This article summarizes the main differences between MDR and the previous MDD; the first one is the new rules have the legal form of “regulation” and in contrast to “directive”, it enters directly into force in the EU Member States and does not have to be transferred into national law.
Despite the technology risks related to AI, the MDR regulatory frameworks does not include any specific requirements for the use of artificial intelligence in medical devices and no law, common specifications or harmonized standards exist to regulate AI application in medical devices.
Melanoma diagnosis, after dermoscopy, is usually confirmed by histological examination on formalin-fixed and paraffin-embedded (FFPE) tissues.
In the MDR there is no special change for embedded software products; they follow the classification of the device of which they are a part.
An overview of the new European Regulation on medical devices (MDR).
The iToBoS project has multiple data flows supporting different types of sharing/exporting of data, both between partners and with external entities. As part of this process, on some of the data, the project will employ masking.
AI is rapidly transforming medicine and health care, allowing for significant advancements in fields such as medical diagnostics, drug development, treatment personalization, supportive health services, genomics, and public health management.
While the GDPR provides a strong legislative foundation to protect the rights and freedoms of European individuals, it cannot (and does not) govern all aspects that influence the direction of the iToBoS project.
An article about the the conundrum of health data in a world of AI-enhanced diagnosis in iToBoS project.
One of the key challenges of research in the field of computer science is assembling the appropriate infrastructure needed for scientists to successfully carry out their work.