iToBoS aims to detect melanoma early, but you should also take steps to prevent it entirely. Sunscreen is an important part of your prevention toolkit, but with hundreds of options on the market, how do choose one that’s right for you?
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.
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.
The new European Regulation on medical devices (MDR).
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.