Simplific'Action: Understanding HDS Certification
Regulations
27/04/2026
Everything e-health innovators need to know about Health Data Hosting (HDS).
What is HDS certification?
Users' personal health data is sensitive and must be protected.
As soon as this data is outsourced, the data host must obtain Health Data Hosting (HDS) certification: this is a regulatory requirement.
Who is affected?
All stakeholders in the healthcare ecosystem:
- Hospitals,
- Healthcare professionals,
- Start-ups,
- Innovators,
- Cloud providers,
- Etc...
Who issues this certification?
On one hand, the French Digital Health Agency (ANS) develops the HDS framework, which establishes compliance for hosting providers.
At the same time, the French Accreditation Committee (COFRAC) accredits certification bodies.
Then, these certification bodies issue the HDS certification based on the HDS reference framework.
Key points to remember
You are outsourcing sensitive health data
HDS certification is mandatory
You host a solution that processes personal health data
If you become a hosting provider, HDS certification is required
Security and the Issue of Digital Sovereignty
Users' personal health data must be stored within the European Economic Area.
This is not just a matter of cybersecurity; it is also a matter of digital sovereignty.
HDS certification provides a security guarantee not only to users but also to healthcare professionals.
Are you launching an e-health solution?
Ask yourself these questions:
- Does my innovation collect health data?
- Is my hosting provider HDS-certified?
- If I host it myself, do I have my certification?