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...
Health policy (Amsterdam, Netherlands)
Mar 6, 2025
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...
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...
Health policy (Amsterdam, Netherlands)
Feb 1, 2025
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...
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...
International journal of law and psychiatry
Oct 19, 2024
This article argues that significant risks are being taken with using GenAI in mental health that should be assessed urgently. It recommends that guidelines for using generative artificial intelligence (GenAI) in mental health care must be establishe...
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...
Artificial intelligence systems (AISs) gain relevance in dentistry, encompassing diagnostics, treatment planning, patient management, and therapy. However, questions about the generalizability, fairness, and transparency of these systems remain. Regu...
The EU AI Act, the first comprehensive regulation of AI, came into effect in August. Here, we provide an overview of the provisions that apply to the field of neurotechnology with respect to research and development and neuroscience practice and disc...
Health policy (Amsterdam, Netherlands)
Sep 7, 2024
In August 2024, the EU Artificial Intelligence Act (AI Act) entered into force. This legally binding instrument sets rules for the development, the placing on the market, the putting into service, and the use of AI systems in the European Union. As t...
Join thousands of healthcare professionals staying informed about the latest AI breakthroughs in medicine. Get curated insights delivered to your inbox.