France
The French Adoption site objective is to aspire to connect to the French Mon Espace Santé ecosystem with industry solutions implementing the xShare Yellow Button, from a SME perspective.
Mon Espace Santé exists at a national level and allows French citizens to store, control and share their data, such as their health documents, securely. The french adoption site work is conducted within the framework of clinical research, involving the implementation of the Yellow Button feature in solutions used for clinical trials. The use case aims to evaluate the implementation of the Yellow Button within a patient-facing transparency portal and electronic consent platform developed by TTSA. This solution is designed to integrate into the Mon Espace Santé ecosystem.
TTSA is an SME, a vendor developing solution applied to clinical research and data management. The transparency portal / electronic consent platform for clinical studies is initially intended to serve as a digital platform enabling patients to access clear, reliable, and up-to-date information about their participation and the use of their data in clinical trials. It also provides information on the conduct, results, and secondary use of data generated from these clinical trials. The firsts’ objectives are to inform patients and citizens and explain how their medical data may be used in the context of research but also to allow patients to exercise their rights (consent, objection, withdrawal). The main functionality of the transparency portal is the electronic consent management for patients to consent to the Informed Consent Form (ICF) for clinical trial and give consent or non -opposition for data reuse. Consent can be given independently to data reuse from the Clinical trial.
This eConsent solution provides patients with an online portal where they can stay informed and actively manage their consents. Through the portal and by the information and ICF workflow, patients can:
- Refuse participation if they do not wish to be involved.
- Request additional information to better understand the implications of their consent.
- Validate their consent once they feel fully informed and comfortable.
Even after signing, patients retain full control over their consent. They can access it at any time, from anywhere, and continue to manage it according to their preferences. Patients have the fundamental right to withdraw or reject their consent at any stage, even after it has been signed, without any impact on their medical care. This ensures that participation remains voluntary and aligned with their wishes and circumstances. The portal supports this right by offering an easy access to signed consent forms for review, clear options to revoke consent without unnecessary barriers and immediate effect of withdrawal, ensuring that the patient’s decision is respected and implemented promptly. By safeguarding the right to reject consent, the solution empowers patients to always remain in control of their decisions.
An added value of the Portal is that it empowers patients to directly manage their health data in compliance with GDPR. With the implementation of the Yellow Button options, patients could choose to link their portal to Mon Espace Santé or to other certified systems such as EHRs, PHRs, or IPS/IPS+ files. Within this secure environment, patients will retain full control over their personal data, with the ability to access their health information at any time, rectify inaccurate or incomplete data, erase data when they no longer wish it to be stored (“right to be forgotten”) and control how and where their information is stored and processed.
The Yellow Button feature also enable patients to share their health data—only under their explicit, informed consent—to other clinical research solutions such as prescreening tools, electronic case report forms (eCRFs), or repositories. This design ensures that data sharing is voluntary and revocable at any time. Patients are fully informed about the purpose and recipients of their data and all processing activities respect GDPR principles.
French adoption site BUC’s objective is to explore the Yellow Button implementation in products aspiring to be part of the Mon Espace Santé ecosystem and demonstrate the interest in clinical research digital solutions.
Personas - use cases
Priority categories
International Patient Summary (IPS)
International Patient Summary for Research (IPS+) (NEW)
Yellow Button basic functionalities
One time share
- Document Provider (IPS+)
- Document Consumer (IPS)
Architecture
Timeline
- Define the use case and assess the integration of the Yellow Button within the solution.
- Develop and validate the Yellow Button functionalities using synthetic data.
- Evolve the eConsent platform into a transparency portal, enabling patients to monitor and manage the reuse of their health data.
- Finalize the inclusion process in the Mon Espace Santé catalog, ensuring compliance with security, interoperability, and ethical requirements.
- Engage public healthcare institutions and conduct pilot studies to validate the solution in real-world clinical research settings and support wider adoption.
Demonstrations / interviews
Challenges and Remarks
The next step for the demonstrator is to assess how the solution can integrate with Mon Espace Santé (MES), France’s national digital health platform. Mon Espace Santé provides a government-approved catalog of digital health services that meet requirements for interoperability, security, ethics, and data protection. Health data exchange is based on HL7 FHIR standards and can be both read and written by approved services, always with the patient’s consent. To be included in the MES catalog, a service must demonstrate health benefits, process meaningful health data, comply with GDPR and security requirements, be publicly accessible, and support MES interoperability. The onboarding process includes registration, compliance assessments, technical validation, committee review, and final approval before publication in the catalog. Integration can only begin once the product reaches production-level maturity.
A key Portal Challenge is evolving the current solution from a standalone eConsent tool into a transparency portal. The demonstrator’s first phase focuses on consuming then sharing IPS data through the Yellow Button. A future phase aims to transform the platform into an “IPS+ creator”, capable of generating enriched health summaries and contributing new data to the ecosystem.
The Clinical Research Challenge is gaining adoption within public hospitals, which operate under strict regulatory and security requirements. Building trust requires strong guarantees in data protection, interoperability, and compliance. Achieving a higher xShare certification/label would strengthen credibility and support adoption by demonstrating alignment with recognized digital health standards.