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...
When an organization processes personal data, it must always rely on a legal basis provided for by the GDPR ensure data protection: consent, contract, legal obligation, public interest mission, safeguarding vital interests, or legitimate interests. The latter...
Good news! Dipeeo compliance software is now listed in Appvizer's ranking of the 9 best GDPR tools GDPR a great recognition for our unique approach, which combines technology and human expertise to serve businesses. A recognition that...
1. Introduction Healthcare in Europe is entering a new phase of digital transformation. Electronic health records, telemedicine, artificial intelligence: health data is now at the heart of improving care and medical innovation. Faced with...
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.
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.
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...
Introduction In a world where our personal information is constantly circulating on the internet, privacy policies have become an essential part of our digital protection. Whether you are an individual concerned about your privacy or a professional managing...
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 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...
