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ONC Certification
Regard's Health IT Module is certified under the ONC 2015Cures Update criteria, supporting interoperability, EHI export,and secure authentication.
CONTENT
170.315(d)(13) Multi-Factor Authentication
The Regard solution relies on the electronic medical record (EMR)'s two-factor authentication protocol known as Smart on FHIR.
EHI Export Overview
EHI (electronic health information) Export is a feature that allows users to export electronic health information (EHI) from certified health IT modules, such as EHRs, in a computable and electronic format.
EHI Export is one of the requirements of the Promoting Interoperability Program, which aims to encourage the adoption and meaningful use of certified EHR technology (CEHRT).
EHI Export has two components: a single-patient EHI export and a patient population EHI export.
- It supports single patient EHI access requests, which can help patients obtain a copy of their health records in a timely and computable manner.
- It supports the entire patient population EHI export, which can help health IT developers and health
systems transfer or migrate data to another system or product.
EHI Export Benefits
Regard meets the certification criterion §170.315(b)(10) Electronic Health Information export by implementing the FHIR Export for Single Patient and Bulk Export.
A user can perform an electronic health information (EHI) export:
For a single patient
- Can export at any time the user chooses.
- Can operate without creating a subsequent support ticket for developer assistance.
- Includes all the EHI for a single patient.
- Is electronic and in a computable format.
- Includes a publicly accessible hyperlink to the export's format, which allows any user to directly access the export file information without preconditions or additional steps.
- The EHI export file format describes the structure and syntax of how the EHI is exported (but not
the EHI itself). - Users can use the export format documentation to process EHI after Regard has exported it and to
facilitate its movement to other systems.
For a single patient
- Includes all the EHI for a patient population.
- Is electronic and in a computable format.
- Includes a publicly accessible hyperlink to the export's format, which allows any user to directly access the export file information without preconditions or additional steps.
- The EHI export file format describes the structure and syntax of how the EHI is exported (but not the EHI itself).
- When healthcare providers switch to health IT systems, they can request Regard action or support for successful migration of patient data.
- Users can use the export format documentation to process EHI after Regard has exported it and to
facilitate its movement to other systems.
Regard can limit users who perform an EHI export
Only administrators have the ability to perform the export.
Single-patient vs. patient population EHI export
Single-patient EHI export enables a user of Regard to export the selected EHI for a single patient at any time the user chooses, without the developer's assistance.
Patient population EHI export enables Regard to create an export of all the EHI for a patient population upon request.
Data elements and format of the EHI export
The data elements that are to be included are more than just the USCDI. The data elements that should be included are what is considered part of the Designated Record Set. See Table 2 starting on page 17 of the AHIMA EHI Task Force Report for other data elements considered PHI that should be part of the export:
https://www.ahima.org/media/vxwhhcti/ehi-task-force-report-revision-final.pdf
All Regard export files use the CSV format.
Path for exported EHI
Users can download the exported data to any folder of their choice on their system.
How to request and access the EHI export
Users can request and access the EHI export through the user interface of Regard for single patient export. Administrators may place a request to Regard to download total patient population export.
Support and more information
For queries related to export and support, please contact Regard by email: hello@withregard.com.
Mandatory Disclosures
Product
Regard SaaS Solution v.1
Certification Criteria
ONC 2015 Cures Update: B10, D1, D5, D12, D13, G5, G4
Date of Certification
May 2, 2024
Unique Certification Number
15.04.04.3192.Rega.01.00.0.240502
CQMS
ISO 9001
This Health IT Module is compliant with the ONC Certification Criteria for Health IT and has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services.
Regard Technologies Real World Test Plan 2025
Standards Advancement Version Process (SVAP)
Standard (and version)
N/A
Updated certification criteria and associated product
N/A
Health IT Module CHPL ID
15.04.04.3192.Rega.01.00.0.240502
Date of ONC ACB notification
N/A
Date of customer notification
N/A
Conformance method and measurement/metric(s)
N/A
Justification for Real World Testing: We are measuring and reporting on the results criteria as required by the ONC for reporting purposes.
170.315 b.10 Electronic Health Export
Measurement/Metric
Description
Success rate in completing EHI data export
This metric measures the overall success rate through internal testing of exporting EHI via the export feature on Regard's platform. We will conduct internal testing as we do not expect our customers to use this functionality during the testing year.
Measurement/Metric
Associated Certification Criteria
Relied Upon Software
Success rate in completing EHI data export
B10
N/A
Measurement/Metric
Justification
Success rate in completing EHI data export
This metric measures the success rate through internal testing of exporting EHI via the export feature on Regard's platform. This is an appropriate metric because it proves the validity of the EHI export functionality.
Care Setting
Justification
All
—
Measurement/Metric
Expected Outcome
Success rate
The expected outcome is that there is a high (close to 100%) success rate that enables users to create an export file with patient electronic health information.
Our EHI export functionality will create an export file, execute at any time, limit the ability of users who can create export, and is in an electronic and computable format.
Test Plan
We don't anticipate having customers using the b10 EHI export functionality. We are doing internal testing with synthetic data in our test (demo) environment.
In order to measure the success rate of the EHI export functionality, we will conduct internal testing given that our customers do not use this feature. We will conduct internal tests on our engineering team to ensure that we can export all EHI. We will select 5 synthetic patients across test customers and report back the success rate based on X/5, X being the number of successful EHI exports that we conduct out of the 5 that we attempt.
Schedule of Key Milestones
Key Milestones
Care Setting
Date/Timeframe
Complete and submit test plan
All
10/30/24
Gather & analyze data
All
2025
Submit results
All
2026
Last updated: June 2026
