Pacific Symposium on Biocomputing. Pacific Symposium on Biocomputing
39670368
The rapid advancement of artificial intelligence and machine learning (AI/ML) technologies in healthcare presents significant opportunities for enhancing patient care through innovative diagnostic tools, monitoring systems, and personalized treatment...
IMPORTANCE: Advances in artificial intelligence (AI) must be matched by efforts to better understand and evaluate how AI performs across health care and biomedicine as well as develop appropriate regulatory frameworks. This Special Communication revi...
Studies in health technology and informatics
39968564
The Canadian health-tech sector faces regulatory challenges amidst rapid innovations in artificial intelligence (AI), digital health, biotechnology, and medical devices. This paper explores the regulatory landscape based on stakeholder interviews and...
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...
Journal of the American Medical Informatics Association : JAMIA
39657218
OBJECTIVES: To assess the potential to adapt an existing technology regulatory model, namely the Clinical Laboratory Improvement Amendments (CLIA), for clinical artificial intelligence (AI).