Kaiku Health Real World Test Plan
2025 Performance Year
| Kaiku Health Real-World Testing | 2025 | 2024 | 2023 |
|---|---|---|---|
| Plans | Download | Download | Download |
| Results | Visit page | Visit page |
Justification for Real-World Testing Approach
Kaiku Health is a certified health information system that provides care teams with several tools for digital health interventions including a set of oncology-specific patient portal features that the certification focuses on. Combined with health information capture through patient-reported outcomes (PROs) and secure messaging, patients are provided timely access to view, download, and transmit their records.
This test plan is designed to test the functionality certified by the ONC Health IT Certification program as it is used in the real world. The following criteria are in the scope of this plan:
- § 170.315(b)(10) Electronic Health Information Export
- § 170.315(e)(1) View, Download and Transmit to 3rd party
Overall Approach
Kaiku Health is a cloud-hosted health information system that is currently sold to Radiation Oncology and Medical Oncology care settings. Cloud hosting enables telemetry connectivity for all sold instances of the health information system. This provides remote event tracking capability which will be used for real world testing of the criterion which is in scope of this plan. This ensures testing results accurately reflect the real-world performance of the health information system.
The tested criterion (b)(10) requires that authorized health care provider users can export Electronic Health Information (EHI) for the patient population as well as for individual patients stored in the system.
The tested criterion (e)(1) requires that patients can view, download and transmit their health information. Remote tracking will therefore focus on patients’ attempts to view, download, and transmit, their health information using the health information system. Additionally, patients need to be able to view the activity log, showing how their health information was accessed for view, download and transmit. Real-world error rates will be established for each of those functionalities.
Milestones
| Milestone | Care Setting | Timeframe |
|---|---|---|
| Baseline remote event and error rate collection period | Radiation Oncology Medical Oncology | January 1 - February 28, 2025 |
| Error rate tracking period | Radiation Oncology Medical Oncology | March 1 - December 31, 2025 |
| Analysis and report creation | Radiation Oncology Medical Oncology | January - February, 2026 |
| Submit Real World Testing report to ACB per instructions | Radiation Oncology Medical Oncology | February 15, 2026 |
Measures used in Overall Approach
Description of Measurement/Metric
| Measurement/Metric | Description |
|---|---|
| Error rate for EHI population export | Total number of errors observed in ‘EHI population export’ functionality, divided by total number of attempts for the ‘EHI population export’ functionality, expressed in %. Baseline error rate will be measured during a baseline collection period (see Milestones). Error rate will be tracked continuously after the baseline collection period. |
| Error rate for EHI single patient export | Total number of errors observed in ‘EHI single patient export’ functionality, divided by total number of attempts for the ‘EHI single patient export’ functionality, expressed in %. Baseline error rate will be measured during a baseline collection period (see Milestones). Error rate will be tracked continuously after the baseline collection period. |
| Error rate for View patient records | Total number of errors observed in ‘View patient records’ functionality, divided by total number of attempts for the ‘View patient records’ functionality, expressed in %. Baseline error rate will be measured during a baseline collection period (see Milestones). Error rate will be tracked continuously after the baseline collection period. |
| Error rate for Download patient records | Total number of errors observed in ‘Download patient records’ functionality, divided by total number of attempts for the ‘Download patient records’ functionality, expressed in %. Baseline error rate will be measured during a baseline collection period (see Milestones). Error rate will be tracked continuously after the baseline collection period. |
| Error rate for Transmit (unencrypted email) | Total number of errors observed in ‘Transmit (unencrypted email)’ functionality, divided by total number of attempts for the ‘Transmit (unencrypted email)’ functionality, expressed in %. Baseline error rate will be measured during a baseline collection period (see Milestones). Error rate will be tracked continuously after the baseline collection period. |
| Error rate for Transmit (secure) | Total number of errors observed in ‘Transmit (secure)’ functionality, divided by total number of attempts for the ‘Transmit (secure)’ functionality, expressed in %. Baseline error rate will be measured during a baseline collection period (see Milestones). Error rate will be tracked continuously after the baseline collection period. |
| Error rate for View Activity Log | Total number of errors observed in ‘View Activity Log’ functionality, divided by total number of attempts for the ‘View Activity Log’ functionality, expressed in %. Baseline error rate will be measured during a baseline collection period (see Milestones). Error rate will be tracked continuously after the baseline collection period. |
Associated Certification Criteria
| Measurement/Metric | Associated Certification Criteria | Relied Upon Software |
|---|---|---|
| Error rate for EHI population export | § 170.315(b)(10) Electronic Health Information Export | MOSAIQ 2.82 (or higher) |
| Error rate for EHI single patient export | § 170.315(b)(10) Electronic Health Information Export | MOSAIQ 2.82 (or higher) |
| Error rate for View patient records | 1170.315(e)(1): View, Download and Transmit to 3rd Party | MOSAIQ 2.82 (or higher) |
| Error rate for Download patient records | 170.315(e)(1): View, Download and Transmit to 3rd Party | MOSAIQ 2.82 (or higher) |
| Error rate for Transmit (unencrypted email) | 170.315(e)(1): View, Download and Transmit to 3rd Party | MOSAIQ 2.82 (or higher) |
| Error rate for Transmit (secure) | 170.315(e)(1): View, Download and Transmit to 3rd Party | MOSAIQ 2.82 (or higher) |
| Error rate for View Activity Log | 170.315(e)(1): View, Download and Transmit to 3rd Party | MOSAIQ 2.82 (or higher) |
Justification for Selected Measurement/Metric
| Measurement/Metric | Justification |
|---|---|
| Error rate for EHI population export | Exporting EHI for patient population is required in § 170.315(b)(10)(i)(A) |
| Error rate for EHI single patient export | Exporting EHI for single patient is required in § 170.315(b)(10)(ii)(A) |
| Error rate for View patient records | Viewing patients’ health information is required in §170.315(e)(1)(i)(A) |
| Error rate for Download patient records | Downloading patients’ health information is required in §170.315(e)(1)(i)(B)(1) |
| Error rate for Transmit (unencrypted email) | Transmitting patients’ health information via unencrypted email is required in §170.315(e)(1) (i)(C)(1)(i) |
| Error rate for Transmit (secure) | Transmitting patients’ health information via a secure channel is required in §170.315(e)(1) (i)(C)(1)(ii) |
| Error rate for View Activity Log | Viewing the Activity Log for access to patients’ health information is required in §170.315(e)(1)(ii)(A) |
Care Settings
Elekta markets its products in the Radiation Oncology and Medical Oncology care settings. The measurements which are part of this plan will be tracked on all instances of Kaiku Health sold in the United States. This includes both care settings.
Expected Outcomes
| Measurement/Metric | Expected Outcomes |
|---|---|
| Error rate for EHI population export | Baseline error rate is expected to be low. Tracking error rate is expected to be comparable or lower than baseline error rate. |
| Error rate for EHI single patient export | Baseline error rate is expected to be low. Tracking error rate is expected to be comparable or lower than baseline error rate. |
| Error rate for View patient records | Baseline error rate is expected to be low. Tracking error rate is expected to be comparable or lower than baseline error rate. |
| Error rate for Download patient records | Baseline error rate is expected to be low. Tracking error rate is expected to be comparable or lower than baseline error rate. |
| Error rate for Transmit (unencrypted email) | Baseline error rate is expected to be low. Tracking error rate is expected to be comparable or lower than baseline error rate. |
| Error rate for Transmit (secure) | Baseline error rate is expected to be low. Tracking error rate is expected to be comparable or lower than baseline error rate. |
| Error rate for View Activity Log | Baseline error rate is expected to be low. Tracking error rate is expected to be comparable or lower than baseline error rate. |
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 the plan is up to date and fully addresses the health IT developer’s Real World Testing requirements.
Authorized Representative Name: Martin Deppe
Authorized Representative Email: martin.deppe@elekta.com
Authorized Representative Phone: +358 40 661 7170
Authorized Representative Signature:
Date: 10 / 11 / 2024