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Health DPO: Why is appointment mandatory?
Summary: The appointment of a health DPO is mandatory in many healthcare institutions and companies due to the sensitivity of the data processed on a large scale. The DPO guides the organization in securing data...
Health data: definition, regulations, and challenges for organizations
Introduction In the age of digital technology and e-health, health data has become a major strategic asset. Digital medical records, health tracking apps, connected devices, and telemedicine platforms such as Doctolib...
Clinical studies & GDPR : everything patients, investigators and sponsors want to know
Clinical trials are essential to the development of new treatments and medical devices. Each clinical trial is a key step toward innovation in healthcare. They make it possible to verify the efficacy, tolerance, and safety of healthcare innovations before they are...
Medical devices: definition, legal framework and challenges
When talking about health, the term "medical device" often comes up, but its definition sometimes remains unclear to both the general public and professionals. However, understanding what this concept covers is essential, as it directly affects the products used...
Healthcare DTx: Everything you need to know about digital therapies
Introduction The acronym "DTx" is appearing more and more frequently in discussions about innovation in healthcare. Behind these three letters lies a silent revolution that is gradually transforming medical care: digital therapeutics.
Clinical Trials: A Comprehensive Guide for Healthcare Professionals
Introduction Clinical trials are a fundamental pillar of medical innovation and the development of new treatments. This rigorous scientific research makes it possible to evaluate the efficacy and safety for patients before new drugs, devices, etc. are authorized for marketing.
Reactovigilance: monitoring and safety of medical devices by the ANSM
Introduction Reactovigilance is a key pillar of health safety in France. This surveillance focuses on incidents and risks of incidents resulting from the use of in vitro diagnostic medical devices (IVDMDs). Definition and regulatory framework of reactovigilance...
Electronic patient records: the key to connected healthcare
Introduction The digital transformation of the healthcare sector has profoundly altered medical and administrative practices. Among the major developments, the electronic patient record (EPR) has become a central tool for monitoring and...
ISO 14971 and medical device conformity: What you need to know
ISO 14971 is an essential international standard for medical device manufacturers. Its history dates back to 2000, when it was first published, and then revised in 2019. It lays down the requirements for rigorous risk management throughout the...
MR001: deciphering the CNIL (National Commission for Information Technology and Civil Liberties) methodology for health research
The reference methodology MR001 (or MR-001) provides a framework for the processing of personal data carried out in the context of health research with the collection of participants' consent. This CNIL (National Commission for Information Technology and Civil Liberties) ) MR001 methodology is intended for research sponsors (hospitals, research centers,...