The European Union is taking the lead globally on the regulation of Artificial Intelligence (AI) and developing important legislation, namely the AI Act. The purpose of this article is to describe this regulation and examine three implications that w...
The longevity of the natural environment is fundamental for sustainable production and consumption. The circular economy conserves natural resources, ensures sustainable production and consumption, and protects the natural environment. The role of ci...
BACKGROUND: The use of real-world data is established in post-authorization regulatory processes such as pharmacovigilance of drugs and medical devices, but is still frequently challenged in the pre-authorization phase of medicinal products. In addit...
The swift progression of AI within the realm of medical devices has precipitated an imperative for stringent regulatory oversight. The United States, the European Union, and China stand as vanguard entities in the regulatory landscape for AI-enhanced...
During the COVID-19 pandemic, Non-Pharmaceutical Interventions (NPIs) were imposed all over Europe with the intent to reduce infection spread. However, reports on the effectiveness of those measures across different European countries are inconclusiv...
The growing number of well-established use (WEU) applications was reported by the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh). The procedures from the CMDh annual statistics and products from the Mutual Recog...
Studies in health technology and informatics
40200447
The integration of Artificial Intelligence (AI) into healthcare has the potential to revolutionize patient care, diagnostics, and treatment planning. However, this integration also introduces significant challenges related to data governance, privacy...
Studies in health technology and informatics
40200444
The European Union's Artificial Intelligence Act (EU AI Act) proposes a comprehensive regulatory framework for rtificial ntelligence (AI), emphasizing transparency, accountability, and ethical considerations, particularly in high-risk sectors like he...
Studies in health technology and informatics
40200442
Artificial Intelligence (AI) is increasingly incorporated into medical devices, revolutionizing diagnostics, treatment planning, and patient monitoring. To ensure AI's safe and ethical use, the European Commission published the AI Act in 2024, which ...
Safe and agile experimentation spaces are essential for developing AI-enabled medical devices and digital health innovations. "Living Labs" offer a collaborative environment for testing technologies in near-real-world settings, capturing user perspec...