Computer Vision in Digital Pathology

The practice of pathology has undergone a foundational change over the last decade, largely thanks to the widespread adoption of whole slide imaging (WSI).

Outlook for AI Regulation worldwide

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.

Artificial Intelligence (AI) and Machine Learning (ML) used in healthcare

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.

ISO standards for histological examination

Melanoma diagnosis, after dermoscopy, is usually confirmed by histological examination on formalin-fixed and paraffin-embedded (FFPE) tissues.

Changes in the classification of healthcare software

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.

Medical Regulations in Europe for Software and Artificial Intelligence

An overview of the new European Regulation on medical devices (MDR).

Next generation data masking engine

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.

Can intelligent systems replace healthcare professionals?

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.

The conundrum of health data in a world of AI-enhanced diagnosis: Legislative frameworks

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.

The conundrum of health data in a world of AI-enhanced diagnosis

An article about the the conundrum of health data in a world of AI-enhanced diagnosis in iToBoS project.