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Host your clients' health data in full compliance with regulations. FeelAgile helps you obtain Health Data Host certification to secure your business, reassure healthcare providers, and open up new markets.
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HDS (Health Data Host) certification is a French regulatory requirement imposed byArticle L.1111-8 of the Public Health Code. Any organization that hosts, processes, or stores personal health data on behalf of third parties must be certified by a body accredited by COFRAC.
The HDS framework defines the security requirements that must be met to host health data in France. It is based on the ISO 27001:2022 standard and adds sector-specific requirements, including the management of healthcare professionals’ access permissions, continuity of data access, and digital sovereignty.
It serves both as a framework for regulatory compliance and as a strong signal of trust to your customers. In an industry where the reliability of the hosting provider is critical to patient care, HDS certification is the standard expected by all stakeholders.
HDS certification has become essential for entering the digital health market. But between interpreting the standards, coordinating teams, and producing documentation, the process takes longer than expected. Here are the six obstacles that companies going it alone consistently face.
HDS combines ISO 27001:2022 with specific healthcare requirements. Determining which provisions apply to your exact scope requires a careful reading that few internal teams are able to master right away.
The certification body evaluates concrete evidence: policies, procedures, logs, and tests. Without a structured roadmap, teams end up going in all directions and deadlines are missed.
A deficiency identified during the audit phase results in a delay in certification and costly remediation cycles. Early support helps address these issues before they become insurmountable.
IT, legal, DPO, business units: HDS certification involves multiple teams simultaneously. Without dedicated leadership, responsibilities become diffuse and the project stalls.
Security policies, business continuity plans, clearance records, backup documentation: compiling a comprehensive and consistent set of documents is time-consuming for teams that are already stretched thin.
Achieving HDS certification is not an end in itself. Surveillance audits, managing changes to the information system, and updating documentation require constant vigilance, which is often underestimated.
Our agile approach turns these challenges into manageable steps. A dedicated project manager guides you through each milestone, simply and efficiently.
Talk to an expert →Whether you're starting from scratch or looking to accelerate an existing initiative, we offer the format that best suits your organization.
Take control of your HDS certification. At yourown pace.
Access our GRC platform and a comprehensive HDS playbook to independently structure your ISMS. The tool handles the framework; you stay in control.
An HDS expert by your side. No blind spots.
Take advantage of a structured support program that combines consulting, training, and auditing to help you move faster, avoid critical mistakes, and feel confident on the day of your certification audit.
Leave it all to us. Get your certification.
We manage every aspect of your HDS project: from the initial planning to obtaining the certificate. Your team can stay focused on its core business.
Each step is clearly defined, documented, and monitored using specific metrics. You always know where you stand.
Assessment of your HDS maturity, definition of the scope of the solution, and identification of gaps relative to the framework. You’ll leave with a clear, prioritized roadmap.
Analysis of risks associated with health data, drafting of security policies, and definition of applicable controls. Each deliverable complies with the standard’s requirements.
Implementation of HDS controls, team training, and system management. You demonstrate how your system actually works.
Simulation of the full audit, correction of non-conformities, management review, followed by support during both phases of the audit conducted by the accredited certification body.
In addition to ISO 27001, we cover all information security certifications
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Here’s what those who have experienced the program firsthand have to say.
"
We had very good support. Our quality system was very well studied by the project manager, which made the whole project easier."
Stefano FIORENTINI - CTO
"
Feel Agile has great process knowledge, a project plan with an efficient tempo and existing documentation material to save time."
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Mickaël KLAUS
"
Thanks to Feel Agile, we were able to obtain ISO 27001 certification without a single non-conformity, which is a rare achievement."
Julien Cassagnabère -RSSI
Everything you need to know about HDS
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