Source: https://www.healthit.gov/test-method/transmission-public-health-agencies-syndromic-surveillance
Timestamp: 2019-04-26 10:38:10+00:00

Document:
Clarification to include reference to health care setting(s) of the system under test.
Corrected standard referenced paragraph typo under SUT.
Create syndrome-based public health surveillance information for electronic transmission in accordance with the standard (and applicable implementation specifications) specified in §170.205(d)(4).
The health IT developer identifies which of the health care setting(s) (Emergency Department, Inpatient, Urgent Care) are applicable to the system under test. The Health IT Module creates syndromic surveillance content using ONC Supplied Test data for each of the test cases for the identified health care setting(s) under the ONC 2015 Certification Test Plan on the Context-Based Validation Tab of the NIST HL7 v2 Syndromic Surveillance Test Suite. All test cases are required that apply to the health care setting(s) supported by the system under test. Input may be performed using manual or automated processes.
For each test case, the Health IT Module generates the indicated HL7 v2.5.1 ADT message type containing the Syndromic Surveillance information and using the provided test data and according to the § 170.205(d)(4) PHIN Messaging Guide for Syndromic Surveillance: Emergency Department, Urgent, Care, Inpatient and Ambulatory Care, and Inpatient Settings, Release 2.0 and associated Erratum.
The tester verifies that the Health IT Module creates the source syndromic surveillance content correctly and without omission through visual inspection of the system under test using the test data specification of each Test Step associated with the selected test case.
The tester imports the syndromic surveillance message into the NIST HL7 v2 Syndromic Surveillance Test Suite and uses the Validation Report produced by the test tool to verify that the Health IT Module passes without error to confirm that the syndromic surveillance message is conformant to the HL7 v2.5.1 ADT message type in the § 170.205(d)(4) standard and associated Erratum.
Updated to provide additional clarifications about the gap certification eligibility of this criterion.
Clarified that testing and certification does not require compliance with ICD-9-CM and permits testing and certification to ICD-10-CM OR SNOMED CT® to meet the implementation guide’s requirements for submitted messages; and updated links to the Implementation Guide and Errata.
Privacy and Security: This certification criterion was adopted at § 170.315(f)(2). As a result, an ONC-ACB must ensure that a product presented for certification to a § 170.315(f) “paragraph (f)” criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
Technical outcome – The health IT is able to create syndrome-based public health surveillance information for electronic transmission to public health agencies according to the HL7 2.5.1 standard, the PHIN Messaging Guide for Syndromic Surveillance Release 2.0, and the August 2015 Erratum to the PHIN Messaging Guide.
Health IT is not required to comply with the implementation guide’s requirement that a sender’s system (Health IT Module) support the ICD-9-CM value set.
Health IT must be tested and certified to only one of the value sets for the implementation guide’s “submitted messages” requirement. More specifically, this means that a Health IT Module can use either the ICD-10-CM or SNOMED CT® value sets in the submitted messages for all of the test steps in the Syndromic Surveillance Test Suite. Where the tool does not have test data that supports the Health IT Module’s value set (either ICD-10-CM or SNOMED CT®), the developer of the Health IT Module must provide the codes and testers must perform a visual inspection of the messages for these test steps to ensure that equivalent and valid ICD-10-CM or SNOMED CT® are used to populate the messages.
It is appropriate to distinguish between ambulatory settings from emergency department, urgent care and inpatient settings. This criterion requires the use of the HL7 2.5.1 standard, PHIN Messaging Guide Release 2.0, and August 2015 Erratum to the PHIN Messaging Guide for the inpatient setting (which includes emergency departments).
This certification criterion is not eligible for gap certification. We note that we adopted a voluntary criterion for ambulatory syndromic surveillance in the 2014 Edition Release 2 final rule (at § 170.314(f)(7)) for health IT to create syndrome-based syndromic surveillance information containing certain data. This 2015 Edition syndromic surveillance certification criterion (at § 170.315(f)(2)) requires an updated implementation guide and erratum for emergency department, urgent care, and inpatient settings. Any system certifying to this criterion at § 170.315(f)(2) must conform to the updated implementation guide and erratum, and therefore this criterion is not gap certification eligible. We note that this 2015 Edition certification criterion for syndromic surveillance does not require any standard for the ambulatory setting, unless the technology is intended to be used in the urgent care setting.

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