Article 51 innovation support
From building the experimentation proposal to implementing the technical platform. We combine regulatory expertise and development capability to bring your innovative project to fruition.
From idea to experimentation
Proposal development
Specification structuring, patient pathway modeling, health economics rationale. We help you formalize your innovation project in the format expected by the Article 51 (French healthcare innovation program) technical committee, with evaluation indicators and the target economic model.
Technical platform
Development of the experimentation platform: data collection, cohort tracking, teleconsultation. The tool is custom-built for your protocol, with features specific to your experimentation and the interfaces needed with existing information systems.
Monitoring & indicators
Experimentation tracking dashboards, data extraction for evaluation. The indicators defined in your proposal are automatically calculated and exportable in the formats required by the evaluator. You monitor your experimentation's progress in real time.
Coordination
Interface with project leaders, ARS (Regional Health Agencies), and field teams. We speak the language of both worlds. Our dual technical and regulatory expertise facilitates exchanges between medical teams, developers, and institutional contacts throughout the project.
Scalability
The tool is designed from the outset for scaling up if the experimentation is successful. The technical architecture is sized to support multi-site deployment without redesign. APIs are documented and interoperability with healthcare IT systems is natively integrated.
Built-in compliance
HDS (Health Data Hosting), GDPR, Pro Sante Connect: compliance is not an add-on, it is the foundation. Every platform component is designed in accordance with the regulatory framework for health data. The AIPD (Data Protection Impact Assessment) is documented and patient consent is natively managed.
Why choose us for your Article 51 project
Combining regulatory expertise and development capability in a single provider is rare. That is our strength.
Dual tech + regulatory expertise
We master both the regulatory framework for Article 51 experimentations (LFSS, specifications, evaluation indicators, economic model) and the technologies needed to build the technical platform. You do not need to coordinate a consulting firm and a separate technical provider: we do both, with the consistency that implies.
Production-ready platforms
We do not deliver mockups or proofs of concept. We develop production-ready platforms, hosted on HDS (Health Data Hosting) infrastructure (Outscale SecNumCloud), with Pro Sante Connect authentication, data encryption, and audit trail. Your experimentation starts on a reliable, secure, and compliant tool from day one.
End-to-end support
From the first brainstorming session to proposal writing, from platform development to experimentation monitoring, from data extraction for evaluation to scaling up: we are at your side every step. A single point of contact who knows your project as a whole and can react quickly to necessary adjustments.
Frequently asked questions
Is my project eligible for the Article 51 program?
The Article 51 (French healthcare innovation program) funds innovative organizational experiments in healthcare. If your project proposes a new care organization, an innovative patient pathway, or a novel prevention approach, it is potentially eligible. We assess relevance together during the scoping phase.
What support do you provide exactly?
Our support is comprehensive: structuring the application file, patient pathway modeling, health economics rationale, technical platform development, experimentation monitoring, and data extraction for evaluation.
How is the project funded?
Article 51 experimentation is funded by the FISS (Healthcare Innovation Fund). The funding covers the additional costs related to the experimentation. Our role is to help you size and justify the budget in the application file.
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