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The Office of the National Coordinator for Health Information Technology (ONC) develops the functional and conformance testing requirements for the testing and certification of Health IT Modules to the certification criteria adopted by the Health and Human Services (HHS) Secretary. Only ONC-approved test methods can be used to test products intended for certification in the ONC Health IT Certification Program (please note that any individual or organization may submit test methods to ONC for approval). Test methods (test procedures, test data, and test tools) are used by ONC-Approved Testing Laboratories (ONC-ATLs) and ONC-Approved Certification Bodies (ONC-ACBs) to evaluate the conformance and functionality of Health IT Modules.
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 as well as the Certification Companion Guide 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.
The public comment period for 2015 Edition Draft test procedures, and test data for both §170.315(g)(1) and (g)(2) criteria ended on November 21st, 2016.The public comment period for the 2015 Edition Draft § 170.315 (c)(1), § 170.315 (c)(2), § 170.315 (c)(3) and § 170.315 (c)(4) ended on July 8th, 2016. The public comment period for the 2015 Edition Draft § 170.315 (g)(1) and § 170.315 (g)(2) and § 170.315 (b)(3), 170.315 (h)(1) and 170.315 (h)(2) Test Procedures ended December 31st 2015. The comment period for the remaining Test Procedures ended on November 30th 2015.
Finally, we encourage commenters to review the Summary of Comment for 2015 Edition NPRM Draft Test Procedures for more information on how the 2015 draft test procedures were updated in response to the first round of public comment.
All test procedures will undergo public review and comment before being finalized and approved by the National Coordinator.The public comment period for 2015 Edition Draft test procedure for the §170.315(f)(5) criteria will end on April 10th, 2017.
Each test procedure includes a grid of testing components that the ATLs would use as the test approach for a particular criteria. The key is below:
| Criterion # | Certification Criterion Name | Test Procedure Link |
|---|---|---|
| § 170.315 (f)(5) | Transmission to Public Health Agencies – Electronic Case Reporting | § 170.315 (f)(5) Transmission to Public Health Agencies - Electronic Case Reporting |
| § 170.315 (g)(1) | Automated Numerator Recording | § 170.315 (g)(1) Automated Numerator Recording |
§ 170.315 (g)(2) | Automated Measure Calculation | § 170.315 (g)(2) Automated Measure Calculation |
| § 170.315 (g)(1)(2) | Automated Measure Calculation and Numerator Recording Test Data | § 170.315 (g)(1)(2) Test Data |
| § 170.315 (c)(1) | Clinical Quality Measures – Record and Export | § 170.315 (c)(1) Clinical Quality Measures - Record and Export |
| § 170.315 (c)(2) | Clinical Quality Measures – Import and Calculate | § 170.315 (c)(2) Clinical Quality Measures - Import and Calculate |
| § 170.315 (c)(3) | Clinical Quality Measures – Report | § 170.315 (c)(3) Clinical Quality Measures - Report |
| § 170.315 (c)(4) | Clinical Quality Measures - Filter | § 170.315 (c)(4) Clinical Quality Measures - Filter |
| § 170.315 (b)(3) | Electronic Prescribing | § 170.315 (b)(3) Electronic Prescribing |
| § 170.315 (h)(1) | Direct Project | § 170.315 (h)(1) Direct Project |
| § 170.315 (h)(2) | Direct Project, Edge Protocol, and XDR/XDM | § 170.315 (h)(2) Direct Project, Edge Protocol, and XDR/XDM |
| § 170.315 (a)(1) | Computerized Provider Order Entry (CPOE) – Medications | § 170.315 (a)(1) Computerized Provider Order Entry (CPOE) - Medications |
| § 170.315 (a)(2) | CPOE – Laboratory | § 170.315 (a)(2) CPOE - Laboratory |
| § 170.315 (a)(3) | CPOE – Diagnostic Imaging | § 170.315 (a)(3) CPOE - Diagnostic Imaging |
| § 170.315 (a)(4) | Drug-Drug, Drug-Allergy Interaction Checks for CPOE | § 170.315 (a)(4) Drug-Drug, Drug-Allergy Interaction Checks for CPOE |
| § 170.315 (a)(5) | Demographics | § 170.315 (a)(5) Demographics |
| § 170.315 (a)(6) | Problem List | § 170.315 (a)(6) Problem List |
| § 170.315 (a)(7) | Medication List | § 170.315 (a)(7) Medication List |
| § 170.315 (a)(8) | Medication Allergy List | § 170.315 (a)(8) Medication Allergy List |
| § 170.315 (a)(9) | Clinical Decision Support | § 170.315 (a)(9) Clinical Decision Support |
| § 170.315 (a)(10) | Drug-Formulary and Preferred Drug List Checks | § 170.315 (a)(10) Drug-Formulary and Preferred Drug List Checks |
| § 170.315 (a)(11) | Smoking Status | § 170.315 (a)(11) Smoking Status |
| § 170.315 (a)(12) | Family Health History | § 170.315 (a)(12) Family Health History |
| § 170.315 (a)(13) | Patient-Specific Education Resources | § 170.315 (a)(13) Patient-Specific Education Resources |
| § 170.315 (a)(14) | Implantable Device List | § 170.315 (a)(14) Implantable Device List |
| § 170.315 (a)(15) | Social, Psychological, and Behavioral Determinants Data | § 170.315 (a)(15) Social, Psychological, and Behavioral Determinants Data |
| § 170.315 (b)(1) | Transitions of Care | § 170.315 (b)(1) Transitions of Care |
| § 170.315 (b)(2) | Clinical Information Reconciliation and Incorporation | § 170.315 (b)(2) Clinical Information Reconciliation and Incorporation |
| § 170.315 (b)(4) | Common Clinical Data Set Summary Record - Create | § 170.315 (b)(4) Common Clinical Data Set Summary Record - Create |
| § 170.315 (b)(5) | Common Clinical Data Set Summary Record - Receive | § 170.315 (b)(5) Common Clinical Data Set Summary Record - Receive |
| § 170.315 (b)(6) | Data Export | § 170.315 (b)(6) Data Export |
| § 170.315 (b)(7) | Data Segmentation for Privacy - Send | § 170.315 (b)(7) Data Segmentation for Privacy - Send |
| § 170.315 (b)(8) | Data Segmentation for Privacy - Receive | § 170.315 (b)(8) Data Segmentation for Privacy - Receive |
| § 170.315 (b)(9) | Care Plan | § 170.315 (b)(9) Care Plan |
| § 170.315 (d)(1) | Authentication, Access Control, Authorization | § 170.315 (d)(1) Authentication, Access Control, Authorization |
| § 170.315 (d)(2) | Auditable Events and Tamper-Resistance | § 170.315 (d)(2) Auditable Events and Tamper-Resistance |
| § 170.315 (d)(3) | Audit Report(s) | § 170.315 (d)(3) Audit Report(s) |
| § 170.315 (d)(4) | Amendments | § 170.315 (d)(4) Amendments |
| § 170.315 (d)(5) | Automatic Access Time-out | § 170.315 (d)(5) Automatic Access Time-out |
| § 170.315 (d)(6) | Emergency Access | § 170.315 (d)(6) Emergency Access |
| § 170.315 (d)(7) | End-User Device Encryption | § 170.315 (d)(7) End-User Device Encryption |
| § 170.315 (d)(8) | Integrity | § 170.315 (d)(8) Integrity |
| § 170.315 (d)(9) | Trusted Connection | § 170.315 (d)(9) Trusted Connection |
| § 170.315 (d)(10) | Auditing Actions on Health Information | § 170.315 (d)(10) Auditing Actions on Health Information |
| § 170.315 (d)(11) | Accounting of Disclosures | § 170.315 (d)(11) Accounting of Disclosures |
| § 170.315 (e)(1) | View, Download, and Transmit to 3rd Party | § 170.315 (e)(1) View, Download, and Transmit to 3rd Party |
| § 170.315 (e)(2) | Secure Messaging | § 170.315 (e)(2) Secure Messaging |
| § 170.315 (e)(3) | Patient Health Information Capture | § 170.315 (e)(3) Patient Health Information Capture |
| § 170.315 (f)(1) | Transmission to Immunization Registries | § 170.315 (f)(1) Transmission to Immunization Registries |
| § 170.315 (f)(2) | Transmission to Public Health Agencies - Syndromic Surveillance | § 170.315 (f)(2) Transmission to Public Health Agencies - Syndromic Surveillance |
| § 170.315 (f)(3) | Transmission to Public Health Agencies – Reportable Laboratory Tests and Values/Results | § 170.315 (f)(3) Transmission to Public Health Agencies - Reportable Laboratory Tests and Values/Results |
| § 170.315 (f)(4) | Transmission to Cancer Registries | § 170.315 (f)(4) Transmission to Cancer Registries |
| § 170.315 (f)(6) | Transmission to Public Health Agencies – Antimicrobial Use and Resistance Reporting | § 170.315 (f)(6) Transmission to Public Health Agencies - Antimicrobial Use and Resistance Reporting |
| § 170.315 (f)(7) | Transmission to Public Health Agencies – Health Care Surveys | § 170.315 (f)(7) Transmission to Public Health Agencies - Health Care Surveys |
| § 170.315 (g)(3) | Safety-Enhanced Design | § 170.315 (g)(3) Safety-Enhanced Design |
| § 170.315 (g)(4) | Quality Management System | § 170.315 (g)(4) Quality Management System |
| § 170.315 (g)(5) | Accessibility-Centered Design | § 170.315 (g)(5) Accessibility-Centered Design |
| § 170.315 (g)(6) | Consolidated CDA Creation | § 170.315 (g)(6) Consolidated CDA Creation |
| § 170.315 (g)(7) | Application Access - Patient Selection | § 170.315 (g)(7) Application Access - Patient Selection |
| § 170.315 (g)(8) | Application Access - Data Category Request | § 170.315 (g)(8) Application Access - Data Category Request |
| § 170.315 (g)(9) | Application Access - All Data Request | § 170.315 (g)(9) Application Access - All Data Request |
| Cypress Implementation Guide | Cypress Quick Start Guide |
| Application | Tool Production URL | NIST Test Process Document |
|---|---|---|
| Immunization | http://hl7v2-iz-r1.5-testing.nist.gov | NIST_IZ_Normative_Test_Process_Document |
| Syndromic surveillance | http://hl7v2-ss-r2-testing.nist.gov/ | NIST_SS_Normative_Test_Process_Document |
| Electronic prescribing | http://erx-2015.nist.gov/ | NIST_eRx_Normative_Test_Process_Document |
| Reportable laboratory results | http://hl7v2-elr-testing.nist.gov/ | NIST_ELR_Normative_Test_Process_Document |
C-CDA Cancer Registry Reporting Validation Tool | http://cda-validation.nist.gov/cda-validation/muCRV.html | None |
| NIST Health Care Survey validator | http://cda-validation.nist.gov/cda-validation/muNHCS.html | None |
| Edge Test Tool (ETT) | http://edge.nist.gov/ | None |
| Transport Test Tool (TTT) (Original) | http://transport-testing.nist.gov/ | None |
The Normative Test Process Documents are available for review and comment. Please submit the comments to the address provided (NTPD_comments@nist.gov)
