AS8_BUC1

Submitted by sfranconi on Tue, 09/10/2024 - 10:09

Patient has access to structured format health data using “Mon espace santé,” and will use the xShare Yellow Button service(s) to decide which data points are to be shared with clinical investigator. Data are available in CDA/FHIR formats.

The patient uses the xShare Yellow Button service(s) to decide which data points are to be shared/donated with clinical investigator. And the xShare Yellow Button service(s) will allow patient data conversion/upload/sharing in structured EEHRxF IPS and sending to the clinical investigator pre-screening tool.

A mapping of the IPS data points and answers to the medical questionnaire will be done followed by automatic completion through the pre-screening tool.

According to the available data, answers to the medical questionnaire are automatically fulfilled. The physician reviews the answers provided by the xShare Yellow Button, and answers the questions left without answer, CT-SCOUT indicates the studies for which the patient is potentially eligible to. The physician selects one or more studies for which he wants to refer the patient and a notification is sent to the study team to facilitate the coordination onsite for future patient inclusion.

Document Version: 
V1.0
Responsible party: 
France adoption side - add contact email address
Source: 
xShare
As-Is Situation: 

Patients have access to their health data through the “Mon espace santé” (My health space) application. The “Mon espace santé” is a patient owned healthcare record and provides to patients and healthcare providers mechanisms to store and maintain data. Through “Mon espace santé” patients can share their data. Data is shared with healthcare professionals.

  • Healthcare professionals in France have access to patient data through their own systems and through the DMP (dossier médical partagé, shared medical record).
  • Data are in CDA and/or FHIR format.

 

There are no mechanisms to enable patients to “donate” their data for secondary use. 

CT-SCOUT is a pre-screening tool used by HCPs at site, which consists in answering a short medical questionnaire filtering automatically the right clinical trials according to the patient profile. The pre-screening performed by CT-SCOUT use real world or data from EHR and do not include specific data from research.

 

Currently available products/services and its vendors: 
DMP (health medical record), “Mon espace santé”, CT-SCOUT
Which health-related standard does your organisation uses and its alignment to the EEHRxF?: 
CDA and FHIR format.
Actors/Users and their Roles: 

Patient

Final user via mobile application, beneficiary.

Healthcare provider

Final user viewing data acquired by patient via button, beneficiary.

EHR

Integrate with the xShare Yellow Button service via API.

Patient mobile application

Integrate with the xShare Yellow Button service via API.

xShare Yellow Button service

Enables the xShare Yellow Button functions via API, benefactor.
User Perspective: 
Until now, patient screening for a clinical trial is conducted by HCPs on site. The patient is invited to participate once the investigative team has identified their potential eligibility, often during a routine visit. The xShare Yellow Button will empower patients to take a proactive role in their medical journey and influence their medical follow-up. Therefore, it would enable patients to:
• Share a selection of personal health data related to their condition to a clinical investigator so that their eligibility to a clinical trial can be assess.
• Share the full patient summary so their full eligibility to a clinical trial can be evaluated by Clinical investigator/research team.
• Be contacted if a new clinical trial matches their health profile so that a clinical investigator can evaluate their eligibility to the new clinical trial.
• Be able to choose the hospital in which a clinical trial matches their health profile so that a clinical investigator can evaluate their potentially eligibility to a clinical trial in the hospital of their choice.
• Be able to get an appointment at the hospital of their choice in which a clinical trial matches their health profile to assess their full eligibility by a clinical investigator during a medical visit.
• Be informed of the clinical trial matching their health profile and evaluate their interest to participate to the clinical trial.
• Know how their data will be used and exercise their data portability rights under GDPR.
• Know which data will be used and exercise their data portability rights under GDPR.
• Modify/delete the access to their data and exercise my data portability rights under GDPR.
Besides benefits for the patient, the use of the xShare Yellow Button will be beneficial for the clinical investigator and the research team. Properly screening patients for eligibility in a clinical trial is one of the most challenging tasks. The xShare Yellow Button could potentially simplify this process by facilitating health data sharing, therefore assisting the PI.
System Perspective: 
The xShare Yellow Button has found its place in the “Settings” and then “Privacy” section of “Mon espace santé”, with, for example, a toggle button to consent to data sharing for identifying eligibility criterion with clinical studies. Through IPS, health data can be converted into EEHRxF, and CT-Scout can access data integrated into the IPS and pre-screen patients or clinical trials.
When a patient is potentially eligible for an ongoing clinical trial at the investigation site, they receive a notification and are contacted to schedule a screening visit. Patient pre-screening data are available in the patient management section of the CT-SCOUT application.
Health Information Domain(s) - HIDs: 
Patient summary
Scenarios for the xShare Yellow Button: 

HIDs

xShare Yellow Button basic functionality

Maturity

 

Download

One-time share

Linked options

Start TRL

End TRL

Patient summary

X

X

X

3

7

Electronic prescription

 

 

 

 

 

Electronic dispensation

 

 

 

 

 

Medical image
and image report

 

 

 

 

 

Laboratory results

 

 

 

 

 

Discharge report

 

 

 

 

 

Telemonitoring

 

 

 

 

 

Care plan

 

 

 

 

 
National/regional strategy: 
The national strategy lead by the French ministry of health with the SUN-ES program aims to contribute to the generalization of fluid and secure sharing of healthcare data, in order to accelerate its use. “Mon espace santé” is a part of this program and the main challenge is to democratize its use by systematically importing healthcare data from hospitals, clinics, laboratories, etc., and enabling patients to empower their data.
Strategy towards EHDS: 
Health data from “Mon espace santé” will be translated to EEHRxF.
Business Goals/Benefits and KPIs: 

The use case is executed to enhance patient inclusion in clinical trials. Indeed, recruitment is one of the most important and challenging aspect of clinical trials. By facilitating patient inclusion, patients can actively participate in their own health within the clinical trial context, which has traditionally been reserved for HCPs. Benefits are for the patient to empower their health with their assessment in clinical trial, for the Clinical investigator and the research team to be able to recruit the right number of patients and for both to advance clinical research. The evaluation can be performed by the following KPIs: 

  • Number of patients with a “Mon espace santé” account activated. 
  • Number of patients using “Mon espace santé” functionalities
  • Number of patients referred for clinical trial. 
  • Number of patients included in clinical trial.

 

Application: 
Patient mobile app and healthcare provider EHR system.
Data Preconditions: 
Coded data aligned with EEHRxF.
System Preconditions: 
FHIR transactions capability and compliant with consent policies.
User Preconditions: 
Patient: familiarity with the xShare Yellow Button.
Trigger: 
The patient allows the link through the xShare yellow Button from “Mon espace santé” to CT-SCOUT.
Challenges/Limitations: 
Collaboration with “Mon espace santé” working team.
Involved stakeholders in the BUC definition: 
Patient, clinical investigator, research team.
Application of pseudonymisation filters: 
Patients will have a pseudonymisation number while being pre-screened in the pre-screening tool.
Basic Workflow: 

Basic Scenario: A patient has been diagnosis with a new condition and wants to know if he/she can be included in a clinical trial in one of the hospital next to his/her home.

Basic flow Steps: 

  1. The patient logs in to “Mon espace santé”.
  2. The patient authorizes the sharing of their data for evaluating their eligibility for a clinical trial with the xShare Yellow Button.
  3. The health data are converted into the EEHRxF/IPS format.
  4. The health data are shared.
  5. CT-SCOUT application interprets the data.
  6. The results of compatible studies and participating centres are accessible to the patient in “Mon espace santé “
  7. The patient gives consent for their data to be sent to their chosen centre.
  8. The centre (Investigator and research team) can contact the patient to finalize the process.
  9. The centre receives this information in the patient management section of CT-SCOUT.
  10. The centre accesses the patient’s pre-screening data.
  11. Finally, the centre contacts the patient to schedule the visit
Alternative Workflows: 

Alternative N°1: The patient health condition changes and the results of compatible studies in the centres evolve accordingly.

Alternative N°2: The patient makes an appointment directly with the centre to discuss his/her eligibility, and shares data with the HCP (QR code) via “Mon espace santé”. Specific pre-screening data are available in CT-SCOUT patient management.