EU establishes ground rules for AI use in HTA
The HTA CG (Member State Coordination Group on Health Technology Assessment) has published General Principles concerning the use of Artificial Intelligence in the preparation of dossiers for Joint Clinical Assessment (JCA) within Health Technology assessment processes. For the purposes of the General Principles document, AI is
EMA and FDA set common principles for AI in medicine development
The European Medicines Agency (EMA) and the US FDA have jointly developed ten principles for good Artificial Intelligence (AI) practice in life cycle management for medicinal products.
The purpose of these principles is to permit AI used in the development of medicinal products to be
FAQ on the Interplay Between the AI Regulation and the IVDR and MDR
The Medical Device Coordination Group (MDCG) and the Joint Artificial Intelligence Board (JAIB) have recently published a FAQ concerning the interplay between the AI Act and the in vitro medical devices Regulation (IVDR) and the Medical Devices Regulation (MDR).
Commission publishes Guidelines on the definition of an artificial intelligence system established by the AI Act
The European Commission has published Guidelines on the definition of an artificial intelligence system established by Regulation (EU) 2024/1689 (AI Act) file:///C:/Users/ewright/Work%20Folders/Downloads/Guidelines_on_the_definition_of_an_artificial_intelligence_system_established_by_AI_Act_VJp35Ve5WA4XFrpUSFj5ohfaBco_112455.pdf