315(f)(3) Transmission to public health agencies – reportable laboratory tests and value results will attest directly to the ONC-ACB to conformance with the updated § 170.315(f)(3) requirements outlined in the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.

Test Lab Verification
Required by December 31, 2025

The ONC-ACB verifies the health IT developer of a Health IT Module certified to the § 170.315(f)(3) Transmission to public health agencies – reportable laboratory tests and value results attests conformance to updated § 170.315(f)(3) criteria requirements.

System Under Test Test Lab Verification
Required by December 31, 2025

The health IT developer of a Health IT Module currently certified to the § 170.315(f)(3) Transmission to public health agencies – reportable laboratory tests and value results will attest directly to the ONC-ACB to conformance with the updated § 170.315(f)(3) requirements outlined in the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.
Required by December 31, 2025

The ONC-ACB verifies the health IT developer of a Health IT Module certified to the § 170.315(f)(3) Transmission to public health agencies – reportable laboratory tests and value results attests conformance to updated § 170.315(f)(3) criteria requirements.

Paragraph (f)(3)(i) ELR standards

System Under Test
  1. The Health IT Module creates Reportable Lab content using ONC-supplied test data for each of the test cases under the ONC Certification Test Plan on the Context-Based Validation Tab of the NIST Electronic Laboratory Reporting (ELR) Test Suite. All test cases are required. Input may be performed using manual or automated processes.
Test Lab Verification

Using the Normative Test Description section of the Normative Test Process Document:

  1. The tester verifies the Health IT Module creates the source Reportable Lab content correctly and without omission through visual inspection of the System Under Test using the test data specification associated with the selected test case.
  2. The tester imports the ELR message into the test tool for validation and uses the Validation Report produced by the NIST Electronic Laboratory Reporting (ELR) Test Suite to verify the Health IT module passes without error to confirm that the reportable laboratory tests and values/results message is conformant to the § 170.205(g) HL7® Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 and the ELR 2.5.1 Clarification Document for EHR Technology Certification.
System Under Test Test Lab Verification
  1. The Health IT Module creates Reportable Lab content using ONC-supplied test data for each of the test cases under the ONC Certification Test Plan on the Context-Based Validation Tab of the NIST Electronic Laboratory Reporting (ELR) Test Suite. All test cases are required. Input may be performed using manual or automated processes.

Using the Normative Test Description section of the Normative Test Process Document:

  1. The tester verifies the Health IT Module creates the source Reportable Lab content correctly and without omission through visual inspection of the System Under Test using the test data specification associated with the selected test case.
  2. The tester imports the ELR message into the test tool for validation and uses the Validation Report produced by the NIST Electronic Laboratory Reporting (ELR) Test Suite to verify the Health IT module passes without error to confirm that the reportable laboratory tests and values/results message is conformant to the § 170.205(g) HL7® Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 and the ELR 2.5.1 Clarification Document for EHR Technology Certification.

Paragraph (f)(3)(ii) Reportable laboratory tests and value/results code sets

System Under Test
Expires on January 1, 2026

The reportable laboratory tests and values/results used in the messages created in (f)(3)(i) use, at a minimum, the versions of the standards specified in the named § 170.207(a)(3) SNOMED CT® standard and the named § 170.207(c)(2) LOINC® standard.

Required by December 31, 2025

The reportable laboratory tests and values/results used in the messages created in (f)(3)(i) use, at a minimum, the versions of the standards specified in the named § 170.207(a)(1) SNOMED CT® standard and the named § 170.207(c)(1) LOINC® standard.

Test Lab Verification
Expires on January 1, 2026

Using the Normative Test Description section of the Normative Test Process Document, the tester uses the Test Tool Validation Report from (f)(3)(i) test cases and visual inspection of both the Test Tool Validation Report and the Health IT configuration file to verify laboratory tests and values/results are represented using the named § 170.207(a)(3) standard and the named § 170.207(c)(2) standard.

Required by December 31, 2025

Using the Normative Test Description section of the Normative Test Process Document, the tester uses the Test Tool Validation Report from (f)(3)(i) test cases and visual inspection of both the Test Tool Validation Report and the Health IT configuration file to verify laboratory tests and values/results are represented using the named § 170.207(a)(1) standard and the named § 170.207(c)(1) standard.

System Under Test Test Lab Verification
Expires on January 1, 2026

The reportable laboratory tests and values/results used in the messages created in (f)(3)(i) use, at a minimum, the versions of the standards specified in the named § 170.207(a)(3) SNOMED CT® standard and the named § 170.207(c)(2) LOINC® standard.

Required by December 31, 2025

The reportable laboratory tests and values/results used in the messages created in (f)(3)(i) use, at a minimum, the versions of the standards specified in the named § 170.207(a)(1) SNOMED CT® standard and the named § 170.207(c)(1) LOINC® standard.
Expires on January 1, 2026

Using the Normative Test Description section of the Normative Test Process Document, the tester uses the Test Tool Validation Report from (f)(3)(i) test cases and visual inspection of both the Test Tool Validation Report and the Health IT configuration file to verify laboratory tests and values/results are represented using the named § 170.207(a)(3) standard and the named § 170.207(c)(2) standard.

Required by December 31, 2025

Using the Normative Test Description section of the Normative Test Process Document, the tester uses the Test Tool Validation Report from (f)(3)(i) test cases and visual inspection of both the Test Tool Validation Report and the Health IT configuration file to verify laboratory tests and values/results are represented using the named § 170.207(a)(1) standard and the named § 170.207(c)(1) standard.
Updated on 03-11-2024
Regulation Text
Regulation Text

§ 170.315 (f)(3) Transmission to public health agencies – reportable laboratory tests and value/results—

Create reportable laboratory tests and values/results for electronic transmission in accordance with:

  1. The standard (and applicable implementation specifications) specified in § 170.205(g).
  2. At a minimum, the versions of the standards specified in § 170.207(a)(1) and (c)(1).
Standard(s) Referenced

Paragraph (f)(3)(i)

§ 170.205(g) Electronic transmission of lab results to public health agencies. Health Level 7 (HL7®) 2.5.1. Implementation specifications. HL7® Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) with Errata and Clarifications and ELR 2.5.1 Clarification Document for EHR Technology Certification

Paragraph (f)(3)(ii)

§ 170.207(a)(3) International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) International Release July 2012 and US Extension to SNOMED CT® March 2012 Release (Adoption of this standard expires on January 1, 2026)

§ 170.207(a)(1) SNOMED CT®, U.S. Edition, March 2022 Release (This standard is required by December 31, 2025)

§ 170.207(c)(2) Logical Observation Identifiers Names and Codes (LOINC®) Database version 2.40, Released July 2012, a universal code system for identifying laboratory and clinical observations produced by the Regenstrief Institute, Inc. (Adoption of this standard expires on January 1, 2026)

§ 170.207(c)(1) Logical Observation Identifiers Names and Codes (LOINC®) Database Version 2.76, February 16, 2022, a universal code system for identifying laboratory and clinical observations produced by the Regenstrief Institute, Inc. (This standard is required by December 31, 2025)

Required Update Deadlines

The following outlines deadlines for required updates for this criterion as they relate to changes published in recent ONC final rules. Developers must update their products to the requirements outlined and provide them to their customers by the stated deadlines. These represent one-time deadlines as set by recent regulatory updates and do not encompass ongoing deadlines related to the Conditions and Maintenance of Certification. Please review those requirements for additional compliance activities related to one’s certification under Certification Dependencies.

Deadline: December 31, 2025

Action to be taken: Developers certified to this criterion must update their code sets to reflect at a minimum the code sets outlined in subparagraph 170.315(f)(3)(ii). 

Certification Dependencies

Conditions and Maintenance of Certification

Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.

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.

  • Quality management system (§ 170.315(g)(4)): 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.
  • Accessibility-centered design (§ 170.315(g)(5)): 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.
Privacy & Security Requirements

This certification criterion was adopted at § 170.315(f)(3). 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 tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification.
  • However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
  • § 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.

For more information on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG.

Version # Description of Change Version Date
1.0

Initial publication
03-11-2024
Regulation Text
Regulation Text

§ 170.315 (f)(3) Transmission to public health agencies – reportable laboratory tests and value/results—

Create reportable laboratory tests and values/results for electronic transmission in accordance with:

  1. The standard (and applicable implementation specifications) specified in § 170.205(g).
  2. At a minimum, the versions of the standards specified in § 170.207(a)(1) and (c)(1).
Standard(s) Referenced

Paragraph (f)(3)(i)

§ 170.205(g) Electronic transmission of lab results to public health agencies. Health Level 7 (HL7®) 2.5.1. Implementation specifications. HL7® Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) with Errata and Clarifications and ELR 2.5.1 Clarification Document for EHR Technology Certification

Paragraph (f)(3)(ii)

§ 170.207(a)(3) International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) International Release July 2012 and US Extension to SNOMED CT® March 2012 Release (Adoption of this standard expires on January 1, 2026)

§ 170.207(a)(1) SNOMED CT®, U.S. Edition, March 2022 Release (This standard is required by December 31, 2025)

§ 170.207(c)(2) Logical Observation Identifiers Names and Codes (LOINC®) Database version 2.40, Released July 2012, a universal code system for identifying laboratory and clinical observations produced by the Regenstrief Institute, Inc. (Adoption of this standard expires on January 1, 2026)

§ 170.207(c)(1) Logical Observation Identifiers Names and Codes (LOINC®) Database Version 2.76, February 16, 2022, a universal code system for identifying laboratory and clinical observations produced by the Regenstrief Institute, Inc. (This standard is required by December 31, 2025)

Required Update Deadlines

The following outlines deadlines for required updates for this criterion as they relate to changes published in recent ONC final rules. Developers must update their products to the requirements outlined and provide them to their customers by the stated deadlines. These represent one-time deadlines as set by recent regulatory updates and do not encompass ongoing deadlines related to the Conditions and Maintenance of Certification. Please review those requirements for additional compliance activities related to one’s certification under Certification Dependencies.

Deadline: December 31, 2025

Action to be taken: Developers certified to this criterion must update their code sets to reflect at a minimum the code sets outlined in subparagraph 170.315(f)(3)(ii). 

Certification Dependencies

Conditions and Maintenance of Certification

Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.

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.

  • Quality management system (§ 170.315(g)(4)): 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.
  • Accessibility-centered design (§ 170.315(g)(5)): 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.
Privacy & Security Requirements

This certification criterion was adopted at § 170.315(f)(3). 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 tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification.
  • However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
  • § 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.

For more information on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG.

Revision History
Version # Description of Change Version Date
1.0

Initial publication
03-11-2024
Testing
Testing Tool

NIST HL7® v2 Electronic Laboratory Reporting (ELR) Validation Tool

Test Tool Documentation

NIST Normative Test Process Document

Criterion Subparagraph Test Data
(f)(3)

Refer to NIST HL7® v2 Electronic Laboratory Reporting (ELR) Validation Tool

Certification Companion Guide: Transmission to public health agencies — reportable laboratory tests and value/results

This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product certification. The CCG is not a substitute for the requirements outlined in regulation and related ONC final rules. It extracts key portions of ONC final rules’ preambles and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the Certification Regulations page for links to all ONC final rules or consult other regulatory references as noted. The CCG is for public use and should not be sold or redistributed.

The below table outlines whether this criterion has additional Maintenance of Certification dependencies, update requirements and/or eligibility for standards updates via SVAP. Review the Certification Dependencies and Required Update Deadline drop-downs above if this table indicates “yes” for any field.

 

Base EHR Definition Real World Testing Insights Condition SVAP Requires Updates
Not Included Yes No No Yes
Certification Requirements
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.
  • This certification criterion is intended for technology used in the inpatient (including emergency departments) setting.
  • There is no transport standard required for this criterion. [see also 77 FR 54247]
  • The NIST Electronic Laboratory Reporting (ELR) Test Tool tests conformance to the requirements in HL7® Version 2.5.1 Implementation Guide (IG): Electronic Laboratory Reporting to Public Health, Release 1 with Errata and Clarifications, and ELR 2.5.1 Clarification Document for EHR Technology Certification. In the Implementation Guide, RE means “Required, but may be empty” and is not an optional requirement. That is, an RE element is required to be implemented in the EHR technology, but operationally the data may or may not be present (depending on business rules and data availability). The Alternate and non-Alternate data elements have been specified as RE in the IG to ensure the technology can support (receive, process, store, send, etc.) both types (whether or not a particular installation site utilizes/needs this capability is irrelevant for certification testing, which is focused on making sure that buyers of certified EHR technology have the capability). Any Text for Patients and Provider are also RE, and therefore not optional for certification. With regard to repeatable fields, Patient Name (PID.5) can have unlimited repeated instances, and the IG indicates that supporting repeatable fields is a requirement. To support this requirement, the ELR Test Tool and Test Data ensure certified technology can support a minimum of two instances of PID.5.
  • The CDC has published the Reportable Condition Mapping Table (RCMT) that provides a subset of LOINC® and SNOMED CT® codes associated with reportable conditions. RCMT can be obtained from CDC vocabulary server PHIN VADS. [see also 77 FR 54247]
  • LOINC® SDO has created a tool known as “RELMA,” which helps to map the local tests to standard LOINC® laboratory tests. LOINC® SDO provides RELMA training twice a year and, through a partnership with LOINC® SDO, the CDC provides RELMA training to the public health community at least twice a year with a special focus on microbiology lab tests. [see also 77 FR 54247]

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.
  • This certification criterion is intended for technology used in the inpatient (including emergency departments) setting.
  • There is no transport standard required for this criterion. [see also 77 FR 54247]
  • The NIST Electronic Laboratory Reporting (ELR) Test Tool tests conformance to the requirements in HL7® Version 2.5.1 Implementation Guide (IG): Electronic Laboratory Reporting to Public Health, Release 1 with Errata and Clarifications, and ELR 2.5.1 Clarification Document for EHR Technology Certification. In the Implementation Guide, RE means “Required, but may be empty” and is not an optional requirement. That is, an RE element is required to be implemented in the EHR technology, but operationally the data may or may not be present (depending on business rules and data availability). The Alternate and non-Alternate data elements have been specified as RE in the IG to ensure the technology can support (receive, process, store, send, etc.) both types (whether or not a particular installation site utilizes/needs this capability is irrelevant for certification testing, which is focused on making sure that buyers of certified EHR technology have the capability). Any Text for Patients and Provider are also RE, and therefore not optional for certification. With regard to repeatable fields, Patient Name (PID.5) can have unlimited repeated instances, and the IG indicates that supporting repeatable fields is a requirement. To support this requirement, the ELR Test Tool and Test Data ensure certified technology can support a minimum of two instances of PID.5.
  • The CDC has published the Reportable Condition Mapping Table (RCMT) that provides a subset of LOINC® and SNOMED CT® codes associated with reportable conditions. RCMT can be obtained from CDC vocabulary server PHIN VADS. [see also 77 FR 54247]
  • LOINC® SDO has created a tool known as “RELMA,” which helps to map the local tests to standard LOINC® laboratory tests. LOINC® SDO provides RELMA training twice a year and, through a partnership with LOINC® SDO, the CDC provides RELMA training to the public health community at least twice a year with a special focus on microbiology lab tests. [see also 77 FR 54247]

Paragraph (f)(3)(i) ELR standards

Technical outcome – The Health IT Module can electronically create reportable laboratory tests and values/results messages, which can be transmitted to public health agencies according to the HL7® 2.5.1 standard, HL7® Version 2.5.1 Implementation Guide for Electronic Laboratory Reporting to Public Health, Release 1 with Errata and Clarifications, and ELR 2.5.1 Clarification Document for EHR Technology Certification.

Clarifications:

  • For the Message Header Segment (MSH) Element Name “MSH-2 (Encoding Characters)” in the “HL7® Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm),” Health IT developers may support either “\&#” or “\&” values according to the reporting requirements of their public health jurisdictions.

Technical outcome – The Health IT Module can electronically create reportable laboratory tests and values/results messages, which can be transmitted to public health agencies according to the HL7® 2.5.1 standard, HL7® Version 2.5.1 Implementation Guide for Electronic Laboratory Reporting to Public Health, Release 1 with Errata and Clarifications, and ELR 2.5.1 Clarification Document for EHR Technology Certification.

Clarifications:

  • For the Message Header Segment (MSH) Element Name “MSH-2 (Encoding Characters)” in the “HL7® Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm),” Health IT developers may support either “\&#” or “\&” values according to the reporting requirements of their public health jurisdictions.

Paragraph (f)(3)(ii) Reportable laboratory tests and value/results code sets

Technical outcome – The Health IT Module can represent data in the reportable laboratory test message using, at a minimum, SNOMED CT®and LOINC®.

Clarifications:

  • ONC provides the following object identifiers (OIDs) to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards.
    • SNOMED CT® OID: 2.16.840.1.113883.6.96
    • LOINC® OID: 2.16.840.1.113883.6.1 [see also 80 FR 62612]
  • Health IT Modules can present for certification to a more recent version of SNOMED CT® and LOINC® than outlined in regulation per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [see also 77 FR 54269]

Technical outcome – The Health IT Module can represent data in the reportable laboratory test message using, at a minimum, SNOMED CT®and LOINC®.

Clarifications:

  • ONC provides the following object identifiers (OIDs) to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards.
    • SNOMED CT® OID: 2.16.840.1.113883.6.96
    • LOINC® OID: 2.16.840.1.113883.6.1 [see also 80 FR 62612]
  • Health IT Modules can present for certification to a more recent version of SNOMED CT® and LOINC® than outlined in regulation per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [see also 77 FR 54269]