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Health Data law in France
GDPR and EHDS (Regulation on Health Data of the European Space (EHDS): Which rules for the processing of health data in Europe?
The entry into force of Regulation 2025/327 concerning the European Health Data Space (“EEDS” or “EHDS”) on 26 March 2025 constitutes a major advancement in
Pseudonymisation and anonymization of health data: what are the consequences of the EDPB’s new guidelines?
I. EDPB Guidelines: Clarifications about anonymization and pseudonymization The EDPB/ICO guidelines, published on January 16, 2025, provide clarification on the concept of pseudonymization as set
The Code of Conduct for CROs: what are the data protection obligations for Contract Research Organizations (CROs)?
With the recent approval of the EUCROF Code of Conduct by the CNIL, Contract Research Organizations (CROs) must now adapt to a new, demanding framework
Transparency Portals & healthcare professionals : how to use them?
Transparency portals are increasingly becoming an indispensable benchmark for healthcare professionals, given the proliferation of sensitive data processing. How do these tools ensure compliance with
CNIL sanction: A software publisher for medical laboratories fined 1.5 million euros in administrative penalties
On April 21, 2022, the CNIL issued an enforcement decision by which the company DEDALUS BIOLOGIE was fined 1.5 million euros. On February 23, 2021,
Health data: definition and legal framework
What are health data, how are they classified, and what is the legal framework applicable to them? Aumans Avocats, a law firm specializing particularly in
The European Health Data Space (EHDS): What Impact for Healthcare Professionals?
I. Presentation of the EHDS Regulation As part of its digital strategy, the European Union is developing several European data spaces aimed at facilitating data
Decentralized Clinical Trials: Definition, Regulations, and French CNIL Standards
I. Decentralized Clinical Trials 1. Definition A clinical trial (Art. 2.2.2), according to Regulation 536/2014, is a clinical study (Art. 2.2.1), which is an investigation