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§170.315(f)(7) Transmission to public health agencies — health care surveys

Version 1.7 Updated on 04-28-2021
Resource Documents
Revision History
Version # Description of Change Version Date
1.0

Final Test Procedure

01-20-2016
1.1

Removed “inpatient” requirement.

04-12-2016
1.2

Added references to Errata for NHCS V1.0.

04-25-2016
1.3

Added Test Tool User Guide link.

10-06-2016
1.4

Added the option to test for conformance to National Health Care Surveys IG Release 1.2 for this criterion; Health IT already certified to NHCS IG Release 1.0 will not be required to retest or recertify to Release 1.2.  Added hyperlinks to NHCS IG 1.2 Validator, NHCS 1.2 Validator Tool Guide and Test Data; Changed references for NHCS IG Release 1.0 to  NHCS IG 1.0 Validator

03-29-2019
1.5

Updated the Privacy & Security requirements per 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule 

06-15-2020
1.6

Updated to include Approved Standards Version Advancement Process (SVAP) Version(s)

03-12-2021
1.7

Updated with link to validation tool for Approved SVAP Standard HL7 CDA® R2 Implementation Guide: National Health Care Surveys (NHCS) R1 STU Release 3

04-28-2021
Regulation Text
Regulation Text

§170.315 (f)(7) Transmission to public health agencies – health care surveys

Create health care survey information for electronic transmission in accordance with the standard specified in §170.205(s)(1).

Standard(s) Referenced
Testing
Criterion Subparagraph Test Data
(f)(7)
SVAP

Please consult the Final Rule entitled: 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications for a detailed description of the certification criterion with which these testing steps are associated. We also encourage developers to consult the Certification Companion Guide in tandem with the test procedure as they provide clarifications that may be useful for product development and testing.

Note: The order in which the test steps are listed reflects the sequence of the certification criterion and does not necessarily prescribe the order in which the test should take place.
 

Testing components

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

 

Paragraph (f)(7) - (Conditional - For Modules Certified to 2015 Edition (f)(7))

System Under Test
ONC-ACB Verification

The health IT developer of a Health IT Module currently certified to the 2015 Edition 170.315(f)(7) Transmission to public health agencies - health care surveys will attest directly to the ONC-ACB to conformance with the updated SVAP version(s) approved. 

The ONC-ACB verifies the health IT developer of a Health IT Module certified to the 2015 Edition 170.315(f)(7) Transmission to public health agencies - health care surveys attests conformance to the SVAP version(s) approved. 


 

Paragraph (f)(7)

System Under Test Test Lab Verification
  1. The health IT developer identifies which of the survey type settings (Outpatient, Emergency Department) are applicable to the system under test. The user enters ONC supplied patient-level test data that will be used to generate the health care survey information for each of the test cases identified as applicable (e.g. Outpatient (OP), Emergency Department (ED)) from the ONC 2015 Edition: National Health Care Surveys Release (NHCS) IG Release 1.0 Validator or NHCS IG Release 1.2 Validator. All test cases are required that apply to the care setting(s) supported by the system under test.
  2. The Health IT Module creates a health care survey document in accordance with the standard at § 170.205(s)(1) HL7 Implementation Guide for CDA Release 2: National Health Care Surveys (NHCS), Release 1.0 or HL7 CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 DSTU Release 1.2 - US Realm for each test case OR;

        SVAP Version(s) Approved: 

  • The Health IT Module creates a health care survey document in accordance with the standard HL7 CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm. 
  1. The tester verifies that the Health IT Module creates the source health care survey content correctly through visual inspection of the system under test using the test data associated with the selected test case.
  2. The tester verifies that the health care survey document is correct and without omission:
    1. The tester imports the health care survey CDA document into the test tool for validation and uses the Validation Report produced by the test tool to verify that the Health IT module passes without error to confirm that the health care survey information document is conformant to the § 170.205(s)(1) and Errata for NHCS V1.0 or HL7 CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 DSTU Release 1.2 - US Realm OR
    • SVAP Version(s) Approved: 
    • The health care survey information document is conformant to the HL7 CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm. 
    1. The tester uses the validation report to verify that the health care survey information document (CDA document) generated by the Health IT Module is correct, and uses the specified value sets.
    2.  The tester uses visual inspection of the CDA document XML and human readable content to verify that the CDA document reflects the data entered into the Health IT Module.

 


Version 1.6 Updated on 03-12-2021
Resource Documents
Revision History
Version # Description of Change Version Date
1.0

Initial Publication

10-27-2015
1.1

Clarifications of the surveys included in the adopted IG (version 1.0) and the approach to testing and certification for each survey.

03-30-2016
1.2

Added reference to Errata for NHCS V1.0.

04-25-2016
1.3

Clarified that ONC will permit and provide testing and certification for conformance to NHCS IG Release 1.2 to meet this criterion; and will not require the retesting and certification of health IT previously certified to NHCS Release 1.0.

05-26-2017
1.4

Deleted “solely" from this sentence "Because of these improvements, NCHS plans to update its reporting requirements and system capacity to solely support Release 1.2 effective January 1, 2018" as NCHS has deferred the date for solely accepting NHCS IG Release 1.2 until January 1, 2019.  

06-04-2018
1.5

Updated the Security requirements per 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule

06-15-2020
1.6

Updated to include Approved Standards Version Advancement Process (SVAP) Version(s)

03-12-2021
Regulation Text
Regulation Text

§170.315 (f)(7) Transmission to public health agencies – health care surveys

Create health care survey information for electronic transmission in accordance with the standard specified in §170.205(s)(1).

Standard(s) Referenced
Testing
Criterion Subparagraph Test Data
(f)(7)
SVAP

Certification Companion Guide: Transmission to public health agencies — health care surveys

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.
 

 

Certification Requirements

Privacy and Security: This certification criterion was adopted at § 170.315(f)(7). 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.

  • 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) “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.
Table for Privacy and Security
Technical Explanations and Clarifications

Applies to entire criterion

Technical outcome – Health IT can create health care survey data for electronic transmission in compliance with all mandatory elements and requirements of the HL7 Implementation Guide (IG) for CDA Release 2: National Health Care Surveys (NHCS), Release 1 – US Realm, Draft Standard for Trial Use, December 2014.

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.
  • In response to a comment requesting clarification regarding the surveys that were included in the IG, we incorrectly indicated in the 2015 Edition final rule that the NHCS was included in the adopted version of the IG (version 1.0) [80 FR 62669]. This was due to a conflation of the name of the IG (NHCS IG), confusion with the three setting types of the two surveys (NAMCS and NHAMCS) included in version 1.0 of the IG, and the pending inclusion of the NHCS in Release 1.1 of the IG. We clarify that the NHCS is not included in the adopted version 1.0 of the IG and is not currently available for certification as part of the 2015 Edition.
  • We clarified in the 2015 Edition final rule that the entire IG would be covered as part of certification. [80 FR 62669] We further clarify that certification to each survey within the IG would be based on the selection of the health IT developer. We expect that such selection would be based on the health care setting that the Health IT Module presented for certification is intended to support. To illustrate, a Health IT Module designed to support providers practicing in:
    • An office setting would be presented for certification to NAMCS.
    • A hospital-based outpatient setting would be presented for certification to NHAMCS with the appropriate IG-identified outpatient constraints.
    • An emergency department would be presented for certification to NHAMCS with the appropriate IG-identified emergency department constraints.
  • Since the publication of the Final Rule, HL7 has published newer versions of the NHCS IG. These versions are Release 1.1 (November 2015) and Release 1.2 (August 2016). Release 1.2 enables collection of inpatient data which is critical to the National Center for Health Statistics' (NCHS) mission and is responsive to stakeholders’ comments on Release 1.1. Because of these improvements, NCHS plans to update its reporting requirements and system capacity to support Release 1.2 effective January 1, 2018. Accordingly, ONC will permit and provide testing and certification for conformance to NHCS IG Release 1.2 to meet this criterion. Health IT already certified to NHCS IG Release 1.0 will not be required to retest or recertify to Release 1.2.
  • The health care surveys for electronic transmission will be collected by CDC only rather than at the jurisdictional level. [see also 80 FR 62669]
  • Health IT developers can choose to use the flexibility of the Standards Version Advancement Process (SVAP) to use more advanced version(s) of standards than the version(s) incorporated by reference in the regulation for this certification criterion. To comply with the Maintenance of Certification requirement in § 170.405(b), a developer that chooses to pursue such updates must include in their Real World Testing plan each Certified Health IT Module updated to newer version(s) of any standard(s) prior to August 31 of the year in which their updates were made and test each Module the following calendar year for conformance to all applicable criteria within its scope, including the newer version(s) of any standard(s). 
  • Health IT developers updating their already certified Health IT Modules who choose to leverage the SVAP flexibility will be required to provide advance notice to all affected customers and its ONC-Authorized Certification Body (ONC-ACB). To be open and transparent to the public, health IT developers must also provide its ONC-ACB with a publicly accessible hyperlink to the SVAP Notice to be published with the Module on the ONC Certified Health IT Product List (CHPL). 

Content last reviewed on May 12, 2021
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