General Information
Plan Report ID Number: [For ONC-Authorized Certification Body use only]
Developer Name: Trinitas LLC
Product Name: FEHR
Version Number: 2024
Certified Health IT Product List (CHPL) ID: 15.04.04.3189.FEHR.01.00.0.240314
Developer Real World Testing Plan Page URL: TBD
Regulation Text
§ 170.315 (b)(10) Electronic Health Information export-
- Single patient electronic health information export.
- Enable a user to timely create an export file(s) with all of a single patient’s electronic health information that can be stored at the time of certification by the product, of which the Health IT Module is a part.
- A user must be able to execute this capability at any time the user chooses and without subsequent developer assistance to operate.
- Limit the ability of users who can create such export file(s) in at least one of these two ways:
- To a specific set of identified users
- As system administrator function.
- The export file(s) created must be electronic and in a computable format.
- The publicly accessible hyperlink of the export’s format must be included with the exported file(s).
- Patient population electronic health information export. Create an export of all the electronic health information that can be stored at the time of certification by the product, of which the Health IT Module is a part.
- The export created must be electronic and in a computable format.
- The publicly accessible hyperlink of the export’s format must be included with the exported file(s).
- Documentation. The export format(s) used to support paragraphs (b)(10)(i) and (ii) of this section must be kept up-to-date.
Regulation text referenced from: Electronic Health Information export | HealthIT.gov
Workflow Summary
In FEHR, there are two workflows to export EHI:
- Single patient EHI export: When an individual patient’s EHI is needed for release or transfer, an administrative user can directly initiate the export through FEHR’s administrative interface. This process generates a secure, encrypted file containing the complete EHI available at the time of certification. The exported data, packaged in a computable format, includes a hyperlink to detailed format specifications to ensure accessibility.
- Patient population EHI export: For scenarios involving multiple patients, such as when a provider transitions to a different practice, authorized administrative users can define criteria to select a population of patients and initiate the EHI export. This functionality is structured to support the organization’s needs for large-scale data transfers efficiently and securely.
Technical Specifications
The files in the EHI export package are consolidated into a single file.
The exported file follows the standard outlined in FEHR’s online documentation, which specifies the format of the data export, and EHI table schemas. FEHR EHI Export Documentation | FEHR EHI Export Documentation
Method and Justification
The following metrics are used to demonstrate conformance to requirements of this criterion by tracking how frequently this functionality is used in real-world settings:
- Metric 1a: Count of Single Patient EHI Exports
- This metric is a count of single patient EHI exports performed by participating organizations, showing the configuration and successful use of EHI export functionality for individual patients.
- Metric 1b: Ratio of Single Patient EHI Exports to All Visits
- To provide context, this metric compares the number of single patient EHI exports to the number of visits within the same timeframe, illustrating the real-world usage volume of this export feature.
- Metric 2: Count of Patient Population EHI Exports
- This metric is a count of patient population EHI exports, demonstrating the setup and successful use of the EHI export functionality for multiple patients at a time.
- Metric 3: Average Patients per Patient Population EHI Export
- This metric shows the average number of patients included in each patient population EHI export, offering context for the scale of each export event.
Care Settings
Fusion Health is marketed to clinics and hospitals with a primary focus on patients residing in secure settings. These settings include a range of environments where individuals reside under controlled supervision and require specialized care. The settings generally include correctional facilities such as jails, prisons, forensic hospitals, and juvenile justice agencies. Correctional healthcare services encompass but are not limited to primary care, chronic care, dental care, urgent care, psychiatry, psychology, physical and rehabilitative therapies, and patient education.
Expected Outcomes
These metrics are expected to show that EHI export functionality is effectively used by participating organizations in real-world settings. It is anticipated that single patient EHI exports will be more frequent than patient population EHI exports, given that individual patient record requests are generally more common.
Schedule of Key Milestones
Key milestones apply to all care settings mentioned above.
| Key Milestone | Date/Time Frame |
|---|---|
| Test Plan Submission to ONC-ACB | November 12, 2024 |
| Data Collection | January 1, 2025 – December 31, 2025 |
| Validation of Expected Outcomes | Quarterly |
| Analysis and Report Creation | January 1, 2025 – January 31, 2026 |
| Results Submission to ONC-ACB | January 31, 2026 |
Non-deployed and/ or Low Use Capabilities
Fusion Health developers may use synthetic patient data in lieu of or in addition to real patient data in real or simulated/test scenarios, executed in environments that mirror production environments.
Attestation
This Real World Testing plan is complete with all required elements, including measures that address all certification criteria and care settings. All information in this plan is up to date and fully addresses the health IT developer’s Real World Testing Requirements.
Authorized Representative Name: Bryan Jakovcic
Authorized Representative Email: compliance@trinitashealth.com
Authorized Representative Phone: 619.732.6146
Date: November 12, 2024