Health data, GDPR and AI
You are developing a health product and aiming for the European market. The office handles the data questions that condition your trials and your launch in Europe, including where your company has no establishment there.
French attorney (avocat), holder of the CIPP/E certification issued by the IAPP.
Admission and scope. Admitted to practice in France (Barreau de Mulhouse). Advice is limited to French and EU law. Not admitted to practice law in any U.S. jurisdiction; no advice on U.S. law.
Biotech · Pharma · Medical devices · Digital health
Health data
What needs to be settled to run your trials, host your data and go to market in Europe.
- Clinical trials: CNIL formalities, transfers of trial data, legal representative in the Union for a sponsor not established there (Article 74 of Regulation (EU) No 536/2014)
- Hosting health data in France: HDS certification (Article L. 1111-8 of the French Public Health Code)
- AI and medical devices: how the AI Act and the Medical Device Regulation fit together
- European Health Data Space (Regulation (EU) 2025/327): preparing now
GDPR and Data Act
- GDPR applicability without an establishment in Europe (Article 3)
- Contracts, data transfers and representative in the Union
- Data breaches and CNIL inspections
- Access to connected product data (Data Act)
AI Act
- Classification of your AI systems
- Transparency and AI literacy
- Contracts with providers
The steps of your project
1
The project
What applies to your products, your data and your AI systems, what could block you, and what to plan. Delivered as a prioritised action plan.
2
The launch
Contracts, transfer mechanisms, GDPR and AI Act documentation, representative in the Union where the law requires one.
3
Running your business
Partners, distributors, hospitals and research organisations: data clauses, buyers’ questionnaires, renewals.
Regulatory calendar
Key deadlines. Updated 31 October 2026.
| Date | Text | Status | Content |
|---|---|---|---|
| 12 Sep 2026 | Data Act | In force | Data access by design for connected products, including medical devices. |
| 2 Dec 2026 | AI Act | Upcoming | Marking of content generated by systems already on the market. |
| 26 Mar 2027 | Health data | Upcoming | General application of the European Health Data Space Regulation. |
| 2 Dec 2027 | AI Act | Upcoming | High-risk systems: hiring, credit, education. |
| 2 Aug 2028 | AI Act | Upcoming | High-risk AI in regulated products, including medical devices. |
| 26 Mar 2029 | Health data | Upcoming | Access to health data for research and innovation, under a permit. |
| 26 Mar 2031 | Health data | Upcoming | Extension to clinical trial, genetic and genomic data. |
Hourly rate and fee agreement: see the Fees page. Back to Companies.
Discuss your project
A first confidential call helps define your needs and prepare a quote.